Ваня Шпилевский

Радбез

Глава 1

25 November 2014

IAEA SAFETY STANDARDS

for protecting people and the environment

Draft version 2.5

Step 8. For Member States’ review and comments

Deadine for Comments: 30 April 2015

Radiation Protection and Safety

in Medical Uses of Ionizing Radiation

Proposed Joint Sponsors:

International Atomic Energy Agency, World Health Organization,

Pan American Health Organization and International Labour Office

DRAFT SAFETY GUIDE

DS399

FOREWORD

By Yukiya Amano

Director General

[standard text to be added]

PREFACE

In 2006, the Agency published the Fundamental Safety Principles (IAEA Safety

Standards Series No.

SF-1), jointly sponsored by the European Atomic Energy Community

(EURATOM), the Food and

Agriculture Organization of the United Nations (FAO), the IAEA,

the International Labour

Organization (ILO), the International Maritime Organization, the OECD

Nuclear Energy Agency

(OECD/NEA), the Pan American Health Organization (PAHO), the United

Nations Environment

Programme (UNEP) and the World Health Organization (WHO). That

publication sets out the

fundamental safety objective and the principles of protection and safety.

Requirements designed to

meet these are established in Radiation Protection and Safety of

Radiation Sources: International

Basic Safety Standards (the BSS), jointly sponsored by the European

Commission (EC/Euratom),

Food and Agriculture Organization of the United Nations (FAO), IAEA,

International Labour

Organization (ILO), OECD Nuclear Energy Agency (OECD/NEA), Pan

American Health

Organization (PAHO), United Nations Environment Programme (UNEP)

and World Health

Organization (WHO).

This Safety Guide, prepared jointly by the IAEA, the WHO, the PAHO and the

International Labour

Office, provides guidance on fulfilling the requirements of GSR Part 3 with

respect to medical uses of

ionizing radiation. It is aimed primarily at end-users in medical radiation

facilities where radiological

procedures are performed, including management, radiological

medical practitioners, medical

radiation technologists, medical physicists, radiation protection

officers and other health

professionals. It also provides recommendations and guidance to health

professionals who refer

patients for radiological procedures; to manufacturers and

suppliers of medical radiological

equipment; and to ethics committees with responsibilities for biomedical

research. This publication

provides recommendations and guidance on appropriate regulatory activities and

infrastructure, and is

therefore also applicable to regulatory bodies, health authorities, government

agencies in general, and

professional bodies.

The Safety Guide addresses all three categories of exposure:

occupational exposure for health

professionals performing radiological procedures; medical exposure,

primarily for the patients

undergoing the radiological procedures but also for carers and comforters and

for volunteers subject

to exposure as part of a programme of medical research; and public

exposure for members of the

public. A systematic approach should be applied to ensure that there is a

balance between being able

to utilize the benefits from medical uses of ionizing radiation and

minimizing the risk of radiation

effects to patients, workers and members of the public.

This Safety Guide supersedes Safety Guide Radiological Protection for Medical

Exposure to Ionizing

Radiation, RS-G-1.5, Safety Reports Series No. 38 Applying

Radiation Safety Standards in

Radiotherapy, Safety Reports Series No. 39 Applying Radiation Safety

Standards in Diagnostic

Radiology and Interventional Procedures Using X Rays, and Safety Reports Series

No. 40 Applying

Radiation Safety Standards in Nuclear Medicine.

CONTENTS

1. INTRODUCTION

BACKGROUND

SCOPE

STRUCTURE

2. GENERAL RECOMMENDATIONS FOR RADIATION PROTECTION AND SAFETY IN

MEDICAL USES OF RADIATION

GENERAL ASPECTS

TYPES OF EXPOSURE SITUATIONS AND CATEGORIES OF EXPOSURE

APPLICATION OF THE RADIATION PROTECTION REQUIREMENTS

Justification

Optimization of protection and safety

Dose limits

GRADED APPROACH

ROLES AND RESPONSIBILITIES

Government

Health authority

Professional bodies

Regulatory body

Medical radiation facility

Ethics committees

Suppliers of sources, equipment and software

Maintenance and servicing organizations

Referring medical practitioners

Patients

EDUCATION, TRAINING, QUALIFICATION AND COMPETENCE

Radiological medical practitioners

Medical radiation technologists

Medical physicists

Radiopharmacists

Other health professionals in the medical radiation facility

Referring medical practitioners

Radiation protection officers

Suppliers, installation, maintenance and servicing personnel

Maintaining competence (CME and CPD)

Equipment and software specific training

MANAGEMENT SYSTEM FOR RADIATION PROTECTION AND SAFETY

SAFETY ASSESSMENTS

3. SPECIFIC RECOMMENDATIONS FOR RADIATION PROTECTION AND SAFETY IN

DIAGNOSTIC RADIOLOGY AND IMAGE GUIDED INTERVENTIONAL PROCEDURES 43

INTRODUCTION

SAFETY OF MEDICAL RADIATION FACILITIES AND MEDICAL RADIOLOGICAL

EQUIPMENT

Radiology facilities

Medical radiological equipment, software and ancillary equipment

OCCUPATIONAL RADIATION PROTECTION

Introduction

Arrangements under the radiation protection programme

Assessment of occupational exposure and workers’ health surveillance

Information, instruction and training

Conditions of service and special arrangements

RADIATION PROTECTION OF PATIENTS, CARERS AND COMFORTERS, AND

VOLUNTEERS IN BIOMEDICAL RESEARCH

Introduction

Justification of medical exposures

Optimization of protection and safety

Pregnant female patients

Unintended and accidental medical exposures

Records and review

RADIATION PROTECTION OF THE PUBLIC

Introduction

Non-occupationally exposed workers and visitors

Monitoring and reporting

PREVENTION AND MITIGATION OF ACCIDENTS

Safety assessments

Accident prevention

Mitigation and contingency plans

4. SPECIFIC RECOMMENDATIONS FOR RADIATION PROTECTION AND SAFETY IN

NUCLEAR MEDICINE

INTRODUCTION

SAFETY OF MEDICAL RADIATION FACILITIES AND MEDICAL RADIOLOGICAL

EQUIPMENT

Nuclear medicine facilities

Radiopharmaceuticals

Medical radiological equipment, software and ancillary equipment

OCCUPATIONAL RADIATION PROTECTION

100

Introduction

100

Assessment of occupational exposure and workers’ health surveillance

108

Information, instruction and training

112

Conditions of service and special arrangements

112

Protection of workers responding to incidents in the nuclear medicine facility

113

RADIATION PROTECTION OF PATIENTS, CARERS AND COMFORTERS, AND

VOLUNTEERS IN BIOMEDICAL RESEARCH

113

Introduction

114

Justification of medical exposures

114

Optimization of protection and safety

117

Pregnant female patients

127

Breast-feeding patients

128

Release of patients after radiopharmaceutical therapy

128

Unintended and accidental medical exposures

129

Records and review

131

RADIATION PROTECTION OF THE PUBLIC

132

Introduction

132

Non-occupationally exposed workers and visitors

132

Members of the public in the wider public domain

133

Death of a patient who has undergone a nuclear medicine procedure

134

Radioactive waste

134

Monitoring and reporting

136

PREVENTION AND MITIGATION OF ACCIDENTS

136

Safety assessments

136

Accident prevention

137

Mitigation and contingency plans

137

SAFETY IN THE TRANSPORT OF RADIOACTIVE MATERIALS

140

5. SPECIFIC RECOMMENDATIONS FOR RADIATION PROTECTION AND SAFETY IN

RADIATION THERAPY

141

INTRODUCTION

141

SAFETY OF MEDICAL RADIATION FACILITIES AND MEDICAL RADIOLOGICAL

EQUIPMENT

143

Radiation therapy facilities

143

Medical radiological equipment, software and ancillary equipment

148

OCCUPATIONAL RADIATION PROTECTION

155

Introduction

155

Arrangements under the radiation protection programme

155

Assessment of occupational exposure and workers’ health surveillance

162

Information, instruction and training

165

Conditions of service and special arrangements

165

Protection of workers responding to incidents in the radiation therapy facility

166

RADIATION PROTECTION OF PATIENTS, CARERS AND COMFORTERS, AND

VOLUNTEERS IN BIOMEDICAL RESEARCH

167

Introduction

167

Justification of medical exposures

167

Optimization of protection and safety

168

Pregnant females patients

177

Release of patients after permanent brachytherapy implants

178

Unintended and accidental medical exposures

178

Records and review

181

RADIATION PROTECTION OF THE PUBLIC

182

Introduction

182

Non-occupationally exposed workers and visitors

182

Radioactive sources no longer in use

184

Monitoring and reporting

184

PREVENTION AND MITIGATION OF ACCIDENTS

184

Safety assessments

184

Accident prevention

185

Mitigation and contingency plans

186

SAFETY IN THE TRANSPORT OF RADIOACTIVE MATERIALS

188

APPENDIX I SUMMARY OF TYPICAL CAUSES OF AND CONTRIBUTING FACTORS TO

ACCIDENTAL EXPOSURES IN MEDICAL USES OF IONIZING RADIATION

190

DIAGNOSTIC RADIOLOGY AND INTERVENTIONAL PROCEDURES

190

NUCLEAR MEDICINE

190

RADIATION THERAPY

191

APPENDIX II AVOIDANCE OF PREGNANCY FOLLOWING RADIOPHARMACEUTICAL

THERAPY

193

APPENDIX III CESSATION OF BREAST FEEDING

194

REFERENCES

196

1. INTRODUCTION

BACKGROUND

1.1. Medical uses of ionizing radiation are amongst the longest established

applications of ionizing

radiation. Current estimates put the worldwide annual number of

diagnostic and interventional

radiological procedures at over 3000 million and at over 5 million radiation

therapy treatments [1].

These medical uses bring considerable public health benefits.

1.2. However, ionizing radiation can cause harm and a systematic

approach should be applied to

ensure that there is a balance between being able to utilize the benefits from

medical uses of ionizing

radiation and minimizing the risk of radiation effects to patients, workers and

members of the public.

1.3. Medical uses of ionizing radiation only have a place in the

context of medical practice. The

system for ensuring radiation protection and safety should fit in with the

larger system for ensuring

good medical practice. This Safety Guide focuses on the system of radiation

protection and safety.

1.4. The International Atomic Energy Agency (IAEA) Fundamental Safety

Principles [2] present the

fundamental safety objectives and principles of protection and safety.

Requirements designed to meet

these are established in Radiation Protection and Safety of Radiation

Sources: International Basic

Safety Standards (the BSS), jointly sponsored by the European Commission

(EC/Euratom), Food and

Agriculture Organization of the United Nations (FAO), IAEA,

International Labour Organization

(ILO), OECD Nuclear Energy Agency (OECD/NEA), Pan American Health Organization

(PAHO),

United Nations Environment Programme (UNEP) and World Health Organization (WHO)

[3].

1.5. This Safety Guide, prepared jointly by the IAEA, the WHO, the PAHO and the

ILO, provides

guidance on fulfilling the requirements of GSR Part 3 [3] (the BSS) with

respect to medical uses of

ionizing radiation.

1.6. The International Commission on Radiological Protection

(ICRP) has developed

recommendations for a system of radiation protection [4]. These and other

current recommendations

of the ICRP and the International Commission on Radiation Units and

Measurements (ICRU) have

been taken into account in preparing this Safety Guide.

1.7. It is assumed in this Safety Guide that the individual State has in place

an effective governmental,

legal and regulatory infrastructure for radiation safety that covers medical

uses of ionizing radiation.

1.8. This Safety Guide supersedes Safety Guide Radiological Protection

for Medical Exposure to

Ionizing Radiation, RS-G-1.5, Safety Reports Series No. 38 Applying Radiation

Safety Standards in

Radiotherapy, Safety Reports Series No. 39 Applying Radiation Safety

Standards in Diagnostic

Radiology and Interventional Procedures Using X Rays, and Safety Reports Series

No. 40 Applying

Radiation Safety Standards in Nuclear Medicine.

1.9. Unless otherwise stated, terms are used with the meanings ascribed to them

in the BSS [3] or the

IAEA Safety Glossary (2007 Edition) [5].

OBJECTIVE

1.10. The BSS [3] establish requirements for protection of people from harmful

effects of exposure to

ionizing radiation, for the safety of radiation sources and for

protection of the environment. This

Safety Guide recommends how medical uses of ionizing radiation should be

carried out safely within

the framework of the BSS.

1.11. The purpose of this publication is to provide recommendations

and guidance on meeting the

requirements for the safe use of radiation in medicine. It is aimed primarily

at end-users in medical

radiation facilities where radiological procedures are performed, including

management, radiological

medical practitioners, medical radiation technologists, medical physicists,

radiation protection officers

and other health professionals. It also provides recommendations and guidance

to health professionals

who refer patients for radiological procedures; to manufacturers and suppliers

of medical radiological

equipment; and to ethics committees with responsibilities for biomedical

research.

1.12. This publication provides recommendations and guidance on

appropriate regulatory activities

and infrastructure, and is therefore also applicable to regulatory bodies,

health authorities, government

agencies in general, and professional bodies.

SCOPE

1.13. This Safety Guide provides recommendations for ensuring radiation

protection and safety of

radiation sources with regard to patients, workers, carers and

comforters, volunteers in biomedical

research, and the public in medical uses of ionizing radiation. It

covers radiological procedures in

diagnostic radiology (including dentistry), image guided interventional

procedures, nuclear medicine,

and radiation therapy. Some of these radiological procedures may be

carried out in other medical

specialties, including, but not limited to, cardiology, vascular surgery,

urology, orthopaedic surgery,

obstetrics and gynaecology, emergency medicine,

gastroenterology, anaesthetics and pain

management.

1.14. Depending on the laws and regulations in a State, medical uses of

ionizing radiation may include

the use of ionizing radiation in other health care practices, such

as chiropractic, osteopathy and

podiatry. These uses are also within the scope of this Safety Guide.

1.15. This Safety Guide does not include recommendations or guidance

on human imaging using

ionizing radiation for purposes other than medical diagnosis, medical

treatment or biomedical

research. Such human imaging using ionizing radiation for other purposes

includes exposing people to

radiation for employment related, legal or health insurance purposes

without reference to clinical

indications, and human imaging using ionizing radiation for the

detection of concealed objects for

anti-smuggling purposes or for the detection of concealed objects that could be

used for criminal acts

that pose a national security threat. These applications will be covered in

Safety Guide DS471 [6].

STRUCTURE

1.16. Following this introductory section, Section 2 gives general

recommendations for radiation

protection and safety in medical uses of ionizing radiation. This

includes the application of the

principles of protection and safety; the use of the graded approach;

roles and responsibilities;

education, training, qualification and competence; management systems for

protection and safety; and

safety assessments.

1.17. Sections 3 – 5 give recommendations for specific areas of medical uses of

ionizing radiation –

Section 3 – diagnostic radiology and image guided interventional

procedures; Section 4 – nuclear

medicine; and Section 5 – radiation therapy. Guidance for hybrid

modalities is addressed in the

relevant sections, as appropriate.

1.18. Appendix I gives summary guidance on typical causes of and contributing

factors to accidental

exposures in medical uses of radiation. Appendices II and III give

recommendations on the avoidance

of pregnancy following radiopharmaceutical therapy and the cessation of

breast feeding following

administration of radiopharmaceuticals for diagnostic examinations,

respectively.

2. GENERAL RECOMMENDATIONS FOR RADIATION PROTECTION AND

SAFETY IN MEDICAL USES OF RADIATION

GENERAL ASPECTS

2.1. Medical uses of ionizing radiation take place in a variety of settings,

including hospitals, medical

centres, health clinics, specialist clinics, and dental practices.

Medical radiation facility is the term

used in the BSS to cover all the possible settings. Many medical radiation

facilities provide services

for more than one medical use of radiation. For example, a large hospital

typically may have facilities

for diagnostic radiology, image guided interventional procedures,

nuclear medicine and radiation

therapy. The authorization process for medical uses of ionizing radiation

varies from State to State. In

some States a single authorization may cover all specialties and activities

within the facility, whereas

others may authorize each specialty or application separately. For

example, in one State a hospital

may have a single authorization covering all of diagnostic radiology,

image guided interventional

procedures, nuclear medicine, and radiation therapy, whereas in another State

each of these areas or

applications may be authorized separately. Despite differences in

authorization, the guidance in this

Safety Guide remains applicable.

2.2. Traditionally each of the areas of diagnostic radiology, nuclear medicine,

and radiation therapy

were separate, with little or no combined usage. This has changed, with the

so-called hybrid imaging

systems involving both diagnostic radiology and nuclear medicine expertise, and

with the planning,

guidance and verification stages of radiation therapy increasingly

involving both imaging and

radiation therapy expertise. Cross references are given where appropriate.

2.3. As already noted above in para. 1.3, the setting for this Safety Guide is

the practice of medicine

(including dentistry, chiropractic, osteopathy and podiatry). The requirements

of the BSS for radiation

protection and safety of radiation sources apply for the uses of radiation in

medicine as elsewhere.

The requirements must be met and fitted in with medical structures and

processes and in health care

pathways, with the objective of improved patient care and patient outcomes.

TYPES OF EXPOSURE SITUATIONS AND CATEGORIES OF EXPOSURE

2.4. The requirements of the BSS are based around the three types of exposure

situations: planned

exposure situations, existing exposure situations, and emergency exposure

situations. Medical uses of

ionizing radiation are a planned exposure situation and the requirements of

Sections 2 and 3 of the

BSS apply, as appropriate. This includes situations of potential exposure that

is an exposure that is not

expected to occur with certainty, but could result from an accident or from an

event or a sequence of

events that may occur but is not certain to occur (BSS [3], paragraph 1.20

(a)]. Potential exposure can

be applicable to any of occupational, public and medical exposure,

where the event, if it occurs,

results in an exposure over and above what would be expected

normally. Situations when the

radiological procedures do not go as planned – that is, unintended and

accidental medical exposures

should be treated as planned exposure situations (BSS [3], paragraph 3.145].

Chapters 2, 4 and 5 of

this safety guide discuss the prevention and mitigation of events leading to a

potential exposure. In

extreme situations in medical settings when dangerous source is

involved (such as a radiotherapy

source), emergency exposure situation may occur affecting either workers or

member of the public.

For preparedness and response for emergency exposure situations requirements of

Sections 4 of the

BSS and specific safety standard GSR Part 7 apply [7].

2.5. Medical uses of ionizing radiation involve all three categories of

exposure: occupational exposure

for those involved in the performance of radiological procedures; medical

exposure, primarily for the

patients undergoing the radiological procedures but also for carers and

comforters and for volunteers

subject to exposure as part of a programme of medical research; and public

exposure for members of

the public, such as in waiting rooms. The requirements for radiation

protection and safety differ

according to the category of exposure, so it is important that the exposure of

persons is categorized

correctly. For example, a nurse assisting with image guided

interventional procedures would be

considered to be occupationally exposed, whereas a nurse working in

an in-patient ward where

occasional mobile radiography is performed by a medical radiation

technologist would not be

considered occupationally exposed but rather as subject to public

exposure. The term carer and

comforter has been introduced into the BSS to cover the persons who,

outside an occupational

capacity, willingly and voluntarily help in the care, support and

comfort of a patient undergoing a

radiological procedure. Carers and comforters are subject to medical

exposure, whereas a casual

acquaintance visiting a patient who has undergone radionuclide therapy

would be considered a

member of the public and hence subject to public exposure. More extensive

guidance is provided in

each of the specialty Sections 3 - 5.

2.6. Unintended and accidental medical exposures are covered in detail in

Sections 3-5. Such events

include the exposure of the wrong person¹.

APPLICATION OF THE RADIATION PROTECTION REQUIREMENTS

2.7. The three general principles of radiation protection, justification,

optimization of protection and

safety and the application of dose limits, are expressed in safety

principles 4, 5, 6 and 10 of the

Fundamental Safety Principles [2]. In terms of Requirement 1 of the

BSS, those responsible for

protection and safety must ensure that the relevant requirements applying these

principles are met.

2.8. Medical exposure differs from occupational and public exposure in

that persons (primarily

patients) are deliberately, directly, and knowingly exposed to radiation for

their benefit. In medical

exposures applying a ‘dose limit’ is inappropriate as it may limit

the benefit for the patient;

consequently, only two of the radiation protection principles apply –

justification and optimization.

Justification plays the role of gatekeeper, as it will determine whether the

exposure will take place or

not. If it is to take place, the radiological procedure

should be performed in such a way that the

radiation protection and safety is optimized.

TABLE 1. SUMMARY OF RADIATION PROTECTION PRINCIPLES AS APPLIED

OCCUPATIONAL AND PUBLIC EXPOSURES IN COMPARISON WITH

MEDICAL

EXPOSURE

Application to occupational and public exposure Application to medical

exposure

Justification of practices: A practice that entails

exposure to radiation should only be adopted if it

yields sufficient benefit to the exposed individuals or

to society to outweigh the radiation detriment.

Justification: The diagnostic or therapeutic benefits

produced by exposures are weighed against the

radiation detriment they might cause, taking into

account the benefits and risks of available alternative

techniques that do not involve medical exposure.

¹ The definition of medical exposure in the BSS [3] was changed from the

previous edition to ensure that the

event of the ‘wrong person’ is kept within the radiation protection and safety

framework for medical exposure

so that it can be investigated by the appropriate people, with corrective

actions to minimize recurrence.

Optimization of protection and safety: Providing the

best available protection and safety measures under

the prevailing circumstances, so that the magnitudes

and likelihood of exposures and the numbers of

individuals exposed be as low as reasonably

achievable, economic and social factors being taken

into account.

Limitation of doses: Doses to individuals are limited

(for occupational and public exposure).

Optimization of protection and safety: In diagnostic

and interventional medical exposure, keeping the

exposure of patients to the minimum necessary to

achieve the required diagnostic or interventional

objective.

In therapeutic medical exposure, keeping the exposure

of normal tissue as low as reasonably achievable

consistent with delivering the required dose to the

planning target volume.

Limitation of doses: Not applicable to medical

exposure.

Justification

2.9. Justification in medical uses of ionizing radiation involves consideration

of all three categories of

exposure – medical, occupational and public exposure.

2.10. From an occupational and public exposure perspective, the

practice should be justified. This

aspect of justification is the process of determining whether the use

of the given radiological

procedure is expected to yield benefits to the individuals that undergo the

procedure and to society

that outweigh the harm (including radiation detriment) resulting from

the procedure. In almost all

cases the occupational and public considerations in justification are

overshadowed by the justification

of medical exposures (see para. 2.11). While medical radiological procedure is

expected to do more

good than harm to the patient, subsidiary account should be taken of the

radiation detriment from the

exposure of the radiological staff and of other individuals.

2.11. The application of the justification principle to medical exposures

requires a special approach,

using three levels . As an overarching justification of medical exposures, it

is accepted that the proper

use of radiation in medicine does more good than harm (level 1). At

the second level generic

justification of a given radiological procedure should be carried out

by the health authority in

conjunction with appropriate professional bodies,. The possibility of

accidental or unintended

exposures should also be considered at this level. This applies to the

justification of new technologies

and techniques as they evolve, but the decisions should be reviewed

from time to time, as more

information becomes available about the risks and effectiveness of the existing

procedure and about

new procedures. For the final level of justification (level 3), the

application of the radiological

procedure to a given individual should be considered. The specific

objectives of the exposure, the

clinical circumstances and the characteristics of the individual involved

should be taken into account.

National or international referral guidelines, developed by professional

bodies together with health

authorities, should be used (BSS paragraph 3.158). Those radiological

procedures that are not justified

should be eliminated. The approach to implementing of justification of a

procedure for an individual

patient (level 3) depends on whether it is a diagnostic procedure, an image

guided intervention, or a

treatment. Specific guidance on justification in each specialty is given in

Sections 3 to 5.

2.12. The level 3 justification of medical exposure for an individual

patient does not include

considerations of occupational exposure. If the proposed radiological

procedure is justified for that

patient, then the participation of particular staff in performing the

procedure is governed by the

requirements for optimization of occupational radiation protection and safety

and occupational dose

limitation.

Optimization of protection and safety

2.13. The optimization of protection and safety, when applied to the

exposure of workers and of

members of the public, and of ‘carers and comforters’ of patients undergoing

radiological procedures,

is a process for ensuring that the magnitude and likelihood of exposures and

the number of individuals

exposed are as low as reasonably achievable, with economic, societal and

environmental factors taken

into account. This means that the level of protection and safety would be the

best possible under the

prevailing circumstances.

2.14. As is the case with justification, the application of the

requirements for optimization to the

medical exposure of patients and to that of volunteers as part of a programme

of biomedical research

requires a special approach. Too low a radiation dose could be as bad as too

high a radiation dose, in

that the consequence could be that a cancer is not cured or the

images taken are not of suitable

diagnostic quality. The medical exposure should always lead to the required

clinical outcome.

2.15. Optimization is a prospective and iterative process that requires

judgements to be made using

both qualitative and quantitative information. Specialty specific guidance on

optimization of medical,

occupational and public radiation protection and safety is given in Sections 3

to 5.

2.16. Dose constraints are applicable to occupational exposure and to public

exposure in medical uses

of ionizing radiation. Dose constraints are also used in optimization

of protection and safety for

‘carers and comforters’ and for volunteers subject to exposure as part of a

programme of biomedical

research. Dose constraints are not applicable to the exposure of patients in

radiological procedures for

the purposes of medical diagnosis or treatment. See also paras. 2.46

to 2.50. Dose constraints are

used, in the planning stage, for optimization of protection and safety, the

intended outcome of which

is that all exposures are controlled to levels that are as low as

reasonably achievable (ALARA),

economic, societal and environmental factors being taken into account.

2.17. The dose constraint for each particular source of radiation exposure is

intended, among other

things, to ensure that the sum of doses from planned operations for all sources

under control remains

within the dose limits. Dose constraints are not dose limits;

exceeding a dose constraint does not

represent non-compliance with regulatory requirements, but it might result in

follow-up actions.

2.18. In X ray medical imaging, image guided interventional procedures

and diagnostic nuclear

medicine, diagnostic reference levels (DRLs) are a tool used in optimization of

protection and safety.

Periodic assessments are to be performed of typical patient doses or,

for radiopharmaceuticals,

activities administered in a medical radiation facility. Doses in this context

may be expressed in one

of the accepted dosimetric quantities as described in para 2.40 [8 - 10]. For

simplicity sake in this

Safety Guide in Sections 3 and 4, the term “dose” will be used when referring

generally to medical

exposure measurements in radiological imaging, with specific forms of dose or

activity used where

needed.

2.19. If comparison with established diagnostic reference levels shows that the

typical patient doses or

activities are either unusually high or unusually low, a local review

is to be initiated to ascertain

whether protection and safety has been optimized and whether any corrective

action is required. DRLs

are not dose limits. See also paras. 2.34 to 2.45.

2.20. Other tools used in optimization of protection and safety

include, inter alia, design and

operational considerations and programmes of quality assurance. These are

described in detail in the

specialty Sections 3 to 5.

Dose limits

2.21. Dose limits apply to occupational exposure and public exposure arising

from any use of ionizing

radiation, including medical applications. Schedule III of the BSS [3] sets out

these dose limits and

they are reproduced here for convenience in Table 2. Dose limits do not apply

to medical exposure –

i.e. exposure of patients, carers or comforters, and volunteers as part of a

programme of biomedical

research.

2.22. The occupational dose limit for the lens of the eye is lower

in the BSS [3] than previously

recommended. There are some areas of medical uses of ionizing

radiation, such as image guided

interventional procedures, where, if good radiation protection practice is not

being followed, there is a

possibility of exceeding this dose limit. Specific guidance is given in the

specialty Sections 3 to 5.

TABLE 2. DOSE LIMITS FOR PLANNED EXPOSURE SITUATIONS (ADAPTED FROM

SCHEDULE III OF THE BSS [3])

OCCUPATIONAL EXPOSURE

For occupational exposure of workers over the age of 18 years, the dose limits

are:

(a) An effective dose of 20 mSv per year averaged over five consecutive years

(100 mSv in 5 years), and

of 50 mSv in any single year;

(b) An equivalent dose to the lens of the eye of 20 mSv per year averaged

over 5 consecutive years (100

mSv in 5 years) and of 50 mSv in any single year;

mSv in a year.

Additional restrictions apply to occupational exposure for a female

worker who has notified pregnancy or is

breast-feeding (BSS para. 3.114).

For occupational exposure of apprentices of 16 to 18 years of age

who are being trained for employment

involving radiation and for exposure of students of age 16 to 18 who use

sources in the course of their studies,

the dose limits are:

(a) An effective dose of 6 mSv in a year;

(b) An equivalent dose to the lens of the eye of 20 mSv in a year;

mSv in a year.

PUBLIC EXPOSURE

For public exposure, the dose limits are:

(a) An effective dose of 1 mSv in a year;

(b) In special circumstances, a higher value of effective dose in a single

year could apply, provided that the

average effective dose over five consecutive years does not exceed 1 mSv per

year;

(d) An equivalent dose to the skin of 50 mSv in a year.

GRADED APPROACH

2.23. The so-called ‘graded approach’ is a concept that underpins the

application of the system for

protection and safety. The BSS in paragraph 2.12 states: “The application of

the requirements for the

system of protection and safety shall be commensurate with the radiation

risks associated with the

exposure situation.”

2.24. The risks associated with medical uses of ionizing radiation

vary significantly, depending

strongly on the particular radiological procedure. At the low risk end are

dental exposures (excluding

cone beam CT), and dedicated bone densitometry (DEXA) studies. At the high risk

end is radiation

therapy, where the doses involved could be lethal, and image guided

interventional procedures, where

radiation injuries can occur. Another aspect to consider when implementing a

graded approach is the

prevalence of a given application – an example is CT, which is increasingly

used in imaging.

2.25. The BSS places responsibilities for a graded approach on each of the

government, the regulatory

body, registrants and licensees, and employers. The government and the

regulatory body use the

graded approach in setting and enforcing regulatory requirements. For example,

it would be expected

that regulatory bodies devote fewer resources and less time to

regulating dental practices than to

regulating the use of radiation in radiation therapy or image guided

interventional procedures.

2.26. The registrants or licensees, and employers use the graded approach in

the measures they take

for protection and safety. For example, the registrant or licensee of a dental

practice would not need to

implement as comprehensive a quality assurance programme as would a radiation

therapy facility in

order to meet the requirements of the BSS.

2.27. Guidance incorporating the graded approach is given in the specific

guidance for each specialty

and the various modalities within those specialties – see Sections 3 to 5.

ROLES AND RESPONSIBILITIES

Government

General

2.28. The roles and responsibilities of the government² with regard to

protection and safety are set out

in requirement 2 and paragraphs 2.13 to 2.28 of the BSS, with further detailed

requirements given in

the IAEA Safety Requirements publication “Governmental, Legal and

Regulatory Framework for

Safety” [10]. These include:

• establishing an effective legal and regulatory framework for

protection and safety for all

exposure situations;

• establishing legislation that meets specified requirements;

• establishing an independent regulatory body with the necessary legal

authority, competence

and resources;

• establishing requirements for education and training in protection and

safety;

² States have different legal structures, and therefore the term

‘government’ as used in the IAEA safety

standards is to be understood in a broad sense, and is accordingly

interchangeable here with the term ‘State’.

• ensuring that arrangements are in place for:

o the provision of technical services (including radiation monitoring

services and

standards dosimetry laboratories), and

o education and training services.

All of these are relevant to the safe use of ionizing radiation in medicine.

2.29. As noted above in para. 1.7, this Safety Guide assumes that an effective

governmental, legal and

regulatory infrastructure for radiation protection and safety is in

place. However there are some

additional considerations that are important for ensuring radiation

protection and safety in medical

uses of ionizing radiation.

2.30. Government has a role to facilitate and ensure that the health authority,

the relevant professional

bodies, and the radiation protection regulatory body communicate and cooperate

in working towards

establishing the infrastructure necessary for radiation protection and safety

in medical uses of ionizing

radiation. The role of the health authority typically includes determining

policy, which in turn may

dictate the resources allocated to the various areas of healthcare, including

medical uses of ionizing

radiation. Up to date information on developments in medical uses of ionizing

radiation, and how that

might shape and influence medical practice, should be available so

that appropriate policy can be

developed and implemented. The professional bodies of the various health

professionals associated

with radiation in healthcare represent the collective expertise of the given

health profession and, as

such, can strongly influence the practice of radiation protection and safety.

The health authority and

the professional bodies should be active working partners with the

radiation protection regulatory

body to achieve effective regulation of medical uses of ionizing radiation. See

paras. 2.52 – 2.68 for

more guidance on the health authority and professional bodies.

2.31. Formal recognition of health professionals should be in place to ensure

that only persons with

the appropriate competencies are allowed to take on particular roles and

responsibilities. In medical

uses of ionizing radiation, this applies in particular to persons

undertaking the role of radiological

medical practitioner, medical radiation technologist, or medical physicist.

Detailed guidance is given

in the sub-section on education, training, qualifications and competence,

paras 2.117 to 2.135.

2.32. Other organizations can make a worthwhile contribution to radiation

protection and safety in

medical uses of ionizing radiation. These include technical standards

associations, medical devices

regulatory agencies, and health technology assessment agencies, which issue

standards or reports that

could have direct implications for radiation safety. Not all States have such

organizations but, where

they exist, the government should ensure that they interact cooperatively with

the radiation protection

regulatory body, the health authority and the relevant professional bodies. In

States that do not have

such organizations, the government should consider means to adopt or

adapt relevant standards or

reports from such organizations in other countries.

2.33. Other organizations can have an indirect, but not necessarily

insignificant, effect on radiation

protection and safety in medical uses of ionizing radiation. Such

organizations include health

insurance or re-imbursement companies and standards accreditation bodies. The

former, by deciding

on what radiological procedures (and other alternative techniques) are

covered. The latter, by

including radiation protection and safety in its scope, can positively

influence how well radiation

protection and safety is being implemented in medical facilities

seeking accreditation. Again,

government should be aware of these players in their country and utilize their

influence to improve

the practice of radiation protection and safety in medical uses of ionizing

radiation.

Diagnostic reference levels

2.34. Diagnostic reference level (DRL) should be used as an important

tool for optimization of

protection and safety for diagnostic medical exposures , (see para. 2.18).

Government has a particular

responsibility to ensure that DRLs are established for their country, or

regions within their country or,

in some cases, regions of several small countries. In establishing values for

the DRLs it is preferable

that, for common imaging procedures, typical (e.g. average or median) doses³

for patients are obtained

from a representative sample of rooms and facilities where these procedures are

being performed. In

this way a snap shot of current practice in the country or region is obtained,

reflecting both good and

poor practices, for that particular imaging procedure. The value of

the DRL for that particular

procedure is typically the rounded 75th percentile of the distribution of the

room/facility typical doses

[12, 13]. In diagnostic nuclear medicine, an ‘optimum’ value for a

DRL is used also instead of a

percentile: a reference level for administrations of activities of

radionuclides sufficient to obtain

information for standard groups of patients (adults and children),

based on the experience of the

professional groups (‘expert judgement’) [12]. In establishing DRLs, it is

fundamental to include only

radiological procedures whose image quality is adequate for the medical

purpose.

2.35. Once established, medical radiation facilities should compare

their typical doses (sometimes

called “facility reference levels”, or “local reference levels”) with the

relevant DRLs, as described in

Sections 3 and 4. Optimization of protection for a particular

radiological procedure should be

reviewed if the comparison shows that the facility’s typical dose

exceeds the DRL, or that the

facility’s typical dose is substantially below the DRL and it is

evident that the exposures are not

producing images of diagnostic usefulness or are not yielding the

expected medical benefit to the

patient. The resulting actions aimed to improve optimization of protection and

safety will usually, but

not necessarily, result in a lower facility typical doses for the procedure or

procedures. At some pre-

determined interval, typically 3 to 5 years, there should be a

review of the established national or

regional DRL values. A new national or regional survey will result in a new

distribution of facility

reference levels that will reflect the improvements made as a result of using

the existing DRLs. It is

likely that the new values of the DRLs will be lower than the

previous values. This cycle of

establishment of national or regional DRLs, use by imaging facilities,

corrective actions by imaging

facilities, and periodic review of national or regional DRLs brings

about a steady improvement in

optimization of protection and safety across the country or region.

2.36. There are several steps to the establishment of DRLs. At the national or

regional level decisions

should be made whether to use actual patients or phantoms to represent a

“standard patient” for each

modality. Phantoms avoid most of the issues with variations in patient size

(see paras. 2.38 and 2.41).

However their use does not truly represent clinical practice with patients and

clinical images and, as

such, would seem less appropriate for use in establishing DRLs.

Nevertheless, a phantom-based

approach, in the absence of adequate patient data, can be used to first

establish DRLs and then in their

utilization [14].

2.37. The imaging procedures, for which DRLs are to be established,

should be decided upon at

national or regional level. The criteria which may help in this decision are

the relative frequencies and

the magnitude of the doses of the imaging procedures – the more frequent and

higher dose procedures

should have a higher priority. Specific consideration should be given to

paediatric imaging. Based on

³ The term ‘doses’ in this subsection on DRLs includes activity for nuclear

medicine procedures, as described in

para 2.18.

national or regional resources, the actual number of procedures for which DRLs

are established will

vary [15, 16].

2.38. The next step is to perform preferably a wide-spread or at least a

representative survey for the

selected procedures. Most imaging radiological procedures are performed on

adults, and traditionally

national DRLs have been established first for adults. For each

room/facility performing the given

procedure, typically a sample size of about 20 patients is used. Not all

adults are the same size, so

many countries [12, 13] have established DRLs for an “standard” adult

patient, limiting patient

eligibility to the sample on the basis of weight, for example 70 kg ± 20 kg,

and aiming for a sample

average in a given weight range, for example 70 kg ± 5 kg. Other countries

adopt a more pragmatic

approach, accepting all adults in the initial sample but excluding extreme

outliers in terms of weight

[17].

2.39. Another consideration with DRLs is whether the procedure is simply

defined in terms of the

anatomical region being imaged, or whether there should be a further

refinement to include the

clinical purpose of the examination. For example, a CT of the abdomen may be

performed differently

depending on the medical question to be answered. For those embarking on

establishing DRLs for the

first time, it is advisable to take the simpler approach.

2.40. The dose metrics used to represent the dose to the patient should be

easily measurable and must

follow ICRU recommendations, as stated in the BSS (BSS para 1.46)

[8]. The following are

commonly used terms in this role: radiography – air kerma-area

product, incident air kerma, or

entrance surface air kerma (which includes backscatter) ; fluoroscopy – air

kerma-area product; CT –

CTDIvₒl, and DLP; mammography – incident air kerma or entrance

surface air kerma and mean

glandular dose; dentistry – incident air kerma or entrance surface air kerma

for intra-oral radiography

and air kerma-area product for panoramic radiography; and image guided

interventional procedures –

air kerma-area product and air kerma at the interventional reference

point. More guidance on dose

metrics is given in Section 3 paras 3.193 – 3.195. It is crucial that the dose

data collected for each

contributing room is for procedures where the image quality was

confirmed as adequate for the

clinical purpose. For nuclear medicine DRLs are set in activity administered to

patient.

2.41. Optimizing protection and safety for average adult patients does

not necessarily mean that

optimization is being achieved for other size or age groups. Past experience in

particular with children

undergoing CT examinations has clearly demonstrated that this is not

the case. This means that

consideration also should be given to establishing DRLs for children undergoing

imaging procedures.

The same problem of size and weight, as discussed in para. 2.38,

also pertains to children. Some

countries have adopted a simple age approach – for example, new born, 1, 5, 10,

and 15 years – while

others normalize patient dose data to particular representative sizes

or weights. More guidance on

grouping patient for establishing typical doses and DRL is given in

Section 3 para 3.204 for

diagnostic and interventional radiology and Section 4 para 4.203 for diagnostic

nuclear medicine.

2.42. The processes and steps towards establishing DRLs, as described

in paras. 2.37 to 2.41, are

likely to involve many players including the imaging facilities, the health

authority, the professional

bodies, and the regulatory body. In particular there should be

collective ownership of the DRLs –

deciding on: what procedures, what age groups, how to collect the data, who

will manage the data,

and when to review and update the DRLs. In some countries a

national governmental body

administers the national patient dose database that underpins the

establishing of DRLs. In other

countries, this role may be taken by the regulatory body or a professional

body. There is no preferred

custodian – what is important is that a patient dose database (for DRLs) is

established and maintained,

DRL values are set, these are promulgated through the regulatory

processes, and a process for

periodic review is established. It may be more appropriate to take a regional

rather than a national

approach to DRLs – either a region in a large country or a region of several

small countries.

2.43. The methodology used in performing the initial survey can range from a

paper-based approach

through to a web-based electronic submission approach. As the interconnectivity

of imaging systems,

with the availability of patient dose metrics, and radiology and

hospital information systems

improves, the process of gathering data for DRLs is likely to become easier.

Countries embarking on

establishing DRLs for the first time should consider the electronic approach.

2.44. The national or regional DRL values should be periodically

reviewed and updated, typically

with a cycle of 3 to 5 years (see para. 2.35). The review can be performed in

many ways, but in all

cases there is first a collection phase, followed by analysis of the data

collected. The collection of

facility reference levels can occur throughout the cycle, or it can be

restricted to a shorter time-frame

towards the end of the cycle. Pragmatically, the occasion of a medical

radiation facility comparing its

practice typical doses with the current DRLs would seem to be an appropriate

time for the facility to

submit their new facility typical doses to the national or regional database

being used for the DRLs.

At the end of the cycle the analysis of the submitted facility typical doses

would take place, and the

values of the DRLs updated accordingly. While increased digital

connectivity would technically

support collection and analysis to be continuous, a given set of DRL values

should be stable for a

period of time to allow the improvement cycle to take place.

2.45. Finally, if the government in a given country is not able to facilitate

the establishment of their

own national DRLs or to participate in a regional approach, there is

the option for government to

facilitate the adoption of another country’s or region’s DRLs. While

such DRLs do not reflect a

country’s own practice, with judicious choice, the adopted DRLs can still

perform the same role of

bringing about an improvement in the implementation of optimization of

protection and safety in the

adopting country. DRLs from countries with significantly different generations

of imaging systems

should be compared with a care

Dose constraints

2.46. Dose constraints are not dose limits; they are tools for

optimization of protection and safety,

including considerations of social and economic factors. The role of dose

constraints for occupational

exposure and for public exposure is introduced above in para. 2.16.

In particular the government,

typically through the radiation protection regulatory body, has

responsibilities with respect to public

exposure, where its primary role is to ensure that no member of public can

exceed the public dose

limit as a result of cumulative public exposure arising from multiple

authorized facilities, including

medical radiation facilities. A simple approach that can be taken is to set a

dose constraint, for public

exposure arising from a single facility, at some fraction of the dose limit.

Some countries use a dose

constraint of approximately one-third of the dose limit – namely an

effective dose of 0.3 mSv per

year. In establishing such a value the regulatory body should

consider the number and type of

radiation sources in use in a particular country or region that may expose the

public.

2.47. In addition to patients, there are two other groups of people that can

incur medical exposure.

These are the carers and comforters and the volunteers in biomedical research.

Because it is medical

exposure, neither of these groups of persons is subject to dose

limits for the exposures incurred.

Instead, reliance is placed on the use of dose constraints as a

means for ensuring optimization of

protection and safety takes place (see para. 2.16). For both of these groups of

people, the government,

through consultation between the health authority, the relevant professional

bodies and the radiation

protection regulatory body, has the responsibility to ensure that dose

constraints are established so that

they can be used.

2.48. For carers and comforters the usual approach is to apply the dose

constraints on an “episode by

episode” basis – i.e. the dose constraint applies to the cumulative exposure of

the carer and comforter

over the duration of that person giving care and comfort to a particular

patient. In the case of a mother

assisting with her child undergoing a diagnostic X ray procedure, the

episode is extremely short –

simply while the X rays are being produced. In the case of a person having

undergone treatment with

radiopharmaceuticals, the episode will last several days until such

time as the radionuclide has

decayed to negligible levels. Consideration should be given to the

cumulative dose of a carer or

comforter if he/she acts in this role for several distinct episodes. In such

cases, a dose constraint per

annum may be used in addition.

2.49. In setting dose constraints for carers and comforters consideration

should be given to the age of

the individual and for a woman the possibility of her being

pregnant. A particular issue is that of

children being in this role. The definition of a carer or comforter includes

that the person “willingly

and voluntarily” helps in this role. It could be argued that young children may

not understand such

concepts. None the less, it is reasonable and likely that the children of a

treated parent would want to

provide comfort, at least. The framework for radiation protection and

safety should accommodate

such human wishes. A pragmatic approach often taken is to effectively treat

children in this role as

members of the public and constrain their medical exposure to an effective dose

of 1 mSv per episode.

A pregnant carer or comforter presents a similar situation, and consideration

should be given to the

embryo or fetus. The same approach of constraining the effective dose to the

embryo/fetus to 1 mSv

per episode is often taken. For an adult carer or comforter, a value of dose

constraint commonly used

is 5 mSv effective dose per episode. For elderly persons more lenient dose

constraints may be used. In

any of these cases flexibility with respect to the dose constraint may need to

be used.

2.50. In setting dose constraints for diagnostic radiological

procedures that are performed on

volunteers participating in a programme of biomedical research, the

intention is that government,

through consultation between the health authority, the relevant professional

bodies and the radiation

protection regulatory body, provides broad guidance for the ethics

committees (see paras. 2.98 –

2.101) who, in turn, would adapt the dose constraints to suit the particular

programme of biomedical

research under consideration. Typical patient doses and national DRLs would be

two considerations

in setting such dose constraints.

Criteria and guidelines for release of patients after radionuclide therapy

2.51. Many factors can influence the exposure that members of the public and

carers and comforters

can incur following the release of a patient who has undergone a therapeutic

procedure with unsealed

sources or who retains implanted sealed sources. Detailed guidance on

these factors for unsealed

sources is given in the Safety Report Series No. 63 [18]. The role of

government, through consultation

between the health authority, the relevant professional bodies and the

radiation protection regulatory

body, is to ensure that criteria are established, with accompanying

guidance, to help simplify the

process when individual medical radiation facilities are considering

the release of their patients.

Guidance for these medical radiation facility actions are given in Sections 4

and 5.

Health authority

2.52. All medical facilities must be authorized by the health authority to

ensure that the facility meets

the applicable requirements for quality of medical services. When the medical

facility uses ionizing

radiation, authorization for medical practice and healthcare should be granted

by the health authority

only if radiation safety requirements are met (para 2.69 – 2.75). As noted

in para. 2.30, the health

authority should contribute to radiation protection and safety.

This includes participation in

establishing DRLs, dose constraints for carers and comforters and for

volunteers in biomedical

research, and criteria and guidance for the release of patients after

radionuclide therapy. See guidance

in paras. 2.34 to 2.51. Coordination and collaboration between the health

authority and the radiation

protection regulatory body should ensure radiation protection and

overall safety of the medical

facility.

2.53. Radiation protection and safety in medical uses of ionizing

radiation should be assured by a

proper specialization of health professionals – namely that only

health professionals with the

appropriate competencies can take on roles that include specific

responsibilities for radiation

protection and safety. The health authority has responsibilities in providing

policy and guidance with

respect to health profession specialties and their sub-specialties,

including scope of practice, and

requirements for competence. Guidance on recognition of competence in a

specialty is given paras.

2.117 to 2.130.

2.54. Adequate numbers of medical personnel and paramedical personnel should

be available for a

medical radiation facility to function correctly and safely. This includes

sufficient capacity to cover

absences of key personnel through sickness, leave or other official

reasons. The health authority,

through its policy making role, should set clear standards for acceptable

medical practice.

2.55. The health authority has particular roles in the application

of the radiation protection

requirements for justification – namely with respect to:

• generic justification of radiological procedures;

• justification of radiological procedures in health screening programmes;

and

• criteria for the justification of radiological procedures for health

assessment of asymptomatic

individuals intended for the early detection of disease, but not as part of a

health screening

programme.

2.56. Generic justification of radiological procedures is an on-going

process as new procedures

become available and as established procedures should be reviewed in the light

of new knowledge and

developments. It should be decided whether a new radiological

procedure should become a new

addition to the armamentarium of existing procedures. Conversely, an

existing radiological procedure

may need to be withdrawn from use because there is evidence that an alternative

technique has better

efficacy. The health authority, together with relevant professional

bodies, should make these

decisions.

2.57. The use of radiological procedures as part of a health screening

programme involves subjecting

asymptomatic populations to radiation exposure. The decision to embark

upon such a programme

should include consideration of, inter alia, the potential of the

screening procedure to detect the

disease, the likelihood of effective treatment of cases detected and,

for certain diseases, the

advantages to the community from the control of the disease. Sound

epidemiological evidence should

provide the basis for such health screening programmes. The health authority,

together with relevant

professional bodies, should consider all the factors before making a decision.

2.58. The use of radiological procedures on asymptomatic individuals, intended

for the early detection

of disease but not as part of an approved health screening programme, is now

increasingly common.

Such radiological procedures are not established medical practice, nor are

they being performed as

part of a programme of biomedical research. Therefore the health

authority, together with relevant

professional bodies, has a role in providing guidance on the applicability and

appropriateness of such

procedures. Such guidance would help the referring medical practitioner and the

radiological medical

practitioner carry out the justification for an individual patient (see Section

3, paras. 3.135 to 3.137).

2.59. National or international referral guidelines should be used as

an important tool in the

implementation of justification of medical exposure for an individual patient .

The health authority

should support the relevant professional bodies in developing and

implementing such referral

guidelines. See also para. 2.65.

2.60. The health authority should also encourage the development of and promote

the implementation

of practice guidelines and technical standards⁴ developed by professional

bodies.

Professional bodies

2.61. Professional bodies are the collective term used in the BSS and in this

Safety Guide to include

the various organizations and entities of health professionals within

a given State. These include

societies, colleges, and associations of health professionals often

within a particular specialty.

Examples, with direct involvement in the use of ionizing radiation,

include representation of

radiologists, radiation oncologists, nuclear medicine physicians, medical

physicists, medical radiation

technologists, and dentists. In large countries, such professional bodies may

be regional, within the

country. Conversely, there may be regional professional bodies covering several

countries. There are

also professional bodies in the wider medical arena that still influence some

aspects of radiation use.

Examples of these include societies, associations and colleges

representing specialties such as

cardiology, gastroenterology, urology, and neurology, who may use

radiation, and other

organizations, such as those that represent general practitioners and primary

care physicians.

2.62. Professional bodies, as stated in para. 2.30, represent the collective

expertise of the given health

profession and specialty and, as such, they also should play a role

in contributing to radiation

protection and safety in medical uses of ionizing radiation. This

includes setting standards for

education, training, qualifications and competence for a given

specialty, and setting technical

standards and giving guidance on practice. Further guidance on education,

training, qualifications and

competence is given in paras. 2.117 to 2.130.

2.63. Relevant professional bodies, in partnership with the health

authority and the radiation

protection regulatory body, have a role with respect to the establishment of

DRLs, dose constraints for

carers and comforters and for volunteers in biomedical research, and

criteria and guidance for the

release of patients after radionuclide therapy, as has been described

in paras. 2.42, 2.47, 2.50, and

2.51, respectively.

2.64. The role of the relevant professional bodies with respect to the

application of the requirements

for justification is described in paras. 2.56 - 2.60.

⁴ The term “practice guidelines and technical standards” is used to represent

the range of documents, statements

and other publications produced by professional bodies to help educate

and guide the respective health

professionals to carry out particular aspects of their specialty.

2.65. Professional bodies should take the lead in the development of

referral guidelines and

appropriateness criteria for use in justification of medical exposure

for an individual patient (para

2.59). It may not be possible for every State to develop its own referral

guidelines. The significant

work of a number of professional bodies around the world could be utilized in

many other countries

through adoption or adaption by the local professional bodies. See

also Section 3 para 3.137 and

Section 4 para 4.159.

2.66. With respect to medical imaging, the process of optimization of radiation

protection and safety

should aim at achieving adequate image quality – not the best possible image

quality, but certainly

sufficient to ensure that diagnosis or treatment is not compromised. From an

operational perspective,

there are many factors that influence the image quality versus patient dose

relationship for a given

procedure. Having standards or norms that specify acceptable image quality is

clearly advantageous,

and relevant professional bodies have a responsibility in this respect.

2.67. For the implementation of optimization of radiation protection

and safety a comprehensive

quality assurance programme for medical exposures should be established. As is

elaborated elsewhere

(para. 2.138), such quality assurance programmes are part of the wider quality

management system of

the medical radiation facility. Nonetheless, there is considerable

benefit in making use of resource

material and standards established by professional bodies for particular areas

of the programme. For

example, many medical physics professional bodies have developed

detailed guidance on

performance testing aspects of a quality assurance programme. Where such

material or standards are

lacking in a State, the relevant professional body could adopt or adapt such

resources from outside the

State.

2. 68. Professional bodies can play a proactive role by encouraging their

members to contribute to

relevant international or national anonymous and voluntary safety reporting and

learning systems, and

by contributing to developing of such systems. The large catchment of

such databases provides a

wealth of information that is educative in helping to minimize

unintended and accidental medical

exposures. Three such international safety reporting systems are the

IAEA’s Safety Reporting and

Learning System for Radiotherapy, SAFRON [19], and Safety in Radiological

Procedures, SAFRAD

[20], and the Radiation Oncology Safety Information System (ROSIS) [21].

Regulatory body

2.69. The radiation protection regulatory body must fulfil its regulatory

functions, such as establishing

requirements and guidelines, authorizing and inspecting facilities and

activities, and enforcing

legislative and regulatory provisions. Detailed requirements specifying these

roles and responsibilities

are given in the BSS [3] and in GSR Part 1 [11], and further general guidance

in Safety Guide GS-G-

1.5 [22]. Guidance on general regulatory body roles and responsibilities with

respect to occupational

radiation protection and radiation protection of the public are given in the

two general safety guides

[23, 24]. An pre-requisite for the regulatory body being able to

perform its regulatory functions

effectively is having staff with appropriate specialist expertise. This is

covered in detail in the IAEA

Safety Standards [3, 11, 22], but should be emphasized in the

context of medical uses of ionizing

radiation, where on the one hand persons are being deliberately exposed to

radiation and, on the other,

health outcome depends on the applicability, availability and use of radiation.

The regulatory controls

should be applied knowledgeably, and not just as an administrative exercise.

Authorization of medical radiation facilities

2.70. The graded approach to medical uses of ionizing radiation has

particular significance for

regulatory bodies because, as described in paras. 2.23 to 2.27, there

is a wide variation in the

complexity of medical radiation facilities. Regulatory bodies

should consider what form of

authorization is appropriate for a given type of medical radiation facility.

Coupled with the type of

authorization is the level of complexity in the documentation that

should be submitted to the

regulatory body prior to the authorization. This includes the degree of detail

in the safety assessment

(see paras. 2.148 - 2.152). The duration of an authorization is another

consideration for the regulatory

body – the more complex facilities would warrant a more frequent renewal

process.

2.71. Typical practices that are amenable to registration are those for which:

(a) safety can largely be

ensured by the design of the facilities and equipment; (b) the

operating procedures are simple to

follow; (c) the safety training requirements are minimal; and (d) there is a

history of few problems

with safety in operations. Registration is best suited to those practices for

which operations do not

vary significantly. These conditions are generally not met in medical uses of

ionizing radiation for the

following three reasons: patient exposure depends on human performance;

radiation protection and

safety is not largely ensured by design; and the training required

is significant. Medical radiation

facilities are, in principle, better candidates for individualized licensing

than for registration. It would

be expected that licensing would be used for radiation therapy facilities,

nuclear medicine facilities,

facilities performing image guided interventional procedures, and for

most diagnostic radiology

facilities. For some simple forms of diagnostic radiology, such as dental

radiography (without cone

beam CT) and DEXA, registration may be acceptable. For both forms of

authorization, the regulatory

body should have standardized forms or templates that help ensure

that the correct information is

submitted to the regulatory body. See also the paragraphs on safety

assessments, paras 2.148 - 2.152.

2.72. No matter what form of authorization is used for a medical radiation

facility, a crucial step prior

to the granting of the authorization is that the regulatory body

ascertains the credentials of key

personnel with responsibilities for radiation protection and safety – including

the radiological medical

practitioners, the medical radiation technologists, the medical physicists and

the radiation protection

officer. This step cannot be over-emphasized as all aspects of

radiation protection and safety in

medical uses of ionizing radiation depend ultimately on the competence of the

persons involved. See

also paras. 2.117 - 2.130.

2.73. Setting up a medical radiation facility may involve the

construction of facilities which are

difficult to modify at a later time. Regulatory bodies may choose a two-stage

process of authorization,

i.e. to require an initial application to build a facility before

construction begins. At this stage the

regulatory body should review the intended medical uses of ionizing radiation,

the facility’s design,

including structural shielding plans⁵, and the planned equipment. This is

followed at a later stage by

the full regulatory body review and assessment leading to the granting of the

authorization. For more

complex medical radiation facilities, such as a radiation therapy

facility, this latter process should

include an inspection by the regulatory body or authorized party.

2.74. Subsequent substantial modifications of a medical radiation

facility, including its medical

radiological equipment and its procedures, may have safety implications. The

regulatory body may

require an application for an amendment to the authorization.

⁵ Although not strictly a radiation safety issue, it is important to ensure

that the building will support the weight

of the structural shielding, for which it may have not been originally

designed.

2.75. The regulatory body should require the renewal of an authorization after

a set time interval. This

allows a review of the findings of inspections and of other information on the

safety performance of

the medical radiation facility. The frequency of renewal should be based on

radiation protection and

safety criteria, with consideration given to the frequency of inspections by

the regulatory body and the

safety record associated with a given type of practice, in general,

or with a particular medical

radiation facility. A renewal cycle longer than 5 years would seem

not appropriate for medical

radiation facilities.

2.76. The authorization of a medical radiation facility to use ionizing

radiation for medical purposes is

a separate exercise to that of the same facility, or the wider medical facility

of which it is part, being

authorized by the health authority to carry out medicine practice and

healthcare (para 2.52). Radiation

safety requirements are only a set of requirements before authorization is

granted to a medical facility

by the health authority. Meeting radiation safety requirements is a

condition necessary but not

sufficient to obtain an authorization to practice medicine. Coordination and

collaboration between the

radiation protection regulatory body and the health authority should be in

place to ensure radiation

protection and overall safety of the medical facility.

Inspection of medical radiation facilities

2.77. On-site inspection by the regulatory body is often the principal means

for face-to-face contact

with personnel in the medical radiation facility. The regulatory body should

have established a system

for prioritization and frequency of inspections, based on the risk and

complexity associated with the

particular medical uses of ionizing radiation. The regulatory body

inspection of medical radiation

facilities should be performed by staff with the specialist expertise to be

able to competently assess

the compliance of the facility with the radiation protection regulations and

authorization conditions.

For further detailed general guidance on inspections see GS-G-1.5 [22].

Particular considerations for the regulatory body with respect to medical,

occupational and public

exposure

2.78. The regulatory body should ensure that all the BSS requirements

with respect to medical,

occupational and public exposure are implemented in authorized medical

radiation facilities, as

described in detail in the relevant subsections of the specialty

Sections 3 to 5. To help medical

radiation facilities fulfil their obligations, there are some particular areas

where the regulatory body

should provide specific guidance.

2.79. Calibration of sources that give rise to medical exposure should be in

place to ensure radiation

safety in medical uses of ionizing radiation, as set out in the BSS

paragraph 3.167, and detailed

guidance is given in Sections 3 to 5. The regulatory body should

specify frequencies for re-

calibrations and, in doing so, should make use of applicable guidance

given by medical physics

professional bodies.

2.80. In the case of the calibration of radiation therapy units, independent

verification prior to clinical

use should be assured (BSS para. 3.167(c)). The regulatory body should be aware

of the limitations on

local resources in their State. The ideal independent verification, by

different independent medical

physicist using different dosimetry equipment, may not be realizable.

The regulatory body has the

responsibility of not allowing the radiation safety of the radiation therapy

unit to be compromised but

at the same time not to unnecessarily close down the facility. The

regulatory body should decide on

acceptable alternatives, such as verification by a second medical physicist

with the same equipment or

only verification using a second set of equipment, or using a form

of verification by postal

thermoluminescence, optically stimulated luminescence dosimetry or equivalent.

2.81. Unintended and accidental medical exposures do occur and the regulatory

body should require

that a system is in place and all practical measures are taken to prevent them,

and, if such exposure

happens, it is properly investigated and corrective actions are implemented.

Arrangements should be

in place to respond promptly in order to mitigate any consequences.

The regulatory body should

require written records to be kept of all unintended and accidental

medical exposures and should

provide guidelines on what information to be included in these reports. The

more significant events

should be reported to the regulatory body, (BSS para. 3.181(d)). The regulatory

body should provide

guidance on what events must be reported to them. One of the reasons for

reporting to the regulatory

body is to enable the regulatory body, in turn, to disseminate

information on the event to relevant

parties so that the recurrence of similar events is minimized. In addition to

mandatory reporting for

regulatory purposes, anonymous and voluntary safety reporting and learning

systems can significantly

contribute to enhance radiation safety and quality in health care.

The regulatory body can be pro-

active and encourage medical radiation facilities to participate in

relevant international or national

anonymous and voluntary safety reporting and learning systems, as discussed in

para 2.68. Further

guidance on this topic is given in the specialty Sections 3 to 5.

2.82. With respect to occupational exposure assessment, the regulatory body

should set requirements

and provide clear guidance on what form of monitoring should be in

place. The BSS (BSS [3],

paragraphs 3.99 to 3.102) requires the employers, registrants and licensees to

make arrangements for

occupational exposure assessment, and in the requirements gives broad criteria

for when individual

monitoring should be arranged and when workplace monitoring may be

sufficient. Occupational

exposures vary widely in medical uses of ionizing radiation, ranging from those

uses where it is quite

clear that individual monitoring should be undertaken, to those uses

where workplace monitoring

would suffice. It is where uses fall between these two situations

that specific direction should be

provided from the regulatory body. Further guidance on this topic is given in

the specialty Sections 3

to 5.

2.83. The regulatory body has a role as custodian of public radiation

protection. Because a member of

the public can be subject to exposure arising from any number of

authorized medical radiation

facilities (or indeed other facilities and activities using radiation), the

regulatory body has an oversight

role to ensure that the sum or cumulative effect of these multiple pathways

does not lead to public

exposure greater than the dose limits (see Table 2). Part of this

role includes the setting of dose

constraints and ensuring that safety assessments include considerations of

public and potential public

exposure.

2.84. The BSS has many requirements for registrants and licensees, and

employers with respect to

occupational radiation protection, to maintain and make available records on a

wide range of matters.

For records pertaining to occupational exposure, the BSS specifies how long

such records should be

maintained, namely to at least until the worker attains the age of 75 years and

for not less than 30

years after cessation of work in which the worker was subject to occupational

exposure (BSS, para.

3.104). For all other records, the period for which they should be maintained

is deferred to the State’s

regulatory body. The period of retention will depend on the type of

record and its usefulness or

relevance after the passage of time. Records relating to a person’s

health or healthcare arguably

should be kept for that persons’ lifetime, but there are significant variations

around the world. Some

States, for example, require medical records to be kept for the lifetime plus

10 years; others require a

much shorter period such as 7 to 10 years. Records for activities

such as calibrations, dosimetry,

quality assurance and investigations of accidents and unintended medical

exposures should be kept for

a significant period as there is always the possibility that the

records will be needed to perform

retrospective assessments of medical, occupational or public exposure. A

retention period of at least

10 years is recommended for these records. On the other hand,

records on personnel education,

training, qualification and competence may be of relevance only when that

person is working at the

medical radiation facility. Further guidance for the regulatory body and for

registrants, licensees and

employers is given in the IAEA Safety Guide on management systems [25].

Authorization for the installation, maintenance and servicing of medical

radiological equipment

2.85. The regulatory body should ensure that persons who install,

maintain or service medical

radiological equipment are appropriately authorized. See also the sub-sections

on responsibilities for

suppliers of sources, equipment and software, and for maintenance and servicing

organizations, and

the guidance on education, training, qualification and competence of

servicing engineers and

technicians given in para. 2.133.

Authorization of other practices related to medical uses of ionizing radiation

2.86. The regulatory body may also require authorization for other activities

related to medical uses of

ionizing radiation, including: import, distribution, assembly, sale, transfer

or transport of radioactive

sources or medical radiological equipment; decommissioning; disposal

of radioactive sources,

material or waste. The requirements to carry out these practices

should have been established by

regulations complemented by regulatory guidance documents.

Dissemination of information

2.87. The BSS (BSS [3], paragraph 2.38) requires that the regulatory body has

mechanisms in place

for the timely dissemination of information - in the context of this Safety

Guide - to medical radiation

facilities, manufacturers and suppliers, the health authority and professional

bodies, on lessons learned

for radiation protection and safety resulting from regulatory experience and

operating experience, and

from incidents and accidents and related findings. Information should

be exchanged through the

publication of newsletters (paper based or electronic) and the

periodic mailing of notices, by

presentations at scientific and professional association meetings, by

establishing a web site, or by co-

sponsoring educational seminars and workshops with professional and scientific

associations. More

rapid actions should be considered in response to actual or potential

problems that may result in

significant consequences.

Medical radiation facility

2.88. In medical uses of ionizing radiation, the prime responsibility for

radiation protection and safety

rests with the person or organization responsible for the medical radiation

facility – normally referred

to as the registrant or licensee. Almost all the requirements in the

BSS applicable to a medical

radiation facility for ensuring radiation safety in medical uses of

ionizing radiation place the

responsibility on the registrant or licensee (and on the employer, in the case

of occupational radiation

protection).

2.89. However medical uses of ionizing radiation involve a

multidisciplinary team led by a health

professional who often is not the registrant or licensee of the authorized

medical radiation facility.

Because of the medical setting in which such exposures occur, primary

responsibility for radiation

protection and safety for patients lies with the health professional

responsible for the radiological

procedure, who is referred to in the BSS and in this Safety Guide

as the ‘radiological medical

practitioner’. The radiological medical practitioner is the generic term that

the BSS uses to refer to a

health professional with specialist education and training in medical

uses of radiation, who is

competent to perform independently or to oversee procedures involving medical

exposure in a given

specialty. Health professionals that could take on the role of the

radiological medical practitioner,

depending on the particular use of radiation and on the laws and

regulations in a State, include

radiologists, nuclear medicine physicians, radiation oncologists,

cardiologists, orthopaedic surgeons,

other specialist physicians, dentists, chiropractors and podiatrists.

More guidance on the health

professionals who could be radiological medical practitioners is given in the

specialty Sections 3 to 5.

See also paras 2.122 - 2.123 on education and training.

2.90. The net effect of paras. 2.88 and 2.89 is that, for medical exposures,

the registrant or licensee

must ensure all requirements are implemented. This normally requires that the

radiological medical

practitioner ensures a given set of actions takes place, usually with the

involvement of further health

professionals – mainly medical radiation technologists and medical

physicists (see paras. 2.91 and

2.92, respectively). The medical exposure sub-sections of the specialty

Sections give guidance on the

many requirements that come under the responsibility of the radiological

medical practitioner.

2.91. The term medical radiation technologist is used in the BSS and this

Safety Guide as the generic

term for a second group of health professionals. A wide variety of

terms are used throughout the

world such as radiographer, radiological technologist, nuclear medicine

technologist, and radiation

therapist. In the BSS, a medical radiation technologist is a health

professional with specialist

education and training in medical radiation technology, competent

to carry out radiological

procedures, on delegation from the radiological medical practitioner, in one of

more of the specialties

of medical radiation technology (e.g. diagnostic radiology, radiation therapy,

nuclear medicine). The

medical radiation technologist is usually the interface between the

radiological medical practitioner

and the patient, and his/her skill and care in the choice of techniques and

parameters determines to a

large extent the practical realization of the optimization of radiation

protection and safety for a given

patient’s exposure in many modalities. More guidance on the roles and

responsibilities of medical

radiation technologists is given in the specialty Sections 3 to 5.

See also paras 2.124 - 2.125 on

education and training.

2.92. In the BSS, a medical physicist is a health professional with specialist

education and training in

the concepts and techniques of applying physics in medicine, and competent to

practise independently

in one or more of the subfields (specialties) of medical physics, (e.g.

diagnostic radiology, radiation

therapy, nuclear medicine). The medical physicist provides specialist

expertise with respect to

radiation protection of the patient. The medical physicist has responsibilities

in the implementation of

the optimization of radiation protection and safety in medical exposures,

including source calibration,

clinical dosimetry, image quality and patient dose assessment, and

physical aspects of the quality

assurance programme, including medical radiological equipment acceptance and

commissioning. The

medical physicist is also likely to have responsibilities in providing

radiation protection and safety

training for health professionals. In addition, he/she may also

perform the role of the radiation

protection officer (RPO), whose responsibilities are primarily in

occupational and public radiation

protection. More guidance on the roles and responsibilities of medical

physicists is given in the

specialty Sections 3 to 5, and in Ref [26]. See also paras 2.126 - 2.127 on

education and training.

2.93. There are other health professionals with responsibilities for radiation

protection of the patient.

These include, for example, radiopharmacists, radiochemists, dosimetrists and

biomedical or clinical

engineers. Detailed guidance is given in Sections 3 to 5.

2.94. For a medical radiation facility, the radiation protection and

safety responsibilities outlined

above for the radiological medical practitioner, the medical radiation

technologist, the medical

physicist and other health professionals with responsibilities for patient

radiation protection should be

assigned through an authorization (or other regulatory means) issued

by the radiation protection

regulatory body in that State.

2.95. The radiation protection officer (RPO) is a person technically competent

in radiation protection

and safety matters relevant for a given type of practice who is designated by

the registrant, licensee or

employer to oversee the application of relevant requirements [3]. For a medical

radiation facility, the

RPO oversee the application of requirements for occupational and

public radiation protection, and

may provide general radiation protection advice to the registrant or licensee.

The RPO have no direct

responsibilities or roles with respect to patient radiation protection.

In many medical radiation

facilities, especially smaller facilities with fewer personnel, the

role of the RPO and the medical

physicist are often performed by the same person who is a medical

physicist. However an RPO,

unless he or she has recognized competence in medical physics, cannot perform

the role of a medical

physicist with respect to medical exposure.

2.96. In addition to the above paragraphs, all health professionals

involved in the medical uses of

ionizing radiation have responsibilities with respect to occupational and

public radiation protection.

(See the occupational and public radiation protection sub-sections of the

specialty Sections 3 to 5.)

2.97. Medical radiation facilities, as they increasingly utilize

digital technologies, should assure

access to an information technology (IT) specialist⁶ who, through specialized

training and experience,

would have responsibilities for the maintenance and quality control of

information technology

software and hardware. The correct functioning of these systems is crucial for

radiation protection and

safety.

Ethics committees

2.98. Participants in a programme of biomedical research may be either

patients, with some disease or

ailment, or they may be healthy individuals. Regardless, they must be

volunteers. The ethics

committee ⁷ has a particular responsibility with respect to

justification of medical exposure of

volunteers exposed as part of a programme of biomedical research (BSS [3]

paragraph 3.161). The

first part of this responsibility is to decide whether to approve the programme

of biomedical research,

including the proposed use of radiation. The use of radiation in a programme of

biomedical research

can include: (a) the use of a diagnostic radiological procedure to assess the

efficacy of the treatment

under investigation (e.g. ranging from a DEXA scan to measure bone mineral

density before, during

and after a given treatment regime, to a CT or a PET-CT examination

to assess some clinical

indicators, again performed before, during and after the treatment);

(b) trials being performed to

assess a new radiopharmaceutical (i.e. the radiation itself is part of the

research, rather than a tool for

assessment); (c) trials being performed to assess a new radiotherapy protocol

alone or in combination

with other therapeutic modalities ; (d) trials being performed to compare

radiological procedures, for

example specificities and sensitivities of different imaging procedures

or efficacy of different

treatments. In making its decision, the ethics committee should be presented

with correct information

on the expected doses and estimates of the radiation risks based on the age,

gender and health status of

the participants. The ethics committee also should obtain information

on who will perform the

radiological procedures and how. The dose estimates and the associated

radiation risks should be

⁶ The IT specialist in this respect is an expert in imaging informatics, with

expertise to improve the efficiency,

accuracy, usability, reliability and interconnectivity of medical

imaging and radiotherapy services within the

medical radiation facility and, if relevant, its parent healthcare facility.

⁷ Ethics committee is the term used in the BSS to refer to a committee

dedicated to the rights and well-being of

research subjects. Other terms such as an Institutional Review Board are used

in some States.

assessed by a medical physicist. This information should be then considered by

the ethics committee

together with the information on the other risks and benefits of the programme.

2.99. The ethics committee has the responsibility to specify any dose

constraints that are to be applied

to the medical exposures incurred as part of the approved programme of

biomedical research. Such

dose constraints would be guided by nationally or regionally established dose

constraints (see para.

2.50). Dose constraints should be adjusted to the expected benefit of the

programme of biomedical

research – the lower the benefit to society, the more stringent the

dose constraint. The ICRP [27]

stratified doses incurred in biomedical research according to radiation risk

and in Publication 103 [4]

assigned numerical values of dose constraints ranging from less than 0.1 mSv to

greater than 10 mSv,

as the benefit to society ranged from “minor” through to “substantial”. Less

stringent dose constraints

may be applied to participants with short life expectancy, see for

example Ref [28]. Particular

attention should be given to setting dose constraints for healthy volunteers

who repeatedly take part in

biomedical research programs which expose them to increased risks.

2.100. Ethics committees may not be aware of these responsibilities. Therefore

it is desirable for the

radiation protection regulatory body to act as a facilitator in

promoting systems so that ethics

committees know about their responsibilities when a proposal for a

programme of biomedical

research which includes radiation exposure is submitted to the ethics

committee. Such a system may

include a “box” in the proposal form that asks the question “Will ionizing

radiation be used as part of

this programme of biomedical research?” And if the answer is yes,

the form should then ask for

information on radiation doses and risks to be provided, having been first

assessed and signed off by a

medical physicist.

2.101. In a parallel initiative, the regulatory body should inform

the registrants and licensees that

radiological procedures requested as part of a programme of biomedical research

are only justified if

that programme has been approved by an ethics committee, and that such an

approval is subject to

dose constraints which would then influence how the procedure would be

performed.

Suppliers of sources, equipment and software

2.102. Suppliers⁸ of medical radiological equipment and developers of software

that could influence

the delivery of the medical exposure have responsibilities with respect

to design and performance.

Generic requirements are given in the BSS paragraph 3.49 and specific

requirements in paragraph

3.161.

2.103. A particular issue with medical radiological equipment and

software in medical uses of

ionizing radiation is that of the language, terminology and icons used on

control panels, on software

screens and in instruction manuals. English and other major languages dominate.

However it is crucial

that the person using the equipment or software fully understands the options

being presented, and

translation into a local language is advisable. A passing knowledge of a major

language is not good

enough – there are documented instances of unintended or accidental medical

exposures arising from

incorrect understanding of the displayed language, see for example Ref [29].

2.104. Many items of medical radiological equipment can be configured and

supplied with different

options. For example, protective tools may be an optional extra, with

a higher price. Basic model

⁸ The definition of supplier (of a source) in the BSS [3] includes

designers, manufacturers, producers,

constructors, assemblers, installers, distributors, sellers, exporters or

importers of a source.

versions of a given piece of equipment should include as a default all the

relevant protective tools and

the features that provide the greatest control over patient radiation

protection. Paring the price back by

removing radiation protection and safety options in order to gain a

sale is not acceptable. Facility

management should not be placed in a position of saving money at

the expense of compromising

radiation safety.

2.105. When medical radiological equipment and software are to be

part of a digital network,

suppliers should facilitate interconnectivity with other relevant systems.

2.106. After installation of medical radiological equipment or

software, the supplier should go

through a formal hand-over to the medical radiation facility’s

registrant or licensee. This should

include the acceptance testing, described in more detail in the specialty

Sections 3 to 5. It should also

include ensuring that specific training in the use of the equipment or software

is given to the medical

radiation facility’s staff, including the radiological medical

practitioners, the medical radiation

technologists, the medical physicists and the local maintenance

engineers. The features of the

equipment or software should be fully understood, including their implications

for patient radiation

protection.

2.107. The radiation protection and safety responsibilities of

suppliers of refurbished medical

radiological equipment should be no different to the responsibilities for the

supply of new equipment.

Further guidance on refurbished equipment is given in Refs [30 – 32].

2.108. The radiation protection and safety responsibilities for donors

of medical radiological

equipment should be no different to those of commercial suppliers for

such equipment. See WHO

Refs for further guidance on donated equipment [33, 34].

2.109. Regulatory control of engineers and technicians who install

medical radiological equipment

varies around the world. In many countries they will be licensed to perform

installation and servicing

and a pre-requisite to obtaining such a licence would be that they

have had appropriate radiation

protection and safety training. Guidance on education, training,

qualification and competence of

installation and servicing personnel is given in para. 2.133.

Maintenance and servicing organizations

2.110. Maintenance and servicing of medical radiological equipment is

usually performed by an

engineer or technician employed either by a company offering such services (who

may also be the

manufacturer and/or the vendor) or by the medical facility itself (as

part of an engineering, bio-

medical / clinical engineering or service department, for example). In either

case, when the medical

radiological equipment is being serviced the equipment is not to be

used for medical exposures –

patients are not to be imaged or treated until service and hand back is

completed (see para 2.111). The

engineer or technician should follow both the radiation protection and

safety rules and procedures

established by his or her employer and the relevant rules and

procedures of the medical radiation

facility, including how to ensure a safe working environment for the

service and how to ensure

restricted access to the area where the service is taking place. Further

guidance on good maintenance

service practice is given in Refs [35].

2.111. Maintenance and servicing continues until the medical radiological

equipment is ready to be

handed back to the medical radiation facility’s registrant or

licensee. It is recommended that the

“hand-over” is formalized. Depending on the maintenance or servicing that has

taken place, there may

be a need for quality control tests to be performed by a medical

physicist before the hand-over is

complete (see Sections 3 – 5, paras. 3.45, 4.58, 5.87, respectively). The

engineering service should

collaborate with medical physicists and radiological practitioners in

setting optimal equipment

performance. The engineer or technician also should inform the registrant or

licensee of any changes

with respect to the medical radiological equipment that may have implications

for radiation safety. At

this stage the equipment is available for medical use. Pressures to

hand medical radiological

equipment back for medical use must not be allowed to compromise radiation

protection and safety –

for example, equipment being used clinically while still in “service mode”.

2.112. Regulatory control of servicing engineers and technicians varies

around the world. In many

countries they will be licensed to perform servicing and a pre-requisite to

obtaining such a licence

would be that they have had appropriate education and training in

radiation protection and safety.

Guidance on education, training, qualification and competence of servicing

engineers and technicians

is given in paragraph 2.133.

Referring medical practitioners

2.113. The health care of the patient is the responsibility of the

physician or health professional

managing the patient. This physician or health professional may decide

that the patient needs to

undergo a radiological procedure, at which point a referral to an appropriate

medical radiation facility

is initiated. “Referring medical practitioner” is the generic term

used in the BSS for the health

professional who initiates the process that may lead to the radiological

procedure being performed.

There may be different requirements in different States about who can act in

the role of a referring

medical practitioner. The referring medical practitioner has a joint

responsibility with the radiological

medical practitioner to decide on the justification of the proposed

radiological procedure. More

detailed guidance is given in the specialty Sections 3 to 5.

2.114. Usually the roles of the referring medical practitioner and the

radiological medical practitioner

are performed by two different persons. However there are some

instances where both roles are

performed by the same person – often called self-referral. A very common

example is the dentist, who

decides whether an X ray examination is needed and, if so, performs

the examination. Dental

professional bodies in many countries have established guidelines for when

dental X ray examinations

are appropriate or not, and using these guidelines should help the

dentist to fulfil both roles

acceptably. In other situations, typically involving medical imaging,

there may be very strong

financial incentives for self-referral because the performance of the

radiological procedure generates

significant income. Again there is a clear role for professional body

guidelines to help minimize

potential misuses of self-referral.

Patients

2.115. Patients are being increasingly involved in the decision making

processes concerning their own

health care, and this includes medical uses of ionizing radiation. The BSS

requires that the registrant

or licensee for the medical radiation facility ensures that the patient is

informed, as appropriate, of

both the potential benefit of the radiological procedure and the radiation

risks (BSS [3], paragraph

3.151(d). Information should always be provided in an understandable format

(e.g. verbally, leaflets,

posters, websites), and in a timely manner. The level of information should be

commensurate with the

complexity, dose and associated risks, and for some radiological procedures

informed consent may be

required, written or verbal. Female patients of childbearing potential

should be informed about the

risk to the embryo or fetus from radiological procedures for either diagnosis

or therapy.

2.116. “Self-presenting” patients are individuals demanding a particular

radiological procedure on the

basis that they believe that this procedure is needed to, for example, detect

cancer or heart disease in

its early stages before symptoms become manifest. These individuals should be

handled in the same

way as any other patient – namely through an appropriate referral and the

ensuing justification.

EDUCATION, TRAINING, QUALIFICATION AND COMPETENCE

2.117. Medical uses of ionizing radiation involve a number of health

professionals performing

radiological procedures – diagnostic examinations, interventional

procedures or treatment. In each

case the radiation protection and safety associated with the radiological

procedure depends strongly

on the skills and expertise of those health professionals involved as

the patient is necessarily and

deliberately exposed to radiation. In other words, education, training,

qualification and competence of

the respective health professionals underpin radiation safety in medical uses

of ionizing radiation.

2.118. The BSS places great emphasis on education and training for all persons

engaged in activities

relevant to protection and safety, with the responsibility placed on

government to ensure that

requirements for education, training, qualification and competence

are established and that

arrangements are in place for the provision of the necessary education and

training. The development

and implementation of a national strategy for education and training⁹

which is based on a national

needs assessment can be useful in this context. Further, the

regulatory body should ensure the

application of the requirements for education, training, qualification

and competence in radiation

protection. This should take place when an authorization application

has been submitted to the

regulatory body and during the periodic inspections of the medical

radiation facility. Finally, the

registrant or licensee of the medical radiation facility has the responsibility

to ensure that all the health

professionals in that facility with responsibilities for protection and safety

have appropriate education,

training, qualification and competence.

2.119. In medical uses of ionizing radiation medical exposure occurs,

and occupational and public

exposure may occur. For the health professionals involved, it is the education,

training, qualification

and competence in the medical exposure aspects that are the most

critical. To this end, the

requirements in the BSS for the health professionals involved in performing

radiological procedures

are quite stringent. For each of the key roles of the radiological

medical practitioner, the medical

radiation technologist, the medical physicist and the radiopharmacist, the

definition in the BSS takes

the same form. Namely, that the person is a health professional, that they have

specialist education

and training in the particular discipline (including radiation protection and

safety), and that they have

been assessed as being competent to carry out that particular role.

See the BSS for the complete

definitions (BSS [3], pp 114, 115, 122, 123]). The competence of a person is

normally assessed by the

State by having a formal mechanism for registration, accreditation or

certification of the particular

specialized health professional. States that have yet to develop such a

mechanism, should assess the

education, training and competence of an individual proposed by a

licensee to act as a specialized

⁹ IAEA Strategic Approach to Education and Training in Radiation, Transport and

Waste Safety, 2011–2020

(IAEA/2010/Note 44)

health professional and to decide, on the basis either of international

standards or standards of a State

where such a system exists, whether the individual can be considered competent.

2.120. A health professional intending to act in any of the roles of

radiological medical practitioner,

medical radiation technologist, medical physicist or radiopharmacist can do so

only if he or she has

the requisite education, training, qualification and competence. It is

the prime responsibility of the

registrant or licensee to ensure that their staff meets these requirements, and

it is the responsibility of

the regulatory body to use the authorization, inspection and

enforcement processes to ensure that

registrants and licensees are discharging their responsibilities in this

respect.

2.121. The institutes and organizations that provide education and training in

radiation protection to

health professionals should use the BSS and its companion Safety

Guides as resources on the

requirements for radiation protection and safety in medical uses of radiation.

Radiological medical practitioners

2.122. The term radiological medical practitioner is applied to a number of

health professionals who

independently perform or oversee radiological procedures within a given

specialty (see also para.

2.89). Some of these health professionals belong to a specialty with

a very long association with

medical uses of ionizing radiation, such as radiology, nuclear

medicine, radiation therapy and

dentistry. In countries where there are well established processes in

place for education, training,

qualification and competence in these specialties, this includes subjects not

only in the specialty itself

but also with respect to radiation protection (patient and

occupational). Typically these specialists

would become registered with the national medical or dental

registration board (or a body with a

similar function), and competence in the specialty should include competence in

radiation protection

and safety. It still falls on the regulatory body and the relevant

professional body to periodically

review the radiation protection and safety aspects of the education and

training to ensure that it is still

up to date and relevant. In States where there is a lack of infrastructure for

education and training in

these specialties, a prospective radiological medical practitioner should gain

the necessary education,

training, and qualification outside the State, both in the specialty itself and

in radiation protection and

safety. The competence of health professionals trained outside the State

should be assessed. In this

situation the regulatory body should seek advice from the health

authority and the relevant

professional body (if it exists), with respect to the adequacy of the

specialization of the individual.

Assessment of the radiation protection and safety aspects would be performed by

the regulatory body.

In time this approach should develop into a standardized process for

dealing with competence

assessments.

2.123. Other specialties, such as orthopaedic surgery and cardiology, have also

had a long association

with medical uses of ionizing radiations, but radiation protection and safety

may not traditionally have

been part of the processes for education, training, qualification and

competence in the specialty. Still

other specialties have a more recent association with medical uses of

ionizing radiation, especially

with respect to image guided interventional procedures. Radiation

protection (patient and

occupational) is often not included in the curriculum for education,

training, qualification and

competence in these specialties. For specialists from these two

groups, oftenadditional or separate

education and training and credentialing in radiation protection and safety

should be arranged, as it

applies to their specialty. The relevant professional bodies and the

regulatory body should work

together in establishing acceptable criteria on education and training

in radiation protection and

safety, and the means for recognition of competence in radiation protection.

Probably the preferred

approach would be for the relevant professional body to administer the process

and maintain a register

of specialists and their radiation protection and safety credentials.

Other possibilities include the

regulatory body taking on the role of overseeing the radiation

protection and safety training and

recognition processes. An individual medical radiation facility can

adopt a ‘credentialing and

privileging’ approach to cover radiation protection and safety education,

training, qualification and

competence [36]. In this approach the prospective radiological medical

practitioner would present all

their relevant data regarding training and experience (including in

radiation protection and safety),

and apply for permission to perform certain medical procedures

involving radiological procedures.

Detailed guidance on appropriate radiation protection and safety education and

training for various

specialties involved in medical use of ionizing radiation is given in

references [37, 38].

Medical radiation technologists

2.124. Medical radiation technologists should require a programme of

education and training in

medical radiation technology that usually includes significant

components of radiation protection

(patient and occupational). On completion of the programme the medical

radiation technologist

typically would become registered with the national registration board

(or a body with a similar

function), and this competence in medical radiation technology should

include competence in

radiation protection and safety.

2.125. Medical radiation technologists may be specialized in various

fields and sub-fields. The

approach to specialties and sub-specialties vary significantly among

countries. In many States, the

medical radiation technologist undergoes a programme specific to

diagnostic radiology, nuclear

medicine or radiation therapy and hence his/her competence would be in that

specialty only. Within

these specialties there may be specific sub-specialties, where the

programme does not necessarily

confer competence. For example, the diagnostic radiology programme in a country

may not cover CT

or image guided interventional procedures to the depth needed for competence.

Additional education

and training should be arranged to achieve competency in the sub-specialty. The

regulatory body, in

terms of reviewing the application for an authorization and during its periodic

inspections, needs to be

aware of issues of specialization and sub-specialization and ensure that only

persons with the correct

credentials can work in the particular roles. Likewise, the registrant or

licensee should ensure that they

employ only persons that have the requisite competence.

Medical physicists

2.126. Even though the International Labour Organization has stated that

medical physicists working

in clinical practice can be considered health professionals [39], the

recognition of medical physicists

as a specialist group of health professionals is not as widespread as needed.

In some countries there

are well established processes for education, training and qualification and

achieving competence in

medical physics, with academic training in medical physics at a university

(typically a post-graduate

programme), clinical training in a hospital or facility, and finally an

assessment of competence. In

some States, the professional body administers this whole process, with

approved universities for the

academic component, approved hospitals or facilities for the clinical

placement, and a professional

standards board for the competence assessment. More details on education,

training, qualification and

competence of medical physicists is given by the IAEA [26, 40 – 43]. There are

also national and

regional requirements and guidance on education, training and recognition of

medical physics expert

[44].The BSS requires specialization for the medical physicist, so, for

example, a medical physicist

with competence only in diagnostic radiology or image guided interventional

procedures cannot act in

the role of a medical physicist in radiation therapy, and vice versa.

2.127. More difficult is where either the State does not recognize medical

physics as a distinct health

profession or where there is no infrastructure in place for the

education and training of medical

physicists. In both cases there is likely to be little in the way of

infrastructure for medical physics in

the country. The problem is similar to that described above in the

second half of para. 2.123 for

radiological medical practitioners. The assessment of education,

training, qualification and

competence of a person seeking to act in the role of a medical

physicist still should take place.

Regardless of the educational process, the final competence assessment should

be specialty-specific as

required by the BSS (BSS [3], para. 3.150).

Radiopharmacists

2.128. A radiopharmacist is usually a pharmacist who has received additional

specialist education and

training and has competency in the preparation and dispensing of

radiopharmaceuticals. Post-graduate

courses in radiopharmacy are available in some countries. A few

countries have a radiopharmacy

professional body, or radiopharmacy can be a specialist sub-group

within the national nuclear

medicine professional body and/or a pharmacy professional body. More details on

education, training,

qualification and competence of persons working in a radiopharmacy is given by

the IAEA [45]. Even

in the absence of a formal infrastructure, the assessment of

education, training, qualification and

competence of a person seeking to act in the role of a radiopharmacist still

should take place.

Other health professionals in the medical radiation facility

2.129. Other health professionals are involved in medical uses of

ionizing radiation. However a

distinction should be made between those who have specific

responsibilities for patient radiation

protection and those whose responsibilities (in terms of radiation

protection) are for occupational

radiation protection only. Health professionals who fall into the

former group, and who are not a

radiological medical practitioner, a medical radiation

technologist, a medical physicist, or a

radiopharmacist, still should have appropriate specialization (as it applies to

the radiation use) and the

respective radiation protection and safety education, training,

qualification and competence. The

guidance given above for health professionals where infrastructure is

lacking would again be

applicable.

2.130. The latter group of health professionals and other professionals

involved in medical uses of

ionizing radiation include specialist nurses (working in a cardiac

investigation suite or theatre or

similar), specialist physicians (such as anaesthetists providing support

to a patient undergoing an

interventional procedure), biomedical engineers, clinical engineers,

radiochemists providing support

to the performance of the radiological procedure, either directly or

indirectly. All these persons should

have formal education and training on radiation protection. An example of such

training for radiation

oncology nurses is given in Ref [46].

Referring medical practitioners

2.131. The referring medical practitioner has a crucial role in the

justification of a given radiological

procedure for a given patient. The referring medical practitioner would be more

effective in this role if

he/she has a good understanding of radiation protection and safety as it

applies to medical uses of

ionizing radiation. Formal processes to require such education and

training under a radiation

protection and safety framework are difficult to put in place. Instead, a more

general approach may be

adopted of promoting education and training in radiation protection and safety

as part of the general

medicine degree curriculum, especially at the time when clinical rotations

begin, and/or as part of the

corresponding specialty education and training programme.

Radiation protection officers

2.132. As defined in the BSS and stated above in para. 2.95, the

RPO should be competent in

radiation protection and safety matters with respect to occupational and public

radiation protection,

relevant for given medical uses of ionizing radiation [3]. The RPO

could come from a range of

backgrounds, often in science, engineering, or health. The additional education

and training required

for the RPO role will depend on the complexity of the technology

and practice of the medical

radiation facility. In some facilities, the RPO may lead a team, all of whom

should have the requisite

education and training. As above for the health professionals, in the

absence of a third-party

recognition process, the regulatory body should liaise with the relevant

professional body (if it exists)

to set standards to allow assessment of persons seeking authorization to act in

the role of RPO. The

ILO has recognized the radiation protection expert as an “Environmental and

occupational health and

hygiene professional” [39].

Suppliers, installation, maintenance and servicing personnel

2.133. Persons who work as engineers or technicians for supply,

installation, maintenance and

servicing of radiological medical equipment and software should be qualified

and competent in such

work. Often they will have been trained by their employer specifically for this

role. Another aspect of

their training should be in the area of radiation protection and

safety – not only for their own

occupational radiation protection and radiation protection of the staff of the

medical radiation facility

where they are working, but also they should have a good working knowledge of

patient radiation

protection in the context of the types of medical radiological

equipment and software they are

servicing. For the last, this particularly includes understanding the

radiation protection and safety

implications of the various features of the equipment or software,

and how that changes when the

features undergo adjustments or revisions. Regulatory control of servicing

engineers and technicians

varies around the world. In some countries licence may be required to perform

servicing and a pre-

requisite to obtaining such a licence should be that they have had appropriate

radiation protection and

safety training.

Maintaining competence (CME and CPD)

2.134. The above paragraphs give guidance on the processes for the

initial education, training,

qualification and competence assessment of the health professional. The health

professionals should

maintain their core competencies, including radiation protection and safety,

and keep abreast of new

developments in medical uses of radiation. One way to demonstrate this is

through formal continuing

medical education (CME) or continuing professional development (CPD)

programmes. In many

countries, the professional bodies administer such programmes, and maintenance

of certification of

competence in a specialty is dependent on satisfactory participation in the

programme. The registrants

and licensees and regulatory bodies can use these programmes as evidence of

continuing competence.

Equipment and software specific training

2.135. Specific training should be assured on the actual medical

radiological equipment and the

software used in the medical radiation facility. This applies in

particular to radiological medical

practitioners and the medical radiation technologists who work directly

with the equipment and

software during radiological procedures, and the medical physicist. They should

understand how the

equipment and software function, including the available options and

how to customize these, and

their implications for patient radiation protection. Practical training should

take place in the medical

radiation facility when new equipment or software is installed and when

significant modifications are

made. From the vendors’ side, the servicing engineer, the applications

specialist and the IT specialist

have a role in providing this specific training for the medical radiation

facility.

MANAGEMENT SYSTEM FOR RADIATION PROTECTION AND SAFETY

2.136. The use of radiation in medicine is just one aspect of medical practice.

The application of the

radiation protection and safety requirements of the BSS should fit in

with the wider set of

requirements that ensure good medical practice. To this end, in

particular, the medical radiation

facility and its management should ensure complementarity between the

requirements for radiation

protection and safety and other healthcare delivery requirements within the

medical facility. This is to

be achieved through an appropriate management structure and management system.

2.137. The BSS has a specific requirement for radiation protection

and safety to be effectively

integrated into the overall management system of a given organization (BSS [3],

requirement 5). In

this Safety Guide, this applies to the medical radiation facility.

The BSS has additional detailed

requirements on the protection and safety elements of the management system,

for promoting a safety

culture, and taking into account human factors (BSS [3], paragraphs 2.47 to

2.52). Further detailed

requirements for facilities and activities, in general, are given in the IAEA

Safety Standards Series

No. GS-R-3 [47] and elaborated in the Safety Guide GS-G-3.1 [25].

The requirements for quality

management are established in these standards and will not be discussed further

in this Safety Guide

other than to emphasize that effective management for radiation

protection and safety requires

commitment from the highest level of management in the medical

radiation facility, including the

provision of all the required resources. The following guidance is

limited to a few particular

components of the management system related to radiation protection and safety.

2.138. The BSS has a requirement for a “protection and safety

programme” in general (BSS [3],

paragraphs 2.42 & 2.43) and a “radiation protection programme”

specifically for occupational

exposure (BSS [3], requirement 24). In addition the BSS has requirements for a

“quality assurance

programme for medical exposures” (BSS [3], paragraphs 3.170 – 3.172).

All three of these

programmes should be part of the overall management system of the

medical radiation facility¹⁰.

Detailed guidance on the radiation protection programme for occupational

exposure and the quality

assurance programme for medical exposures is given in the specialty Sections 3

to 5.

2.139. Depending on the size of the medical radiation facility, committees

might be formatedto help

the implementation of the radiation protection and safety programme

aspects of the management

system. One such committee might be a radiation safety committee, with the

function of advising on

safe operation and compliance with radiation protection and safety

regulatory requirements. The

members of the committee should be at the senior level and would typically

include an administrator

representing the management, a radiological medical practitioner, a medical

radiation technologist, a

medical physicist, and the radiation protection officer. For the day-to-day

oversight of the radiation

protection programme, a radiation protection officer should be appointed, who

should report to the

committee. The licensee should ensure that the RPO is provided with

the resources required to

oversee the programme, as well as the authority to communicate with the

committee on a periodic

basis. The RPO should be able to communicate directly with the licensee,

and with the regulatory

body as needed, such as in the case of breaches of compliance which may

compromise safety.

¹⁰ The medical radiation facility may be a “stand alone” entity, such as a

medical imaging centre, or it may be

part of a larger organization, such as a hospital. The focus of

this section on management systems is at the

medical radiation facility level, but it should be recognized that, where the

medical radiation facility is part of a

larger organization, the medical radiation facility management system should be

part of the larger organization’s

management system.

2.140. Another committee might be the quality assurance committee,

with oversight of the quality

assurance programme for medical exposures within the medical radiation

facility. The committee

would determine policy and give direction to the programme, ensure proper

documentation is being

maintained and review the effectiveness of the programme. The

radiation safety and the quality

assurance committees have some functions in common, especially with regard to

medical exposure,

and the health professional representation is likely to be the same.

Harmonization of the work of both

committees is required to avoid either the duplication of or the

inadvertent omission of some

functions.

2.141. Any management system should include continuous quality

improvement which implies a

commitment by staff to strive for continuous improvement in the medical uses of

ionizing radiation.

Feedback from operational experience and from lessons learned from

accidental exposures or near

misses should be used systematically, as part of the continuous quality

improvement.

2.142. The BSS requires that the medical radiation facility is able to

demonstrate effective fulfilment

of the requirements for protection and safety in its management system (BSS

[3], paragraph 2.50).

This will include monitoring, conducted to verify compliance with the

requirements for protection and

safety (BSS [3], requirement 14, and paragraphs 3.37 and 3.38).

2.143. There are requirements for records to be kept, and made available as

needed, in many sections

in the BSS. The management system of the medical radiation facility should

provide for such record

keeping and access. Details on what should be provided are described in

Sections 3 to 5.

2.144. Digital information systems are becoming increasingly available

to provide various support

functions to the management system of the medical radiation facility, including

handling requests for

radiological procedures, scheduling radiological procedures, tracking

patients, and the processing,

storage, and transmission of information pertaining to the patient.

Further, they may be used for

viewing imaging studies and providing reports of study interpretations.

Example of systems with

some or all of these functions include picture archiving and

communication systems (PACSs),

radiology information systems (RIS), hospital information systems (HIS),

and the electronic health

record (EHR). These systems should operate independently, but may also

interconnect with each

other. Imaging devices and other medical radiological equipment can be

interconnected by computer

networks and exchange information in accordance with standards such as

TCP/IP (Transmission

Control Protocol/Internet Protocol, or the Internet protocol suite), DICOM,

HL7, and IHE (Integrating

the Healthcare Enterprise) [48 – 50]. These information systems

are complex and expert

implementation and support should be assured. Digital information systems when

used appropriately

can have a positive effect on the practice of radiation protection and

safety in medical uses of ionizing

radiation. For example, use of these systems can help avoid performing

unnecessary or inappropriate

studies and repeat studies by making patient information available to

multiple users. Further,

connected digital systems should minimize the need for multiple manual

data entry, with its

associated risks, such as in radiation therapy. These systems can

also help in monitoring doses to

patients and image receptors, and monitor retakes; the information from this

monitoring can help in

the implementation of optimization of protection for imaging procedures.

2.145. These digital information systems and procedures for their use should be

designed to protect

against data loss, which in the context of the medical radiation

facility may compromise radiation

protection and safety by, for example, having to repeat examinations. It is

the responsibility of the

medical radiation facility to meet the records retention, security, privacy,

and retrieval requirements of

the relevant State authorities.

2.146. The management system should include a review cycle. The general

principles for audits and

reviews are well established [25, 47]. For a medical radiation facility, a

possible tool for this is the

clinical audit. Clinical audit may be considered as the systematic and critical

analysis of the quality of

clinical care, including the procedures used for diagnosis and

treatment, the associated use of

resources and the effect of care on the outcome and quality of life for the

patient [50]. A clinical audit

looks beyond a strict radiation protection and safety focus, and seeks to

assess the quality and efficacy

of the medical practice offered in the facility – ultimately the

patient health outcome. This should

include the radiation protection and safety aspects of medical uses

of ionizing radiation and,

importantly, keeps these aspects in the context of medical practice, ensuring a

common goal. Thus,

while the BSS does not require a clinical audit, its use may be seen as

fulfilling both the radiation

protection and safety and the medical aspects of the medical radiation

facility’s management system.

More detailed guidance on clinical audits is given in the three IAEA

publications [52 - 54].

2.147. The BSS in the context of medical exposures does require the performance

of a radiological

review and this should be incorporated into the medical radiation facility’s

management system ([3],

paragraph 3.182). At its simplest, the radiological review includes an

investigation and critical review

of the current practical application of the requirements for justification

and optimization of radiation

protection and safety for the radiological procedures that are being performed

in the medical radiation

facility. The radiological review involves at least the radiological medical

practitioners, the medical

radiation technologists and the medical physicists at the medical radiation

facility.

SAFETY ASSESSMENTS

2.148. In the context of medical uses of ionizing radiation, a safety

assessment means an assessment

of all relevant aspects of radiation protection and safety for a medical

radiation facility, including the

siting, design and operation of the facility. The safety assessment

can occur before a facility is

operational or when a major change in operation is contemplated. The safety

assessment deals with

finding ‘what can go wrong’ and how it can be prevented and, in

case it occurs, how it can be

mitigated. As noted above (paragraph 2.70), the regulatory body has the

responsibilities to establish

requirements for safety assessments and, once the safety assessment has been

submitted, to review

and evaluate it prior to granting an authorization (see BSS [3], requirement 13

and paragraph 3.29).

2.149. The BSS gives requirements on: what a safety assessment should include,

what the registrant

or licensee should take into account, its documentation and placement in the

management system, and

when additional reviews of the safety assessment should take place

(BSS [3], paragraphs 3.30 to

3.36). Further more detailed requirements on safety assessment for facilities

and activities, in general,

are given in the IAEA Safety Standards Series No. GSR Part 4 [55]. For medical

radiation facilities,

the safety assessment should include not only considerations of occupational

and public exposure, but

also medical exposure and the possibility of unintended or accidental medical

exposures.

2.150. The BSS specifies two types of safety assessments: generic,

and specific to the facility or

source. A generic safety assessment is usually sufficient for types of sources

with a high degree of

uniformity in design. A specific safety assessment is usually required

in other cases; however, the

specific safety assessment should not include those aspects covered by a

generic safety assessment, if

a generic safety assessment has been conducted for the source. The safety

assessments needed in the

context of medical uses of ionizing radiation will range in complexity, but

even if the source itself is

covered by a generic safety assessment, its placement in the medical

radiation facility will nearly

always require some form of specific safety assessment. It is very

useful if the regulatory body

develops a set of templates [11, 55] to be used by medical radiation facilities

for safety assessments

for the various modalities and specialties in medical uses of ionizing

radiation.

2.151. The BSS requires potential exposure to be considered in the safety

assessment of a new facility

being planned or a planned modification to an existing facility.

Potential exposure refers to

prospective exposure that may or may not occur, but could result from an

accident or from an event or

a sequence of events that may or may not occur. As discussed in paragraph 2.4,

in majority of cases in

medical use of radiation the potential exposure can be treated as a

planned exposure situation.

Facilities should have procedures in place to deal with the occurrence of such

events.

2.152. The BSS (BSS [3], paragraphs 3.43 and 3.44) requires, if the safety

assessment indicates that

there is a reasonable likelihood of an emergency affecting either workers or

member of the public, an

emergency plan to be prepared, including arrangements for the prompt

identification of an emergency,

and for effective response. Situations that can lead to emergency in

medical settings are loss of control

over a dangerous radiation therapy source in result of unauthorized or

malicious act, or conventional

emergencies such as fires and earthquakes. Further more detailed requirements

on emergency

preparedness and response are given in the GSR Part 7 [7].

3. SPECIFIC RECOMMENDATIONS FOR RADIATION PROTECTION AND

SAFETY IN DIAGNOSTIC RADIOLOGY AND IMAGE GUIDED

INTERVENTIONAL PROCEDURES

INTRODUCTION

3.1. This chapter covers radiographic and fluoroscopic diagnostic

procedures, image-guided

interventional procedures, and imaging studies using X-ray radiation

which are part of radiation

therapy or nuclear medicine processes. These radiological procedures

usually take place in permanent

facilities but they can also take place in mobile facilities.

3.2. The radiographic procedures aim to image a particular organ or tissue in 2

or 3 dimensions, and

include general radiography, computed tomography (CT), cone-beam CT

(CBCT), mammography,

tomosynthesis, dental radiography (intraoral, panoramic and CBCT) and

bone densitometry (dual

energy X ray absorptiometry, DEXA).

3.3. Fluoroscopic diagnostic procedures aim to provide real time

assessment of the anatomy and

pathology of a system or organ. Examples include cardiac,

gastrointestinal, urological, and

gynaecological examinations.

3.4. During image-guided interventional procedures, fluoroscopy

(primarily) or CT is used as an

imaging tool to facilitate the diagnosis and treatment of vascular and

non-vascular diseases. Examples

of vascular procedures include coronary angiography/angioplasty, uterine artery

embolizations, aortic

valve implantations and aortic endographs. Common non-vascular procedures

include, for example,

biliary drainage/stenting and liver cytostatic agent injections.

Fluoroscopically guided intra-operative

procedures include, for example, intramedullary nailing and vertebroplasty.

3.5. The generic term “medical radiation facility” is used widely in Section 2

to mean any medical

facility where radiological procedures are performed. In Section 3,

the narrower term “radiology

facility” is used to cover any medical radiation facility where

diagnostic radiology and/or image

guided interventional procedures are performed. A radiology facility includes

the traditional radiology

department in a hospital or medical centre; a stand-alone X ray imaging

facility; the interventional

cardiology (or other specialty) department, unit or facility, either

stand alone or as part of a larger

entity; or a dental practice.

3.6. Many different health professionals can take on the role of the

radiological medical practitioner

(see Section 2 para. 2.89) in diagnostic radiology or image guided

interventional procedures,

depending inter alia on national laws and regulations. They

typically include radiologists,

cardiologists, orthopaedic surgeons, neurosurgeons, plastic

surgeons, vascular surgeons,

gastroenterologists, urologists, respiratory and other specialist

physicians and surgeons, dentists,

chiropractors and podiatrists.

3.7. Section 2 of this Safety Guide provides general guidance on the

framework for radiation

protection and safety in medical uses of radiation, including roles

and responsibilities, education,

training, qualification and competence, and the management system for

protection and safety. This is

relevant to diagnostic radiology and image guided interventional procedures and

reference to Section

2 should be made as indicated.

SAFETY OF MEDICAL RADIATION FACILITIES AND MEDICAL RADIOLOGICAL

EQUIPMENT

Radiology facilities

Fixed facilities – X ray room design

3.8. The BSS, paragraph 3.51, set out the broad requirements that should

be met when choosing a

location and designing a radiology facility. Provisions for the

incorporation of radiation safety

features are best made at the facility design stage (X ray rooms and other

related rooms). The siting

and layout out should take into account the types of radiological

procedures, workload and patient

flow, both within the radiology facility and, in cases where the radiology

facility is part of a larger

hospital or medical centre, with other departments of the wider

facility. Guidance on setting up

diagnostic radiology and interventional radiology facilities is given in Refs

[56 - 58].

3.9. The three factors relevant to dose reduction (time, distance and

shielding) can be combined in the

design to optimize occupational and public radiation protection. Larger rooms

are preferable to allow

easy access for patients on a bed trolley. At the same time they allow for

easier patient positioning and

facilitate both equipment and patient movement during the procedure,

which in the case of

fluoroscopy and image-guided interventional procedures helps reduce time

and exposure. Larger

rooms should also reduce the levels of secondary radiation (scatter and

leakage) potentially reaching

areas occupied by staff and also public areas, typically reducing the level of

shielding required.

3.10. Shielding requirements should be individually tailored to suit the

practice requirements based on

the intended patient workload and the type of examinations to be

undertaken. Further assessments

should be undertaken when the intended use of a room changes; X ray

equipment is upgraded; or

surrounding room occupancy is altered.

3.11. Shielding should consider both structural and ancillary protective

barriers at the design stage

(see para. 2.73]. In rooms using fluoroscopy with staff working close to the

patients, such as rooms

for image guided interventional procedures, ceiling mounted protective

screens and table mounted

leaded curtains should be installed. Such ancillary protective barriers for

image guided interventional

procedures should be part of the initial facility plan, designed so as to not

interfere with the medical

procedure, e.g. sterility requirements. Shielding of walls should be at least

two metres high, and any

doors and viewing windows in walls or doors should have at least the same lead

equivalence as the

minimum shielding specifications for the shielded wall or barrier in

which they are located. Due

consideration should be given to the provision of floor and / or

ceiling shielding when rooms

immediately below and above the X ray installation respectively are occupied.

All penetrations and

joints in shielding should be arranged so that they are equally as

effective in shielding radiation. More

details with respect to structural shielding are given in paras 3.17 to 3.23.

3.12. General safety features of radiography, mammography, CT and fluoroscopy

rooms include:

(a) A protective barrier should be placed at the control console to

shield staff to the extent that

staff should not should wear protective clothing while at the

console. This is particularly

important in mammography where structural shielding in walls, ceiling and floor

may not be

necessary.

(b) For radiography, all possible intended directions of the X

ray beam should be taken into

consideration in the room design so that the X ray beam cannot be directed at

any area which

is not shielded and lead to potentially unacceptable doses being received in

this area.

secondary radiation and be

shut when the X ray beam is on. For radiography, the X ray room should be

designed so as to

avoid the direct incidence of the X ray beam on the access doors.

(d) The medical radiation technologist should be able to clearly observe

the patient at all times

during an X ray diagnostic procedure and be able communicate with him/her.

3.13. Signs and warning lights, preferably positioned at eye level, should be

used at the entrances of

controlled and supervised areas to prevent inadvertent entry (see also para.

3.270 on control of public

access). For controlled areas, the BSS, paragraph 3.90, requires the

use of the symbol of the

International Organization for Standardization (ISO) [59]. The signs

should be clear and easily

understandable. Warning lights, such as illuminated and/or flashing signs as

appropriate, should be

activated when radiation is being produced inside the controlled or supervised

area. Door interlocks

are not appropriate in X ray diagnostic radiological procedures, because

should the X ray beam be

stopped, the medical procedure may have to be repeated. However, to

prevent unauthorized entry

once the procedure has started, some rooms have doors that can be open from the

inside only. This

particularly is used for rooms in which image guided interventional procedures

are performed.

3.14. A stable power supply should be available. An emergency diesel

generator may not be

sufficiently stable to power a CT or interventional radiology suites

and should not be relied upon.

Uninterruptible power supply (UPS) or battery backup systems should be

installed to capture the

active information at time of the outage and to power down all

software in a controlled manner.

Servers should be programmed to automatically shut down when the power supply

is interrupted.

3.15. The design of the facility may should include an air conditioning system

sufficient to maintain

the temperature in the examination room (and sometimes in areas with computer

equipment) within

the range defined by the equipment manufacturers.

Mobile facilities

3.16. Mammography and CT “vans” are commonly used in areas where

fixed facilities are not

available. Other modalities may also be offered via a mobile

facility. General safety features of

mobile facilities include:

(a) Mobile facilities should be built so that protection is optimized mainly

through shielding as

distance is often limited and time depends on the procedure.

(b) An appropriate power supply should be available with reliable connections.

facility personnel.

(d) Waiting areas, if they exist, should be appropriately shielded to

afford levels of protection

consistent with public exposure limits. Waiting areas are common in mammography

mobile

facilities, but not in CT.

(e) To facilitate the imaging procedure, including patient flow, mobile CT

facilities are usually

operated adjacent to a hospital or clinic, from where they may draw water and

electricity, and

where patients can use the toilets, waiting and changing rooms and have access

to physician

offices. Similarly, mammography mobile facilities may also utilize hospital or

clinic facilities.

Shielding calculation considerations

3.17. Two widely used methodologies for shielding calculations are given in

Refs [60, 61], but other

methodologies are also available and used, e.g. Ref [62], as well as specific

shielding calculations for

the WHIS-RAD X-ray unit¹¹ [63]. The nominal design dose in occupied

areas is derived by the

process of constrained optimization, i.e. selecting a source related dose

constraint, with the condition

that the individual doses from all relevant sources is well below

the dose limits for the persons

occupying the area to be shielded. Nominal design doses are levels of air kerma

used in the design

calculations and evaluation of barriers for the protection of individuals, at a

reference point beyond

the barrier. Specifications for shielding are calculated on the basis

of the attenuation they should

provide to satisfy the nominal design doses.

3.18. The shielding thickness is obtained from the attenuation factor, which is

required to reduce the

dose that would be received by staff and the public if shielding were not

present (a) to a dose value

that can be considered as acceptable, as a result of an optimization process,

i.e. a nominal design dose

derived by a process of optimization (b):

(a) Doses that would be received without shielding are calculated by

using workload values, ‘use

factors’ for a given beam direction (fraction of the total amount of radiation

emitted in that

direction) and ‘occupancy factors’ (fraction of the total exposure

that will actually affect

individuals at a place, by virtue of the time permanence in that place). For

secondary barriers,

the ‘use factor’ is always unity, since scatter and leakage

radiation is propagated in all

directions all the time. If tabulated figures are used, care should be taken

that they reflect the

actual usage in the facility and not generic “national” scenarios.

Potential practice changes

and workload increases should be considered as part of the calculations.

(b) Once the dose that would be received without shielding is

known, attenuation should be

calculated to reduce this dose to a design level or to a level that can be

considered ‘optimized

protection’, i.e. a dose below which additional cost and effort in shielding is

not warranted by

the dose being averted. This may require successive calculations to determine

where this level

lies.

¹¹ World Health Imaging System is a general purpose X-ray equipment built in

accordance with specifications

developed by WHO for developing countries.

3.19. When using a shielding methodology to optimize occupational and public

radiation protection,

decisions should be made about many factors that can greatly

influence the final results for the

shielding specification. Those decisions may be based on conservative

assumptions, which together

may lead to an unduly over-conservative shielding specification. Realistic

assumptions should be used

as much as possible, with some allowance for future changes in use.

Adequateness of the shielding

specification should be ensuredas corrective actions after building has been

completed will invariably

be difficult and expensive. Further, it is likely that the building materials

used to provide the shielding

will come in specific discrete thicknesses or densities and this can

be used to provide a “safety

margin” over the calculated shielding values. If using a material

other than lead, tabulated values

should be used only for materials that exactly match those being

considered in terms of chemical

composition, density, and homogeneity. The following are some assumptions that

will each lead to

conservatism in the shielding specification:

(a) For primary barriers, the attenuation by the patient and image

receptor is not considered;

(b) Workload, use and occupancy factors are overestimated;

(d) Distances are always the minimum possible;

(e) Leakage radiation is the maximum all the time;

(f) Field sizes used for the calculation of scatter radiation are

overestimated;

(g) Attenuation of the materials is usually considered for the maximum

beam quality used;

(h) The numerical value of calculated air kerma (in mGy) is directly

compared with dose limits or

constraints (mSv), which are given in terms of effective dose. However, the

actual effective

dose to personnel or members of the public is substantially lower than the air

kerma, given the

dose distribution within the body for the beam qualities used in diagnostic and

interventional

radiology.

3.20. Particular attention should be given to hybrid imaging systems where the

shielding should be

calculated for each modality and combined as appropriate [58, 64, 65]. See also

Section 4, paras. 4.32

– 4.35.

3.21. Considerations should be given during the design phase to make

sure that radiosensitive

equipment and consumables are appropriately shielded, for example

computed radiography (CR)

cassettes and X ray films. Where used, darkrooms for film processing may

require extra shielding to

prevent film fogging.

Adequacy of shielding

3.22. Specification of shielding, including calculations, should be

prepared by a RPO or medical

physicist. In some countries there may be a requirement for shielding

plans to be submitted to the

regulatory body for review or approval prior to any construction (see also

Section 2 para. 2.73).

3.23. The adequacy of the shielding should be verified, preferably during

construction, and certainly

before the room is placed in clinical use, and similarly after any

future structural modifications.

Clearly requirements of the regulatory body must be met (Section 2 para. 2.73).

Display and interpretation (reading) rooms design

3.24. To facilitate the interpretation by the radiological medical

practitioner, images should be

displayed in rooms specifically designed for these purposes. A proper level

of ambient light in the

viewing room should be ensured. See also paras. 3.40 to 3.41 on

image display devices and view

boxes.

3.25. Viewing rooms with workstations for viewing digital images should be

ergonomically designed

to facilitate image processing and manipulation so that reporting can be

performed accurately. The

viewing monitors of the workstations should meet applicable standards (see

para. 3.40).

Medical radiological equipment, software and ancillary equipment

3.26. This sub-section considers medical radiological equipment,

including its software, used in

diagnostic radiology or image guided interventional

procedures, including radiography,

fluoroscopy/angiography, CT, cone beam CT (CBCT), mammography, dental

radiology, bone mineral

densitometry (e.g. DEXA), tomography (including tomosynthesis). It is also

applicable to the X ray

based component of hybrid imaging modalities, including PET-CT,

SPECT-CT, and PET-

mammography, and the X ray based component of image-guided radiation therapy

systems. Some of

this equipment may be used in a nuclear medicine facility or in a radiation

therapy facility, rather than

a radiology facility.

3.27. The requirements for medical radiological equipment and its

software are given in the BSS

paragraphs 3.49 and 3.162. The International Electrotechnical Commission

(IEC), through its

Technical Committee 62 on Electrical equipment in medical practice and in

particular Sub-committee

62B on Diagnostic imaging equipment and Sub-committee 62C on Equipment

for radiotherapy,

nuclear medicine and radiation dosimetry, has published international standards

applicable to medical

radiological equipment. Current IEC standards relevant to X ray imaging include

the following Refs

[66 – 110]. For those relevant to the radiopharmaceutical based component of

hybrid imaging, see

Section 4 para. 4.40. It is recommended that the IEC website is visited to view

the most up-to-date list

of standards: http://www.iec.ch. The International Organization for

Standardization (ISO), through its

Technical Committee 85 on Nuclear energy, nuclear technologies, and

radiological protection and in

particular Sub-committee 2 on Radiological protection, may

publish international standards

applicable to medical radiological equipment. It is recommended that the

ISO website is visited to

view the most up-to-date list of standards: http://www.iso.org.

3.28. As licensees take responsibility for the radiation safety of medical

radiological equipment they

use, they should impose purchasing specifications that include

conditions to meet relevant

international standards of the IEC and ISO and/or equivalent national

standards. In some countries

there may be a medical devices agency or similar organization that gives type

approval to particular

makes and models of medical radiological equipment.

3.29. Displays, gauges and instructions on the operating consoles of medical

radiological equipment,

and accompanying instruction and safety manuals, may be used by staff who may

not understand, or

who may have a poor understanding of, the manufacturer’s original

language. In such cases, the

accompanying documents should comply with IEC and ISO standards and should be

translated into

the local language or into a language acceptable by the local staff.

The software should be designed so

that it can be easily converted into the local language resulting in displays,

symbols and instructions

that will be understood by the staff. The translations will require a quality

assurance process to ensure

proper understanding and avoid operating errors. The same applies to

maintenance and service

manuals and instructions for maintenance and service engineers and technicians,

where these persons

do not have an adequate understanding of the original language. See also

Section 2 para. 2.103.

3.30. All medical radiological equipment should be supplied with all

appropriate radiation protection

tools as a default, rather than as optional extras. This applies to both

patient radiation protection and

occupational radiation protection. See also Section 2 para. 2.104.

Design features of medical radiological equipment

3.31. The design of medical radiological equipment should be such

that its performance is always

reproducible, accurate and predictable, and that it has features that

facilitate the appropriate personnel

in carrying out the requirement in the BSS for operational

optimization of patient protection

(paragraph 3.163(b)) – namely that it provides “appropriate techniques and

parameters to deliver a

medical exposure of the patient that is the minimum necessary to

fulfil the clinical purpose of the

procedure, with account taken of the relevant norms of acceptable image quality

… .” Many design

features contribute to the performance of medical radiological equipment and

should be considered

when purchasing such equipment, as indicated briefly in the following

paragraphs. Further details on

design features and performance standards of medical radiological

equipment used in diagnostic

radiology or for image guided interventional procedures are given in Refs [72 –

81, 83, 85 - 91, 103,

105 – 115]. See also later paragraphs on quality assurance and acceptance

testing, and in particular

para. 3.231.

3.32. General design features for medical radiological equipment used

in diagnostic radiology and

image guided interventional procedures should consider the following:

(a) Means to immediately detect any malfunction of a single component

of the system that may

lead to an inadvertent under- or over-exposure of the patient or exposure of

staff so that the

risk of any unintended or accidental medical exposure is minimized;

(b) Means to minimize the frequency and impact of human error in the

delivery of unintended or

accidental medical exposure;

likelihood of unintended

or accidental medical exposures;

(d) All operational parameters for radiation generators, such as

generating tube potential,

filtration, focal spot position and size, source-image receptor

distance, field size indication

and either tube current and time or their product, should be clearly and

accurately shown;

(e) Radiation beam control mechanisms are provided, including

devices that indicate clearly

(visually and/or audibly) and in a fail-safe manner when the beam is ‘on’;

(f) X ray tubes should have inherent and added filtration

adequate to remove low energy

component of the X ray beam which do not provide diagnostic information;

(g) Collimating devices to define the radiation beam; in the case of a

light beam diaphragm the

light field should align with the radiation field;

(h) With the exception of mammography and CT equipment, diagnostic and

interventional X ray

equipment should be fitted with continuously adjustable beam

collimating devices. Such

devices allow the operator¹² to limit the area being imaged to the size of the

selected image

receptor or the region of interest, whichever is the smaller;

(i) When preset protocols are provided, the technique factors

being used should be readily

accessible and modifiable by appropriate personnel;

(j) Radiation leakage is kept as low as reasonably achievable and

should not exceed 1 mGy in an

hour measured at 1 metre from the focal spot, or is less than maximum levels

specified in

international standards or in local regulations.

3.33. Specific design features for medical radiological equipment used

for radiography should

include:

¹² The term “operator” is used generically in this section. The

operator is usually a medical radiation

technologist, but may sometimes be a radiological medical practitioner, such as

a radiologist.

(a) The provision of devices that automatically terminate the irradiation

after a preset time, tube

current–time product, or dose to the automatic exposure control detector, or

the dead man hand

switch is released;

b) Automatic exposure control (AEC) systems are incorporated in

radiographic units where

practicable. Such AEC systems should be able to compensate for energy

dependence, patient

thickness and exposure rate, for the expected range of clinical

imaging conditions, and be

suited to the type of image receptor being used – film/screen or digital.

3.34. Specific design features for medical radiological equipment used for CT

should include:

(a) Console display of all CT parameters that directly influence the

image acquisition (these may

be displayed over a number of screens);

(b) Console display of estimated volume CT air kerma index (CVOL or

CTDIvₒl) and CT air kerma

length product (PKL,CT or DLP) for the procedure/acquisition;

expressed in terms of volume CT air

kerma index and/or CT air kerma length product;

(d) Dose modulation (rotational and z-axis):

(e) A comprehensive range of beam widths and pitches and other ancillary

devices, e.g. dynamic

collimation, to ensure over ranging in CT is kept as low as

reasonably achievable by

facilitating the appropriate choice of beam width and pitch to limit

patient dose while

maintaining diagnostic image quality;

(f) Reconstruction algorithms that result in dose reduction without

compromising image quality,

such as iterative reconstruction algorithms.

3.35. Specific design features for medical radiological equipment used

for mammography (both

digital and film-screen systems) should include:

(a) Various anode/filter combinations;

(b) Compression and immobilization capabilities;

(d) Display on the console of a dose index, for example

incident air kerma or mean glandular

dose.

3.36. Specific design features for medical radiological equipment used

for fluoroscopy should

include:

(a) The provision of a device that energizes the X ray tube

only when continuously depressed

(such as an exposure footswitch or ‘dead man’s switch’);

(b) Indication or display of the elapsed time and air kerma area product,

and/or entrance surface

dose monitors;

(d) Pulsed fluoroscopy and pulsed image acquisition modes;

(e) Last image hold – the capture and display of the last acquired frame;

(f) Road mapping;

(g) Interlocks which prevent energizing the X ray beam inadvertently when

the image detector is

removed from the imaging chain.

(h) The ability to disconnect the exposure footswitch between cases.

3.37. In addition to those listed in para 3.36, design features for medical

radiological equipment used

for image guided interventional procedures should include:

(a) X ray tubes that have high heat capacities to enable operation at

high tube currents and short

times;

(b) A generator with capability of at least 80 kilowatts (kW) of power;

minimize the range of kVp and

exposure time needed to compensate for differences in thickness);

(d) For paediatric work:

i. The generator supports an X ray tube with a minimum of three focal

spots;

ii. The anti-scatter grid is removable;

iii. Image acquisition frame rate capability extends up to at least 60

frames per second for

small children;

(e) Transmission chambers installed at the end of the

collimators to measure air kerma area

product;

(f) Imaging detectors that allow different fields of view

(magnification) to improve the spatial

resolution;

(g) Automatic collimation;

(h) Dual-shape collimators incorporating both circular and elliptical

shutters to be used to modify

the field for cardiac contour collimation;

(i) Additional filtration in the X ray beam (commonly copper filters)

that is selectable (often as

part of the automatic brightness control system)

(j) Extra filtration (0.2 mm - 0.9 mm) that may be automatically set

according to patient weight

and angulation of the C-arm;

(k) Dose per pulse and the number of pulses per second that are

selectable;

(l) Wedge filters that move automatically into the field of view to

block areas where there is no

tissue and thus no need for imaging;

(m) Possible manipulation of diaphragms while in ‘last image hold’;

(n) Display and recording in a digital format dose report of the

following parameters:

i. Reference air kerma rate;

ii. Cumulative reference air kerma;

iii. Cumulative air kerma area product;

iv. Cumulative time of fluoroscopy;

v. Cumulative number of image acquisitions, (acquisition runs and

frames per run);

vi. Integrated reference air kerma;

(o) System for Digital subtraction angiography (DSA).

3.38. All digital medical radiological equipment should have the following

additional features:

(a) Real time dose display and end-of-case dose report (radiation dose

structured report (RDSR),

DICOM object), including dose metrics export for the purpose of DRLs and

individual patient

dose calculation;

(b) Connectivity to RIS/PACS.

3.39. For medical radiological equipment used for performing diagnostic and

interventional radiology

procedures on children, there should be additional design features

that both facilitate successful

radiological procedures on patients that are typically uncooperative

and suit imaging very small

patients. Such features include the capability of very short

exposure times for radiography,

specifically designed automatic exposure controls, provision of “paediatric

modes” for the automatic

brightness control systems in fluoroscopy and image guided interventional

procedures, and paediatric

protocols for CT.

Other equipment

3.40. All equipment used for digital image display should meet appropriate

international and/or local

standards, for example meeting the performance specifications of the AAPM Task

Group 18 [116].

See paras. 3.24 to 3.25 for guidance on reporting rooms.

3.41. View boxes, for viewing films, should have sufficient uniform brightness

to facilitate diagnosis,

and the colour of view boxes should be matched through the complete

set of view boxes. Means

should be available (masks) to restrict the illuminated area of the radiograph

to avoid dazzling. View

boxes used for mammography should have higher luminance performance. Detailed

guidance is given

in Refs [117 – 122]. See paras. 3.24 to 3.25 for guidance on reporting rooms.

3.42. For radiology facilities where film is being used as an image receptor,

film processing plays a

crucial role in ensuring the medical exposure results in a diagnostic image.

Automatic film processors

should meet appropriate standards. Film-screen based mammography should

have dedicated film

processors with extended processing cycles. If manual processing is

being performed, specially

designed developer, fixer and washing tanks should be used, with

developer temperature-based

processing times. The darkroom for processing should meet relevant

international and/or local

standards for light-tightness and be equipped with an appropriately filtered

safe-light, compatible with

the film being used. Further details are given in Refs. [86, 117 – 122].

Maintenance

3.43. The BSS (BSS, paragraphs 3.15(i) and 3.41) gives requirements for

maintenance to ensure that

sources meet their design requirements for protection and safety

throughout their lifetime and to

prevent accidents as far as reasonably practicable. The registrant or

licensee should ensure that

adequate maintenance (preventive and corrective) is performed to ensure

that medical radiological

equipment retain, or improve through appropriate hardware and/or

software upgrades, their design

specifications for image quality and radiation protection and safety

for their useful lives. The

registrant or licensee should, therefore, establish the necessary

arrangements and coordination with

the manufacturer’s representative or installer before initial operation and on

an on-going basis.

3.44. All maintenance procedures should be included in the quality

assurance programme at the

frequency recommended by the manufacturer of the equipment and

relevant professional bodies.

Servicing should include a report describing the equipment fault, the work done

and the parts replaced

and adjustments made, which should be filed as part of the quality assurance

programme. A record of

maintenance carried out should be kept for each item of equipment: this should

include information

on any defects found by users (a fault log), remedial actions taken

(both interim and subsequent

repairs) and the results of testing before equipment is reintroduced to

clinical use.

3.45. In line with the guidance in Section 2 para. 2.111, after any

modifications or maintenance, the

person responsible for maintenance should immediately inform the licensee of

the medical radiation

facility before it is returned to clinical use. The person responsible for the

use of the equipment, in

conjunction with the medical physicist, the medical radiation

technologist and other appropriate

professionals, should decide whether quality control tests are needed

with regard to radiation

protection, including image quality, and whether changes to protocols are

needed.

3.46. The electrical and mechanical safety aspects of the medical radiological

equipment should be

part of the maintenance programme, and can have direct or indirect

effects on radiation safety.

Authorized persons who understand the specifications of the medical

radiological equipment should

perform this work. See also Section 2 paras. 2.110 – 2.112. Electrical and

mechanical maintenance

should be included in the QA programme at a frequency recommended and

preferentially performed

by the manufacturer of the medical radiological equipment or

authorized agent. Servicing should

include a written report describing the findings. These reports and follow up

corrective actions should

be archived as part of the QA programme.

OCCUPATIONAL RADIATION PROTECTION

Introduction

3.47. In diagnostic imaging procedures described in paras. 3.1 to

3.4, occupationally exposed

individuals are usually the medical radiation technologists and the

radiological medical practitioners

(including, for example, radiologists and, in dental practices, dentists

operating the X ray machine). In

a trauma centre, other health professionals such as nurses, emergency

department physicians and

anaesthetists who may have to be present when using portable or fixed X ray

machines, including C-

arm fluoroscopes, or who may have to be present in the CT room when the unit is

operating may also

be considered occupationally exposed.

3.48. In image guided interventional procedures and during surgery, as

described in para. 3.4, the

occupationally exposed individuals are the radiological medical

practitioners who perform the

interventions (including but not limited to radiologists, cardiologists,

vascular surgeons, orthopaedic

surgeons, neurosurgeons, urologists, anaesthetists¹³, respiratory physicians,

and gastroenterologists),

medical radiation technologists, and other health professionals who are

present and part of the

interventional team, including the anaesthetist, nurses, and

technicians who monitor patient

physiological parameters. Some complex and lengthy procedures may

require more than one

interventionist.

3.49 Additional occupationally exposed personnel may include medical

physicists, biomedical,

clinical or service engineers and some contractors, depending on their role.

3.50. Other radiology facility workers such as patient porters, orderlies,

assistants, cleaners and other

service support, for whom radiation sources are not directly related to their

work, require the same

level of protection as members of the public, as stated in the BSS paragraph

3.78.

3.51. This sub-section contains guidance very specific to diagnostic

radiology and image guided

interventional procedures. For more general and comprehensive guidance on

occupational radiation

protection, including guidance on radiation protection programmes,

assessment of occupational

exposure and providers of dosimetry services, applicable to all areas of

radiation use (including non-

medical uses), reference should be made to the IAEA Safety Guide

Occupational Radiation

Protection [23].

Arrangements under the radiation protection programme

Classification of areas

3.52. Various areas and rooms in a radiology facility should be classified as

controlled or supervised

areas, in line with the requirements given in BSS paragraphs 3.88 to 3.92. All

other rooms and areas,

not so-designated, are considered as “public domain” and levels of radiation in

these areas should be

low enough to ensure compliance with the dose limits for public exposure.

3.53. All X ray rooms should be designated as controlled areas; in addition,

areas where mobile X ray

units are used can also be categorized as controlled areas during

the time in which radiological

¹³ Called anaesthesiologists in some States.

procedures are being carried out. Open plan emergency departments (i.e. an area

without fixed walls

where curtains or similar are used to create cubicles), with either fixed or

mobile X ray units, can also

be categorized as controlled areas during the time in which radiological

procedures are being carried

out. In order to avoid uncertainties about the extent of controlled areas, the

boundaries should, when

possible, be walls and doors.

3.54. Supervised areas may involve areas surrounding X ray rooms. A typical

design of a radiology

department includes two basic areas: an area for staff circulation

and an area for circulation of

patients, which includes reception and waiting rooms, and corridors from which

the X ray rooms can

be accessed through the dressing cabinets. The staff area includes dark rooms,

film and workstation

reading rooms and internal corridors. Most of the staff area may be classified

as a supervised area, not

primarily because of the exposure level, which can be kept very low, but rather

as a “buffer zone”

owing to the potential for other individuals inadvertently entering the X ray

rooms and receiving an

exposure.

3.55. The control console may be inside the X ray room, separated by structural

shielding, or outside

the X ray room in the staff area, with visual control of

the X ray room and with patient

communication. Control console areas should have restricted access to

unauthorized individuals to

avoid the distraction of the operator, which might lead to

unnecessary exposure or repeated exposures.

For this reason, control panel areas should be either classified as controlled

or supervised, despite the

fact that the radiation levels may be very low.

Local rules and procedures

3.56. The BSS, in paragraph 3.93, establishes a hierarchy of preventive

measures for protection and

safety with engineered controls, including structured and ancillary

shielding, being supported by

administrative controls and personal protective equipment. To this end, and as

required in the BSS

paragraph 3.94, written local rules and procedures should be in place in any

radiology facility. Their

purpose is to ensure protection and safety for workers and other

persons. These local rules and

procedures should include measures to minimize occupational radiation exposure

during both normal

work and unusual events. The local rules and procedures also should cover the

wearing, handling and

storing of personal dosimeters, and specify investigation levels and

ensuing follow-up actions (see

paras. 3.98 – 3.123).

3.57. Since all personnel involved in using radiation in a radiology facility

should know and follow

the local rules and procedures, the development and review of these local rules

and procedures should

include representatives of all health professionals involved in diagnostic

radiology and image guided

interventional procedures.

3.58. Equipment (hardware and software) should be operated in a manner

that ensures satisfactory

performance at all times with respect to both the tasks to be accomplished and

radiation safety. The

manufacturer’s operating manual should be used as an important

resource in this respect, but

additional procedures are likely to be needed. The final documented

set of operational procedures

should be approved by the radiology facility’s licensee, and

incorporated into the facility’s quality

management system (see Section 2, paras. 2.136 – 2.147).

3.59. Radiology facility staff should understand the documented

procedures for their work with

radiation and for the operation of the equipment with which they are working,

including the safety

features, and should be trained, with periodic refresher training, in what to

do when things go wrong.

Additional training should occur when new medical radiological equipment is

brought into use in the

radiology facility.

3.60. Many local rules and procedures address aspects of some, or

all, of occupational radiation

protection, patient radiation protection and public radiation protection,

either directly or indirectly, as

well as ensuring a successful diagnostic examination or

intervention. This is the case with the

following paragraphs (3.61 to 3.82) – while placed in this section on

occupational radiation protection

because they are to be followed by workers, the local rules and

procedures often also have

significance for patient and/or public radiation protection. The

following paragraphs (3.61 to 3.82)

give recommendations that should be incorporated into the radiology

facility’s local rules and

procedures.

3.61. For those radiological procedures where there is no need for staff to be

in the room during an

exposure, all attending staff should position themselves in the appropriately

shielded areas.

3.62. Immobilization devices (e.g. CT head cradle) should be used

whenever possible and as

appropriate to minimize exposure to the patient, staff or carer or comforter.

Immobilization of patients

should not be performed by staff and, if possible, not by any person. If

immobilization requires the

use of a person, then this should be someone, such as a relative of the

patient, who has agreed to be a

carer and comforter, and is afforded radiation protection accordingly (see

paras. 3. 238 – 3.242).

3.63. For general radiography:

(a) At no time should the X ray tube be pointed at the control console

area;

(b) Given that the patient is the source of scatter, care should be

taken to ensure that the patient

position is as far from the control console as is feasible, taking

into account the room

configuration and accessories, and preferably more than one metre distant from

the console.

3.64. For mobile radiography:

(a) Operators¹⁴ should wear lead aprons and maintain as much

distance as possible between

themselves and the patient (to minimize exposure to scatter), whilst

still maintaining good

visual supervision of the patient and being able to communicate verbally with

him/her;

(b) Other staff (e.g., nursing, medical and ancillary staff) are

not considered as occupationally

exposed workers and hence should be afforded protection as a member of the

public. This is

achieved by ensuring such persons are as far away from the patient

as possible during the

exposure (at least 3 meters) or are behind appropriate barriers;

patient, protective aprons

should be worn (e.g., an anaesthetist with a ventilated patient or a

nurse with an unstable

patient);

(d) Verbal warning of an imminent exposure is given;

(e) Consideration should be given to other patients who may be nearby.

(See also sub-section on

public radiation protection, para. 3.269.)

3.65. In many emergency departments, ceiling suspended X ray equipment

provides a versatile

environment for performing rapid trauma radiography. Appropriate occupational

radiation protection

can be afforded through the following:

(a) Lead aprons should be worn by staff members that need to be adjacent

to the patient being

exposed;

(b) The primary beam should be directed away from staff and other

patients whenever possible;

¹⁴ The term “operator” is used generically in this section. The

operator is usually a medical radiation

technologist, but may sometimes be a radiological medical practitioner, such as

a radiologist.

during exposure, whilst still

maintaining good visual supervision of the patient;

(d) Where available, mobile shields should be used;

(e) Any pregnant staff member (other than radiology staff)

should be asked by the medical

radiation technologist to leave the vicinity during exposure;

(f) Verbal warning of imminent exposure is given.

3.66. For CT, when staff need to be in the room during exposures,

additional measures should be

taken:

(a) In the case of CT interventions, the interventionist should use

appropriate personal protective

equipment (protective apron, thyroid shield, protective eye-wear). In addition,

care should be

exercised to avoid placing hands in the primary beam and immediate

notification to the

interventionist should be given if this does happen;

(b) In the case of persons providing medical support, e.g.,

anaesthetists, a protective apron should

be worn and the person should position themselves as far from the gantry as

possible, whilst

still maintaining good visual supervision of the patient.

3.67. For diagnostic fluoroscopic procedures, when staff need to be

in the room, the following

measures should be taken:

(a) The staff member performing the procedure should use

personal protective equipment

(protective apron, thyroid shield, protective eye-wear, gloves). In

addition, care should be

exercised to avoid placing hands in the primary beam;

(b) In the case of persons providing medical support, e.g.,

anaesthetists, a protective apron should

be worn and the person should position themselves as far from the patient as

possible during

screening.

3.68. For radiological procedures performed with mobile fluoroscopic units

(C-arm systems):

(a) The staff member performing the procedure should use

personal protective equipment

(protective apron, thyroid shield, protective eye-wear, gloves). In

addition, care should be

exercised to avoid placing hands in the primary beam and immediate

notification to the

fluoroscopist should be given if this does happen;

(b) Only essential staff should remain in the room. All such staff are

considered occupationally

exposed workers;

patient, protective aprons

should be worn (e.g., an anaesthetist with a ventilated patient or a

nurse with an unstable

patient). At no time should a pregnant staff member take on this role;

(d) For other practical advice, including X ray tube orientation and

positioning, mobile shields,

technical parameter selection, see the section on image guided

interventional procedures

(paras 3.74 to 3.81).

3.69. For mammography, the medical radiation technologist should stand behind

the protective barrier

attached to the mammography unit when making the exposure.

3.70. For dental facilities with intraoral and panoramic (OPG)

equipment, personal protective

equipment is not usually needed. Radiation protection is afforded through the

use of distance from the

patient. Typically, a distance of at least two metres is recommended.

3.71. Cone beam CT (CBCT) is in use in some dental facilities, and should be

housed in a room that

has been designed and shielded accordingly (see para. 3.34). The staff should

be positioned behind the

protective barrier at the control console when exposures are being made.

3.72. For DEXA, the radiation levels around the unit are very low

and there are no specific

precautions that should be taken with respect to occupational

radiation protection. Typically the

operator can be in the room with the patient when the machine is

operating. The operators’ desk

should be positioned at least 1 m away from a pencil beam, and at least 2 m

from a fan-beam system.

In the case of fan-beam and cone-beam configurations or if the

distances above cannot be

accommodated, the use of protective screens should be considered.

3.73. Local rules for pregnant workers and persons under 18 should

reflect the guidance given in

paras. 3.127 – 3.129 and 3.130 respectively.

Local rules and procedures – image guided interventional procedures

3.74. Image guided interventional procedures, performed either in

fluoroscopy rooms or dedicated

interventional rooms, tend to be complex and are performed on patients who can

be quite ill and/or

have a life threatening condition. As a consequence, more staff will

be needed in the room to attend to

the patients’ individual medical needs (e.g., interventionists,

anaesthetists, medical radiation

technologists, nurses, and sometimes other specialists). Not only will more

staff be exposed during

interventional procedures, they may also be standing close to the

patient where dose rates from

radiation scattered by the patient are high.

3.75. Interventional procedures require specifically designed and dedicated

equipment. The exposure

rate in the vicinity of the patient is lower on the beam exit side

of the patient. For a vertical

orientation, an under-couch X ray tube with an over-couch image receptor has

lower levels of scatter

in the area of the operator’s trunk and head than an over-couch X ray

tube with an under-couch image

receptor. A similar situation exists with lateral projections, where the

maximum scatter radiation is on

the X ray tube side of the patient. Staff should, where practicable, always

stand on the image receptor

side of the patient during lateral or oblique projections.

3.76. There are simple methods of reducing exposure to staff as a

result of operational factors,

including choosing where to stand or to be positioned in the room. Since the

patient is the main source

of scatter radiation, the staff should remain as far away as practicable from

the patient when exposures

are taking place, to reduce exposure to staff. For the interventionist, taking

a step or even half a step

back during image acquisition results in a significant reduction in

occupational dose. As discussed in

para. 3.75, the X ray tube orientation and positioning will determine where it

is best to stand in order

to be in an area subject to relatively low scatter.

3.77. Staff should never be subject to direct beam exposure. This includes

avoiding placing the hands

in the beam whenever possible. When hands of the operator are close to the

direct beam, an under-

couch X ray tube with an over-couch image receptor should be used,

because the exposure rate is

lower on the beam exit side of the patient and the exposure to the operator’s

hands is significantly

reduced.

3.78. There are many operational factors that affect the

patient dose during image guided

interventional procedures, and these factors in turn affect staff dose because

the dose to the patient

determines the amount of scatter being produced. Methods to reduce

patient dose are described in

paras 3.182 to 3.187, and should always be used to reduce both patient and

staff doses.

3.79. Medical radiological equipment specifically designed for

image guided interventional

procedures often incorporates protective devices, such as ceiling

suspended lead acrylic viewing

screens, and under-table and lateral shielding attachments to the X ray

couch, and personal mobile

shields. Alternatively, such devices can be purchased separately. These devices

can afford individuals

significant radiation protection, but they can sometimes be cumbersome

to use. However, the

appropriate use of these devices will result in a significant reduction in

staff doses.

3.80. Higher incidence of radiation injuries to the lens of the eye has been

reported for interventionists

and nurses performing image guided interventional procedures [123]. For

this reason it is strongly

recommended that interventionists, and other staff who routinely work close to

the patient, always use

ceiling mounted screens and/or protective eye-wear. This is further reinforced

by the requirement to

comply with the relatively low dose limit (20 mSv per year) for the lens of the

eye. It is quite likely

that the dose limit would be exceeded for an interventionist performing several

hundred image guided

interventional procedures in a year if that person used no protection for the

eyes.

3.81. Further specific guidance on interventional radiology and interventional

cardiology, endorsed by

several regional professional societies, can be found in references [124, 125].

3.82. Some image guided interventional procedures are performed using CT and

the guidance given in

para 3.66 applies.

Personal protective equipment

3.83. As required in the BSS paragraph 3.93 and 3.95, personal

protective equipment and in-room

protective equipment should be available and used when structural

shielding and administrative

controls alone cannot afford the required level of occupational

radiation protection. This typically

arises when staff are required to be in the room where and when the

radiological procedures are taking

place, such as with image guided interventional procedures and

fluoroscopy, and with mobile

radiography. The need for these protective devices should be established by the

radiology facility’s

RPO or medical physicist.

3.84. Personal protective equipment is worn on the person and

includes protective aprons, thyroid

protectors, protective eye-wear, and protective gloves. Protective aprons are

available in many shapes,

configurations, materials and lead equivalence, and should be chosen to

best suit the intended use.

Some aprons require using fully overlapping panels to provide complete

coverage. Expert advice on

personal protective equipment should be sought from the RPO or medical

physicist.

3.85. For image guided interventional procedures, wrap around aprons,

preferably consisting of vests

and skirts to spread the weight, should be used. They should cover:

(a) From the neck down to at least 10 cm below the knees;

(b) The entire breast bone (sternum) and shoulders;

at least halfway down

the thighs;

(d) The back from the shoulders down to and including the buttocks.

3.86. Protective gloves are useful to protect the hands near the beam but may

produce the opposite

effect during fluoroscopy with automatic brightness control (ABC) when

the hands enter the area

covered by the sensor of the ABC, because this would drive the exposure to

higher levels for both the

staff and the patient and would be ineffective in protecting the hands. Even if

the fluoroscopy system

operates without ABC, leaded gloves may prolong the procedure because

they do no afford the

necessary tactile sensitivity and thus their value is questionable.

3.87. Protective eye-wear, especially for use in image guided interventional

procedures, should cover

the entire orbit. This requires lateral protection provided by shielded sides

and that the glasses are a

close fit.

3.88. The lead-equivalence of personal protective equipment should be

specified at the maximum

operating X Ray tube potential (kVp) applicable for its intended use.

3.89. Non-lead based personal protective equipment, incorporating

shielding materials, such as tin,

tungsten, bismuth, and antimony, may be preferable if they are lighter and

easier to use. Care should

be taken in interpreting claimed lead equivalences for non-lead based

protective equipment, and

expert advice from the RPO or medical physicist should be sought.

3.90. Protective equipment for pregnant workers should be carefully

considered, as wrap around

aprons may no longer provide adequate protection for the embryo/fetus

to meet BSS requirements

(BSS paragraph 3.114). The RPO or medical physicist should be consulted as

needed.

3.91. Personal protective equipment, in particular protective aprons,

can lose their protective

effectiveness if mistreated or not appropriately used or cared for.

All personnel that use personal

protective equipment have the responsibility for its appropriate use and

care, for example ensuring

aprons are correctly hung and stored to minimize damage.

3.92. Personal protective equipment should be examined under

fluoroscopy at least annually to

confirm its shielding integrity.

In-room protective devices

3.93. Additional protective devices for use in fluoroscopy and image guided

interventional procedures

include:

(a) Ceiling suspended protective screens for protecting eyes and the

thyroid while keeping visual

contact with the patient. Technical advances with such screens include

systems that move

with the operator;

(b) Protective lead curtains or drapes mounted on the patient table;

mounted on coasters (full body);

(d) Disposable patient protective drapes.

Monitoring of the workplace

3.94. The BSS, in paragraphs 3.96-3.98, sets out the requirements and

responsibilities for workplace

monitoring. Workplace monitoring comprises measurements made in the working

environment and

the interpretation of such results. Workplace monitoring serves several

purposes, including routine

monitoring, special monitoring for specific occasions, activities or tasks, and

confirmatory monitoring

to check assumptions made about exposure conditions. Workplace monitoring can

be used to verify

the occupational doses of personnel whose work involves exposure to

predictable low levels of

radiation. It should be particularly used for staff members who are not

individually monitored. Further

general guidance on workplace monitoring is given in Ref [23].

3.95. Workplace monitoring in areas around each of the medical

radiological equipment in the

radiology facility, when it is being operated, should be carried out when:

(a) The room and shielding construction has been completed,

regardless whether it is a new

construction or a renovation, and before the room is first used clinically;

(b) New or substantially refurbished equipment is commissioned

(both direct and indirect

radiation such as leakage and scatter should be measured);

installed or there is a significant

upgrade;

(d) New techniques are introduced;

(e) Servicing on the medical radiological equipment has been

performed, which may have an

impact on the radiation delivered.

3.96. Workplace monitoring should be performed and documented as part of the

radiology facility’s

radiation protection programme. The radiology facility’s RPO or medical

physicist should provide

specific advice on the workplace monitoring programme, including any

investigations that arise

through investigation levels being exceeded (see para. 3.115).

3.97. The survey meters used for radiation monitoring should be calibrated in

terms of ambient dose

equivalent. For diagnostic radiology and image guided interventional

procedures, the quantity is

H*(10) and the unit the Sv and its sub-multiples.

Assessment of occupational exposure and workers’ health surveillance

Occupational exposure assessment

3.98. The purpose of monitoring and dose assessment is, inter alia, to provide

information about the

actual exposure of workers and confirmation of good working practices and

regulatory compliance. It

contributes to reassurance and motivation. The BSS require individual

monitoring for any worker who

normally works in a controlled area or any worker who occasionally works in a

controlled area and is

likely to receive significant occupational exposure (see BSS paragraphs 3.99 to

3.102). Workers who

may require individual monitoring include radiologists,

cardiologists, gastroenterologists,

endoscopists, urologists, orthopaedic surgeons, neurosurgeons, respiratory

physicians, anaesthetists,

medical physicists, biomedical/clinical engineers, medical radiation

technologists, nurses, and the

RPO.

3.99. Monitoring involves more than just measurement. It includes

interpretation, assessment,

investigation and reporting, which may lead to corrective measures, if

necessary. Individual external

doses are assessed using individual monitoring devices that

include thermoluminescent dosimeters

(TLD), optical stimulated luminescence dosimeters (OSLD), film badges, and

electronic dosimeters.

Care should be taken when using electronic dosimeters in pulsed X ray

fields that they function

correctly. Individual monitoring devices must be calibrated, traceable

to a standards dosimetry

laboratory. For more detailed guidance see Ref [23].

3.100. Each dosimeter is to be used for monitoring only the person to whom it

is issued, for work

performed at that radiology facility and should not be taken to other

facilities where that person may

work. For example, if a person is issued with a dosimeter at

hospital A it should be worn only at

hospital A and not at any other hospitals or medical centres where he/she may

also work. Monitoring

results can then be interpreted for the person working in a specific

radiology facility, and allow

appropriate review of the effectiveness of the optimization of

protection for that individual in that

facility. See also paras. 3.117 to 3.118.

3.101. The monitoring period (period of dosimeter deployment) specified

by regulatory bodies in

most countries is typically in the range of one to three months. A one

month monitoring period is

usually used for persons performing procedures associated with higher

occupational exposures, such

as image guided interventional procedures. A longer monitoring period (two or

three months) is more

typical for personnel exposed to lower doses, as a one month cycle would

usually mean that the actual

occupational dose was less than the minimum detection level of the

dosimeter resulting in no

detectable doses. With a longer cycle it is more likely to obtain a

reading. The radiology facility

should send the dosimeters to the dosimetry service provider who should then

process the dosimeters

and return the dose reports, all in a timely manner. Some regulatory

bodies may specify a

performance criterion for timely reporting.

3.102. The operational dosimetric quantity used is the personal dose

equivalent Hp(d). For weakly

penetrating and strongly penetrating radiation, the recommended depths, d, are

0.07 mm and 10 mm,

respectively. Radiation used in diagnostic radiology and image guided

interventional procedures is

usually relatively strongly penetrating, and therefore d = 10 mm for dosimeters

being used to assess

effective dose. Hp(10) is used to provide an estimate of

effective dose that avoids both

underestimation and excessive overestimation [23]. In diagnostic

radiology and image guided

interventional procedures, the overestimation is somewhat larger because

of the lower photon

penetration from X ray beams in the kV range [126, 127]. If a protective apron

or thyroid shield is

being worn, the relationship between Hp(10) effective dose becomes

more complex and additional

guidance is given below in para. 3.109.

3.103. For monitoring the skin and extremities, a depth of 0.07 mm (d = 0.07)

is recommended, and

Hp(0.07) is used to provide an estimate of equivalent dose to the skin and

extremities.

3.104. For monitoring the lens of the eye, a depth of 3 mm (d = 3) is

recommended, and Hp(3) is used

to provide an estimate of equivalent dose to the lens of the eye. In practice,

however, the use of Hp(3)

has not been widely implemented for routine individual monitoring. In cases

where eye doses are a

concern, such as in image guided interventional procedures, Hp(0.07), and to a

lesser extent Hp(10),

can be considered as an acceptable surrogate operational quantity. More

guidelines are provided in the

IAEA publication [128].

3.105. There are three dose limits applicable to workers in

diagnostic radiology and image guided

interventional procedures – effective dose; and equivalent dose to the lens of

the eye, and to skin and

extremities. The dosimeter being worn will be used to estimate one or more of

the quantities used for

the dose limits. Depending on the work being performed by the person being

individually monitored,

there may be a preferred position for wearing the dosimeter, and more than one

dosimeter may be

used.

3.106. For individual monitoring with only one dosimeter in diagnostic

radiology and image guided

interventional procedures:

(a) If the monitored worker never wears a protective apron, the

dosimeter should be worn on the

front of the torso between the shoulders and the waist;

(b) If the monitored worker sometimes wears a protective apron, the

dosimeter should be worn on

the front of the torso between the shoulders and the waist, and

under the apron when it is

being worn;

dosimeter should be worn on the

front of the torso at shoulder or collar level outside the apron (see also

para. 3.107);

(d) If the working situation is such that the radiation is always or

predominantly coming from one

side of the person, such as in image guided interventional procedures, the

dosimeter should be

placed, in addition to the guidance in (a) to (c), on the front of the torso on

the side closest to

the source of radiation.

3.107. For individual monitoring with two dosimeters, such as in

image guided interventional

procedures where the monitored worker always wears a protective apron,

one dosimeter should be

worn on the front of the torso at shoulder or collar level outside the apron

on the side closest to the

source of radiation. The other dosimeter should be worn on the front

of the torso between the

shoulders and the waist and under the apron, preferably on the side closest to

the source of radiation.

3.108. Specialized dosimeters, such as ring dosimeters for monitoring

finger doses, will have their

own specific wearing instructions which should be followed.

3.109. When a protective apron is being used, the assessment of

effective dose may not be

straightforward:

(a) A single dosimeter placed under the apron, reported in Hp(10),

provides a good estimate of the

contribution to the effective dose by the parts of the body

protected by the apron, but

underestimates the contribution of the unprotected parts of the body (thyroid,

head and neck,

and extremities).

(b) A single dosimeter worn outside the apron, reported in

Hp(10), provides a significant

overestimate of effective dose and should be corrected for the

protection afforded by the

apron by using an appropriate algorithm [ 123, 127 129].

other outside the apron, an

algorithm should be applied to estimate effective dose from the two reported

values of Hp(10)

[127, 129].

3.110. As noted in para. 3.104, dosimeters for reporting Hp(3) are not widely

available. A dosimeter

worn outside the apron at collar or neck level, reported in either Hp(0.07) or

Hp(10), can provide a

surrogate estimate for the equivalent dose to the lens of the eye. Whether

protective eye-wear was

being worn or not should be taken into account to correctly interpret the dose

estimate.

3.111. When not in use, individual dosimeters should be kept in an established

place and protected

from damage or from irradiation. If an individual’s dosimeter is lost, the RPO

should perform a dose

assessment, record this evaluation of the dose and add it to the worker’s dose

record. Where there is a

national dose registry, it should be informed of the dose estimate

in a timely manner. The most

reliable method for estimating an individual’s dose is to use his or her recent

dose history. In those

cases where the individual performs non-routine types of work, it may be better

to use the doses of co-

workers having similar exposure conditions as the basis for the dose estimate.

3.112. In some radiology facilities and for some individuals with a low level

of occupational exposure

(e.g. general dental practitioners), area dosimetry to estimate the level of

dose per procedure can be an

acceptable alternative to individual monitoring. Knowing the typical level of

dose per procedure for

positions where personnel are placed during exposures and the number of

procedures per year, the

RPO can estimate personnel doses.

3.113. Similarly, occupational doses can be estimated from the results of

workplace monitoring. The

effective dose for personnel can be inferred from the measured ambient dose

equivalent H*(10). ICRP

Publication 116 provides conversion coefficients from ambient dose equivalent

to effective dose for

different types of radiation and energies [126]. The conversion coefficients

for photons are close to

unity except for very low energy, such as the energy of scattered photons from

a mammography X ray

beam.

3.114. An additional direct reading operational dosimeters, such as

appropriately calibrated electronic

dosimeters, may be also used in image guided interventional procedures, as

these devices can give the

worker an instant indication of both the cumulative dose and the current dose

rate and are a useful

educative tool for the optimization of occupational radiation protection [23].

Investigation levels for staff exposure

3.115. Investigation levels are separate from dose constraints and dose limits;

they are a tool used to

provide a ‘warning’ of the need to review procedures and performance,

investigate what is not

working as expected and take timely corrective action. Exceeding an

investigation level should

prompt such actions. The following are examples for radiology facilities of

levels and their related

tasks that should not normally be exceeded and, therefore, could be suitable as

investigation levels.

For example, monthly values higher than 0.5 mSv (for the dosimeter worn under

the protective apron)

should be investigated. Values higher than 2 mSv per month [125]

from the over-apron dosimeter

may indicate that eye doses may be of concern. Values higher than 15 mSv per

month for hand or

finger dosimeters should also be investigated. Abnormal conditions and/or

events should also trigger

an investigation. In all cases the investigation is carried out with a view to

improve implementation of

optimization of occupational protection and results should be recorded.

Investigation levels should

also be set for workplace monitoring.

3.116. The investigation is to be initiated as soon as possible

following the trigger or event and a

written report is to be prepared concerning the cause, including determination

or verification of the

dose, corrective or mitigating actions, and instructions or recommendations to

avoid recurrence. Such

reports should be reviewed by quality assurance and radiation safety

committees, as appropriate, and

the holder of the licence should be informed. In some cases, the regulatory

body may also need to be

informed.

Persons who work in more than one place

3.117. Personnel may work regularly in more than one radiology facility. The

facilities may be quite

separate entities in terms of ownership and management, or they may have common

ownership but

separate management, or they may have common ownership and management, but be

physically quite

separate. No matter which, the occupational radiation protection

requirements for the particular

radiology facility apply when the person is working in that facility. As

described above in para. 3.100,

a dosimeter issued for individual monitoring should be worn only in the

facility for which it is issued

as this facilitates effective implementation of optimization of protection in

that facility. This approach

is logistically more easily implemented as each physical site has its own

dosimeters – there is no need

to transport dosimeters between facilities, with the risk of either

loss or forgetting them. In cases

where the facilities are under common ownership it may be seen as an

unnecessary financial burden to

provide more than one set of dosimeters for staff that work in more than one of

its facilities. However

the radiation protection advantages of having the dosimeter results linked to a

person’s work in only

one radiology facility remain. See also para. 3.119.

3.118. There is however an additional consideration, namely

ensuring compliance with the

occupational dose limits. Any person who works in multiple radiology

facilities should notify the

licensee for each of those facilities. Each licensee, through their RPO,

establishes formal contact with

the licensees of the other radiology facilities, and their RPOs, so that each

facility has an arrangement

to ensure that a personal dosimeter is available and that there is

an on-going record of the

occupational doses for that person in all the facilities where they work.

3.119. Some personnel, such as consultant medical physicists or service

engineers, may perform work

in many radiology facilities and, maybe as well, other medical

radiation facilities. They may be

employed by a company or be self-employed, providing contracted services to the

radiology and other

facilities. In such cases it is simpler for the company or the

self-employed person to provide the

dosimeters for individual monitoring. In other words, in these cases

for each person the same

dosimeter is used for work performed in all radiology facilities (and other

medical radiation facilities)

in the monitoring period.

Records of occupational exposure

3.120. Paragraphs 3.103 to 3.107 of the BSS state the requirements

for records of occupational

exposure, placing obligations on the employer, registrant and licensee.

Apart from demonstrating

compliance with legal requirements, records of occupational exposure

should be used within the

radiology facility for additional purposes, including assessing the

effectiveness of the facility’s

implementation of optimization of protection, and evaluating trends in

exposure. National or local

regulatory bodies might specify additional requirements for records of

occupational exposure and for

access to the information contained in those records. Employer shall provide

workers with access to

records of their own occupational exposure (BSS, para 3.106 (a). Further

general guidance on records

of occupational exposure is given in [23].

Workers’ health surveillance

3.121. The primary purpose of health surveillance is to assess the

initial and continuing fitness of

employees for their intended tasks, and requirements are given in BSS

paragraphs 3.108 to 3.109.

3.122. No specific health surveillance related to exposure to ionizing

radiation is necessary for staff

involved in diagnostic radiology or image guided interventional procedures,

with perhaps the possible

exception of initial and periodic eye assessments for visual acuity

and contrast resolution for

personnel performing significant numbers of image guided interventional

procedures. Only in cases of

overexposed workers, at doses much higher than the dose limits (e.g. a few

hundred millisieverts or

higher), would special investigations involving biological dosimetry and

further extended diagnosis

and medical treatment be necessary [23]. Under normal working conditions, the

occupational doses

incurred in diagnostic radiology and image guided interventional procedures are

low and no specific

radiation related examinations are required for persons who are occupationally

exposed to ionizing

radiation, as there are no diagnostic tests that yield information

relevant to normal exposure. It is,

therefore, rare for considerations of occupational exposure arising from the

working environment of a

radiology facility to significantly influence the decision about the

fitness of a worker to undertake

work with radiation or to influence the general conditions of service [23].

3.123. Counselling should be available to workers who have or may have been

exposed in excess of

dose limits, and information, advice and, if indicated, counselling should be

available to workers who

are concerned about their radiation exposure. In diagnostic radiology and image

guided procedures,

the latter group may include women who are or may be pregnant such as, for

example, female medical

radiation technologists and nurses working in therapy wards.

Counselling should be given by

appropriately experienced and qualified practitioners. Further guidance is

given in [23].

Information, instruction and training

3.124. All staff involved in diagnostic radiology and image guided

interventional procedures should

fulfil the respective training and competence criteria described in

Section 2, paras. 2.117 to 2.135.

This will include general education, training, qualification and competence for

occupational radiation

protection. Radiological medical practitioners, medical radiation

technologists and nurses working

with hybrid units (such as PET-CT, SPECT-CT) may have trained

exclusively in their original

specialty. They should undertake radiation protection training relevant

to the additional imaging

modality.

3.125. The BSS, in paragraph 3.110, places responsibilities on

employers to provide, inter alia,

specific instruction and training for protection and safety as it

pertains to their radiology facilities.

This is not only for new staff but also for all staff as part of

their continuing professional

development. Specific instruction and training should be provided when

new medical radiological

procedures, equipment, software and technologies are introduced.

Conditions of service and special arrangements

3.126. As required in BSS paragraph 3.111, no special benefits are to be

offered to staff because they

are occupationally exposed. It is simply not acceptable to offer benefits as

substitutes for measures for

protection and safety.

Female workers (pregnant)

3.127. A female worker should notify the licensee that she is pregnant as soon

as she knows of her

condition, so that radiation protection requirements for the embryo/fetus as a

member of the public

can be met.

3.128. The limitation of the dose to the embryo/fetus does not mean

that pregnant women should

avoid work with radiation, but it does imply that the employer should carefully

review the exposure

conditions with regard to both normal exposure and potential exposure. A

possible solution includes

reassigning a pregnant worker to a location that may have lower

ambient dose equivalent; for

example, from fluoroscopy to radiography or to CT. Adequate training

should accompany such

reassignments.

3.129. When applying the dose limit of 1 mSv to the fetus, the

reading of the dosimeter may

overestimate fetal dose by a factor of 10. If the reading corresponds to a

dosimeter worn outside a lead

apron, the overestimation of fetal dose may rise to a factor of 100 [130].

Counselling for pregnant

workers should be available (see also para. 3.123).

Persons under 18

3.130. In many countries there is the possibility of students aged

16 or more, but under 18,

commencing their studies and training to become a medical radiation

technologist or other health

professional that may involve occupational exposure to ionizing radiation. The

BSS paragraph 3.116

states the requirements for access to controlled areas and the dose limits for

such persons are more

restrictive – see Table 2 in this Safety Guide and Schedule III of the BSS.

RADIATION PROTECTION OF PATIENTS, CARERS AND COMFORTERS, AND

VOLUNTEERS IN BIOMEDICAL RESEARCH

Introduction

3.131. The section covers what is more formally called ‘medical exposure’

in radiation protection.

Medical exposure is defined in the BSS and described in Section 2, para. 2.5.

It concerns radiation

protection of the patient, carers and comforters, and volunteers in

biomedical research. The term

‘patient’, when used in the context of medical exposure, means the person

undergoing the radiological

procedure. Other patients in the radiology facility, including those who may be

waiting for their own

radiological procedure, are considered as members of the public and

their radiation protection is

covered in paras. 3.264 to 3.273.

3.132. As described in Section 2 para. 2.8, there are no dose limits for

medical exposure, making it

very important that there is effective application of the requirements for

justification and optimization.

Justification of medical exposures

3.133. The requirements of the BSS for justification of medical exposure,

paragraphs 3.156 to 3.163,

incorporate the ‘3 level approach’ to justification [4, 131, 132].

3.134. The roles of the health authority and professional bodies with respect

to ‘level 2’ or generic

justification of radiological procedures, justification of health screening

programmes, and justification

of screening intended for the early detection of disease, but not as

part of a health screening

programme, are described in Section 2 paras. 2.55 to 2.58, and 2.64.

Justification for the individual patient

3.135. The BSS invokes a joint approach to justification at the individual

patient level, with a shared

decision involving both the referring medical practitioner (who initiates the

request for a radiological

procedure) and the radiological medical practitioner. A referral should be

regarded as a ‘request for a

professional consultation or opinion’ rather than an ‘instruction or order to

perform’. The referring

medical practitioner brings the knowledge of the medical context and

the patient’s history to the

decision process, while the radiological medical practitioner has the

specialist expertise on the

radiological procedures. The efficacy, benefits and risks of alternative

methods (both involving and

not involving ionizing radiation) should be considered. In all cases the

justification is informed by

national or international referral guidelines, for example Refs [133 – 141].

Ultimate responsibility will

be identified by individual member states’ regulations.

3.136. The patient also should be informed about the expected benefits, risks

and limitations of the

proposed radiological procedure(s), as well as the consequences of not

undergoing the procedure.

3.137. Justification, which is a radiation protection principle, is implemented

more effectively as part

of the medical process of determining ‘appropriateness’. Appropriateness

uses an evidence-based

approach to choose the best test for a given clinical scenario,

taking into account the diagnostic

efficacy of the radiological procedure as well as alternative

procedures that do not use ionizing

radiation, for example, ultrasound, MRI or endoscopy. Useful tools to support

this decision making

process include national or international imaging referral guidelines

developed by professional

societies [133 – 141]. Imaging referral guidelines can be disseminated through

electronic requesting

systems¹⁵ and clinical decision support tools or systems.

3.138. In determining appropriateness of the radiological procedure for

an individual patient, the

following questions should be asked by the referring medical practitioner

[138];

(a) Has it been done already? A radiological procedure that has already

been performed within a

reasonable time period (depending on the procedure and clinical

question) should not be

repeated. The results (images and reports) of previous examinations should be

available, not

only within a given radiology facility but also between different

facilities. Digital imaging

¹⁵ Such electronic requesting systems include the so-called CPOE – computerized

physician order entry, noting

that for imaging such a system should generate a request rather than an order.

modalities and electronic networks should facilitate this process. Individual

patient exposure

records should facilitate decision making process if available.

(b) Is it needed? The results of the proposed radiological procedure

(positive or negative) should

influence the patient’s management.

procedure in relation to the

progression of the suspected disease and the possibilities for

treatment, all should be

considered as a whole.

(d) Is this the best investigation to answer the clinical question?

Advances in imaging techniques

are taking place continually, and the referring medical practitioner may need

to discuss with

the radiological medical practitioner what is currently available for a given

problem.

(e) Has the clinical problem been explained to the radiological

medical practitioner? The

medical context for the requested radiological procedure is crucial to

ensure the correct

technique is performed with the correct focus.

3.139. For a large percentage of radiological procedures, primarily ‘well

established’ and low dose

procedures, the practical implementation of justification may be

achieved through the medical

radiation technologist, who is effectively representing the radiological

medical practitioner with the

formal understanding that, if there is uncertainty, the radiological

medical practitioner is contacted

and the final decision is taken by the radiological medical

practitioner in consultation with the

referring medical practitioner. Such justification is guided by

national or international referral

guidelines.

3.140. For the smaller percentage of radiological procedures, primarily because

of a combination of

complexity, difficult medical context, and higher dose, the

justification is likely to be led by the

radiological medical practitioner with the referring medical practitioner

providing any needed further

clarification on the medical context. Again the justification is informed by

national or international

referral guidelines.

3.141. Two particular groups of patients are identified in the BSS,

paragraph 3.157, for special

consideration with respect to justification – patients who may be pregnant and

paediatrics.

(a) Due to the higher radiosensitivity of the embryo/fetus, it

should be ascertained whether a

female patient is pregnant before performing an X ray examination for diagnosis

or an image

guided interventional procedure. Determining pregnancy status is a requirement

in the BSS,

paragraph 3.176, for those radiological procedures that could result in

significant dose to the

embryo or fetus. Pregnancy would then be a factor in the

justification process and might

influence the timing of the proposed radiological procedure or whether another

examination is

more appropriate. Confirmation of pregnancy may occur after the

initial justification and

before the radiological procedure is performed. Repeat justification is

required taking into

account the additional sensitivity of the pregnant female patient and embryo or

fetus.

(b) As children are at greater risk of incurring

radiation-induced stochastic effects, paediatric

examinations require special consideration in the justification process.

3.142. Review of the justification may need to take place if circumstances

change. For example, the

performance of a low dose procedure that has been justified but, at

the time of performing the

examination, a high dose protocol is needed. Such a case might be the

justification for low dose CT

for renal colic would have to be reviewed if high-dose enhanced CT urography is

actually needed to

answer the clinical question.

3.143. ‘Self-referral’ occurs when a health professional undertakes a

radiological procedure for

patients as a result of justification based on their own previous

clinical assessment. Examples of

acceptable self-referral practice include: dentistry, cardiology,

orthopaedics, vascular surgery,

urology, and gastroenterology. Relevant professional bodies in many

countries develop appropriate

guidance for their specialty, for example dental associations [142].

3.144. ‘Self-presentation’ occurs when a member of the public asks

for a radiological procedure

without a referral from a health professional. This may have been

prompted by media reports or

advertising. Examples include ‘individual health assessment’ which often

involves CT procedures in

asymptomatic individuals for early detection of cancer (e.g. whole body CT,

lung CT or colon CT)

and/or quantification of coronary artery calcification (coronary artery CT).

Justification is required, as

for all radiological procedures. Relevant professional bodies have an

important role in considering

evidence for developing guidance when new practices are proposed, as for

example in the case of CT

[143]. Member states may choose to incorporate this into legislation [144].

3.145. Approaches to support the implementation of the requirements

for justification for medical

exposures should consider the development of means to improve

‘awareness, appropriateness and

audit’. Awareness of the need for justification underpins the whole

process. Means for promoting

awareness include traditional education and training, such as at

medical school or during specialty

training, web-based learning or learning through work flow at the right

time,(e.g. junior doctors in the

emergency department), and the use of feedback in the reporting process.

Appropriateness has been

described in paras. 3.137 – 3.138, and the process of audit is used for

monitoring and feedback to

improve both awareness and appropriateness.

Justification – biomedical research volunteers

3.146. The role of the ethics committee in the justification of medical

exposure of volunteers exposed

as part of a programme of biomedical research is described in Section 2 para

2.98.

Justification – carers and comforters

3.147. The justification of medical exposure incurred by a carer or comforter

is effectively carried out

by the radiological medical practitioner or medical radiation technologist

involved in the radiological

procedure, prior to the performance of the procedure. It depends on

the carer or comforter being

correctly informed about the radiation doses and risks involved, and his or her

understanding of this

information and consequent agreement to take on the role of carer or comforter.

Optimization of protection and safety

3.148. In medical exposures, optimization of protection and safety has

several components, some

applied directly to the radiological procedure about to be performed and others

providing the support

or framework for the other components. These components of optimization of

protection and safety

are described in the following paras. 3.149 to 3.243.

Design considerations

3.149. The use of appropriate and well-designed medical radiological

equipment underpins any

radiological procedure in diagnostic radiology or any image guided

interventional procedure. X ray

generators and their accessories should be designed and manufactured so as to

facilitate the keeping of

medical exposures as low as reasonably achievable consistent with

obtaining adequate diagnostic

information or guidance for the intervention. Extensive guidance on design

considerations is given in

the sub-section on medical radiological equipment, paras. 3.26 to 3.39. This

guidance is applicable to

both stand-alone and hybrid systems. Ultimately, as stated in the BSS

paragraph 3.162, it is the

responsibility of the radiology facility licensee to ensure that

his/her facility uses only medical

radiological equipment and software that meets applicable international or

national standards.

Operational considerations - general

3.150. Following justification, the diagnostic radiological procedure or image

guided interventional

procedure is performed in such a way as to optimize patient

protection, as required in the BSS

paragraph 3.163. The level of image quality sufficient for diagnosis is

determined by the radiological

medical practitioner and is based on the clinical question posed and the

anatomical structures imaged

(e.g., the diagnosis of the pattern of sinusitis on CT requires only

a low dose procedure as high

contrast structures viz. air and bone are being imaged). With image guided

interventional procedures,

additionally, the level of image quality should be sufficient to guide the

intervention.

3.151. The following points apply to all diagnostic radiological

procedures or image guided

interventional procedures:

(a) There should be an effective system for correct identification of

patients, with at least two

forms of verification, for example name, birthday, address, medical record

number.

(b) Patient details should be correctly recorded, such as age, gender, weight,

height, pregnancy

status.

3.152. The first step in operational considerations of optimization is to

select the appropriate medical

radiological equipment. For example, a chest X ray should be performed using

dedicated equipment

with a generator producing high output enabling the use of a long source

to image receptor distance

(typically 1.8 m) and a short exposure time to ensure a reproducible

diagnostic quality image by

minimizing patient respiratory and cardiac motion.

3.153. The volume (area) of the patient that is exposed should

bestrictly limited to that of clinical

interest. This is achieved through collimation for radiography, mammography,

fluoroscopy and image

guided interventional procedures, and through choice of scan

parameters in CT. For digital

radiography image cropping, performed after the exposure, does not achieve the

same reduction in

exposed volume as collimation. See also the paragraphs below for more

specific guidance for the

different modalities.

3.154. Patient co-operation should be achieved to produce a diagnostic

quality image. This is

particularly relevant when imaging children. Good communication helps

to achieve this. Verbal

interaction between the medical radiological technologist or the medical

radiological practitioner and

the patient should be in place before, during and after the procedure.

3.155. Optimization of protection for women undergoing radiological

procedures during pregnancy

should take into account the woman and the embryo/fetus. Routine diagnostic CT

examinations of the

pelvic region with and without contrast injection can reach lead to a dose of

50 mSv to the uterus

which is assumed to be equivalent to the fetal dose in early

pregnancy. When CT scanning is

indicated in a pregnant patient, Low-dose CT protocols should be used and the

scanning area should

be reduced to a minimum possible.

3.156. Shielding of radiosensitive organs such as the gonads, lens of

the eye, breast and thyroid

should be used when appropriate.

3.157. For each modality there are a number of factors which can be adjusted to

influence the image

quality and patient dose relationship. Written protocols that specify the

operational parameters to be

used for common diagnostic radiological procedures should be developed, adopted

and implemented

in each radiology facility. The protocol ‘technique charts’ should be posted

adjacent to each X ray

generator and be specific for each piece of equipment. The protocols should

take into account patient

habitus, especially mass. The protocols are best developed using

guidelines from national or

international professional bodies, and hence reflect current best practices, as

for example in Refs [145

– 155]. For modern digital equipment many of the factors are

automated through menu-driven

examination selections on the console. Nevertheless, in setting up

these options, significant scope

exists for optimization of protection through the appropriate

selection of values for the various

technical parameters, thereby producing effectively an electronic ‘technique

chart’.

3.158. Size specific written protocols should be developed for children, from

neonates to teenagers,

and include additional operational considerations, such as the use of

additional filtration or the

removal of grids when appropriate [151, 154, 155].

3.159. The BSS paragraph 3. 166 (b) set special requirement to the

optimization of protection for

individuals subject to medical exposure as part of an approved health

screening programme. All

aspects should be considered before the approval of the program and

during its implementation:

selection of X-ray equipment suitable for the particular screening, parameters

settings, etc. Dedicated

quality assurance program should be implemented to meet screening objectives,

as described in more

details in paras 3.225 – 3.237.

Operational considerations - radiography

3.160. In developing protocols for radiography, many technique factors should

be considered which

can influence the image quality and the patient dose for the radiographic

projection. Detailed guidance

on appropriate choices for those factors is widely available [145, 150, 151,

156 – 162]. Such factors

include:

(a) The tube potential (kV); current (mA); exposure time; focal

spot size; filtration; source to

image receptor distance (SID, FID or FFD); choice of anti-scatter

grids or Bucky device;

collimation; image receptor size; patient positioning, immobilisation and

compression;

(b) The number of projections needed (e.g. PA chest X ray rather than PA

and lateral X rays);

pelvic radiographs in boys);

3.161. Suitably calibrated and maintained automatic exposure controlled

systems (AEC) should be

used when available and appropriate. Particular attention should be given to

paediatric radiography to

ensure that the AEC sensor(s) is(are) within the radiation field. AEC systems

are calibrated based on

the radiation exposure at the detector required to produce the desired level of

optical density (OD) for

film-screen systems or a pre-determined acceptable level of signal to noise

ratio (SNR), or surrogate,

for digital systems. The value for the SNR should be established as part of

setting up the protocols for

radiographic projections for each particular X ray unit. When AEC is

not available, consideration

should be made of the patient size and thickness of the body part imaged in

determining technique

factors.

3.162. For digital systems, users should understand how the selection of

“exposure index” (or similar

term for exposure indicator) affects patient dose. For some manufacturers,

increasing the index lowers

the dose; for others, it increases it [163].

3.163. For film-based image acquisition systems, additional factors

include: the type (speed and

spectral response) of film–screen combination and film processing conditions

(e.g. the chemicals used

and developing time and temperature).

3.164. Mobile and portable radiographic equipment usually produce

images of lower quality

compared with fixed units, and should only be used for examinations where it is

impractical or not

medically acceptable to transfer patients to a fixed unit.

3.165. Patient should be properly positioned and immobilized. In addition,

instructions should be clear

and in the language understood by the patient (e.g. “Please hold your breath”).

Operational considerations - mammography

3.166. In developing protocols for mammography, consideration of

radiographic technique factors

should be made as for radiography, in para 3.160. Additional factors

that should be considered

include: adequate compression; tissue composition (e.g. dense glandular breasts

identified on previous

mammograms); and correct choice of anode and filters. Detailed guidance on

appropriate choices for

technique factors and additional factors is available [119 - 122, 147, 164 –

166].

3.167. For film-based mammographic systems, additional factors include:

the type of film–screen

combination and film processing conditions (e.g. the chemicals used,

and developing time and

temperature), as discussed in Refs [119 – 121].

3.168. Breast tomosynthesis is an evolving technique where guidance

for optimization is likely to

become available as the modality matures. A review of features that influence

image acquisition has

been made in Ref. [167].

3.169. Viewing conditions are of paramount importance for both

digital and film-based

mammography systems, and the operational performance should be meet the

conditions described in

paras. 3.24, 3.25 and 3.41. Poor viewing conditions not only

compromise the reporting of a good

quality image, but they may also lead to changes in technique

factors, in a mistaken attempt to

compensate for the poor viewing conditions, that actually result in

sub-optimal image quality. For

example, use of low luminance viewing boxes may lead to radiographs being

produced that have a

low density with insufficient diagnostic content. Although the dose may be

reduced, there might be an

unacceptable loss of diagnostic information.

Operational considerations - CT

3.170. In developing protocols for CT, many technique factors and

features should be considered

which can influence the image quality and the patient dose for the

examination, including: tube

potential; tube current; tube current modulation with noise index; pitch; beam

width; total scan length,

over-ranging and over-beaming. These and other factors may be

optimized through automatic

exposure control systems where available. The choice of protocol will be

determined by the clinical

question to be answered (e.g. for cardiac CT, a low dose protocol is sufficient

for stratifying risk in

patients with intermediate probability for coronary artery disease,

whereas a higher dose contrast

enhanced protocol is needed for patients with suspected coronary artery

disease). Detailed guidance

on appropriate choices for these factors and features is available [65, 146,

152, 153, 155, 157, 160,

161, 168 – 172].

3.171. Careful consideration should be made as to the need for multiple phase

studies to answer the

clinical question (e.g. CT abdomen portal venous phase only for routine

detection of liver metastases

rather than triple phase - arterial, portal venous and delayed phase

acquisitions). Protocols for

optimized CT procedures for common clinical conditions should be

agreed, put in place and used.

This applies particularly to children where protocols based on size should be

used [153, 160, 161].

3.172. Consideration of a spiral or axial technique will depend on the

indication and will have an

implication on image quality and dose (e.g. for diffuse lung disease a

non-contiguous single slice

protocol is preferred for high resolution lung CT, and delivers lower patient

dose).

3.173. Improved image presentation, reconstruction algorithms and

post-processing features to reduce

image noise can have the potential to enable the choice of a protocol with

reduced patient dose. An

example is the use of iterative reconstruction algorithms.

3.174. Proper positioning of the patient and proper setting of the scanned

anatomical area of interest

should be achieved, e.g. CT thorax with both arms raised or CT of the wrist in

the ‘superman position’

(i.e. with the patient lying prone with the affected arm stretched out

above his or her head) are of

considerable advantage to avoid artefact and to reduce dose. Immobilizing

devices may be used where

appropriate. Special attention should be made for proper immobilisation of

paediatric patients by use

of straps, swaddling clothes, plastic holders for the head or

body, foam pads, sponges, sand bags,

pillows or other objects.

3.175. Including the lens of the eye in the primary beam should be avoided.

This may be achieved in

brain scans by using a head cradle or, in some cases, tilting the gantry.

3.176. For CT angiography, use of software to detect the arrival of contrast

medium in the relevant

vessel to trigger the volume acquisition has image quality advantages and

avoids repeat acquisitions

(e.g. detecting contrast medium in the pulmonary artery in CT pulmonary

angiography).

3.177. For cardiac CT and CT angiography, use of software to control

acquisition with respect to the

patient electrocardiograph (ECG-gated or ECG triggered studies) should

be considered, when

appropriate, to reduce radiation dose.

3.178. For hybrid imaging with CT (e.g. PET-CT and SPECT-CT), consideration

should be given to

the use of a low dose CT protocol to correct for PET or SPECT attenuation,

which may necessitate a

second diagnostic procedure of the primary area of interest or a

higher dose CT protocol (often

contrast-enhanced) as part of the hybrid procedure.

3.179. Cone beam CT (CBCT) is used for imaging the head and neck

(e.g. sinuses where there is

significant artefact from dental amalgam) as well as for dental indications.

Operational aspects with

respect to optimization are still evolving. Guidance is available [173, 174]

and factors that should be

considered include: tube potential, tube current-exposure time product, field

of view, voxel size, and

the number of projections.

Operational considerations - dentistry

3.180. In developing protocols for conventional intra-oral radiography, factors

that can influence the

image quality and the patient dose include: tube potential (kV);

current (mA); exposure time;

collimation; focus to skin distance; and for analogue systems, film speed and

processing development

time and temperature. Detailed guidance on appropriate choices for those

factors is available [175,

176].

3.181. In developing protocols for panoramic imaging, additional factors that

can influence the image

quality and the patient dose include: patient positioning (e.g. jaw open /

closed); collimation (e.g. for

temporomandibular joint examinations only these areas should be

included); and for analogue

systems, film/screen speed and processing development time and temperature.

Detailed guidance on

appropriate choices for those factors is available [175, 176].

Operational considerations - image guided interventional procedures

3.182. The choice of imaging modality for guidance will depend on

the clinical scenario (e.g.

fluoroscopic guidance for percutaneous coronary intervention, CT guidance for

biopsy). Occasionally

more than one modality may be used in a single interventional procedure to

improve effectiveness and

safety. This may result in a lower dose when the second modality is

non-ionizing (e.g. ultrasound is

used to locate the renal pelvis in percutaneous nephrostomy before fluoroscopic

catheter placement).

Furthermore the correct selection of equipment with appropriate size

(and shape) of flat panel or

image intensifier will improve diagnostic image quality.

3.183. Patient co-operation should be ensured forthe successful

interventions (e.g. movement may

compromise accuracy of roadmaps when performing aneurysm embolization in

neuro-intervention). It

is imperative that patients are briefed about the intervention prior

to the commencement of the

procedure so that they know what to expect and how to cooperate.

3.184. In developing protocols for fluoroscopically guided interventional

procedures, many technique

factors and features should be considered which can influence the image quality

and the patient dose

for the intervention, including: tube potential; tube current; use of pulsed

fluoroscopy (hence pulse

width and rate); dose rate mode (effectively the image intensifier or flat

panel detector input air kerma

rate); collimation, and collimation tracking with focus to detector

distance; filtration (fixed and

variable); use of magnification; total fluoroscopy time for the

intervention; image acquisition dose

mode (effectively the image intensifier or flat panel detector input

air kerma per frame); image

acquisition frame rate; number of frames per run and the total

number of acquisitions. Detailed

guidance on appropriate choices for these factors and features is available

[123, 157, 158, 160, 161,

177 – 180].

3.185. Many of the factors in para. 3.182 are automated through an

algorithm-driven ‘automatic

brightness control system’ (ABC). Nevertheless, in setting up the

algorithm, scope exists for

optimization of protection through the selection of values for these

parameters. For example, image

intensifier or flat panel detector input air kerma rates (for fluoroscopy) and

input air kerma per frame

(for image acquisition) are set during installation and adjusted thereafter

during periodic maintenance

and servicing. The values actually used for these settings can vary

considerably. High rate dose modes

in fluoroscopy should be used only during the minimum indispensable

time necessary to the

procedure. The use of magnification modes should be kept to a minimum

consistent with a successful

intervention.

3.186. In the course of the intervention the tube orientation and position may

need to be changed – for

long procedures the area of skin where the X ray beam is incident upon the

patient should be changed

during the procedure to avoid deterministic skin effects. As a

default from a radiation protection

perspective, it is preferable to have the X ray tube under the

patient (i.e. “under couch”). Steep

oblique projections should be avoided. The distance between the X ray tube and

patient should always

be maximized to reduce patient dose. Typically for a vertical beam this

is achieved by having the

table as high as possible for the primary operator. In conjunction with this,

the image intensifier or flat

panel detector is positioned as close to the patient as possible.

3.187. Particular paediatric considerations include: use of special filtration,

removal of the grid; gonad

protection.

3.188. In developing protocols for CT guided interventional procedures,

technique factors that should

be considered, which can influence the image quality and the patient

dose for the intervention,

include: tube potential; tube current; and beam width. The number of image

acquisitions should be

kept to a minimum consistent with a successful intervention.

Operational considerations - fluoroscopy

3.189. See fluoroscopic considerations in the image guided

interventional procedures sub-section,

paras. 3.184 – 3.187.

Operational considerations - bone densitometry

3.190. Selection of the appropriate site for densitometry will take into

account both the anatomical

area of clinical concern as well as the likelihood of non-representative images

and measurements due

artefacts (e.g. massive vertebral osteophytes may obviate the value of lumbar

densitometry).Guidance

is given in Ref [181].

Operational considerations - emergency radiology

3.191. Special considerations for the emergency department include:

judicious patient positioning

taking into account injury or disease (e.g. lateral shoot through

projection of the hip); and CT

protocols with the minimum number of acquisitions (e.g. contrast enhanced CT

for polytrauma when

one acquisition only is needed for diagnosis and expedience).

Calibration - general

3.192. Following the BSS paragraph 1.46, for diagnostic radiology and image

guided interventional

procedures the dosimetric quantities and units of ICRU are to be used [8, 182].

Further guidance on

dosimetry in diagnostic radiology is given in Refs [9, 183].

3.193. Calibration requirements for medical radiological equipment and

dosimetry equipment are

given in the BSS paragraph 3.167. Responsibility is assigned to the

radiology facility’s medical

physicist. After the initial calibration, the intervals for periodic

calibrations may differ, depending on

the complexity of the medical radiological equipment. Related to calibrations

are the constancy tests

on equipment performance performed as quality control tests. These are

described in paras 3.228 and

3.230 – 3.231.

Calibration – medical radiological equipment

3.194. In diagnostic radiology, including medical radiological equipment used

for radiation therapy

simulation and treatment verification and hybrid imaging systems,

and for image guided

interventional procedures, ‘source calibration’ is to be interpreted as

the measurement of certain

dosimetric quantities which are modality-dependent and should be carried out in

reference conditions.

3.195. For diagnostic radiographic and fluoroscopic medical radiological

equipment, including

conventional radiation therapy simulators, the dosimetric quantities are:

incident air kerma, Kₐ,i, in Gy,

incident air kerma rate, Ķₐ,i, in Gy.s⁻¹ and air kerma-area product,

PKA, in Gy.m² (noting that some

manufacturers use μGy.m² or mGy.cm² or Gy.cm²).

3.196. In CT, the dosimetric quantities are (see also [8, 9, 182 - 186]):

(a) CT air kerma index, CK, usually in mGy. In many countries

the more colloquial term

computed tomography dose index, CTDI, is used, and has been accepted by ICRU

[182];

(b) Weighted CT air kerma index, CW, usually in mGy, which is the CT air

kerma calculated from

measurements at the centre and periphery of a standard PMMA CT head or body

phantom. As

in (a), this quantity is often simply called weighted CTDI or CTDIW;

account the helical pitch

or axial scan spacing. As in (a), this quantity is often simply called volume

CTDI or CTDIVOL;

(d) CT air kerma-length-product, PKL,CT, usually in mGy.cm. In

many countries the more

colloquial term dose-length-product, DLP, is used, and has been accepted by

ICRU [182].

3.197. In mammography, three dosimetric quantities are used: incident air

kerma, entrance surface air

kerma and mean glandular dose, DG, usually in mGy [8, 9].

3.198. Measurements of these dosimetric quantities, when being used to

calibrate or characterize a

given X ray, CT or mammography unit output or performance, should be

made for a range of

representative technique factors used clinically, and following recognized

protocols such as in Ref [9].

Calibration – dosimetry instrumentation

3.199. Dosimetry instrumentation used at a radiology facility should

be calibrated at appropriate

intervals. A period of two to three years is recommended. See also para. 3.235

on associated quality

assurance guidance.

3.200. The BSS in paragraph 3.167(d) requires the calibration of

dosimetry instrumentation to be

traceable to a standards dosimetry laboratory (SDL). Ideally this

would be to the national SDL

(primary or secondary) in the State concerned, with access either directly or

through a duly accredited

calibration facility. However, it may be necessary for dosimetry

instruments to be sent to another

country or state if there is no national SDL in the country or state where the

instruments are used. At

present only some of the secondary SDLs of the IAEA/WHO network provide

calibration services

using diagnostic radiology spectra and dose rates representative of clinical

practice. However, since

dosimetry accuracy is not as critical in diagnostic radiology as in radiation

therapy, calibrations with

comparable radiation qualities should be sufficient. Alternatively, the

regulatory body may accept

instrument manufacturers’ “calibrations” as spelled out in the “certificate of

calibration” issued by the

instrument manufacturer, provided that the manufacturer operates or uses a

calibration facility that is

itself traceable to a SDL and appropriate calibration conditions have been

used. This certificate should

state the overall uncertainty of the calibration factors.

3.201. Records of calibration measurements and associated calculations,

including uncertainty

determinations (budgets), should be maintained as described in

para. 3.263. Uncertainty

determinations for several radiological examinations have been calculated by

the IAEA [9, 161].

3.202. There is a role for cross-calibration of dosimeters, where the

radiology facility’s dosimeters

that have been officially calibrated are used to check or compare

with other dosimeters. This is

particularly important for field KAP meters which should be calibrated (or

cross-calibrated) against a

reference KAP meter or air kerma dosimeter in situ in the clinical rather than

in a SDL environment

[9]. It might also occur when a radiology facility has many dosimeters, and

to calibrate all dosimeters

could be too costly. Cross-calibration can also be utilized as a constancy

check, as part of periodic

quality control tests.

Dosimetry of patients

3.203. The BSS paragraph 3.168 requires facilities to ensure that

patient dosimetry in diagnostic

radiology and image guided interventional procedures is performed and

typical doses for their

radiological procedures are determined. Knowledge of a facility’s typical

doses forms the basis for

applying methods of dose reduction as part optimization of protection. It also

enables the radiology

facility to use diagnostic reference levels (see paras. 3.217 to 3.224) as

another tool for optimization

of protection.

3.204. Clearly, the more radiological procedures at the radiology facility for

which typical doses are

known, the better the basis for optimization of protection. However,

pragmatically, the BSS requires

typical dose determination for only common radiological procedures in radiology

facilities. What is

common will vary from facility to facility, and country to country, but in

general there are some core

common examinations, including:

(a) Radiography – head, chest, abdomen and pelvis;

(b) CT – head, chest, abdomen and pelvis, for specified clinical

indications;

(d) Mammography – cranio-caudal, medio-lateral-oblique;

(e) Dentistry – intraoral, panoramic (orthopantomography), cone-beam CT

(f) Bone densitometry (DEXA) – spine and hip.

3.205. For image guided interventional procedures, the facility should

ascertain typical doses for the

broad types of procedures they perform. For example, an interventional

cardiology facility would

characterize typical doses for percutaneous coronary interventions,

including PTCAs. A facility

performing neurological procedures might characterize typical doses for

their diagnostic cerebral

angiograms and for their embolization interventions. Other image guided

interventional procedures

might include ERCP (endoscopic retrograde cholangiopancreatography) and

TIPS (transjugular

intrahepatic portosystemic shunt).

3.206. The term ‘typical dose’, as used in the BSS paragraph 3.168, means the

average or median of

the doses for a sample of relatively standard-sized patients, at

clinically acceptable image quality.

Patient size has a large influence on dose, so some selection or grouping of

patients is required. Such

groupings include ‘average adult’, often based around an average weight of 70

kg with a range of ± 20

kg. Groupings for children have sometimes been based on age, such as new born

(0 years), infant (1

year), small child (5 years), child (10 years) and teenager (15 years), but

more recently size-specific

groupings are being used. The radiology facility should adopt patient size

groupings that correspond

with the groupings used in their country or state for DRLs. The

sample size used for each patient

grouping and radiological procedure should be sufficient to assure confidence

in the determination of

the mean dose. Such sample sizes are typically in the range of 20 patients, but

clearly the larger the

sample the better the statistics.

3.207. Dose in the term ‘typical dose’, as used in the BSS

paragraph 3.168, means for the given

radiological procedure an accepted dosimetric quantity as described in

paras. 3.195 - 3.196. For

particular reasons, e.g. for risk estimation or for collective dose estimation,

organ doses or effective

dose can be estimated from typical dose.

3.208. Patient dosimetry to determine typical doses should be carried

out in conjunction with an

assessment of the diagnostic image quality. Exposure alone is not meaningful if

it does not correspond

to images that are adequate for an accurate diagnosis. Therefore patients

included in the sample used

for determining typical doses should be only those whose radiological

procedure resulted in

acceptable image quality.

3.209. The results of the surveys used to determine typical doses at the

radiology facility should be

used as part of the facility’s on-going review of the implementation of

optimization of protection, and

that additionally will be used for comparison with established DRLs (see paras.

3.217 to 3.224). The

results should also be submitted to the organization in their country or

state that is responsible for

establishing and reviewing the national or regional DRLs. Patient dosimetry

surveys, required by the

BSS, should take place at intervals of no more than 5 years and

preferably no more than 3 years.

Another trigger for a survey would be the introduction of new

equipment or technology into the

radiology facility or when significant changes have been made to the protocols

or the equipment.

3.210. Sometimes patient dosimetry in diagnostic radiology or

image guided interventional

procedures may be required for specific individual patients,

either through measurements or

calculations. Reasons might include an unintended or accidental medical

exposure, where estimation

of patient doses is required as part of the investigation and report (see

para. 3.256) or because there is

a need to estimate embryo or fetal doses (see para. 3.155).

3.211. There are several indirect and direct methods to estimate patient dose

in diagnostic radiology

and image guided interventional procedures. Methodologies for these

determinations are explained in

detail in Refs [8, 9, 180, 182 – 187] and summarized below:

(a) Estimations based on incident air kerma (Kₐ,i ) or

entrance surface air kerma (Kₐ,ₐ)

measurements corrected for the techniques used (X ray tube potential,

current and time,

source-skin-distance, etc.). This approach can be used for radiography,

fluoroscopy and

mammography.

(b) Estimations based on measured air kerma-area product (PKA). This

approach can be used for

radiography, fluoroscopy and CBCT.

(b) Estimations based on measurements of CT air kerma index (CVOL) and

CT air kerma-length

product (PKL,CT). This approach can be used for CT.

the DICOM radiation dose

structured reports. The accuracy of the reported dose quantities should have

been validated at

acceptance testing and commissioning and during QA procedures as explained in

para. 3.235.

This approach is applicable to all digital modalities.

(d) Direct measurements in selected organs such as the skin in

interventional procedures. For this

purpose thermoluminescent and optically-stimulated dosimeters (TLDs and OSLs)

as well as

radiochromic or silver halide film can be used.

(e) In the case of CT, size-specific dose estimates, SSDE, can be made,

where CVOL values are

corrected taking into consideration the size of the patient using linear

dimensions measured on

the patient or patient images [182, 187].

3.212. When needed, organ doses can be derived from the quantities

mentioned in para. 3.211 by

using conversion coefficients derived from Monte Carlo codes applied to

anatomical models. Methods

for doing this are discussed in Ref [9].

Dosimetry of patients - specific considerations for image guided interventional

procedures

3.213. For interventional procedures using X rays, in addition to the

quantities that are related to

stochastic effects, such as air kerma-area product, it is critical to monitor

cumulative doses to the most

exposed areas of skin because of the potential for reaching the

threshold for tissue effects in

complicated cases [188, 189].

3.214. The determination of the dose to the most exposed area of skin is not

straightforward since

exposure parameters and projection angles change during the procedure and the

most exposed area

cannot always be anticipated. This makes the knowledge of the skin

dose distribution (sometimes

called ‘dose mapping’ over the skin) necessary. A comprehensive review of

approaches to obtain dose

mapping and to determine the most exposed area of the skin is given in Ref

[180].

3.215. An established method for dose mapping uses low sensitivity X ray films,

such as films used in

radiation therapy and radiochromic films. However, determination of the dose is

only possible after

the procedure.

3.216. The cumulative dose at the interventional reference point Kₐ,r, defined

as the kerma in air at

15 cm from the isocentre in the direction of the X ray tube [74], either

displayed during the procedure

and/or obtained from the DICOM header, may be used as a conservative estimate

for peak skin dose.

The degree of over-estimation depends on several factors, including how often

the beam projection

was changed. The cumulative dose at the interventional reference point gives

the least over-estimation

when most of the radiation is delivered in just one beam projection.

The accuracy of the reported

cumulative dose at the interventional reference point should have been

validated at acceptance testing

and commissioning and during QA procedures, as explained in para. 3.233.

Diagnostic reference levels

3.217. The BSS, paragraphs 3.168 - 3.169, requires that radiology facilities

perform patient dosimetry

surveys, as described in paras 3.203 to 3.209, and that these results are

compared with the established

DRLs for their country or region. The purpose is to ascertain whether the

typical dose in the facility

for a given radiological procedure compares favourably, or not, with the value

of the DRL for that

radiological procedure. Guidance on establishing national or regional

DRLs in given in Section 2,

paras. 2.34 to 2.45.

3.218. A review of optimization of protection for that particular radiological

procedure is triggered if

the comparison shows that the facility’s typical dose exceeds the DRL, or that

the facility’s typical

dose is substantially below the DRL and it is evident that the exposures are

not producing images of

diagnostic usefulness or are not yielding the expected medical benefit to the

patient.

3.219. Given the uncertainties in determining a facility’s typical dose

(see paras 3.206 and 3.207),

questions can arise over whether a DRL has really been exceeded or not. Some

countries adopt an

algorithmic approach, for example where the facility’s typical dose,

minus two times its standard

error, should be greater than the value of the DRL [13]. A simpler

approach, based purely on the

facility’s typical value, may be sufficient as the purpose is to

identify the need for a review, and

perhaps it is better to perform more reviews than fewer.

3.220. No individual patient’s dose should be compared with a DRL. It is the

facility’s typical dose, as

determined by the representative patient sample, which is compared.

3.221. Further, the comparison is not a case of “Does the radiology facility

comply with the DRL?”

DRLs are not dose limits. It is mandatory to use them for the comparison

exercise to identify practices

that warrant further investigation.

3.222. The review of how the given radiological procedure is being performed

and its optimization of

protection, triggered by the DRL comparison, may conclude that there are valid

reasons supported by

sound clinical judgement why the radiology facility has a typical dose that

exceeds the DRL. These

reasons should be documented as part of the facility’s QA programme.

Adequateness of image quality

should be always taken into account. On the other hand, the review

may identify areas for

improvement resulting in revised protocols for that radiological procedure.

The results of the DRL

comparison and any ensuing review and actions should be documented as part of

the facility’s QA

programme.

3.223. The fact that a radiology facility’s typical dose for a

radiological procedure is less than the

DRL for that procedure does not mean necessarily that optimization of

protection for that radiological

procedure has been fully achieved. DRLs are only one of the tools for

optimization, aimed specifically

at identifying the outliers in performance.

3.224. The regulatory body in a given country may specify frequencies

for performing DRL

comparisons. Otherwise, the general guidance on patient dosimetry, described

above in para. 3.207,

would be applicable.

Quality assurance for medical exposures

3.225. The BSS paragraph 3.170 requires radiology facilities to have a

comprehensive programme of

quality assurance for medical exposures. General guidance on management

systems is given in

Section 2, paras 2.135 to 2.146, and it is simply re-iterated here

that the programme of quality

assurance for medical exposures should fit in with, and be part of, the

facility’s wider management

system. The paragraphs in this subsection give guidance on the technical

aspects of the programme of

quality assurance for medical exposures.

3.226. The purpose of the programme of quality assurance for medical exposures

is to help ensure

successful implementation of optimization of patient protection in the

radiology facility and to

minimize the occurrence of unintended and accidental medical exposures.

3.227. The complexity of the programme of quality assurance for medical

exposures will depend on

the type of facility. A dental practice with intra-oral only radiography will

have a simpler programme

compared with a facility that offers all modalities of diagnostic

radiology as well as image guided

interventional procedures. Nonetheless, most of the elements of the programme

are common, and it is

more in the degree of implementation that there are differences. The BSS

paragraph 3.171 establishes

the common elements of the programme.

3.228. Measurements on medical radiological equipment are one

of the components of the

programme. Acceptance tests are required for new or significantly refurbished

or repaired equipment,

or after the installation of new software or modification of existing

software that could affect

protection and safety of patients. The acceptance test is followed immediately

by commissioning, and

then on-going periodic quality control tests, including constancy tests. The

purpose is to ensure that,

at all times, all medical radiological equipment is performing correctly,

accurately, reproducibly and

predictably. Acceptance and commissioning tests should be performed in the same

way for equipment

and/or software that has been donated.

3.229. Depending on the equipment purchase agreement, acceptance tests may be

performed by the

manufacturer’s representative in the presence of the local medical

physicist and the radiological

medical practitioner representing the user, or, if acceptable to the

manufacturer and/or the purchaser,

by a medical physicist jointly with the manufacturer’s

representative. The process involves

verification of all specifications and features of the equipment.

3.230. After acceptance and before clinical use on patients, commissioning is

carried out by or under

the supervision of the medical physicist. Commissioning should include

measurements of all

parameters and conditions of use that are expected in clinical use, including

setting up or validating

image acquisition protocols. For most modalities (CT, image guided

interventional procedures,

tomosynthesis, mammography, DR/CR, fluoroscopy) the medical

physicist should be directly

involved in the measurements, calculations and interpretation of data to

characterize the equipment’s

performance. For the least complex modalities (dental and DEXA) the

medical physicist should

provide documented advice on how the commissioning should be performed. At

commissioning, the

baseline for subsequent constancy tests is established.

3.231. There are many published reports from international and national

organizations and national or

regional professional bodies giving detailed guidance on the

performance tests and quality control

tests that should be performed on the various modalities, including recommended

frequencies [111,

112, 117 – 122, 166, 170, 175, 176, 179 – 181, 183, 190 – 211].

In addition, many of these

organizations have extensive websites where any new or updated

publications on the topic can be

found. The regulatory body may have its own specific requirements on

the tests that should be

performed and their frequencies. It would be expected that such

specific requirements would have

been established with consultation between the regulatory body and the relevant

professional bodies.

3.232. Quality control tests also should be performed on other

equipment or devices that have an

impact on the successful outcome of the radiological procedure. Such equipment

and devices include,

but are not limited to: film processors, darkrooms, and cassettes for

facilities using film-based

imaging; CR plates and CR readers for facilities with CR systems; and view

boxes, workstations, and

reporting rooms. Many of the references given in para. 3.231 are applicable

here.

3.233. The results of the quality control tests should be compared with

established tolerance limits.

These limits may have been established to ensure compliance with a regulatory

requirement for the

performance of particular physical parameters or they may be set on the basis

of recommended values

given in published reports, such as referenced in para. 3.231.

As required in the BSS paragraph

3.171(b), if the measured values fall outside the tolerance limits, corrective

actions should take place.

Such corrective actions are likely to include maintenance or servicing of the

equipment, and hence the

radiology facility should have a preventive maintenance programme in

place. In some cases, the

equipment may be outside the tolerance limits by a significant amount and the

equipment should be

immediately taken out of clinical use and not returned until the servicing has

taken place and it has

been ascertained that the equipment meets the performance requirements.

3.234. The programme of quality assurance for medical exposures in

the radiology facility should

include use of “checks and balances” to ensure that the facility’s protocols

and procedures for imaging

and interventional procedures, including radiation protection and

safety, are being followed. The

periodic review of the protocols and procedures themselves is part of the

facility’s radiological review

(see 3.260 – 3.262). In addition a review of imaging procedures may

have been triggered by a

comparison with DRLs (see paras. 3.217 to 3.224).

3.235. The BSS paragraph 3.171(e) specifically requires that dosimetry and

monitoring equipment are

part of the QA programme. This is to ensure that such

instrumentation has a current calibration,

typically within 2 or 3 years (see para. 3.199), and that it is functioning

correctly. The programme of

quality assurance for medical exposures should establish a calibration cycle

for each instrument and a

set of quality control checks on the operation of each instrument to be

performed at set intervals. This

applies to stand alone dosimetry equipment and to dosimeters integrated into

the medical radiological

equipment, such as KAP meters in fluoroscopic systems, and to software of the

medical radiological

equipment itself that calculates, displays and reports dose metrics such as

CTDI and DLP in CT and

Kₐr in image guided interventional procedures.

3.236. Maintaining records is a crucial aspect of the programme of

quality assurance for medical

exposures. This includes the procedures used in the programme, and the results

of the quality control

tests, the dosimetry surveys, the DRL comparisons, corrective actions

and the investigations of

unintended and accidental medical exposures. When planning and

developing an effective QA

programme, licensees should recognize that it demands strong managerial

commitment and support in

the form of training and time, personnel and equipment resources.

The regulatory body, during its

inspections of a radiology facility, should review the records of the programme

of quality assurance

for medical exposures.

3.237. In line with standard practices for quality management, the BSS in

paragraph 3.172 requires

regular and independent audits of the programme of quality assurance for

medical exposures, adding

that the frequency of such audits will depend on the complexity of the

radiological procedures being

performed in the facility. Such audits may be internal or external.

Internal audits are usually

logistically simpler to implement, while the external audit generally has the

advantage of bringing in

an outside perspective. The audit of the radiology facility’s

programme of quality assurance for

medical exposures can be incorporated into more comprehensive audits that the

facility is performing

for its management system. Further, the results of the audit of the programme

of quality assurance for

medical exposures will be a major input into the radiology facility’s

radiological review (see paras.

3.260 to 3.262).

Dose constraints – carers and comforters

3.238. Some diagnostic radiological procedures, particularly of children, can

be better performed with

the assistance of a helper – the carer or comforter, for example a relative in

the case of a paediatric

patient, or a relative or friend for a disabled or very elderly or very ill

patient. In these circumstances,

the carer or comforter will be exposed, usually to a low dose.

3.239. The BSS paragraph 3.153 states that a carer or comforter must be

informed about the radiation

risks involved in helping with the radiological procedure and about the means

to be taken to afford

appropriate radiation protection to the carer or comforter. The carer or

comforter should indicate that

he/she has understood the information and is still willing to help with the

radiological procedure.

3.240. The radiation protection afforded the carer or comforter should be

optimized, and as part of this

process dose constraints should be applied, as required in the BSS

paragraph 3.173. These are the

dose constraints established by government, as a result of

consultation with the health authority,

relevant professional bodies and the regulatory body, as required by the BSS

paragraph 3.149(a)(ii)

(see also Section 2, paras, 2.48 to 2.49).

3.241. The radiology facility should have written protocols for the

optimization of protection

measures for carers and comforters who hold patients during radiological

procedures. The measures

should utilize the basic methods for radiation protection, i.e., time and

distance. The protocol should

include the following:

(a) Methods to avoid the need for holding patients, for example the

administration of sedatives

(especially for long procedures such as CT examinations) and the use of infant

restraints;

(b) Criteria specifying which carers and comforters are allowed

to hold patients, for example

friends and relatives, provided that they are not pregnant, but not employees

such as porters

and nurses (see also Section 2 para. 2.49);

that his or her exposure is as

low as reasonably achievable, for example by ensuring that the carer or

comforter is not in the

direct beam of the radiation device and that appropriate personal protective

equipment is used,

for example a protective apron or ancillary shields of a specified lead

equivalence;

(d) The values of the dose constraints to be applied (see

Section 2 para. 2.49) depend on the

radiological exam or intervention; a common value may be 5 mSv per event as

stated in para

2.49. Although it is unlikely that a child, closely related to the patient,

would be a carer or

comforter for a diagnostic radiological procedure, in cases where this is

unavoidable, his or

her dose should be constrained to less than 1 mSv.

3.242. Registrants and licensees should be able to demonstrate that the

effective dose to the carer or

comforter, by applying the protocol, is unlikely to exceed the dose

constraint. It is relatively

straightforward to estimate effective doses to carers and comforters

from measurements of the

ambient dose equivalent rates at the positions where they will be

situated. These determinations

should be made in advance to verify that dose constraint will not be exceeded.

Therefore, individual

dose monitoring is normally not necessary.

Dose constraints – volunteers in biomedical research

3.243. Some individuals will undergo diagnostic radiological procedures

as part of their voluntary

participation in an approved programme of biomedical research (see Section 2

para. 2.98). Part of the

approval process for the biomedical research will have been the

setting of dose constraints for the

radiological procedures (see Section 2 paras 2.98 - 2.99). When the volunteer

presents him/herself at

the radiology facility, he/she is to be afforded the same radiation protection

as if he/she were a patient

ready to undergo a radiological procedure within a normal healthcare pathway,

but with the additional

restriction that his/her exposure will be subject to a dose

constraint, either a nationally established

dose constraint or as specified by the ethics committee that approved

the biomedical research

programme (see Section 2 paras. 2.50, 2.98 and 2.99).

Pregnant female patients

3.244. Female patients who are pregnant form a special sub-group of

patients that should be

particularly considered with respect to radiation protection. These

considerations have been described

in para. 3.141(a) for justification and para. 3.155 for optimization. None of

these considerations can

take place if it is not known that the patient is pregnant. Therefore it is

crucial, as is required in the

BSS paragraphs 3.175 -3.176, for the radiology facility to have in

place means for ensuring that

pregnancy status is known for female patients.

3.245. The first approach is through posting of clear signs, in

languages easily understood by the

range of people using the radiology facility, asking the question

“Are you pregnant or possibly

pregnant?” and, if so, “Please tell the staff”. Such signs should be

posted widely in the facility,

including waiting rooms and cubicles. The second approach is to ask female

patients directly whether

they are or might be pregnant. This may not always be so easy given social and

cultural sensitivities,

but it should be done when needed.

3.246. Neither of the approaches described in para. 3.245 work if the woman

does not know if she is

or may be pregnant. For this reason, the BSS (paragraph 3.176) has

an additional requirement on

facilities to have “procedures in place for ascertaining the pregnancy

status of a female patient of

reproductive capacity before the performance of any radiological

procedure that could result in a

significant dose to the embryo or fetus”. Such radiological procedures

would include those that

involve primary beam irradiation of the abdomen or pelvis area

delivering relatively high patient

doses directly to the embryo or fetus, or to volumes near the uterus

such that significant scattered

radiation reaches the embryo or fetus. Cooperation with the referring

medical practitioner, through

standard requests for pregnancy status for specified radiological procedures,

is one approach. In case

of doubt, a pregnancy test or hormonal level determination to assess menopausal

status may be carried

out.

Unintended and accidental medical exposures

Prevention of unintended and accidental medical exposures

3.247. The BSS, paragraphs 3.179 to 3.181, sets out requirements both for

minimizing the likelihood

of unintended and accidental medical exposures and for the ensuing

investigation if such exposures

occur. The pathways identified in the BSS for potentially leading to unintended

or accidental medical

exposures include flaws in the design of medical radiological

equipment, failures of medical

radiological equipment while in operation, failures and errors in software that

control or influence the

delivery of the radiation, and human error. General strategies for addressing

those pathways include

regular maintenance of medical radiological equipment and software, a

comprehensive quality

assurance programme, and continuing education and training of staff. The

lessons learned from events

that have occurred should be used for preventing or minimizing unintended and

accidental medical

exposures, as described in para. 3.257.

3.248. A reduction in the probability of unintended or accidental

medical exposures in diagnostic

radiology and image guided interventional procedures can be brought about by:

(a) The introduction of safety barriers at identified critical points

in the radiology pathway, with

specific quality control checks at these points. Quality control is not

confined to physical tests

or checks but can include such as actions as correct identification of the

patient.

(b) Actively encouraging a culture of always working with awareness and

alertness.

radiology pathway.

(d) Education and training, including continuous professional

development, of all staff involved

in providing radiology services.

(e) Clear definitions of the roles, responsibilities and functions of

staff in the radiology facility

that are understood by all staff.

3.249. Preventive measures should include incident and near incident reporting,

analysis and feedback

including lessons learnt from international experience [123]. Preventive

measures should also include

each radiology facility checking the robustness of their safety system against

reported incidents. ICRP

85 [123] contains a review of case histories from a collection of unintended

and accidental medical

exposures in image guided interventional procedures.

3.250. Building on the guidance from paras 3.248 to 3.249, the following

three-step strategy can help

to prevent unintended and accidental medical exposures in the radiology

facility:

(a) allocate responsibilities to appropriately qualified health

professionals only and ensure that a

quality management system is in place that includes radiation safety;

(b) use the lessons learned from unintended and accidental medical

exposures to test whether the

quality management system, including for radiation safety, is robust

enough against these

types of events;

go wrong” or “what other

potential hazards might be present” in a systematic, anticipative

manner to all steps in the

diagnostic and interventional radiology process.

Investigation of unintended and accidental medical exposures

3.251. The events that constitute unintended or accidental medical exposures

are detailed in the BSS

paragraph 3.180. Unintended and accidental medical exposures may occur in all

imaging procedures;

however, the consequences in CT may be more severe and in image guided

interventional procedures

may be even more severe [123, 169].

3.252. Exposure of the wrong patient or wrong body part is always a possibility

in a radiology facility.

Many patients have similar names, for example, or patients may not have a

clear understanding of

what procedures are meant to take place. Facilities should have procedures

in place that consist of

several independent methods of patient identification, and verification of

examination requisition and

patient orientation.

3.253. One of the events requiring investigation is when the exposure was

“substantially greater than

was intended”. This situation may occur when the radiological procedure did not

go according to plan

– for example, the AEC in radiography may not have terminated the exposure when

expected because

the wrong sensors were selected or there was a hardware malfunction; or one or

more of the technique

factors in the examination protocol, for example for a CT examination, were

incorrectly set giving a

much higher dose than intended.

3.254. Another event that should be investigated is the inadvertent exposure of

the embryo or fetus in

the course of a radiological procedure, where at the time of the procedure it

was not known that the

woman was pregnant.

3.255. Radiation injuries have and do occur in image guided

interventional procedures. A given

procedure that may be performed in accordance with the facility’s protocol

still has the potential to

result in tissue effects because there were difficulties with the particular

patient. However, most cases

of reported severe radiation injuries involving ulceration and

necrosis were associated with

unnecessary and extreme exposure conditions, such as: (a) very short

distance between the X ray

source and the patient; (b) use of high dose-rate mode for a time much longer

than necessary; (c) fixed

projection exposing the same area of skin; and (d) malfunction of automatic

exposure control systems.

These situations cannot be considered to be normal, their occurrence can be

avoided and their severity

can be substantially reduced by optimization; they should be considered

accidental medical exposure

and investigated with a view to improve. Facilities performing

image guided interventional

procedures should have systems in place for identifying patients who

may be at risk from late

radiation injuries, typically based on estimates of peak skin

dose, cumulative dose at the

interventional reference point or kerma area product. For so-identified

patients, information should be

added to the patient’s medical record so that appropriate observation and

follow up is implemented.

For example, it is recommended that patients with estimated skin doses of 3 Gy

should be followed up

10-14 days after exposure [123]. Further information on trigger levels

for patient follow up are

available in the IAEA SAFRAD website [20]. Any resulting radiation

injury should receive

appropriate medical care.

3.256. The BSS, paragraph 3.181, states what should be done in the course of

the investigation. This

includes calculation or estimation of patient doses, which should be performed

by a medical physicist,

and notification of the event to the patient’s referring medical practitioner.

A record of the calculation

method and results should also be placed in the patient file. When required,

counselling of the patient

should be undertaken by someone with appropriate experience and clinical

knowledge.

3.257. The investigation of unintended and accidental medical

exposures, as required by the BSS

paragraphs 3.180 – 3.181, has three main purposes. The first is to

assess the consequences for the

patient (s) affected and provide remedial and health care actions if

necessary. The second is to

establish what went wrong and how to prevent or minimize the

likelihood of a recurrence in the

radiology facility – i.e. the investigation is for the facility’s and

their patients’ benefit. The third

purpose is to provide information to other persons or other radiology

facilities. Dissemination of

information about unintended and accidental medical exposures and

radiation injuries has greatly

contributed to increasing awareness worldwide of methods for avoiding

radiation injuries, for

example, by the FDA and ICRP Publication 85 [123, 188, 212, 213].

This might be through the

regulatory body and/or the health authorities for more significant events or as

required by a country’s

regulations, where the regulatory body disseminates information on the

event and the corrective

actions to other facilities that might learn from the event. Independently from

any legal requirement

for reporting to the regulatory body, the implementation of voluntary and

anonymous safety reporting

and learning systems can significantly contribute to improving safety and

safety culture in health care.

This includes participation in voluntary international or national

databases designed as educative

tools. One such database for image guided interventional procedures is

the so-called SAFRAD

reporting system (Safety in Radiological Procedures) [20]. Facilities

performing image guided

interventional procedures should participate in SAFRAD or similar databases.

3.258. As noted in para. 3.257, the BSS requires reporting to the regulatory

body and to the health

authority if appropriate for “significant” events. Further, the regulatory body

in a given country may

also specify their own requirements for reporting events to them. It

is difficult to quantify

“significant” – specifying a numerical trigger value immediately

creates an artificial distinction

between values immediately below that value (and hence should not be reported)

and those just above

the value (which should be reported). However, the attributes of

“significant” events can be

elaborated, and events with one or more of these attributes should be reported

to the regulatory body

and the health authority. Such attributes would include the occurrence of,

or the potential for, serious

unintended or unexpected health effects due to radiation, the likelihood of a

similar event occurring in

other radiology facilities, a large number of patients were affected,

and gross misconduct or

negligence by the responsible health professionals. As stated in para. 3.257

above, one of the roles of

the regulatory body for such a reported event is to disseminate

information on the event and the

lessons learned to all potentially affected parties – typically other

radiology facilities and relevant

professional bodies, but also in some cases manufacturers, suppliers, and

maintenance companies.

3.259. Irrespective of whether the event is also reported to the

regulatory body, feedback to staff

should be provided in a timely fashion and, where changes are

recommended, all staff should be

involved in bringing about their implementation.

Records and review

Radiological review

3.260. The BSS in paragraph 3.182 requires the performance of a periodic

radiological review at the

radiology facility. This involves considering both justification and

optimization aspects of radiation

protection. For the latter, the results of the programme of quality assurance

for medical exposures,

including the periodic independent audit, would be a significant input into the

process. As described

in Section 2, paras. 2.146 and 2.147, the wider clinical audit [52]

could include the radiological

review with its assessment of the effective application of the

requirements for justification and

optimization in the facility for the radiological procedures being performed.

3.261. To facilitate compliance with the BSS paragraph 3.182 and to learn from

periodic radiological

reviews, the methodology used, the original physical, technical and

clinical parameters considered,

and the conclusions reached should be documented and taken into account prior

to any new review

that may result in an update of the radiology facility’s policies and

procedures.

3.262. Radiological reviews should consider changes in patient

management that result from the

diagnostic or interventional procedure, the effect of introducing new

technologies on efficiency and

cost, and comparisons of different imaging modalities and of protocols for the

same pathologies.

Records

3.263. Records should be in place to demonstrate on-going compliance

with radiation protection

requirements. The BSS, paragraphs 3.183 to 3.185, specify requirements

for keeping personnel

records, records of calibration, dosimetry and quality assurance, and

records for medical exposure.

These records should be kept for the period specified by the country’s

regulatory body. In the absence

of such a requirement, a suggested period for keeping records is 10

years. In the case of children,

records should be kept for a longer time.

RADIATION PROTECTION OF THE PUBLIC

Introduction

3.264. Public exposure may arise from the performance of diagnostic

radiology and image guided

interventional procedures to persons in and around the radiology facility.

3.265. The requirements of the BSS for public protection, paragraphs 3.117 to

3.123, 3.125 to 3.127,

and 3.135 to 3.137, apply to radiology facilities. This sub-section contains

guidance very specific to

radiology facilities. For more general and comprehensive guidance on

radiation protection of the

public, reference should be made to the IAEA Safety Guide Radiation Protection

of the Public [24].

Non-occupationally exposed workers and visitors

3.266. Non-occupationally exposed workers are those persons who work at the

radiology facility but

not in a role that is directly involved in the use of X rays, for example ward

nurses, imaging staff who

work exclusively with non-radiation imaging modalities (ultrasound or

MRI), clerical staff, and

cleaning personnel. It also includes those persons who work at the wider

medical facility where the

radiology facility is located. These persons are to be afforded the same level

of radiation protection as

any member of the public, as required by the BSS paragraph 3.78.

3.267. Visitors to the radiology facility include those persons who will be

undergoing a radiological

procedure, for the time during the visit when the radiological

procedure is not taking place – for

example, while they are sitting in the waiting room. Similarly for

carers and comforters – any

exposure other than during the radiological procedure in which they

are helping will be public

exposure. Other visitors, including persons delivering goods or

supplies, sales personnel,

accompanying persons and escorts, and other patients in the facility, are also

considered members of

the public.

External exposure

3.268. The primary means for protecting the public (non-occupationally exposed

workers and visitors)

is to ensure that the shielding of the radiology facility (see paras. 3.17 –

3.23) is sufficient so that

public exposure resulting from being in any immediate adjacent area,

including rooms above and

below, accessible by either non-occupationally exposed workers or visitors

would be in compliance

with the public dose limits, and preferably less than any dose constraint that

the regulatory body may

have applied (see Section 2 paras. 2.16 and 2.46.)

3.269. Particular consideration should be given to patients in the

radiology facility, who are not

undergoing a radiological procedure, but are in the vicinity when

mobile radiography is being

performed in their ward or area, or when fixed radiography is being performed

in an open area, such

as in an emergency department. In these cases a combination of

distance, placement of mobile

shielding and careful control of the X ray beam direction should

ensure that appropriate public

radiation protection is being afforded.

Control of access

3.270. Access to areas where radiation is being used should be controlled to

provide for controlling

doses to visitors and non-occupationally exposed workers. According to the BSS,

paragraph 3.128,

access of visitors to radiology or interventional rooms or other

controlled areas while in use is

restricted. Exceptionally, a visitor, for example a health professional from

another medical facility,

may be accompanied by a staff member who knows the protection and

safety measures for the

controlled area. The radiology facility should have written procedures

specifying when such

exceptions can take place and who may do the accompanying. Similarly,

the facility should have

established the rules regarding non-occupationally exposed workers,

especially regarding access to

controlled and supervised areas. Particular attention, in all cases,

should be made with respect to

potentially pregnant women.

3.271. Controlled and supervised areas should be clearly identified to help

prevent inadvertent entry

to areas where diagnostic radiology or image guided interventional procedures

are being performed

[59]. See also para. 3.13. Further control can be afforded by the use of keys

(or passwords) to restrict

access to the control panels of medical radiological equipment to only

authorized persons.

Monitoring and reporting

3.272. The BSS, requirement 32 and paragraph 3.137, sets out the requirements

that should be met by

the radiology facility with respect to monitoring and reporting. In the

radiology facility, procedures

should be in place to ensure that:

(a) The requirements regarding public exposure are satisfied and to assess

such exposure;

(b) Appropriate records of the results of the monitoring programmes are kept.

3.273. The programme for monitoring public exposure arising from diagnostic

radiology and image

guided interventional procedures should include dose assessment in the areas in

and surrounding the

radiology facility which are accessible to the public. This can be

achieved from the shielding

calculations in the planning stage, combined by area monitoring at the initial

operation of the facility

and periodically thereafter. Records of these assessments should be kept for

typically 7-10 years, but

in any case for periods that meet any relevant regulatory requirements.

PREVENTION AND MITIGATION OF ACCIDENTS

Safety assessments

3.274. To comply with the BSS requirements for safety assessment

(paragraphs 3.29 to 3.36), the

registrant or licensee should conduct a safety assessment applied to

all stages of the design and

operation of the radiology facility. The safety assessment report should be

submitted to the regulatory

body if required. Basically, the safety assessment deals with determining

‘what can go wrong’ and

how it can be prevented and, in case it occurs, how it can be mitigated.

Section 2, paras 2.148 – 2.152,

describes general considerations for facilities using ionizing radiation for

medical purposes.

3.275. The safety assessment should be systematic and contain

information on identification of

possible events leading to accidental exposure (see Appendix I for a summary of

typical causes and

contributing factors to accidental exposures in diagnostic radiology and image

guided interventional

procedures). The safety assessment should not only cover these events, but also

aim at anticipating

other events that have not previously been reported. Clearly the

safety assessment should be

documented.

3.276. The safety assessment should be revised when:

(a) New or modified medical radiological equipment or their accessories are

introduced;

(b) Operational changes occur, including workload;

indicates that the safety

assessment should be reviewed.

Accident prevention

3.277. Accident prevention is clearly the best means for avoiding

potential exposure and the BSS,

paragraphs 3.39 to 3.41, set out requirements based on good

engineering practice and defence in

depth, as well as facility-based arrangements, to achieve this. Design

considerations for medical

radiological equipment and the radiology facility are described in paras 3.8 to

3.46.

3.278. The licensee should incorporate:

(a) Defence in depth measures to cope with identified events, and evaluation of

the reliability of the

safety systems (including administrative and operational procedures, equipment

and facility design).

(b) Operational experience and lessons learned from accidents and errors. This

information should be

incorporated into the training, maintenance and quality assurance programmes.

3.279. For diagnostic radiology and image guided interventional

procedures, possible scenarios for

potential exposure include flaws in the design of medical radiological

equipment, failures of medical

radiological equipment while in operation, failures and errors in software that

control or influence the

delivery of the radiation, and human error. In addition in the

radiology facility, another possible

scenario is the rupture of radioactive sources, such as those used in dosimetry

systems calibration.

3.280. Potential public exposure from a radiation generator may occur

if a person (for example a

cleaner) enters an interventional or conventional fluoroscopy room in between

cases and depresses the

exposure footswitch (usually a foot pedal placed on the floor). To prevent

such potential exposure

equipment should be provided with a special X ray interlock in the control

panel to disconnect the

exposure footswitch in between cases, as described in para. 3.36(h).

3.281. Inadvertent entry to the room when a patient is undergoing a

radiological procedure is another

way for potential public exposure. Means for control of entry has

been addressed in paras. 3.268-

3.269.

3.282. For medical exposure, potential exposure, when it does occur, is

manifest as an unintended or

accidental medical exposure. Means for preventing or minimizing unintended and

accidental medical

exposures are described in para. 3.245, and the ensuing investigation

and corrective actions are

described in paras, 3.251 – 3.257.

Mitigation and contingency plans

3.283. Because the radiation source in almost all cases is an X ray

generator and tube, turning the

primary electrical source off immediately stops any radiation being

produced. All relevant staff

should be adequately trained to be able to recognize when medical

radiological equipment is not

functioning correctly or, for example, when a programming error in the software

is suspected. If there

are implications for occupational and/or patient protection and if medical

considerations allow it, the

radiological procedure should be discontinued and the X ray unit turned off.

3.284. Some radiology facilities may have sealed radioactive sources

for dosimetry instrument

calibration purposes or even possibly I-125 sources for

low-intensity X ray imaging scopes

(lixiscopes). Source loss or encapsulation rupture may lead to

contamination. See Section 4 para.

4.291 for guidance on source loss.

4. SPECIFIC RECOMMENDATIONS FOR RADIATION PROTECTION AND

SAFETY IN NUCLEAR MEDICINE

INTRODUCTION

4.1. This chapter covers nuclear medicine, the branch of clinical

medicine in which unsealed

radioactive materials are administered to patients for diagnosis or treatment

of disease, or for clinical

or pre-clinical research. Treatment using sealed sources is covered in Section

5. X ray imaging such

as CT, which may occur in conjunction with a nuclear medicine procedure such as

in hybrid imaging,

is mainly covered in Section 3 with appropriate cross-references.

4.2. All nuclear medicine procedures involve the administration of a

radiopharmaceutical to the

patient. For diagnostic nuclear medicine procedures, trace amounts of

compounds are labelled with

photon or positron emitters, forming what is called a radiopharmaceutical. For

photon emitters, the

distribution of the radiopharmaceutical in the human body can be imaged in

several ways, such as

planar imaging -including whole body imaging- or single photon emission

computerized tomography

(SPECT). In the case of positron emitters, the detection of annihilation

photons allow registering the

three-dimensional spatial distribution of the radiopharmaceutical using

positron emission tomography

(PET). In hybrid imaging, SPECT and PET are combined with an X ray based

modality, such as in

PET-CT and SPECT-CT, and more recently also with magnetic resonance imaging,

such as in PET-

MRI. In addition, probes may be used for the intra-operative localization of

tumours and lymph nodes

or leaks, and for uptake measurements in specific organs, such as the thyroid

or lungs. In therapeutic

nuclear medicine, therapeutic activities of radiopharmaceuticals are

administered that are usually

labelled with beta or beta-gamma emitting radionuclides, more recently

also with alpha emitters;

therapy with Auger electrons is mostly experimental. The nuclear medicine

facility may also perform

in vitro studies, although these are not a primary focus of this Safety Guide.

Some nuclear medicine

facilities may also have an associated cyclotron facility for on-site

radionuclide production. Detailed

guidance for such cyclotron facilities is beyond the scope of this Safety

Guide.

4.3. The generic term “medical radiation facility” is used widely in Section 2

to mean any medical

facility where radiological procedures are performed. In Section 4,

the narrower term “nuclear

medicine facility” is used to cover any medical radiation facility where

nuclear medicine procedures

are performed. A nuclear medicine facility may be a nuclear medicine

department inside a wider

hospital or medical centre, or may be a stand-alone facility providing nuclear

medicine services. In

some cases, the nuclear medicine facility may be a mobile facility.

4.4. The defined term “radiological procedure” is used in the BSS to cover all

imaging and therapeutic

procedures using ionizing radiation. In a nuclear medicine facility

both imaging and therapeutic

radiological procedures may occur, and this needs to be borne in mind when

reading the following

guidance in Section 4. In cases where the guidance is specific to one or other

of imaging or treatment,

additional qualifiers, such as “imaging”, “diagnostic”, “therapy” or

“treatment”, are used.

4.5. Different health professionals can take on the role of the

radiological medical practitioner in

nuclear medicine procedures, depending inter alia on national laws and

regulations. They primarily

include nuclear medicine physicians, but may include other

specialists such as radiologists,

cardiologists or radiation oncologists.

4.6. Section 2 of this Safety Guide provides general guidance on the

framework for radiation

protection and safety in medical uses of radiation, including roles

and responsibilities, education,

training, qualification and competence, and the management system for

protection and safety. This is

relevant to nuclear medicine and reference to Section 2 should be made as

indicated or needed.

SAFETY OF MEDICAL RADIATION FACILITIES AND MEDICAL RADIOLOGICAL

EQUIPMENT

Nuclear medicine facilities

4.7. Provisions for the incorporation of radiation safety features are best

made at the facility design

stage. The siting and layout should take into account workload and

patient flow, both within the

nuclear medicine facility and, in cases where the nuclear medicine facility is

part of a larger hospital

or medical centre, with other departments of the wider facility. The nuclear

medicine facility is likely

to provide services to both inpatients and outpatients, so the location of the

facility should give easy

access to both groups. Consideration should also be given to provide

easy exit routes for patients,

after the examination or treatment has been performed, that minimize movement

through the facility.

4.8. A typical nuclear medicine facility using unsealed sources¹⁶

requires areas for the following:

source storage and preparation (radiopharmacy or radioisotope

laboratory or “hot lab”),

radiopharmaceutical administration to patient, uptake rooms, imaging (in vivo),

sample measurement

(in vitro), radioactive waste storage and predisposal processing

. For those nuclear medicine facilities

performing therapy with radiopharmaceuticals, a dedicated ward for

patients undergoing such

treatments should be considered. In addition, a nuclear medicine

facility requires separate waiting

areas for patients before and after radiopharmaceutical administration,

changing areas and toilets. The

facility will also have areas where radioactive materials are not

expected to be found, such as in

offices, reporting areas and staff rooms, including cloakrooms, showers

and toilets for staff. For

detailed guidance on setting up nuclear medicine facilities, including

PET-CT facilities, reference

should be made to Refs [65, 214 - 219]. The following paragraphs give a general

overview.

4.9. For security purposes, nuclear medicine facilities should be

located in areas where access by

members of the public to the rooms where sources, including

generators, and radiopharmaceutical

dispensing equipment are used and stored can be restricted. Further, the

proximity of source storage

facilities to personnel that may respond in the event of a security breach

should also be considered.

4.10. As a general rule, the design of the nuclear medicine facility should

make provisions for safety

systems or devices associated with the equipment and rooms. This includes

electrical wiring related to

emergency ‘off’ switches, as well as safety interlocks and warning signals.

4.11. A stable power supply should be available for the facility.

Uninterruptible power supply (UPS)

or battery backup systems should be installed to capture the active information

at time of any outage

¹⁶ In a nuclear medicine facility the only sealed sources present are those

used as check sources for calibration of

the activity meters and the flood sources to check the uniformity of the gamma

cameras.

and to power down all software in a controlled manner. Servers

should be programmed to

automatically shut down when the power supply is interrupted.

4.12. The design of the facility may include an air conditioning

system sufficient to maintain the

temperature in the examination room within the parameters defined by the

equipment manufacturers.

For example, temperature control is needed for uptake rooms in a PET facility

to prevent artefacts

(brown fat uptake) occurring if room temperatures are too low.

4.13. Issues to be considered for the design of the nuclear medicine

facility include: optimizing

protection against external radiation and contamination, maintaining low

radiation background levels

to avoid interference with imaging equipment, meeting radiopharmaceutical

requirements (see para.

4.38), and ensuring safety and security of sources (locking and control of

access).

4.14. For external exposure, the three factors relevant to dose reduction

(time, distance and shielding)

should be combined in the design to optimize occupational and public

radiation protection. Larger

rooms are preferable to allow easy access for patients on a bed trolley and to

reduce exposure of the

staff as well as the public, and at the same time allow for

patient positioning and easy movement

during the procedures.

4.15. The design of the nuclear medicine facility should include

provision for secure and shielded

storage for the radioactive sources. Shielding should be appropriate

to the type and energy of the

emitted radiation. Storage may be provided in a room or a separate space

outside the work area or in a

locked cupboard, safe, refrigerator or freezer situated in the work area.

Separate radiopharmaceutical

storage compartments and an area for temporary storage of radioactive waste

should be provided with

appropriate protection.

4.16. Special consideration should be given to avoiding interference with work

in adjoining areas,

such as imaging or counting procedures, or where fogging of films stored nearby

can occur.

4.17. Signs and warning lights should be available at the entrances of

controlled and supervised areas

to prevent inadvertent entry (see also paras. 4.266 - 4.267 on control of

public access). For controlled

areas, the BSS, paragraph 3.90, requires the use of the symbol of the

International Organization for

Standardization (ISO) [59]. Signs and warning lights should be particularly

available at the entrances

of source preparation and storage areas, hybrid imaging rooms, and for

rooms for hospitalized patients

undergoing radiopharmaceutical therapy (see, also below on treatment wards,

paras. 4.28 – 4.30). The

signs should be clear and easily understandable. Warning lights, such

as illuminated and flashing

signs, should be activated when CT is being used in hybrid imaging.

4.18. Bathrooms designated for use by nuclear medicine patients should be

finished in materials that

are easily decontaminated. Nuclear medicine facility staff should not use the

patient bathrooms, as it

is likely that the floors, toilet seats and sink tap handles will be

contaminated.

Mobile facilities

4.19. In some countries, PET-CT scanners are mounted on a truck and this

mobile unit provides a

service to specific regions of that country. These mobile units should meet the

same requirements of

the BSS as fixed facilities and the relevant guidance in this Safety Guide is

applicable.

Areas where unsealed radioactive materials are handled

4.20. Radiopharmacies or laboratories where unsealed radioactive materials are

handled, such as the

source preparation area, should have:

(a) Means to prevent access by unauthorized persons;

(b) Adequate storage space for equipment used in the given room or area to be

available at all

times, to minimize the potential for spreading contamination to other areas;

(d) Shielded storage for radioactive sources;

(e) Shielded temporary storage for both solid and liquid radioactive waste,

and places designated

for the authorized discharge of liquid radioactive waste;

(f) Shielding to protect workers where significant external exposure may

occur;

(g) A wash-up area for contaminated articles, such as glassware;

(h) An entry area where protective clothing can be stored, put on

and taken off, and which is

provided with a hand wash-up sink and a contamination monitor;

(i) Taps and soap dispenser that are operable without direct hand contact and

disposable towels

or a hot air dryer;

(j) An emergency eyewash, installed near the hand washing sink; and

(k) An emergency shower for decontamination of persons.

Detailed guidance is given in Refs [66, 214 – 219].

4.21. Radiopharmacies, laboratories and other work areas for

manipulation of unsealed radioactive

materials should be provided with equipment kept specifically for this purpose,

which should include:

(a) Tools for maximizing the distance from the source, for example tongs and

forceps;

(b) Syringe shields;

to the source;

(d) Double walled containers (the outer being unbreakable) for liquid samples;

(e) Drip trays for minimizing the spread of contamination in the case of

spillage;

(f) Disposable tip automatic pipettes (alternatively, hypodermic syringes to

replace pipettes);

(g) Lead walls or bricks for shielding;

(h) Lead barriers with lead glass windows;

(i) Barriers incorporating a low atomic number material (i.e. acrylic) for

work with beta emitters;

(j) Radiation and contamination monitoring equipment (surface and air);

(k) Carrying containers, wheeled if necessary, for moving radioactive

materials from place to

place;

(l) Equipment to deal with spills (decontamination kits).

4.22. Drainpipes from sinks in the radiopharmacy or laboratory should go as

directly as possible to the

main building sewer and should not connect with other drains within the

building, unless those other

drains also carry radioactive material. This is to minimize the possibility of

a ‘backup’ contaminating

other non-controlled, areas. The final plans of the drainage system, which are

supplied to maintenance

personnel, should clearly identify the drains from radiopharmacies and

laboratories. Pipelines through

which radioactive materials flow should be marked to ensure

that monitoring precedes any

maintenance.

4.23. Some countries require that drainpipes from a nuclear medicine

facility and especially from

radionuclide therapy wards terminate in a delay tank. Requirements on this

issue differ very much

among countries but each nuclear medicine facility should comply with their

country’s regulations.

4.24. The floors of areas with the potential for contamination should be

finished in an impermeable

material which is washable and resistant to chemical change, curved to the

walls, with all joints sealed

and glued to the floor. The walls should be finished in a smooth and washable

surface, for example

painted with washable, non-porous paint. The surfaces of the room

where unsealed radioactive

materials are used or stored, such as benches, tables, seats, and door and

drawer handles, should be

smooth and non-absorbent, so that they can be cleaned and

decontaminated easily. Supplies (for

example, gas, electricity and vacuum equipment) should not be mounted on bench

tops, but on walls

or stands.

4.25. The floor and benches, including worktops, should be strong enough to

support the weight of

any necessary shielding materials or of radionuclide generators. The need for

lifting equipment for

radionuclide generators should be assessed.

4.26. Radiopharmacies or laboratories in which radioactive aerosols or

gases may be produced or

handled should have an appropriate ventilation system that includes a fume

hood, laminar air flow

cabinet or glove box. The fume hood should be constructed of material that is

smooth, impervious,

washable and resistant to chemicals. The working surface should have a slightly

raised lip to contain

any spills. The ventilation system should be designed such that the

radiopharmacy or laboratory is at

negative pressure relative to surrounding areas.

4.27. The airflow should be from areas of minimal likelihood of

airborne contamination to areas

where such contamination is likely. All air from the radiopharmacy or

laboratory should be vented

through a fume hood and should not be recirculated either directly,

in combination with incoming

fresh air in a mixing system, or indirectly, as a result of proximity of the

exhaust to a fresh air intake.

For reasons of asepsis, some radiopharmacies may require a positive rather than

a negative pressure.

In this case, the pressure gradient can be obtained by placing other

workstations requiring negative

pressure next to the radiopharmacy workstation.

Treatment rooms and wards

4.28. Floors and other surfaces of rooms designated for patients

undergoing radiopharmaceutical

therapy should be covered with smooth, continuous and non-absorbent materials

that can be easily

cleaned and decontaminated. Shielding should be designed using appropriate dose

constraints for staff

and public. Secure areas should be provided with bins for the temporary storage

of linen and waste

contaminated with radioactive materials. Storage areas should be clearly

marked, using the radiation

sign.

4.29. Rooms designated for patients undergoing radiopharmaceutical

therapy should have separate

toilet and washing facilities. A sign requesting patients to flush the toilet

at least twice and wash their

hands should be displayed to ensure adequate dilution of excreted radioactive

materials and minimize

contamination. The facilities should include a wash-up sink as a

normal hygiene measure. For

guidance on bathrooms and their use see para. 4.18.

4.30. The design of safe and comfortable accommodation for carers and

comforters (see also paras.

4.232 – 4.236) should beconsidered for nuclear medicine facilities with

radiopharmaceutical therapy

patients.

Shielding calculation considerations

4.31. The shielding should be designed to meet the requirements for

optimization of protection and

taking into consideration the classification of the areas within the facility,

the type of work to be done

and the radionuclides (and their activity) intended to be used.

Shielding should consider both

structural and ancillary protective barriers at the design stage (see para

2.73). It is convenient to shield

the source, where possible, rather than the room or the person. The need for

wall shielding should be

assessed, for example in the design of therapy and of PET-CT facilities to

reduce occupational and

public exposure to acceptable levels. Wall shielding may be needed in the

design of rooms housing

sensitive instruments (to keep a low background), such as well

counters, probes and imaging

equipment (gamma cameras and PET scanners). In designing such wall

shielding, consideration

should be given to the height of the wall to ensure scattered radiation, such

as from a CT scanner,

does not pass over the wall into the area being protected.

4.32. Methodologies and data for shielding calculations for nuclear medicine

facilities are given in

Refs [58, 64, 215], and reference should be made to Section 3, paras 3.17 –

3.21) for shielding with

respect to X ray imaging systems (e.g. CT) used as part of hybrid imaging

equipment. The nominal

design dose in occupied areas is derived by the process of constrained

optimization, i.e. selecting a

source related dose constraint, with the condition that the individual doses

from all relevant sources

are well below the dose limits for the persons occupying the area

to be shielded. Nominal design

doses are levels of air kerma used in the design calculations and

evaluation of barriers for the

protection of individuals, at a reference point beyond the barrier.

Specifications for shielding are

calculated on the basis of the attenuation they should provide to

satisfy the nominal design doses.

Potential practice changes and workload increases should be considered.

4.33. Care should be taken to avoid multiplication of conservative

assumptions which can lead to

unrealistic overestimates of required shielding. Typical conservative

assumptions are: attenuation by

the patient is usually not considered; decay of short-lived radionuclides, such

as ¹⁸F, is not considered;

workload, use and occupancy factors are overestimated; and the persons

to be protected are

considered as remaining permanently in the most exposed place of the

adjacent roomTherefore, a

balanced decision should be achieved and accumulation of overly conservative

measures that may go

beyond optimization should be avoided.

4.34. Specification of shielding, including calculations, should be

performed by a RPO or medical

physicist. In some countries there may be a requirement for shielding

plans to be submitted to the

regulatory body for review or approval prior to any construction (see also

Section 2 para 2.66).

4.35. The adequacy of the shielding should be verified, preferably during

construction, and certainly

before the facility, room or area comes into clinical use. Clearly requirements

of the regulatory body

must be met (Section 2 para. 2.73).

Display and interpretation (reading) rooms design

4.36. To facilitate the interpretation by the radiological medical

practitioner, images should be

displayed in rooms specifically designed for these purposes. A low

level of ambient light in the

viewing room should be achieved. See also Section 3, paras. 3.40 - 3.41 on

image display devices and

view boxes.

4.37. Viewing rooms with workstations for viewing digital images should be

ergonomically designed

to facilitate image processing and manipulation so that reporting can be

performed accurately. The

viewing monitors of the workstations should meet applicable standards (see

Section 3, para. 3.40).

Radiopharmaceuticals

4.38. Radiopharmaceuticals should be manufactured according to good

manufacturing practice

following relevant international standards [217, 218, 222 - 224] for:

(a) Radionuclide purity;

(b) Specific activity;

(d) Chemical purity;

(e) Pharmaceutical aspects: toxicity, sterility and pyrogenicity.

Medical radiological equipment, software and ancillary equipment

4.39. This sub-section considers medical radiological equipment,

including its software, used in a

nuclear medicine facility. Such equipment falls into two categories –

those that detect ionizing

radiation from the unsealed or sealed sources and those that generate ionizing

radiation. The former

includes probes, gamma cameras, SPECT scanners, and PET scanners, since these

have an influence

on the activity to be administered to the patient in order to obtain the

desired diagnosis. The latter

includes CT, typically as part of a hybrid imaging system such as a PET-CT or

SPECT-CT scanner.

Some hybrid equipment utilizes MRI, and although these are not generating

ionizing radiation and are

outside the scope of this Safety Guide, their performance can influence the

efficacy of the nuclear

medicine procedure and hence such equipment should meet relevant IEC standards

or equivalent.

4.40. The requirements for medical radiological equipment and its

software are given in the BSS

paragraphs 3.49 and 3.161. The International Electrotechnical Commission

(IEC), through its

Technical Committee 62 on Electrical equipment in medical practice and in

particular Sub-committee

62B on Diagnostic imaging equipment and Sub-committee 62C on Equipment

for radiotherapy,

nuclear medicine and radiation dosimetry, has published international standards

applicable to medical

radiological equipment. Current IEC standards relevant to nuclear

medicine include the following

Refs [225 – 234]. For those relevant to the X ray based component of hybrid

imaging, see Section 3

para. 3.27. It is recommended that the IEC website is visited to

view the most up-to-date list of

standards: http://www.iec.ch. The International Organization for

Standardization (ISO), through its

Technical Committee 85 on Nuclear energy, nuclear technologies, and

radiological protection and in

particular Sub-committee 2 on Radiological protection, may

publish international standards

applicable to medical radiological equipment. It is recommended that the

ISO website is visited to

view the most up-to-date list of standards: http://www.iso.org .

4.41. As the licensees take responsibility for the radiation safety of medical

radiological equipment

they use, they should impose purchasing specifications that include

conditions to meet relevant

international standards of the IEC and ISO and/or equivalent national

standards. In some countries

there may be a medical devices agency or similar organization that gives type

approval to particular

makes and models of medical radiological equipment.

4.42. Some nuclear medicine facilities may operate a cyclotron for on-site

radionuclide production.

As the cyclotrons are not directly involved in the exposure of the patient,

they should not comply with

the BSS requirements for medical radiological equipment. Nevertheless, they

should comply with the

more general requirements of the BSS for radiation generators (requirement 17

and paragraphs 3.49 -

3.60), as well as additional regulatory requirements, in a given Member State,

for the preparation and

control of radiopharmaceuticals.

4.43. Displays, gauges and instructions on operating consoles of medical

radiological equipment, and

accompanying instruction and safety manuals, may be used by staff who may not

understand, or who

may have a poor understanding of, the manufacturer’s original

language. In such cases, the

accompanying documents should comply with IEC and ISO standards and should be

translated into

the local language. The software should be designed so that it can be easily

converted into the local

language resulting in displays, symbols and instructions that will be

understood by the staff. The

translations will require a quality assurance process to ensure proper

understanding and avoid

operating errors. The same applies to maintenance and service manuals

and instructions for

maintenance and service engineers and technicians, where these persons

do not have an adequate

understanding of the original language. See also Section 2 para. 2.103.

Design features for medical radiological equipment

4.44. The performance of probes, gamma cameras, SPECT systems and PET scanners

determine the

efficacy of the diagnostic radiological procedures and hence can influence the

amount of radioactivity

needed to be administered to the patient, even whether the procedure

is diagnostically successful.

Many design features contribute to their performance and should be considered

when purchasing such

equipment, as indicated briefly in the next paragraphs and detailed in Refs

[192, 210, 211, 219, 225 –

241].

4.45. Design features for probes used for uptake measurements that

should be considered include

energy response, energy resolution, sensitivity, counting precision,

linearity of count rate response

and geometrical dependence.

4.46. Design features for probes used intra-operatively that should be

considered include energy

resolution, background count rate, sensitivity in scatter, sensitivity

to scatter, shielding (side and

back), counting precision, linearity of count rate response (with scatter), and

count rate recorded by

visual display and by an audible sound, the intensity of which is proportional

to the count rate.

4.47. Design features for gamma and SPECT cameras as well as their

accessories that should be

considered include:

(a) Detector performance;

(b) Detector head and gantry design;

(d) Automatic patient–detector distance sensing;

(e) Collimators;

(f) Pulse height analysis;

(g) Imaging table and attachments;

(h) Data acquisition, including:

a. General acquisition features;

b. Static acquisition;

c. Dynamic acquisition;

d. List mode acquisition;

e. Gated cardiac acquisition;

f. Whole body imaging;

g. Tomography.

(i) Data processing system, including data display, image manipulation,

region of interest (ROI)

generation and display, curve generation, display and arithmetic, processing of

SPECT data,

quality control software and test data;

(j) Accessories that include physiological triggering, anatomical

landmarking, and phantoms.

4.48. Design features for PET scanners that should be considered include:

(a) Detector design and performance;

(b) Spatial resolution;

(d) Sensitivity;

(e) Accuracy;

(f) Time of flight capability;

(g) Data acquisition, including 2D and 3D whole body imaging, and

cardiac and respiratory

gating;

(h) Data processing system, including image reconstruction algorithms and

image manipulation.

4.49. Guidance on medical radiological equipment using X rays, used for imaging

as part of nuclear

medicine, is given in Section 3, paras. 3.26 – 3.39.

4.50. All digital medical radiological equipment should have connectivity to

RIS/PACS.

Ancillary equipment

4.51. All equipment used for digital image display should meet appropriate

international and/or local

standards, for example meeting the performance specifications of the AAPM Task

Group 18 [115].

Workstations and image processing and display software should be specifically

designed for nuclear

medicine, ensuring DICOM conformance, and network interconnectivity. Guidance

on DICOM image

and data management for nuclear medicine is given in Ref [242]. See paras. 4.36

- 4.37 for guidance

on reporting rooms.

4.52. The nuclear medicine facility should have equipment, instruments

and test objects for

measurements, dosimetry and quality control which may include liquid

scintillation counters, well

counters, activity meters, dose calibrators, check sources, flood

sources, phantoms, geometry and

mechanical test tools. Where applicable, such instrumentation should adhere to

relevant IEC standards

or national equivalents. Further guidance on appropriate equipment,

instruments and test objects is

given in Refs [227, 240, 243].

4.53. The nuclear medicine facility should be equipped with radiation

monitoring, including survey

meters and portable contamination monitors.

4.54. Radiopharmaceutical dispensing equipment should adhere to relevant IEC

standards or national

equivalents.

Security of sources

4.55. The objective of source security is to ensure continuity in the control

and accountability of each

source at all times in order to meet the requirement in BBS paragraph 3.53. In

the nuclear medicine

facility the sources include unsealed radiopharmaceuticals as well as

radionuclide generators,

radiopharmaceutical dispensing equipment, and sealed sources used for

calibration or QC tests.

Requirements for the identification and documentation of unsealed

radioactive uses are given by ISO

[228]. Situations that are particularly critical with respect to source

security in the nuclear medicine

facility include receipt of radiopharmaceuticals, storage of sources, movement

of sources within the

facility, and storage of radioactive waste. The nuclear medicine

facility licensee should develop

procedures to ensure the safe receipt and movement of radioactive sources

within the institution and

establish controls to prevent theft, loss, unauthorized withdrawal of

radioactive materials or entrance

of unauthorized personnel to the controlled areas. An inventory of sources

should be maintained, with

procedures in place to check and confirm the sources are in their assigned

locations and are secure.

Procedures to stimulate proactive behaviour should be in writing, for

example, to trigger a search

when a delivery of radiopharmaceuticals is not received at the expected

time.

Maintenance

4.56. The BSS (BSS, paragraphs 3.15(i) and 3.41) gives requirements for

maintenance to ensure that

sources meet their design requirements for protection and safety

throughout their lifetime and to

prevent accidents as far as reasonably practicable. The licensee

should ensure that adequate

maintenance (preventive and corrective) is performed as necessary to ensure

that medical radiological

equipment used in the nuclear medicine facility retains, or improves

through appropriate hardware

and/or software upgrades, its design specification for image quality, radiation

protection and safety for

its useful life. The licensee should, therefore, establish the necessary

arrangements and coordination

with the manufacturer’s representative or installer before initial operation

and on an on-going basis.

4.57. All maintenance procedures should be included in the quality

assurance programme at the

frequency recommended by the manufacturer of the equipment and

relevant professional bodies.

Servicing should include a report describing the equipment fault, the work done

and the parts replaced

and adjustments made, which should be filed as part of the quality assurance

programme. A record of

maintenance carried out should be kept for each item of equipment: this should

include information

on any defects found by users (a fault log), remedial actions taken

(both interim and subsequent

repairs) and the results of testing before equipment is reintroduced to

clinical use.

4.58. In line with the guidance in Section 2, para. 2.111, after any

modifications or maintenance, the

person responsible for maintenance should immediately inform the licensee of

the nuclear medicine

facility before it is returned to clinical use. The person responsible for the

use of the equipment, in

conjunction with the medical physicist, the medical radiation

technologist and other appropriate

professionals, should decide whether quality control tests are needed

with regard to radiation

protection, including image quality, and whether changes to protocols are

needed, especially in the

amount of administered activity.

4.59. The electrical and mechanical safety aspects of the medical

radiological equipment are an

important part of the maintenance programme, and can have direct or

indirect effects on radiation

safety. Authorized persons who understand the specifications of the medical

radiological equipment

should perform this work. See also Section 2 paras. 2.110 – 2.112.

Electrical and mechanical

maintenance should be included in the QA programme at a

frequency recommended and

preferentially performed by the manufacturer of the medical radiological

equipment. Servicing should

include a written report describing the findings. These reports should be

archived as part of the QA

programme.

OCCUPATIONAL RADIATION PROTECTION

Introduction

4.60. In nuclear medicine, described in paras. 4.1 to 4.5,

occupationally exposed individuals are

usually the medical radiation technologists, the radiological medical

practitioners (including, for

example, nuclear medicine physicians), the radiopharmacists and the medical

physicists. Other health

professionals such as nurses, particularly in nuclear medicine

facilities providing therapy services,

may also be considered occupationally exposed.

4.61. Additional occupationally exposed personnel may include

biomedical, clinical or service

engineers and some contractors, depending on their role.

4.62. Other nuclear medicine facility workers such as administrative

personnel, patient porters,

orderlies, assistants, cleaners and other service support personnel, for whom

radiation sources are not

directly related to their work, require the same level of protection as members

of the public, as stated

in the BSS paragraph 3.78.

4.63. This sub-section contains guidance very specific to nuclear

medicine. For more general and

comprehensive guidance on occupational radiation protection, including

guidance on radiation

protection programmes, assessment of occupational exposure and providers

of dosimetry services,

applicable to all areas of radiation use (including non-medical uses),

reference should be made to the

IAEA Safety Guide Occupational Radiation Protection [23].

Arrangements under the radiation protection programme

Classification of areas

4.64. Various areas and rooms in a nuclear medicine facility should

be classified as controlled or

supervised areas, in line with the requirements given in BSS paragraphs 3.88

and 3.91, respectively.

Once designated, these areas should meet the requirements detailed in

the BSS paragraphs 3.89 to

3.90 (for controlled areas) and 3.92 (for supervised areas),

including requirements for area

delineation, signage, protection and safety measures, control of

access, provision of personal

protective equipment, provision of individual and area monitoring,

provision of equipment for

monitoring for contamination, and provision of personal decontamination

facilities. All other rooms

and areas, not so-designated, are considered as “public domain” and levels of

radiation in these areas

should be low enough to ensure compliance with the dose limits for public

exposure.

4.65. In a nuclear medicine facility, rooms for radiopharmaceutical preparation

(i.e. radiopharmacies

or hot labs), injection of the radiopharmaceuticals and for storage and decay

of radiopharmaceuticals

meet the criteria for controlled areas and should be so designated. Imaging

rooms, particularly those

housing radiopharmaceutical dispensing equipment (i.e. PET radiopharmaceutical

and radioactive gas

and aerosol dispenser devices), should also be considered controlled

areas. Rooms with patients

undergoing radiopharmaceutical therapy should be controlled areas. Rooms

housing hybrid machines

that have an X ray component (SPECT-CT, PET-CT) should be considered

controlled areas when the

X ray unit is energized. A warning light at the entry to the room should

indicate the machine is on to

prevent unintended passage.

4.66. Supervised areas may include examination rooms (with probes, gamma

cameras and SPECT and

PET systems) and waiting rooms dedicated to patients who

have been injected with

radiopharmaceuticals (e.g. uptake rooms in a PET facility).

4.67. The area around the control panel of hybrid imaging equipment (e.g.

PET-CT and SPECT-CT)

should be classified as either a controlled or a supervised area, even though

the radiation levels may

be very low due to the shielding design. In either case, this should ensure

restricted access and hence,

among other things, avoid distraction of the operator which may lead

to accidental or unintended

medical exposure of patients. See also Section 3, para. 3.55.

4.68. In order to avoid uncertainties about the extent of controlled

and supervised areas, the

boundaries should, when possible, be walls and doors or other physical

barriers, clearly marked or

identified with ‘radiation area’ signs.

Local rules and procedures

4.69. The BSS, in paragraph 3.93, establishes a hierarchy of preventive

measures for protection and

safety with engineered controls, including structured and ancillary

shielding, specific physical

barriers, signs and interlocks, being supported by administrative

controls and personal protective

equipment. To this end, and as required in the BSS paragraph 3.94, written

local rules and procedures

should be established in a nuclear medicine facility. Their purpose is to

ensure protection and safety

for workers and other persons. These local rules and procedures should include

measures to minimize

occupational radiation exposure during both normal work and unusual

events. The local rules and

procedures should also cover the wearing, handling and storing of personal

dosimeters, and specify

investigation levels and ensuing follow-up actions (see paras. 4.117 – 4.131).

4.70. Since all personnel involved in using radiation in nuclear medicine

should know and follow the

local rules and procedures, the development and review of these local rules

and procedures should

include representatives of all health professionals involved in nuclear

medicine.

4.71. Equipment (hardware and software) should be operated in a manner

that ensures satisfactory

performance at all times with respect to both the tasks to be accomplished and

radiation safety. The

manufacturer’s operating manual is an important resource in this respect, but

additional procedures

should be also considered. The final documented set of operational

procedures should be approved by

the nuclear medicine facility’s licensee, and incorporated into the

facility’s quality management

system (see Section 2, paras. 2.136 – 2.147).

4.72. Nuclear medicine staff should understand the documented

procedures for their work with

radiopharmaceuticals and for the operation of the equipment with which they are

working, including

the safety features, and should be trained, with periodic refresher training,

in what to do when things

go wrong. Additional training should occur when new radiopharmaceuticals or

devices are brought

into nuclear medicine practice.

4.73. Many local rules and procedures address aspects of some, or

all, of occupational radiation

protection, patient radiation protection and public radiation protection,

either directly or indirectly, as

well as ensuring a successful diagnostic examination or application of the

treatment. This is the case

with the following paragraphs (4.74 to 4.108) – while placed in this section on

occupational radiation

protection because they are to be followed by workers, the local rules and

procedures often also have

significance for patient and/or public radiation protection. These following

paragraphs (4.74 to 4.108)

give recommendations that should be incorporated into the nuclear medicine

facility’s local rules and

procedures. In addition, reference should also be made to para. 4.55 on the

security of sources.

4.74. Work procedures should be formulated so as to minimize exposure from

external radiation and

contamination, to prevent spillage from occurring and, in the event of

spillage, to minimize the spread

of contamination (surface and airborne). For instance, all manipulation

for dispensing radioactive

materials should be carried out over a drip tray. Work with unsealed sources

should be restricted to a

minimum number of specifically designated areas.

4.75. No food or drink, cosmetic or smoking materials, crockery or cutlery

should be brought into an

area where unsealed radioactive materials are used. An exception to this is

when food is radiolabelled

for patient studies. Food or drink should not be stored in a refrigerator used

for unsealed radioactive

materials. Personal cell phones and handkerchiefs should never be used in these

areas; an adequate

supply of paper tissues should be provided. Before a person enters an area

where radioactive material

is handled, any cut or break in the skin should be covered by a waterproof

dressing.

4.76. In areas classified as controlled, protective clothing should be worn as

determined by prior risk

assessment of potential contamination. Protective clothing is unlikely

to be necessary for persons

accompanying patients into gamma camera rooms. On leaving the controlled area,

protective clothing

that is contaminated should be placed in an appropriate container. The method

of removing gloves

should be based on the surgical technique, in order to avoid transferring

activity to the hands.

4.77. Staff leaving a controlled area, classified as such on account of the

potential for contamination,

should, after removal of their protective clothing, wash their hands

and then monitor their hands,

clothing and body. Liquid soap should be provided unless aseptic considerations

require an alternative

cleaner. Non-abrasive nail brushes should only be used if contamination

persists after simple washing.

See also paras. 4.104 – 4.108 below on decontamination of persons.

4.78. Pipettes should never be operated by mouth. Syringes used for

handling radioactive liquids

should be appropriately shielded wherever practicable. The distance

between the fingers and the

radioactive liquid should be as large as can be achieved.

4.79. The work area should be kept tidy and free from articles not required for

work. A monitoring

and cleaning programme should be established to ensure minimal spread of

contamination. Cleaning

and decontamination can be simplified by covering benches and drip trays with

disposable material

such as plastic backed absorbent paper.

4.80. All containers used for radioactive material should be

clearly labelled, indicating the

radionuclide, chemical form and activity at a given date and time. Batch number

and expiry date and

time should be added as appropriate. All such containers are to be adequately

sealed and shielded at

all times. Except for very small activities, containers are not to be handled

directly and, if possible,

tongs or forceps for vials and syringe shields should be used. Records of

stocks, administrations and

pre-disposal waste management should be kept.

4.81. The amount of shielding material required can be minimized by

positioning it close to the

source. A variety of materials can be used for this purpose, such as lead,

tungsten, lead glass and lead

composite. Shielding incorporating acrylic is more suitable for beta emitters,

as it lowers the amount

of bremsstrahlung produced. Lead should be coated to provide a cleanable

surface.

4.82. The attenuation by lead aprons at the typical gamma energies

used in nuclear medicine is

modest, and even less for non-lead based protective aprons. Automatic

dispensers and injectors, and

mobile shields are preferred alternatives.

4.83. The following protective approaches can reduce occupational exposure

significantly:

(a) For preparation and dispensing of radiopharmaceuticals, working behind a

lead glass bench

shield, using shielded vials and syringes, and using disposable gloves.

(b) During examinations, when the distance to the patient is short, using a

movable transparent

shield.

4.84. All radioactive sources should be returned to safe storage immediately

when no longer required.

4.85. All operations involving radioactive gases or aerosols should be carried

out in a fume hood or

similar ventilated device to prevent airborne contamination. Exhaust

vents should be situated well

away from air intakes. The administration of aerosols to patients,

such as for ventilation studies,

should be performed using a mouthpiece or mask for the patient.

4.86. Glassware and implements for use in the radiopharmacy should be

appropriately marked and

under no circumstances removed from that area.

4.87. Packaging and containers for radioactive material should be

checked for contamination on

opening.

4.88. Containers, lead pots, etc., that no longer contain radioactive material

and require to be managed

as non-radioactive waste should have any radiation warning labels

removed or obliterated before

removing them from regulatory control.4.89. For X ray based imaging

(e.g. CT) in the nuclear

medicine facility, reference should be made to the guidance, where appropriate,

in Section 3, paras.

3.61 - 3.73.

4.90. Local rules for pregnant workers and persons under 18 should

reflect the guidance given in

paras. 4.144 – 4.148 and 4.149 respectively.

Specific local rules and procedures for radiopharmaceutical therapy

4.91. Administration is normally by the oral route, intravenous

injection (systemic), intra-arterial

injection (locoregional) or instillation into closed joints

(intra-articular/radiosynoviorthesis) or body

cavities (intracavitary).

(a) Shielded syringes should be utilized during the intravenous or

intra-arterial administration of

radiopharmaceuticals as necessary to ensure extremity doses are

maintained below

occupational dose constraints. Absorbent materials or pads should be placed

underneath an

injection or infusion site. The facility RPO should be consulted to determine

the necessity of

other protective equipment (e.g., shoe covers, step-of-pads,

etc.) for particular

radiopharmaceutical therapies.

(b) For intravenous or intra-arterial administrations by bolus injections,

when dose-rates warrant,

the syringe should be placed within a syringe shield (plastic for beta-emitting

radionuclides to

minimize bremsstrahlung, high atomic number materials for photon-emitting

radionuclides)

with a transparent window to allow for visualization of the

material in the syringe. For

intravenous administrations by slower drip or infusions, the activity

container should be

placed within a suitable shield. For high-energy photons, a

significant thickness of lead or

other high atomic number material may need to be used. In addition,

consideration should be

given for shielding pumps and lines.

radioactive material should

be placed in a shielded, spill-proof container. Care should be taken to

minimize the chance for

splashing liquid, or for dropping capsules. Appropriate long-handled tools

should be utilized

when handling unshielded radioactive materials.

4.92. Patients hospitalized for therapy with radiopharmaceuticals should

be attended by staff

(physicians, nurses, aids, cleaning staff) trained in radiation protection.

This also includes night staff.

The training should cover radiation protection and specific local

rules, in particular, for situations

where there is a risk of significant contamination from urine, faeces or

vomiting. Ward nurses should

be informed when a patient may pose a radioactive hazard.

4.93. Local rules should be established concerning the type of

nursing that can be performed

according to the level of ambient dose equivalent. In general,

non-essential nursing should be

postponed to take advantage of the reduction of activity by decay

and excretion. Blood and urine

analyses should be performed prior to therapy Procedures should be established

for the handling of

any potentially contaminated item (bed linen, clothing, towels, crockery,

etc.).

4.94. As described above in para. 4.65, rooms occupied by patients treated with

radiopharmaceuticals

should be controlled areas, and both a radiation sign and a warning sign

should be posted. Access

should be restricted and a list of relevant contacts (such as nuclear medicine

and on-call physicians,

medical radiation technologists, radiation protection officer) should be

provided. Protective clothing,

such as laboratory coats, gloves and shoe covers, should be available at the

entrance to the room. The

nursing staff should be familiar with the implications of the procedures for

controlled areas, the time

and date of administration, and any relevant instructions to carers and

comforters.

4.95. Values of ambient dose equivalent at suitable distances should be

determined by the RPO or

medical physicist. This information will assist in deriving appropriate

arrangements for entry by staff

and by carers and comforters. These arrangements should be made in writing in

the local rules.

4.96. On leaving the work area, staff should remove any protective clothing and

wash their hands.

4.97. Patients treated with radiopharmaceuticals should use designated toilets.

Measures to minimize

contamination should be implemented (such as laying plastic backed

absorbent paper on the floor

around the toilet bowl, sitting down when using the toilet and instructions to

flush the toilet at least

twice in the absence of delay tanks).

4.98. Particular attention and measures to limit spread of contamination are

required in the case of

incontinent patients and in the risk of vomiting after oral administration of

the radiopharmaceutical.

Plastic backed absorbent paper on the bed and floor can help reduce

spread of contamination.

Contaminated bedding and clothing should be changed promptly and retained for

monitoring.

4.99. Crockery and cutlery may become contaminated. Local rules should

specify washing up and

segregation procedures, and the management of single use dishes, cutlery and

food waste.

4.100. Nursing care items should be covered when possible to prevent

contamination. For example,

the stethoscope can be covered with a glove. The blood pressure cuff

and the thermometer should

remain in the room until the release of patient, and then checked

for contamination before being

returning to regular use again.

4.101. The staff should be informed about the treatment procedure and any

relevant medical history.

If the medical condition of a patient deteriorates such that

intensive care becomes necessary, the

advice of the RPO should be sought immediately. While urgent medical care is a

priority and should

not be delayed, it may be necessary to restrict the maximum time that

individual health professionals

spend with a patient.

Specific local rules and procedures in PET facilities

4.102. PET imaging personnel can receive relatively large annual

occupational radiation doses

compared to their counterparts in general nuclear medicine. The main

contribution to the occupational

dose for personnel comes from patient handling. PET radiopharmacists,

at facilities performing

radiopharmaceutical synthesis and unit dose preparations, can receive

significant hand and body

doses, even where heavily shielded ‘hot cells’ are available to

moderate dose. For these reasons, local

rules and procedures for PET facilities should emphasize the means described

above for minimizing

the dose to personnel when handling radiopharmaceuticals and the injected

patient.

4.103. Radiopharmaceuticals should be stored and transported in lead

or tungsten containers

specifically designed to limit external radiation levels from radionuclides

used for PET. An additional

plastic shield inside a lead or tungsten syringe shield will absorb

positrons before striking the

tungsten, minimizing unwanted production of bremsstrahlung radiation. The use

of tongs to handle

unshielded radiopharmaceutical vials markedly reduces hand doses. Automatic

systems are available

which allow safe and quick radiopharmaceuticals dispensing into syringes, thus

minimizing operators’

actions.

Decontamination of persons

4.104. Hands should be washed on completing work with unsealed

radioactive materials and on

leaving an area that is controlled, because of potential

contamination. If detectable contamination

remains on the hands after simple washing, use of a surfactant or

chelating agent specific to the

chemical form of the contaminant agent may be more successful. A

decontamination kit and

procedures for its use shoul be available on site.

4.105. The RPO should be consulted when contamination of parts of the body

other than the hands is

suspected, or when the procedures for decontamination of the hands

are ineffective. Special care

should be taken in the decontamination of the face to restrict entry of

radioactive material into the

eyes, nose or mouth.

4.106. If the skin is broken or a wound is sustained under

conditions where there is a risk of

radioactive contamination, the injury should be irrigated with water

as soon as appropriate, taking

care not to wash contamination into the wound. As soon as the first aid

measures have been taken, the

person should seek further treatment, including decontamination if

necessary The RPO should be

consulted as needed.

4.107. Contaminated clothing should be removed as soon as practicable,

taking care not to spread

contamination.

4.108. All staff working with unsealed sources should be trained in the

procedures for dealing with

accidents, spills or contaminated persons, with refresher training at

appropriate intervals. This

includes instructions on appropriate use of showering and eye washing.

Personal protective equipment and in-room protective devices

4.109. The BSS, paragraphs 3.93 and 3.95, requires that personal protective

equipment and in-room

protective equipment are available and used when structural shielding

and administrative controls

alone cannot afford the necessary level of occupational radiation

protection. The need for this

protective equipment should be established by the nuclear medicine

facility’s RPO or medical

physicist.

4.110. In a nuclear medicine facility, protective equipment includes the

following:

(a) Shields for bench tops, vials, syringes, activity meters and for

the preparation of the

radiopharmaceuticals (i.e. L-blocks and side blocks) of a material and

thickness appropriate to

the type and energy of the radiation. Particular considerations for the choice

of shield include:

a. Alpha emitters such as ²¹¹At may need to be shielded by high

atomic number

materials because of their characteristic X rays and high-energy gamma

components;

b. 223Ra does not need a high atomic number shield because the gamma

component does

not contribute significantly to the dose;

c. Solutions containing pure low-energy beta emitters such as ¹⁴C

and ⁹⁰Sr require a

plastic shield to attenuate the beta particles;

d. Solutions containing high-energy beta emitters such as ³²P and ⁹⁰Y

require a plastic

shield to attenuate the beta particles followed by a high atomic

number material

shield for the bremsstrahlung radiation;

e. Solutions containing radionuclides which have both beta and gamma

radiations (such

as ⁸⁹Sr, ¹⁵³Sm, ¹⁶⁹Er, ¹⁷⁷Lu, and ¹⁸⁶Re) may need in addition a lead shield to

attenuate

the high-energy gamma components;

f. Gamma emitters always require high-Z material shielding.

(b) Protective clothing should be used in work areas where there is a

likelihood of contamination,

such as radiopharmaceutical preparation areas. The protective

clothing may include

laboratory gowns, waterproof gloves (made of latex or non-latex such as

neoprene, polyvinyl

chloride or nitrile), overshoes, and caps and masks for aseptic work. The

clothing serves both

to protect the body of the wearer and to help to prevent the transfer of

contamination to other

areas. The clothing should be monitored and removed before leaving

designated areas;

however, when moving between supervised areas such as the camera room and the

injection

area, it may not be necessary to change the protective clothing

unless a spill is suspected.

Protective clothing should be removed prior to going to other areas such as

staff rooms.

enough to protect

against external beta radiation.

(d) Lead aprons should be worn when entering a room with hybrid imaging (e.g.

PET-CT) if the

X rays are about to be used and the staff member needs to be in the room with

the patient.

Lead aprons may also be worn when preparing and administering high

activities of ⁹⁹ᵐTc,

although their use is not recommended, as other protective measures are more

effective.

(e) Tools for remote handling of radioactive material, including tongues and

forceps.

(f) Containers for radioactive waste and radioactive source transportation.

(g) Fume hoods, fitted with appropriate filters, should be used with volatile

radiopharmaceuticals

such as ¹³¹I, ¹³³Xe and ²¹¹At. The sterility of the intravenous

radiopharmaceuticals should be

preserved.

Monitoring of the workplace

4.111. The BSS, in paragraphs 3.96-3.98, sets out the requirements and

responsibilities for workplace

monitoring. Workplace monitoring comprises measurements made in the working

environment and

the interpretation of such results. Workplace monitoring serves several

purposes, including routine

monitoring, special monitoring for specific occasions, activities or tasks, and

confirmatory monitoring

to check assumptions made about exposure conditions. Workplace monitoring

can be used to verify

the occupational doses of personnel whose work involves exposure to

predictable low levels of

radiation. It is particularly important for staff members who are not

individually monitored. In the

nuclear medicine facility, workplace monitoring should address

both external exposure and

contamination. Further general guidance on workplace monitoring is given in Ref

[23].

4.112. Laboratories and other areas in which work with unsealed

sources is undertaken should be

monitored, both for external radiation and for surface

contamination, on a systematic basis.

Contamination monitoring is required for:

(a) All working surfaces (including the interior of enclosures),

tools, equipment and devices

(including dosimetry systems, computers and peripherals, and stress testing

units), the floor

and any items removed from these areas;

(b) Contained workstations, ventilation systems and drains during maintenance;

leaving an area that is

controlled due to the risk of contamination (monitors should be available near

the exit);

(d) Clothing, bedding and utensils used by radiopharmaceutical therapy

patients.

4.113. Periodic monitoring with a survey meter and contamination monitor or by

wipe tests should be

conducted for controlled and supervised areas. Continuous monitoring with an

area monitor should be

considered for source storage and handling areas. If a package

containing radioactive sources is

damaged upon arrival, a survey of removable contamination and the external

radiation field should be

carried out.

4.114. Workplace monitoring with respect to X ray based imaging systems used in

nuclear medicine

should follow the guidance given in Section 3, para. 3.95.

4.115. Workplace monitoring should be performed and documented as part of the

nuclear medicine

facility’s radiation protection programme. The nuclear medicine facility’s RPO

or medical physicist

should provide specific advice on the workplace monitoring programme, including

any investigations

that arise when investigation levels are being exceeded (see paras. 4.130 –

4.131).

4.116. The survey meters used for external radiation monitoring should

be calibrated in terms of

ambient dose equivalent. For nuclear medicine, the quantity is H*(10) and the

unit the Sv and its sub-

multiples. Contamination monitors should be calibrated in appropriate

operational quantities. See also

further guidance on calibration in paras. 4.195 – 4.200.

Assessment of occupational exposure and workers’ health surveillance

Occupational exposure assessment

4.117. The purpose of monitoring and dose assessment is, inter alia, to provide

information about the

actual exposure of workers and confirmation of good working practices and

regulatory compliance. It

contributes to reassurance and motivation. The BSS require individual

monitoring for any worker who

normally works in a controlled area or who occasionally works in a controlled

area and is likely to

receive significant occupational exposure (see BSS paragraphs 3.99 to

3.102). Workers who may

require individual monitoring include nuclear medicine physicians, other

specialist doctors, medical

radiation technologists, medical physicists, the RPO, radiopharmacists and any

other persons involved

in the preparation, dispensing and administering of radiopharmaceuticals to

patients for diagnosis and

therapy, staff dealing with radioactive waste, biomedical engineers,

maintenance and servicing

personnel, and any nursing or other staff who need to spend time with nuclear

medicine patients or

work in controlled areas.

4.118. Monitoring involves more than just measurement. It includes

interpretation, assessment,

investigation and reporting, which may lead to corrective measures, if

needed. Individual external

doses are assessed by using individual monitoring devices that include

thermoluminescent dosimeters

(TLD), optical stimulated luminescence dosimeters (OSLD), film badges, and

electronic dosimeters.

Individual monitoring devices must be calibrated, traceable to a standards

dosimetry laboratory. For

more detailed guidance see Ref [23].

4.119. Each dosimeter is to be used for monitoring only the person to whom it

is issued, for work

performed at that nuclear medicine facility and should not be taken

to other facilities where that

person may work. For example, if a person is issued with a dosimeter at

hospital A it should be worn

only at hospital A and not at any other hospitals or medical

centres where he/she may also work.

Monitoring results can then be interpreted for the person working in

a specific nuclear medicine

facility and allow appropriate review of the effectiveness of the

optimization of protection for that

individual in that facility. See also paras. 4.132 to 4.134.

4.120. The monitoring period (period of dosimeter deployment) specified

by regulatory bodies in

most countries is typically in the range of one to three months. It is

determined by such factors as

service availability, work load and type of work. A one month monitoring period

is usually used for

persons performing procedures associated with higher occupational exposures. A

longer monitoring

period (two or three months) is more typical for personnel exposed to lower

doses, as a one month

cycle would usually mean that the actual occupational dose was less than the

minimum detection level

of the dosimeter resulting in no detectable doses. With a longer cycle

it is more likely to obtain a

reading. In certain circumstances (e.g. introduction of new procedures, high

dose rate work) shorter

monitoring periods may be needed. In these situations, the supplementary use of

electronic dosimeters

may be appropriate. Unnecessary delays in the return, reading and reporting of

dosimeters should be

avoided – the nuclear medicine facility should send the dosimeters to the

dosimetry service provider

who should then process the dosimeters and return the dose reports, all

in a timely manner. Some

regulatory bodies may specify a performance criterion for timely reporting.

4.121. The operational dosimetric quantity used for external radiation is the

personal dose equivalent

Hp(d). For weakly penetrating and strongly penetrating radiation, the

recommended depths, d, are 0.07

mm and 10 mm, respectively. Both weakly penetrating and strongly penetrating

radiation are used in

nuclear medicine. Hp(10) is used to provide an estimate of

effective dose that avoids both

underestimation and excessive overestimation [23].

4.122. For monitoring the skin and extremities, a depth of 0.07 mm (d = 0.07)

is recommended, and

Hp(0.07) is used to provide an estimate of equivalent dose to the skin and

extremities. When there is a

possibility of high exposure to the hands, such as in the

preparation and administration of

radiopharmaceuticals, extremity dosimeters should be worn (if

compatible with good clinical

practice).

4.123. For monitoring the lens of the eye, a depth of 3 mm (d = 3) is

recommended, and Hp(3) is used

to provide an estimate of equivalent dose to the lens of the eye. In practice,

however, the use of Hp(3)

has not been widely implemented for routine individual monitoring. In

nuclear medicine it would

generally be expected that the dose to the lens of the eye is not higher than

for the rest of the body. A

possible exception is during the handling of sources for preparation

and administration, but with

accepted practices (as described in 4.69 to 4.90) the lens of the eyes should

be adequately protected.

Nonetheless, monitoring of eyes doses may need to be considered.

4.124. There are three dose limits applicable to workers in nuclear

medicine – effective dose, and

equivalent dose to the lens of the eye, and to skin and extremities.

However, in nuclear medicine,

exposures from both external radiation and internal contamination are relevant.

The dosimeter being

worn will measure external radiation only and will be used to estimate one or

more of the quantities

used for the dose limits. Depending on the work being performed by the person

being individually

monitored, there may be a preferred position for wearing the dosimeter, and

more than one dosimeter

may be used. In nuclear medicine, dosimeters are usually worn on the front of

the upper torso (and

under any protective clothing), as occupational exposure arising from

most nuclear medicine

procedures results in the whole body being fairly uniformly exposed.

See para. 4.122 for when

extremity dosimeters should be worn.

4.125. When a protective apron is being used, the assessment of

effective dose may not be

straightforward:

(a) A single dosimeter placed under the apron, reported in Hp(10),

provides a good estimate of the

contribution to the effective dose by the parts of the body

protected by the apron, but

underestimates the contribution of the unprotected parts of the body (thyroid,

head and neck,

and extremities).

(b) A single dosimeter worn outside the apron, reported in

Hp(10), provides a significant

overestimate of effective dose and should be corrected for the

protection afforded by the

apron by using an appropriate algorithm [ 123, 127 129].

estimate of the effective

dose that is sufficient for radiation protection purposes.

4.126. In nuclear medicine, certain workers may be at risk of both surface

(skin) contamination and

internal contamination by ingestion, inhalation or adsorption of radioactive

material. Employers are

responsible (BSS paragraph 3.102) to identify those persons and arrange

appropriate monitoring. This

requirement is typically met by monitoring the thyroid with an external

detector assessing the iodine

uptake for individuals handling radioiodine and by monitoring the hands after

the protective gloves

have been removed. In some special cases, it may be required to

measure the activity of urine

samples. The committed effective dose should be calculated as part of

the worker’s total effective

dose [23].

4.127. When not in use, individual dosimeters should be kept in an established

place and protected

from damage or from irradiation. If an individual’s dosimeter is lost, the RPO

should perform a dose

assessment, record this evaluation of the dose and add it to the worker’s dose

record. Where there is a

national dose registry, it should be informed of the dose estimate

in a timely manner. The most

reliable method for estimating an individual’s dose is to use his or her recent

dose history. In those

cases where the individual performs non-routine types of work, it may be better

to use the doses of co-

workers having similar exposure conditions as the basis for the dose estimate.

4.128. In some cases occupational doses may be estimated from the results of

workplace monitoring.

The effective dose for personnel can be inferred from the measured ambient dose

equivalent H*(10),

provided the dose gradient in the workplace is relatively low. ICRP

[125] provides conversion

coefficients from ambient dose equivalent to effective dose for

different types of radiation and

energies.

4.129. The use of additional direct reading operational dosimeters,

such as electronic dosimeters,

should be considered for use in a nuclear medicine facility, e.g. in

a new department or with the

introduction of new procedures, as these devices can give the worker an instant

indication of both the

cumulative and the current dose rate and also allow pre-setting of an alarm to

alert when a given level

has been reached [23]. These dosimeters are also useful for staff

involved in radiopharmaceutical

therapies and for pregnant workers where a ‘real-time’ radiation exposure

reading is recommended.

Investigation levels for staff exposure

4.130. Investigation levels are separate from dose constraints and dose limits;

they are a tool used to

provide a ‘warning’ of the need to review procedures and performance,

investigate what is not

working as expected and take timely corrective action. Exceeding an

investigation level should

prompt such actions. In nuclear medicine, one could use predetermined values

such as 0.5 mSv per

month for effective dose or 15 mSv per month for finger dose. Suitable

alternatives may be doses that

exceed an appropriate fraction (e.g. 25%), pro rata per monitoring period, of

the annual dose limits or

a pre-set value above a historical average. Abnormal conditions and/or events

should also trigger an

investigation. In all cases the investigation is with a view to improve

implementation of optimization

of occupational protection and results should be recorded. Investigation levels

should also be set for

workplace monitoring.

4.131. The investigation is to be initiated as soon as possible

following the trigger or event and a

written report is to be prepared concerning the cause, including determination

or verification of the

dose, corrective or mitigating actions, and instructions or recommendations to

avoid recurrence. Such

reports should be reviewed by quality assurance and radiation safety

committees, as appropriate, and

the holder of the licence should be informed. In some cases, the

regulatory body should also be

informed.

Persons who work in more than one place

4.132. Personnel may work in more than one nuclear medicine facility. The

facilities may be quite

separate entities in terms of ownership and management, or they may have common

ownership but

separate management, or they may even have common ownership and management, but

be physically

quite separate. No matter which, the occupational radiation protection

requirements for the particular

nuclear medicine facility apply when the person is working in that

facility. As described above in

para. 4.119, a dosimeter issued for individual monitoring should be worn only

in the facility for which

it is issued as this facilitates effective implementation of optimization of

protection in that facility.

This approach is logistically more easily implemented as each physical site has

its own dosimeters –

there is no need to transport dosimeters between facilities, with the risk of

losing them or forgetting

them. In cases where the facilities are under common ownership it may be seen

as an unnecessary

financial burden to provide more than one set of dosimeters for staff that work

in more than one of its

facilities. However the radiation protection advantages of having the

dosimeter results linked to a

person’s work in only one nuclear medicine facility remain. See also para.

4.134.

4.133. There is however an additional consideration, namely

ensuring compliance with the

occupational dose limits. Any person who works in more than one nuclear

medicine facility should

notify the licensee for each of those facilities. Each licensee, through their

RPO, establishes formal

contact with the licensees of the other nuclear medicine facilities, and their

RPOs, so that each facility

has an arrangement to ensure that a personal dosimeter is available

and that there is an on-going

record of the occupational doses for that person in all the facilities where

they work.

4.134. Some personnel, such as consultant medical physicists or service

engineers, may perform work

in many nuclear medicine facilities and, maybe as well, other medical radiation

facilities. They may

be employed by a company or be self-employed, providing contracted

services to the nuclear

medicine and other facilities. In such cases it is simpler for the company or

the self-employed person

to provide the dosimeters for individual monitoring. In other words, in these

cases for each person the

same dosimeter is used for his/her work performed in all nuclear

medicine facilities (and other

medical radiation facilities) in the monitoring period.

Records of occupational exposure

4.135. Paragraphs 3.103 to 3.107 of the BSS state the detailed

requirements for records of

occupational exposure, placing obligations on the employer, registrant

and licensee. Apart from

demonstrating compliance with legal requirements, records of occupational

exposure should be used

within the nuclear medicine facility for additional purposes, including

assessing the effectiveness of

the facility’s implementation of optimization of protection, and

evaluating trends in exposure.

National or local regulatory bodies might specify additional requirements for

records of occupational

exposure and for access to the information contained in those records. Further

general guidance on

records of occupational exposure is given in [23].

Workers’ health surveillance

4.136. The primary purpose of health surveillance is to assess the

initial and continuing fitness of

employees for their intended tasks, and requirements are given in BSS

paragraphs 3.108 to 3.109.

4.137. No specific health surveillance related to exposure to ionizing

radiation is necessary for staff

involved in nuclear medicine. Under normal working conditions, the occupational

doses incurred in

nuclear medicine are low and no specific radiation related medical surveillance

is required as there are

no diagnostic tests that yield information relevant to low dose

exposure. It is, therefore, rare for

considerations of occupational exposure arising from the working environment of

a nuclear medicine

facility to significantly influence the decision about the fitness of a worker

to undertake work with

radiation or to influence the general conditions of service [23].

4.138. Only in cases of overexposed workers, at doses much higher than the dose

limits (e.g. a few

hundred millisieverts or higher), would special investigations involving

biological dosimetry and

further extended diagnosis and medical treatment be necessary [23]. In case of

internal contamination,

additional investigations to determine uptake and retention may be required.

Interventions to facilitate

excretion or limit uptake of the radioactive agent should be considered, as

appropriate.

4.139. Counselling should be available to workers who have or may have been

exposed in excess of

dose limits, and information, advice and, if indicated, counselling should be

available to workers who

are concerned about their radiation exposure. In nuclear medicine, the

latter group may include

women who are or may be pregnant. Counselling should be given by appropriately

experienced and

qualified practitioners. Further guidance is given in [23].

Information, instruction and training

4.140. All staff involved in nuclear medicine should fulfil the

respective training and competence

criteria described in Section 2, paras. 2.117 to 2.135. This will include

general education, training,

qualification and competence for occupational radiation protection in

nuclear medicine. Nuclear

medicine physicians, medical radiation technologists, medical physicists

and nurses may not have

been trained with respect to the X ray based component of hybrid imaging

systems, such as PET-CT,

and as such should undertake radiation protection training relevant to

the additional imaging

modalities in their nuclear medicine facility.

4.141. The BSS, in paragraph 3.110, places responsibilities on

employers to provide, inter alia,

specific instruction and training for protection and safety as it

pertains to their nuclear medicine

facilities. This is not only for new staff but also for all staff as part of

their continuing professional

development. Specific instruction and training should be provided when new

radiopharmaceuticals,

medical radiological equipment, software and technologies are introduced.

4.142. Information on potential contamination risks should be given to

ancillary staff, including

information technology specialists, and contractors doing occasional

work in a nuclear medicine

facility and/or radiopharmaceutical laboratory.

Conditions of service and special arrangements

4.143. As required in BSS paragraph 3.111, no special benefits are to be

offered to staff because they

are occupationally exposed. It is simply not acceptable to offer benefits as

substitutes for measures for

protection and safety.

Special arrangements – female workers (pregnant or breast-feeding)

4.144. A female worker should notify the licensee that she is pregnant as soon

as she knows of her

status, or if she is breast feeding, so that radiation protection requirements

for the embryo/fetus and

baby as a member of the public can be met respectively.

4.145. Limitation of the dose to the embryo/fetus does not mean that pregnant

women should avoid

working with radiation, but it does imply that the employer should

carefully review the exposure

conditions with regard to both normal exposure and potential exposure.

For example, a pregnant

worker may be restricted from spending a lot of time in the radiopharmacy or

working with solutions

of radioiodine [130]. The main risk with radioiodine is that it

crosses the placental barrier and

concentrates in the fetal thyroid.

4.146. Other possible solutions include reassigning a pregnant worker to duties

where the likelihood

of an accident or incident is unlikely or to a location that may have lower

ambient dose equivalent.

Adequate training should accompany such reassignments. A further consideration

is to avoid having

pregnant workers respond to an incident or accident such as a radioactive spill

(see also paras. 4.291 –

4.296).

4.147. The use of personal electronic dosimeters are valuable in assessing

radiation doses to pregnant

workers and subsequently the embryo/fetus. See also para. 4. 129.

4.148. When applying the dose limit of 1 mSv to the embryo/fetus, embryo/fetal

doses are not likely

to exceed 25% of the personal dosimeter measurement of external exposure. This

value depends on

the penetration of the radiation, i.e. on the photon energy of the

radionuclides in use. Information,

advice and, if indicated, counselling for pregnant workers should be available

(see also para. 4.139).

Special arrangements – persons under 18

4.149. In many countries there is the possibility of students aged

16 or more, but under 18,

commencing their studies and training to become a medical radiation

technologist or other health

professional that may involve occupational exposure to ionizing radiation. The

BSS paragraph 3.116

states the requirements for access to controlled areas, and the dose limits for

such persons are more

restrictive – see Table 2 in this Safety Guide and Schedule III of the BSS.

Protection of workers responding to incidents in the nuclear medicine facility

4.150. The practice of nuclear medicine is a planned exposure

situation, and when circumstances

result in incidents that lead to, or could lead to, unintended or accidental

exposures of patients or staff,

they are still within the framework of a planned exposure situation. The

potential occurrence of such

should be considered in advance in the facility’s safety assessment and

contingency plans developed

accordingly – see guidance in paras. 4.280 – 4.297 in the section

on prevention and mitigation of

accidents.

4.151. Occupational exposure of staff responding to these incidents is still

subject to the occupational

dose limits and the contingency plans for incidents should include

considerations for the optimization

of protection for the responding workers. The contingency plans should

also include allocation of

responsibilities and provide for the training of the relevant staff in

executing the mitigation measures,

which should be periodically rehearsed. Most of these situations, for example

spillage of radioactive

materials on work surfaces, can be executed in a planned manner so that doses

can be kept low. There

may be cases with high doses, for example in medical emergencies

involving immediate care of

patients in the case of a stroke or cardiac arrest, when large amounts of

radioactive material have been

incorporated (e.g. 2 GBq of ¹³¹I), but in these events the dose is

justified because the procedure is

lifesaving. However, even in the case of urgent surgery, rotation of personnel

may be utilized if the

surgical procedure is lengthy, to help maintain optimized occupational

radiation protection for this

situation. The advice of the facility’s RPO is needed for these situations. See

the guidance in paras.

4.295 – 4.296 for more details.

RADIATION PROTECTION OF PATIENTS, CARERS AND COMFORTERS, AND

VOLUNTEERS IN BIOMEDICAL RESEARCH

Introduction

4.152. This section covers what is more formally called ‘medical exposure’ in

radiation protection.

Medical exposure is defined in the BSS and described in Section 2, para. 2.5.

It concerns radiation

protection of the patient, carers and comforters, and volunteers in

biomedical research. The term

‘patient’, when used in the context of medical exposure, means the person

undergoing the radiological

procedure. Other patients in the nuclear medicine facility, including

those who may be waiting for

their own radiological procedure, are considered as members of the

public and their radiation

protection is covered in paras. 4.260 – 4.269.

4.153. As described in Section 2 para. 2.8, there are no dose limits for

medical exposure, making it

very important that there is effective application of the requirements for

justification and optimization.

Justification of medical exposures

4.154. The requirements of the BSS for justification of medical exposure, BSS

paragraphs 3.155 to

3.161, incorporate the ‘3 level approach’ to justification [4, 131, 140].

4.155. The roles of the health authority and professional bodies with respect

to ‘level 2’ or generic

justification of radiological procedures, justification of health screening

programmes, and justification

of screening intended for the early detection of disease, but not as

part of a health screening

programme, are described in Section 2 paras. 2.55 – 2.59 and 2.64 – 2.65.

Justification for the individual patient

4.156. The BSS invokes a joint approach to justification at the individual

patient level, with a shared

decision involving both the referring medical practitioner (who initiates the

request for a radiological

procedure) and the radiological medical practitioner. A referral for a

nuclear medicine procedure

should be regarded as a ‘request for a professional consultation or opinion’

rather than an ‘instruction

or order to perform’. The referring medical practitioner brings the knowledge

of the medical context

and the patient’s history to the decision process, while the radiological

medical practitioner has the

specialist expertise on the radiological procedures. The efficacy,

benefits and risks of alternative

methods (both involving and not involving ionizing radiation, such as for

example CT or ultrasound)

should be considered. Ultimate responsibility for justification will be

identified by individual member

states’ regulations.

4.157. In the case of radiopharmaceutical therapy, the requirements for

justification are implemented

more effectively as part of the medical process of determining the best

approach to treatment. When a

patient is referred by a referring medical practitioner for treatment, careful

consideration should be

made by a multidisciplinary team, including such specialists as

radiation oncologists or

endocrinologists, regarding whether to treat the patient with

radiopharmaceutical therapy or some

other form of radiation therapy, another modality, a combined

treatment approach (sequential or

concomitant) or not to be treated at all. Ideally every treatment

decision should be discussed and

documented in a tumour board or equivalent multidisciplinary meeting.

4.158. The patient also should be informed about the expected benefits, risks

and limitations of the

proposed radiological procedure(s), as well as the consequences of not

undergoing the procedure.

4.159. In nuclear medicine imaging, requirements for justification are applied

more effectively as part

of the medical process of determining ‘appropriateness’. Appropriateness

uses an evidence-based

approach to choose the best test for a given clinical scenario, taking into

account diagnostic efficacy

and justification as well as alternative procedures that do not use

ionizing radiation, for example,

ultrasound or MRI. Useful tools to support this decision making

process include national or

international imaging referral guidelines developed by professional

societies [133 – 140, 245], in

some cases disseminated through electronic requesting systems¹⁷ and clinical

decision support tools or

systems.

4.160. In determining appropriateness of the nuclear medicine imaging

procedure for an individual

patient, the following questions should be asked by the referring medical

practitioner [138];

(a) Has it been done already? A radiological procedure that has already

been performed within a

reasonable time period (depending on the procedure and clinical

question) should not be

repeated. In some cases an alternative procedure may have already been

performed in another

facility, making the proposed radiological procedure unnecessary – for

example a CTPA

performed recently in one facility for a patient who presents as a

potential V/Q patient at

another facility. The results (images and reports) of previous

examinations should be

available, not only within a given nuclear medicine facility but also

between different

facilities. Digital imaging modalities and electronic networks should

facilitate this process.

(b) Is it needed? The results of the proposed radiological procedure

(positive or negative) should

influence the patient’s management.

procedure in relation to the

progression of the suspected disease and the possibilities for

treatment, all should be

considered as a whole.

(d) Is this the best investigation to answer the clinical question?

Advances in imaging techniques

are taking place continually, and the referring medical practitioner may need

to discuss with

the radiological medical practitioner what is currently available for a given

problem.

(e) Has the clinical problem been explained to the radiological

medical practitioner? The

medical context for the requested radiological procedure is crucial to

ensure the correct

technique is performed with the correct focus.

4.161. Three particular groups of patients are identified in the BSS,

paragraph 3.157, for special

consideration with respect to justification in nuclear medicine –

patients who may be pregnant or

breast-feeding, and paediatric patients.

(a) Due to the higher radiosensitivity of the embryo/fetus, it should

be ascertained whether a

female patient is pregnant before performing a nuclear medicine

procedure. Determining

pregnancy status is a requirement in the BSS, paragraph 3.176, for

those radiological

procedures that could result in significant dose to the embryo or fetus.

Pregnancy would then

be a factor in the justification process and might influence the

timing of the proposed

radiological procedure or whether another examination or treatment is more

appropriate. Care

should be taken to ascertain that the examination is indeed indicated for a

medical condition

that requires prompt medical treatment. Confirmation of pregnancy may occur

after the initial

justification and before the radiological procedure is performed.

Repeat justification is

required taking into account the additional sensitivity of the pregnant woman

and embryo or

fetus.

a. Most diagnostic procedures with ⁹⁹ᵐTc do not cause high

fetal doses. For

radionuclides that do not cross the placenta, fetal dose is

derived from the

radioactivity in maternal tissues. Some radiopharmaceuticals, or their

breakdown

¹⁷ Such electronic requesting systems include the so-called CPOE – computerized

physician order entry, noting

that for imaging such a system should generate a request rather than an order.

components, that do cross the placenta and concentrate in a specific organ or

tissue

can pose a significant risk to the fetus. Particular attention should

be drawn to

radiopharmaceuticals labelled with iodine isotopes. Radiopharmaceuticals

labelled

with other radionuclides, in particular positron emitters, need special

consideration. In

all these instances the medical physicist should estimate the fetal

dose. Detailed

information on doses to the embryo and fetus from intakes of radionuclides

by the

mother is given by the ICRP [246].

b. As a rule, a pregnant woman should not be subject to radioiodine therapy

unless the

application is lifesaving. Otherwise, the therapeutic application should

be deferred

until after the pregnancy and after any period of breast feeding

[130, 247]. In

particular, radioiodine will easily cross the placenta, and the fetal thyroid

begins to

accumulate iodine at about ten weeks of gestation.

(b) In breast feeding patients excretion through the milk and

potentially enhanced breast dose

should be considered in the justification process. Detailed information

on doses to infants

from the ingestion of radionuclides in mother’s milk is given by the ICRP [248]

and can be

calculated using available software, for example [249].

stochastic effects, paediatric

examinations require special consideration in the justification process [245].

4.162. ‘Self-referral’ occurs when a health professional undertakes a

radiological procedure for

patients as a result of justification based on their own previous clinical

assessment. Most examples of

acceptable self-referral practice occur with X ray imaging, such as dentistry,

and relevant professional

bodies in many countries develop appropriate guidance for their specialty (see

Section 3 para. 3.143).

Self-referral in nuclear medicine, if it occurs, would need to be

guided by such professional

guidelines.

4.163. ‘Self-presentation’, including ‘individual health assessment’,

occurs when a member of the

public asks for a radiological procedure without a referral from a health

professional. This may have

been prompted by media reports or advertising. Self-presentation for nuclear

medicine procedures is

not widely prevalent, but for any such case justification is required, as for

all radiological procedures.

Relevant professional bodies have an important role in considering evidence for

developing guidance

when new practices are proposed. Member states may choose to

incorporate this approach into

legislation [144].

4.164. Approaches to support applications of the requirements for justification

for medical exposures

should consider the development of means to improve ‘awareness,

appropriateness and audit’.

Awareness of the need for justification underpins the whole process. Means for

promoting awareness

include traditional education and training, such as at medical school or during

specialty training, web-

based learning or learning through work flow at the right time, (e.g. junior

doctors in the emergency

department), and the use of feedback in the reporting process. Appropriateness

has been described in

paras. 4.159 to 4.161, and the process of audit is used for monitoring and

feedback to improve both

awareness and appropriateness.

Justification – biomedical research volunteers

4.165. The role of the ethics committee in the justification of medical

exposure of volunteers exposed

as part of a programme of biomedical research is described in Section 2 para

2.98.

Justification – carers and comforters

4.166. The justification of medical exposure incurred by a carer or comforter

is effectively carried out

by the radiological medical practitioner or delegated to the medical radiation

technologist involved in

the radiological procedure, prior to the performance of the procedure.

It depends on the carer or

comforter being correctly informed about the radiation doses and risks

involved, and his or her

understanding of this information and consequent agreement to take on the role

of carer or comforter.

Optimization of protection and safety

4.167. In medical exposures, optimization of protection and safety has

several components, some

applied directly to the radiological procedure(s) about to be

performed and others providing the

support or framework for the other components. These components of optimization

of protection and

safety are described in the following paras. 4.168 to 4.236.

Design considerations

4.168. The use of appropriate and well-designed medical radiological

equipment and associated

software underpins any nuclear medicine procedure. Gamma cameras,

SPECT-CT and PET-CT

scanners and their accessories should be designed and manufactured so as to

facilitate the keeping of

medical exposures as low as reasonably achievable consistent with

obtaining adequate diagnostic

information. Guidance on design considerations is given in the sub-section on

medical radiological

equipment, paras. 4.44 to 4.50. Guidance on design considerations

applicable for X ray imaging

systems as part of hybrid systems is given in Section 3, paras. 3.31 to 3.39.

Ultimately, as stated in the

BSS paragraph 3.162, it is the responsibility of the nuclear medicine facility

licensee to ensure that

his/her facility uses only medical radiological equipment and

software that meets applicable

international or national standards.

Operational considerations - general

4.169. Following justification, the nuclear medicine procedure is

performed in such a way as to

optimize patient protection, as required in the BSS paragraph 3.163 for

diagnostic procedures and in

paragraph 3.166 for radiopharmaceutical therapy procedures. The level of image

quality sufficient for

diagnosis is determined by the radiological medical practitioner and is based

on the clinical question

posed.

4.170. The following points apply to all nuclear medicine patients, whether

undergoing diagnostic or

therapeutic procedures:

(d) There should be an effective system for correct identification of

patients, with at least two

forms of verification, for example name, birthday, address, medical record

number.

(e) Patient details should be correctly recorded, such as age, gender, weight,

height, pregnancy

and breast-feeding status, current medications, allergies.

(f) Patient clinical history should be reviewed.

Operational considerations – diagnostic imaging

4.171. The nuclear medicine facility should have a written protocol

for each diagnostic procedure

performed in the facility, designed to maximize the clinical information to be

obtained from the study,

taking into consideration the appropriate diagnostic reference level for the

procedure (see Section 2

paras. 2.34 – 2.45). These protocols are best developed using guidelines from

national or international

professional bodies, and hence reflect current best practices, as for example

in Refs [65, 214, 215, 250

– 255]. For modern digital equipment many of the factors are

automated through menu-driven

selections on the equipment console. Nevertheless, in setting up these options,

significant scope exists

for optimization of protection through the appropriate selection of

values for the various technical

parameters, thereby producing effectively an electronic protocol.

Protocols should be periodically

reviewed in line with the requirements for quality assurance and

radiological reviews (see paras.

4.231 and 4.256 - 4.258).

4.172. Deviations from such protocols may be necessary owing to the special

needs of a particular

patient or because of the local unavailability of components for a test. In

these cases the radiological

medical practitioner should record a valid reason for his or her decision.

4.173. Equipment should be operated within the conditions established in the

technical specifications,

and in any licence conditions, ensuring that it will operate satisfactorily at

all times, in terms of both

the tasks to be accomplished and radiation safety, so that optimal image

acquisition and processing

can be achieved with the minimum of patient exposure.

4.174. Many factors influence the relationship between image quality and

patient dose in diagnostic

nuclear medicine procedures. Detailed guidance on appropriate choices

for those factors is widely

available and should be followed [65, 214, 215, 219, 250 – 255]. Such factors

include:

(a) Appropriate selection of the best available radiopharmaceutical and

its activity, noting the

special requirements for children and for patients with impairment of organ

function;

(b) Adherence to patient preparation requirements specific to the

study to be performed.

Examples include:

a. Use of methods for blocking the uptake in organs not under study and for

accelerated

excretion when applicable;

b. Correct hydration.

can be influenced by

drugs such as diuretics or gall bladder stimulants, whenever they do not

interfere adversely

with the procedure. This method is sometimes used to increase the

specificity of the

examination, but has also a positive influence on radiation protection – e.g.

the use of diuretic

challenge in renography.

(d) For children undergoing diagnostic procedures, the amount of activity

administered should be

chosen utilizing methodologies described in international or national

guidelines [66, 214, 215,

219, 251, 252, 256 – 258].

(e) Using appropriate image acquisition parameters:

a. For nuclear medicine with a gamma camera, this may include selection of

collimator,

acquisition matrix, energy windows, acquisition zoom, time per frame,

imaging

distance;

b. For PET systems, this may include 2D and 3D acquisitions, matrix size,

field of view,

time of flight, attenuation correction, slice overlap, scatter

correction, coincidence

timing;

(f) Using appropriate reconstruction parameters such as

algorithm, matrix, filters, scatter

correction, zoom factor,

(g) Utilizing quantitative and qualitative capabilities, such as the

generation of region-of-interest

(ROI) analysis, time-activity curve generation, image reformatting, or

tissue uptake ratios,

specific for the clinical need.

4.175. Many radionuclides are excreted by the kidneys. Bladder doses can be

minimized by drinking

plenty of fluid and frequent bladder emptying. Patients, particularly in the

case of children, should be

encouraged to void frequently, especially in the immediate interval following

the examination.

4.176. While most adults can maintain the required position without

restraint or sedation during

nuclear medicine examinations, it may be necessary to immobilize or

sedate children so that the

examination can be completed successfully. Increasing the administered

activity to reduce the

examination time is an alternative that can be used in elderly patients with

pain.

4.177. In some cases, if the patient is healthy and cooperative, activity

might be reduced and scan

times increased – e.g. lung scans for pregnant women. In all cases, however,

diagnostic information

produced should not be compromised by reduction in activity.

4.178. Care should be taken to ensure that there is no contamination

on the collimator surface or

elsewhere as this might impair the quality of the images.

Operational considerations – radiopharmaceutical therapy

4.179. The nuclear medicine facility should have written

protocols for each type of

radiopharmaceutical therapy performed in the facility, designed to meet the

requirements of the BSS

paragraph 3.165. These protocols are best developed using guidelines from

national or international

professional bodies, and hence reflect current best practices, as for example

in Refs [214, 215, 250 –

254, 259, 260]. For modern digital equipment many of the factors are automated

through menu-driven

selections on the equipment console. Nevertheless, in setting up these options,

significant scope exists

for optimization of protection through the appropriate selection of

values for the various technical

parameters, thereby producing effectively an electronic protocol.

Protocols should be periodically

reviewed in line with the requirements for quality assurance and

radiological reviews (see paras.

4.231 and 4.256 - 4.258).

4.180. In addition to the guidance in paras. 4.169 – 4.171 (for both

diagnostic and therapy nuclear

medicine procedures), the following provisions should be in place:

(a) Verbal and written information and instructions to patients about

their radiopharmaceutical

therapy and about how to minimize exposure to family members and the public,

and advice

on pregnancy and contraception after therapy. For detailed guidance,

including sample

information sheets, see Refs [214, 18, 261, 262];

(b) Special attention to preventing spread of contamination due to patient

vomit and excreta;

administration of therapeutic doses of

radiopharmaceuticals (see guidance in paras. 4.243 – 4.245).

4.181. The BSS, paragraph 3.165, gives requirements concerning the

activity of the therapeutic

radiopharmaceutical to be administered. Algorithms for determining appropriate

activities for a given

patient based on radiation doses to critical organs do exist, but there

is no standardized algorithm.

Methodologies are discussed in Refs [214, 251, 263-268]. Typically, therapeutic

radiopharmaceuticals

are administered at standard fixed activities (in gigabecquerel or millicurie),

standard fixed activities

per unit body mass (MBq kg–¹ or mCi kg–¹) or standard fixed activities per

unit body surface area

(MBq m–² or mCi m–²), based on the results of toxicity and side effects in

clinical trials.

4.182. For female patients, their pregnancy and breast-feeding status

should be evaluated before

administration of a therapy dose (see also paras. 4.238 – 4.242). Immediately

prior to administration

of a therapeutic radiopharmaceutical, the following information, as

applicable, should be verified

preferably by two individuals:

(a) Dose on the radiopharmaceutical label matches the prescription;

(b) Identification of the patient by two independent means;

(d) Identity of the radiopharmaceutical;

(e) Total activity;

(f) Date and time of calibration.

4.183. The administered activity should be verified in an activity

meter (dose calibrator) or other

suitable device to ensure that the total activity does not deviate

significantly from the prescribed

administered activity (e.g. < 10 % deviation), and the measured value recorded.

Corrections should be

calculated for residual activity in the syringe, cups, tubing, inline filter,

or other materials used in the

administration.

4.184. Radiopharmaceutical therapy patients should be informed in advance that

it will be necessary

for medical personnel to minimize close or direct contact, so that

this precaution will not be

interpreted as a lack of concern.

4.185. Both females and male patients should be advised about avoiding

conception after therapeutic

administrations. Data on the periods during which conception should be avoided

after administration

of a radiopharmaceutical to females for therapeutic purposes are

given in Appendix II, with further

guidance in Ref. [251]. These times have been derived with a view to the need

for further therapy,

which may be compromised if the patient becomes pregnant.

4.186. The administration of therapeutic doses of relatively long lived

radionuclides in ionic chemical

forms to males is a possible source of concern because of the appearance of

larger quantities of these

radionuclides in ejaculate and in sperm. It may be prudent to advise sexually

active males who have

been treated with for example ³²P (phosphate), ⁸⁹Sr (strontium chloride), ¹³¹I

(iodide), ²²³Ra (chloride),

to avoid fathering children for a period of four months after treatment. The

period of four months is

suggested as this is longer than the life of a sperm cell [251, 269].

Operational considerations – pregnant female patients

4.187. Administration of radiopharmaceuticals for therapy to female

patients who are pregnant or

might be pregnant should be generally avoided. There may be

exceptions when the treatment is

lifesaving. See also paras. 4.161 on justification and 4.238 – 4.240 on the

need to ascertain pregnancy

status.

4.188. Diagnostic nuclear medicine procedures with ⁹⁹ᵐTc and

radiopharmaceuticals that do not cross

the placenta do not cause high fetal doses. Protection of the fetus can be

optimized by using smaller

administered activities and longer imaging times. This is feasible if the

patient is able to remain still.

4.189. Specific assessment of individual fetal doses is not usually necessary

after diagnostic nuclear

medicine studies involving ⁹⁹ᵐTc radiopharmaceuticals. In the case of

other radiopharmaceuticals

(such as iodine or gallium), calculation of dose to the individual

fetus and risk estimation may be

necessary.

4.190. In the case of radiopharmaceuticals that are rapidly eliminated by

the maternal kidneys, the

urinary bladder is the major source of fetal irradiation.

After the administration of such

radiopharmaceuticals, maternal hydration and frequent voiding

should be encouraged. Some

radiopharmaceuticals, for example radioactive iodides, including those

administered for diagnostic

purposes, cross the placenta freely and are taken up by the fetal

tissues, for example the thyroid.

Failure to ascertain whether a patient is pregnant when administering ¹³¹I for

a scan, for example, may

lead to a severe accidental exposure of the fetus.

4.191. Of special concern is also the use of CT in PET-CT or

SPECT-CT examinations. Routine

diagnostic CT examinations of the pelvic region with and without contrast

injection can lead to a dose

of 50 mSv to the uterus, which is assumed to be equivalent to the fetal

dose in early pregnancy. When

PET-CT or SPECT-CT scanning is indicated in a pregnant patient, low-dose CT

protocols should be

used and the scanning area should be reduced to a minimum. See also Section 3,

paras. 3.170 – 3.178.

4.192. If FDG is being used for the PET component of hybrid

imaging, a lower activity of FDG

should be used. Further guidance is given in Refs [65, 270].

Operational considerations – breast feeding

4.193. Female patients should be advised that breast feeding is

generally contraindicated after

therapeutic administration of some radiopharmaceuticals, because of both the

external irradiation of

the suckling baby and the potential excretion of radioactivity through the

breast milk. See also paras.

4.161 on justification and 4.241 – 4.242 on the need to ascertain

breast-feeding status.

4.194. Depending on the radiopharmaceutical, breast feeding may need to be

interrupted for a period

or even stopped following its administration for a diagnostic procedure. More

specific advice is given

in Appendix III and Refs. [214, 247, 251].

Calibration

4.195. Requirements for calibration of sources and instruments used

for dosimetry of patients are

given in the BSS paragraph 3.167. For nuclear medicine, responsibility

is assigned to the nuclear

medicine facility’s medical physicist. Unsealed sources for nuclear

medicine procedures should be

calibrated in terms of activity of the radiopharmaceutical to be administered,

with the activity being

determined and recorded at the time of administration. Detailed guidance on

acceptable protocols for

making activity measurements can be found in the following references [243,

271].

4.196. Radionuclides should be checked for radioactive impurities when these

are liable to be present.

This applies particularly to short lived radionuclides, as longer- lived

impurities may be present and

could deliver a significant fraction of the absorbed dose.

4.197. The calibration of X ray based imaging devices that are part of hybrid

imaging systems, such

as CT in PET-CT or SPECT-CT, should follow the guidance for such modalities in

Section 3. See

also Section 5 for hybrid imaging systems used in radiation therapy

simulation and treatment

planning.

4.198. In the nuclear medicine facility, instruments used for dosimetry of

patients, such as activity

meters (dose calibrators), also should be calibrated at appropriate intervals

using calibrated reference

sources that cover the energy range used in clinical practice. After the

initial calibration, the intervals

for periodic calibrations may differ, depending on the availability of

calibration radioactive sources in

the department. A period of one to two years is recommended.

4.199. The BSS in paragraph 3.167(d) requires the calibration of

dosimetry instrumentation to be

traceable to a standards dosimetry laboratory (SDL). Ideally this

would be to the national SDL

(primary or secondary) in the State concerned, with access either directly or

through a duly accredited

calibration facility. However, it may be necessary for instruments used for

dosimetry of patients to be

sent to another country or state if there is no national SDL in

the country or state where the

instruments are used.

4.200. Records of calibration measurements and associated calculations,

including uncertainty

determinations (budgets), should be maintained as described in para. 4.230.

Dosimetry of patients – diagnostic procedures

4.201. The BSS paragraph 3.168 requires nuclear medicine facilities to ensure

that patient dosimetry

is performed and typical doses for their diagnostic

radiological procedures are determined.

Knowledge of a facility’s typical doses forms the basis for applying

methods of optimization of

protection. It also enables the nuclear medicine facility to use diagnostic

reference levels (see paras.

4.210 to 4.217) as another tool for optimization of protection. Administered

activity (in MBq) is the

most widely used surrogate for dose in diagnostic nuclear medicine,

however organ doses and

effective doses can be calculated from activity using established methodologies

– see para 4.208.

4.202. Clearly, the more radiological procedures at the nuclear

medicine facility for which typical

doses are known, the better the basis for optimization of protection. However,

pragmatically, the BSS

requires only common radiological procedures for diagnostic medical

exposures. What is common

will vary from facility to facility, and country to country, but in general

there are some core common

examinations, including: thyroid scans, bone scans, myocardial perfusion

imaging, FDG-PET/CT in

oncology, renal scans, and lung scans.

4.203. The term ‘typical dose’, as used in the BSS paragraph 3.168, refers to

the average or median

dose or activity for a particular size of patients. Patient size has a large

influence on doses, so some

selection or grouping of patients is required. Such groupings include

‘average adult’, often based

around an average weight of 70 kg with a range of ± 20 kg. Groupings for

children have sometimes

been based on age, such as new born (0 years), infant (1 year), small child (5

years), child (10 years)

and teenager (15 years), but more recently size-specific groupings are

being used. The nuclear

medicine facility should adopt patient size groupings that correspond with the

groupings used in their

country or state for DRLs. The sample size used for each patient grouping and

radiological procedure

should be of sufficient size to assure confidence in the determination of the

mean dose. Such sample

sizes are typically in the range 10 to 20 patients, but clearly the

larger the sample the better the

statistics.

4.204. Dose in the term ‘typical dose’ means for the given procedure the

effective dose, organ doses,

or, in the case of X ray imaging, an accepted dosimetric quantity as

described in Section 3 paras.

3.195 - 3.196. For combining doses from radiopharmaceuticals and X rays, organ

doses will need to

be used.

4.205. Patient dosimetry to determine typical doses in diagnostic nuclear

medicine should be carried

out in conjunction with an assessment of the diagnostic image

quality. Exposure alone is not

meaningful if it does not correspond to images that are sufficient for an

accurate diagnosis. Therefore

patients included in the sample used for determining typical doses

should be only those whose

radiological procedure resulted in acceptable image quality.

4.206. The results of the surveys used to determine typical doses at

the nuclear medicine facility

should be used as part of the facility’s on-going review of the

implementation of optimization of

protection, and additionally will be used for comparison with established DRLs

(see paras. 4.210 to

4.217). The results should also be submitted to the organization in

their country or state that is

responsible for reviewing the national or regional DRLs. With these

considerations in mind, the

patient surveys of administered activities, from which patient doses can be

calculated as required by

the BSS, should take place at intervals of no more than 5 years and preferably

no more than 3 years.

Another trigger for a survey would be the introduction of new

radiopharmaceuticals, equipment or

technology into the nuclear medicine facility or when significant

changes have been made to the

protocols or the equipment.

4.207. Sometimes patient dosimetry in diagnostic nuclear medicine procedures

may be required for

specific individual patients. Reasons might include an unintended or

accidental medical exposure

where an estimation of patient doses is required as part of the

investigation and report (see para.

4.252), or there may be the need to estimate embryo or fetal doses (see para.

4.189).

4.208. There are several indirect and direct methods to estimate

patient dose in diagnostic nuclear

medicine procedures. In the case of hybrid systems, the contribution

from each of X rays and

radionuclides should be calculated and combined. Methodologies and data for the

determination of

doses from radiopharmaceuticals are given in Refs [232, 234, 240,

241, 255 – 259] and for

methodologies for X ray imaging see Section 3, paras. 3.211.

Dosimetry of patients – radiopharmaceutical therapy procedures

4.209. The BSS paragraph 3.168 requires nuclear medicine facilities to

determine typical absorbed

doses to patients for their therapeutic radiological procedures. As in para.

4.208, methodologies for

the determination of doses from therapy radiopharmaceuticals are explained in

detail in Refs [249,

251, 257, 258, 272 – 278].

Diagnostic reference levels

4.210. The BSS, paragraphs 3.168 - 3.169, requires that nuclear medicine

facilities perform patient

dosimetry surveys for their diagnostic procedures, as described in paras 4.201

to 4.208, and that these

results are compared with the established DRLs for their country or region. The

purpose is to ascertain

whether the typical dose or activity in the facility for a given diagnostic

nuclear medicine procedure

compares favourably, or not, with the value of the DRL for that

nuclear medicine procedure.

Guidance on establishing national or regional DRLs in given in Section 2,

paras. 2.34 to 2.45.

4.211. A review of optimization of protection for that particular

nuclear medicine procedure is

triggered if the comparison shows that the facility’s typical dose or activity

exceeds the DRL, or that

the facility’s typical dose or activity is substantially below the

DRL and it is evident that the

exposures are not producing images of diagnostic usefulness or are not yielding

the expected medical

benefit to the patient.

4.212. Given the uncertainties in determining a facility’s typical dose or

activity, questions can arise

over whether a DRL has really been exceeded or not. Some countries adopt an

algorithmic approach,

for example where the facility’s typical dose or activity, minus two times its

standard error, should be

greater than the value of the DRL [13]. A simpler approach, based

purely on the facility’s typical

value, may be sufficient as the purpose is to identify the need for a review,

and perhaps it is better to

perform more reviews than fewer [12, 13].

4.213. No individual patient’s dose or activity should be compared with

a DRL. It is the facility’s

typical dose or activity, as determined by the representative patient sample,

which is compared.

4.214. Further, the comparison is not a case of “Does the nuclear medicine

facility comply with the

DRL?” DRLs are not dose limits. It is mandatory to use them for the comparison

exercise to identify

practices that warrant further investigation.

4.215. The review of how the given nuclear medicine procedure is

being performed and its

optimization of protection, triggered by the DRL comparison, may

conclude that there are valid

reasons supported by sound clinical judgement why the nuclear medicine facility

has a typical dose or

activity that exceeds the DRL. These reasons should be documented as

part of the facility’s QA

programme. On the other hand, the review may identify areas for improvement

resulting in revised

protocols for that nuclear medicine procedure. The results of the DRL

comparison and any ensuing

review and actions should be documented as part of the facility’s QA programme.

4.216. The fact that a nuclear medicine facility’s typical dose or

activity for a nuclear medicine

procedure is less than the DRL for that procedure does not mean

necessarily that optimization of

protection for that nuclear medicine procedure has been fully

achieved. DRLs are only one of the

tools for optimization, aimed specifically at identifying the outliers in

performance.

4.217. The regulatory body in a given country may specify frequencies

for performing DRL

comparisons. Otherwise, the general guidance on patient dosimetry, described

above in para. 4.206,

would be applicable.

Quality assurance for medical exposures

4.218. The BSS paragraph 3.170 requires nuclear medicine facilities to

have a comprehensive

programme of quality assurance for medical exposures. General guidance on

management systems is

given in Section 2, paras 2.136 to 2.147, and it is simply

re-iterated here that the programme of

quality assurance for medical exposures should fit in with, and be

part of, the facility’s wider

management system. The paragraphs in this subsection give guidance on the

technical aspects of the

programme of quality assurance for medical exposures.

4.219. The purpose of the programme of quality assurance for medical exposures

is to help ensure

successful implementation of optimization of patient protection in the nuclear

medicine facility and to

minimize the occurrence of unintended and accidental medical exposures.

4.220. The complexity of the programme of quality assurance for medical

exposures will depend on

the type of nuclear medicine facility. A facility with only limited diagnostic

procedures will have a

simpler programme compared with a facility that offers a comprehensive

diagnostic service, including

PET-CT imaging, radiopharmaceutical therapy, and that has a radiopharmacy.

Nonetheless, most of

the elements of the programme are common, and it is more in degree of

implementation that there are

differences. The BSS paragraph 3.171 establishes the common elements of the

programme.

4.221. Measurements on medical radiological equipment are one

of the components of the

programme. Acceptance tests are required for new or significantly refurbished

or repaired equipment,

or after the installation of new software or modification of existing

software that could affect

protection and safety of patients. The acceptance test is followed immediately

by commissioning, and

then on-going periodic quality control tests, including constancy tests. The

purpose is to ensure that,

at all times, all medical radiological equipment is performing correctly,

accurately, reproducibly and

predictably. Acceptance and commissioning tests should be performed in the same

way for equipment

and/or software that has been donated.

4.222. Depending on the equipment purchase agreement, acceptance tests may be

performed by the

manufacturer’s representative in the presence of the local medical

physicist and the radiological

medical practitioner representing the user, or, if acceptable to the

manufacturer and/or the purchaser,

by a medical physicist jointly with the manufacturer’s

representative. The process involves

verification of all specifications and features of the equipment; in

particular, protection and safety

features including displayed and reported dose metrics.

4.223. After acceptance and before clinical use on patients, commissioning is

carried out by or under

the supervision of the medical physicist. Commissioning should include

measurements of all

parameters and conditions of use that are expected in clinical use. For

most situations the medical

physicist should be directly involved in the measurements, calculations and

interpretation of data to

characterize the equipment’s performance. In some simple situations it

may be sufficient for the

medical physicist to provide documented advice on how the commissioning should

be performed. At

commissioning, the baseline for subsequent constancy tests is established.

4.224. There are many published reports from international and national

organizations and national or

regional professional bodies giving detailed guidance on the quality

control tests that should be

performed in nuclear medicine, including recommended frequencies [192, 193,

197, 210, 211, 214,

215, 217, 225 – 241, 243, 271, 277, 279 – 281]. In addition, many

of these organizations have

extensive websites where any new or updated publications on the topic will be

able to be found. The

regulatory body may have its own specific requirements on the tests that

should be performed and

their frequencies.

4.225. For guidance on the quality control tests for X ray imaging devices used

in nuclear medicine,

see Section 3, para. 3.231.

4.226. In nuclear medicine there is the additional factor of the

radiopharmaceuticals themselves. The

quality assurance programme for medical exposures should ensure that

radiopharmaceuticals intended

for administration to patients are prepared in a manner that meets

clinical needs and satisfies both

radiation safety and pharmaceutical quality requirements [214, 217, 218].

Therefore, radiopharmacist

should be involvemed.

4.227. The BSS paragraph 3.171(e) specifically requires that dosimetry and

monitoring equipment are

part of the QA programme. This is to ensure that such

instrumentation has a current calibration,

typically within 2 years (see para. 4.198), and that it is

functioning correctly. The programme of

quality assurance for medical exposures should establish a calibration cycle

for each instrument and a

set of checks on the operation of each instrument to be performed at set

intervals. This applies to stand

alone dosimetry equipment and to equipment software related to dosimetry –

e.g. software used to

calculate “specific uptake values (SUV)” from which doses can be estimated.

Detailed guidance on

quality control tests for such nuclear medicine instrumentation is given in

[192, 193, 197, 210, 211,

214, 215, 217, 225 – 241, 243, 271, 277, 279 – 281].

4.228. The results of the quality control tests should be compared with

established tolerance limits.

These limits may have been established to ensure compliance with a regulatory

requirement for the

performance of particular physical parameters or they may be set on the basis

of recommended values

given in published reports, such as referenced in para. 4.224.

As required in the BSS paragraph

3.171(b), if the measured values fall outside the tolerance limits, corrective

actions should take place.

Such corrective actions are likely to include maintenance or servicing of the

equipment, and hence the

nuclear medicine facility should have a maintenance programme in

place. In some cases, the

equipment may be outside the tolerance limits by a significant amount and the

equipment should be

immediately taken out of clinical use and not returned until the servicing has

taken place and it has

been ascertained that the equipment now meets the performance requirements.

4.229. The programme of quality assurance for medical exposures in nuclear

medicine should include

use of “checks and balances” to ensure that the facility’s protocols and

procedures for imaging and

therapy, including radiation protection and safety, are being followed.

The periodic review of the

protocols and procedures themselves is part of the facility’s radiological

review (see 4.256 – 4.258).

In addition a review of imaging procedures may have been triggered by a

comparison with DRLs (see

paras. 4.210 to 4.217).

4.230. Maintaining records is a crucial aspect of the programme of

quality assurance for medical

exposures. This includes the procedures used in the programme, and the results

of the quality control

tests including trend analysis, the dosimetry surveys, the DRL comparisons,

corrective actions and the

investigations of unintended and accidental medical exposures. When

planning and developing an

effective QA programme, licensees should recognize that it demands strong

managerial commitment

and support in the form of training and time, personnel and

equipment resources. The regulatory

body, during its inspections of a nuclear medicine facility, should

review the records of the

programme of quality assurance for medical exposures.

4.231. In line with standard practices for quality management, the BSS in

paragraph 3.172 requires

regular and independent audits of the programme of quality assurance for

medical exposures, adding

that the frequency of such audits will depend on the complexity of the

radiological procedures being

performed in the facility. Such audits may be external or internal.

Internal audits are usually

logistically simpler to implement, while the external audit generally has the

advantage of bringing in

an outside perspective. The audit of the nuclear medicine facility’s programme

of quality assurance

for medical exposures can be incorporated into more comprehensive

audits that the facility is

performing for its management system. Further, the results of the audit of the

programme of quality

assurance for medical exposures will have a major input into the

nuclear medicine facility’s

radiological review (see paras. 4.256 to 4.258).

Dose constraints – carers and comforters

4.232. Some diagnostic radiological procedures in nuclear medicine,

particularly of children, can be

better performed with the assistance of a carer or comforter, for example a

relative in the case of a

paediatric patient, or a relative or friend for a disabled patient. In these

circumstances, the carer or

comforter will be exposed. This is usually to a low dose, such as when caring

for a child undergoing a

renal examination, but in some cases the dose is not insignificant e.g. staying

with a child during a

PET examination. Further, in nuclear medicine there is also the additional

consideration of exposure

of carers and comforters after the diagnostic procedure, or in the case of

radiopharmaceutical therapy

with radioiodine, their exposure during the course of the treatment.

This exposure is defined as

medical exposure (see the BSS) and as such is not subject to dose

limits. However the BSS,

paragraphs 3.153 and 3.173, requires that such carers and comforters are

afforded radiation protection

through the application of the requirements for optimization of

protection and safety and, in

particular, the use of dose constraints in this process. These are the dose

constraints established by

government, as a result of consultation with the health authority, relevant

professional bodies and the

regulatory body, as required by the BSS paragraph 3.149(a)(ii). Guidance on

setting dose constraints,

including considerations for children and pregnant women, is given in Section

2, paras, 2.48 to 2.49.

4.233. The nuclear medicine facility should have written protocols for

implementing measures for the

optimization of protection for carers and comforters of patients

during or after nuclear medicine

procedures. The measures should utilize the basic methods for radiation

protection, i.e. shielding, time

and distance (proximity), and measures to minimize spread of

contamination. The protocol should

include the following:

(a) Criteria specifying who would be acceptable for acting as a carer or

comforter;

(b) Methods for ensuring that the carer or comforter receives a dose

that is as low as reasonably

acceptable;

para. 2.49).

4.234. Licensees should be able to demonstrate that the effective dose to the

carer or comforter, by

applying the protocol, is unlikely to exceed the dose constraint. In

some cases it is relatively

straightforward to estimate effective doses to carers and comforters

from measurements of the

ambient dose equivalent rates at the positions where they will be

situated. These determinations

should be made in advance to verify that dose constraint will not be exceeded.

Therefore, individual

dose monitoring is normally not necessary. For carers and comforters in a

therapy ward, consideration

may be given to the use of electronic dosimeters.

4.235. The BSS paragraph 3.153 states that a carer or comforter must be

informed about the radiation

risks involved in helping with the radiological procedure and about the means

to be taken to afford

appropriate radiation protection to the carer or comforter. The carer or

comforter should indicate that

he/she has understood the information and is still willing to provide support,

care and comfort to the

patient that is or has undergone a nuclear medicine procedure. In

the case of radiopharmaceutical

therapy with iodine, for both patients still in the hospital and for those that

have been released (see

also para. 4.245), appropriate written instructions should be provided to the

carer or comforter of the

patient (including for example, time and proximity to the patient, minimizing

physical contact and not

sharing food or drinks). Further guidance is given in Refs [18, 261].

4.236. Guidance applicable to carers and comforters supporting patients

undergoing X ray imaging

radiological procedures as part of the nuclear medicine procedure in the

nuclear medicine facility is

given in Section 3 paras. 3.236 to 3.240.

Dose constraints – volunteers in biomedical research

4.237. Some individuals will undergo diagnostic nuclear medicine

procedures as part of their

voluntary participation in an approved programme of biomedical research (see

Section 2 para. 2.98).

Part of the approval process for the biomedical research will have been the

setting of dose constraints

for the nuclear medicine procedures (see Section 2 para. 2.99). When the

volunteer presents at the

nuclear medicine facility, they are to be afforded the same radiation

protection as if they were a

patient presenting for a nuclear medicine procedure within a normal health care

pathway, but with the

additional measure that their exposure will be subject to a dose

constraint, either a nationally

established dose constraint or as specified by the ethics committee

that approved the biomedical

research programme (see Section 2 paras. 2.50 and 2.99).

Pregnant female patients

4.238. Female patients who are pregnant form a special sub-group of

patients that should be

particularly considered with respect to radiation protection. These

considerations have been described

in para. 4.161 for justification and paras. 4.187 - 4.192 for optimization.

None of these considerations

can take place if it is not known that the patient is pregnant. Therefore it is

crucial, as is required in

the BSS paragraphs 3.175 -3.176, for the nuclear medicine facility to have in

place means for ensuring

that pregnancy status is known for female patients.

4.239. The first approach is through posting of clear signs, in

languages easily understood by the

range of people using the nuclear medicine facility, asking the question “Are

you pregnant or possibly

pregnant?” and, if so, “Please tell the staff”. Such signs should be

posted widely in the facility,

including waiting rooms and cubicles. The second approach is to ask female

patients directly whether

they are or might be pregnant. This may not always be so easy given social and

cultural sensitivities,

but it may should be done when needed.

4.240. Neither of the approaches described in para. 4.239 will work if the

woman does not know if

she is or may be pregnant. For this reason, the BSS (paragraph 3.176) has an

additional requirement

on facilities to have “procedures in place for ascertaining the pregnancy

status of a female patient of

reproductive capacity before the performance of any radiological

procedure that could result in a

significant dose to the embryo or fetus”. In nuclear medicine, pregnancy status

should be ascertained

for all radiopharmaceutical therapy and it is advisable for all diagnostic

procedures, in particular for

those radiopharmaceuticals that are known to cross the placental

barrier. Cooperation with the

referring medical practitioner, through standard requests for

pregnancy status for specified

procedures, is one approach. In case of doubt, a pregnancy test or hormonal

level determination to

assess menopausal status may be carried out.

Breast-feeding patients

4.241. As above for pregnant women, breast-feeding patients form a special

sub-group of patients that

should be particularly considered with respect to radiation protection

in nuclear medicine. These

considerations have been described in para. 4.161 for justification

and paras. 4.193 – 4.194 for

optimization. None of these considerations can take place if it is not known

that the patient is breast-

feeding. Therefore it is crucial, as is required in the BSS

paragraphs 3.175 -3.176, for the nuclear

medicine facility to have in place means for ensuring that breast-feeding

status is known for female

patients.

4.242. The first approach is through posting of clear signs, in languages able

to be understood by the

range of people using the nuclear medicine facility, simply asking

the question “Are you breast

feeding?” and, if so, informing staff. Such signs should be posted

widely in the facility, including

waiting rooms and cubicles. The second approach is to directly ask female

patients whether they are

breast feeding. This may not always be so easy given social and

cultural sensitivities, but it may

should be done when needed.

Release of patients after radiopharmaceutical therapy

4.243. As required in the BSS paragraph 3.178, a nuclear medicine facility

should have arrangements

in place to manage the release of patients who have undergone

radiopharmaceutical therapy. Once the

patient is released, two groups of persons should be afforded appropriate

radiation protection – the

general public with whom the patient may encounter or interact, and members of

the patient’s family

and close friends who may be viewed simply as also being members of the public

or as carers and

comforters. Exposure of members of the public is subject to the

public dose limits (see Section 2

Table 2), while exposure of carers and comforters is not subject to dose

limits but is instead controlled

through dose constraints (see paras. 4.232 – 4.236). Further, as

discussed in para 2.46, public

exposure arising from a single “source”, such as a patient who has undergone

radiopharmaceutical

therapy, should be subject to dose constraints set at some fraction of the dose

limits.

4.244. The nuclear medicine facility’s medical physicist or radiation

protection officer should

establish prior to the release of a patient that the retained radioactivity in

the patient is such that the

doses that could be received by members of the public would not

exceed public dose limits, and

would be unlikely to exceed the relevant dose constraints for both members of

the public and carers

and comforters. An acceptable method to estimate the acceptable retained

activity for patients being

discharged from hospitals is to calculate the time integral of the

ambient dose equivalent rate,

considering the activity, energy and the effective half-life of the

radionuclides. When deciding on the

discharge for a particular patient, the living conditions of the patient, such

as the extent to which he or

she can be isolated from other family members, in particular children and

pregnant women, should

also be considered. Safe management of the patient’s contaminated

excreta should be addressed.

Special consideration should be given to the case of incontinent patients.

In the case of carers and

comforters, the assumptions made for the calculations should be

consistent with the written

instructions that will be given at the time the patient is discharged from the

facility. Published data

would suggest that systematic dose monitoring is not necessary. For detailed

guidance on all aspects

pertaining to the release of patients see the Refs [18, 261].

4.245. As indicated in 4.244, the patient or legal guardian of the

patient should be provided with

written instructions on how to keep doses to members of the public and carers

and comforters as low

as reasonably achievable. Areas of particular concern are children and pregnant

partners of patients.

Detailed guidance, including sample information sheets, is given in the Refs

[18, 261].

Unintended and accidental medical exposures

Prevention of unintended and accidental medical exposures

4.246. The BSS, paragraphs 3.179 to 3.181, sets out requirements both for

minimizing the likelihood

of unintended and accidental medical exposures and for the ensuing

investigation if such exposures

occur. The pathways identified in the BSS for potentially leading to unintended

or accidental medical

exposures include flaws in the design of medical radiological

equipment, failures of medical

radiological equipment while in operation, failures and errors in software that

control or influence the

delivery of the radiation, and human error. General strategies for addressing

those pathways include

regular maintenance of medical radiological equipment and software, a

comprehensive quality

assurance programme, and continuing education and training of staff. The

lessons learned from events

that have occurred should be usedfor preventing or minimizing

unintended and accidental medical

exposures, as described below in para. 4.248.

4.247. A reduction in the probability of unintended or accidental

medical exposures in nuclear

medicine can be brought about by:

(f) The introduction of safety barriers at identified critical

points in the nuclear medicine

pathway, with specific quality control checks at these points. Quality control

is not confined

to physical tests or checks but can include such as actions as

double checks of the

radiopharmaceutical and activity to be administered, and correct identification

of the patient.

(g) Actively encouraging a culture of always working with awareness and

alertness.

(h) Providing detailed protocols and procedures for each process

in the nuclear medicine

pathway.

(i) Education and training, including continuous professional

development, of all staff involved

in providing nuclear medicine services.

(j) Clear definitions of the roles, responsibilities and functions of

staff in the nuclear medicine

facility that are understood by all staff.

4.248. Preventive measures should include incident and near incident reporting,

analysis and feedback

including lessons learnt from international experience [282]. Preventive

measures should also include

each nuclear medicine facility checking the robustness of their safety

system against reported

incidents. IAEA Safety Reports Series No. 17 [282] contains reviews

of case histories from an

extensive collection of accidental medical exposures, including

examples relevant to nuclear

medicine.

4.249. Building on the guidance from paras 4.247 to 4.248, the following

three-step strategy can help

to prevent unintended and accidental medical exposures in nuclear medicine:

(d) allocate responsibilities to appropriately qualified health

professionals only and ensure that a

quality management system is in place that includes radiation safety;

(e) use the lessons learned from unintended and accidental medical

exposures to test whether the

quality management system, including for radiation safety, is robust

enough against these

types of events;

(f) identify other latent risks by posing the question “what else could

go wrong” or “what other

potential hazards might be present” in a systematic, anticipative

manner to all steps in the

nuclear medicine process.

Investigation of unintended and accidental medical exposures

4.250. The events that constitute unintended or accidental medical exposures

are detailed in the BSS

paragraph 3.180, and for a nuclear medicine facility include those

associated with diagnostic

procedures and with radiopharmaceutical therapy. For diagnostic procedures,

reference should also be

made to Section 3 paras. 3.249 - 3.252, for aspects relating to X

ray imaging. Unintended and

accidental medical exposures may occur at any stage in the

nuclear medicine process. For

radiopharmaceutical therapy, unintended or accidental medical

exposures may be either

underexposures or overexposures. The events in the BSS paragraph 3.180 also

include ‘near misses’,

and these should be considered in the same way as actual events.

4.251. One of the events identified in the BSS paragraph 3.180 is when the

activity administered in

radiopharmaceutical therapy was “substantially different from (over or under)”

the prescribed dose.

Consensus recommendations regarding the level of activity difference

that would be considered as

substantially different appear to be lacking, but a pragmatic approach

for use within the nuclear

medicine facility might be deviations greater than 10%. The nuclear medicine

facility should have in

place a system with clear procedures for identifying when this type of event

occurs.

4.252. The BSS, paragraph 3.181, states what should be done in the course of

the investigation. This

includes calculation or estimation of patient doses, which should be performed

by a medical physicist.

A record of the calculation method and results should also be placed

in the patient file. When

required, counselling of the patient should be undertaken by someone with

appropriate experience and

clinical knowledge.

4.253. The investigation of unintended and accidental medical

exposures, as required by the BSS

paragraphs 3.180 – 3.181, has three main purposes. The first is to

assess the consequences for the

patient (s) affected and provide remedial and health care actions if

necessary. The second is to

establish what went wrong and how to prevent or minimize a

recurrence in the nuclear medicine

facility – i.e. the investigation is for the facility’s and their patients’

benefit. The third purpose is to

provide information to other persons or other nuclear medicine

facilities. Dissemination of

information about unintended and accidental medical exposures and

radiation injuries has greatly

contributed to improving methods for minimizing their occurrence. This

might be through the

regulatory body and/or the health authorities for more significant events or as

required by a country’s

regulations, where the regulatory body disseminates information on the

event and the corrective

actions to other facilities that might learn from the event. Independently from

any legal requirement

for reporting to the regulatory body, the implementation of voluntary and

anonymous safety reporting

and learning systems can significantly contribute to improve safety and safety

culture in health care.

This includes participation in voluntary international or national

databases designed as educative

tools, as is the case for image guided interventional procedures and radiation

therapy – see Sections 3

and 5, paras. 3.257 and 5.272, respectively.

4.254. As noted in 4.253, the BSS requires reporting to the regulatory body and

to the health authority

if appropriate for “significant” events. Further, the regulatory body

in a given country may also

specify their own requirements for reporting events to them. It is difficult to

quantify “significant” –

specifying a numerical trigger value immediately creates an artificial

distinction between values

immediately below that value (and hence should not be reported) and

those just above the value

(which should be reported). However, the attributes of “significant”

events can be elaborated, and

events with one or more of these attributes should be reported to the

regulatory body. Such attributes

would include the occurrence of, or the potential for, serious unintended or

unexpected health effects

due to radiation (in this case the health authority should be also informed),

the likelihood of a similar

event occurring in other nuclear medicine facilities, a large number

of patients were affected, and

gross misconduct or negligence by the responsible health professionals. As

stated in 4.253 above, one

of the roles of the regulatory body for such a reported event is to disseminate

information on the event

and the lessons learned to all potentially affected parties – typically other

nuclear medicine facilities

and relevant professional bodies, but also in some cases manufacturers,

suppliers, and maintenance

companies.

4.255. Irrespective of whether the event also reported to the regulatory body,

feedback to staff should

be provided in a timely fashion and, where changes are recommended, all staff

should be involved in

bringing about their implementation.

Records and review

Radiological review

4.256. The BSS in paragraph 3.182 requires the performance of a periodic

radiological review at the

nuclear medicine facility. This involves considering both justification

and optimization aspects of

radiation protection. For the latter, the results of the programme of

quality assurance for medical

exposures, including the periodic independent audit, would be a significant

input into the process. As

described in Section 2, paras. 2.146 – 2.147, the wider clinical audit could

include the radiological

review with its assessment of the application of the requirements for

justification and optimization in

the facility for the nuclear medicine procedures being performed [53].

4.257. To facilitate compliance with the BSS paragraph 3.182 and to learn from

periodic reviews, the

methodology used, the original physical, technical and clinical

parameters considered, and the

conclusions reached should be documented and taken into account prior to any

new review that may

result in an update of institutional policies.

4.258. Radiological reviews should consider changes in patient

management that result from the

diagnostic nuclear medicine procedures, and the effect of

introducing new technologies or

radiopharmaceuticals on efficiency and cost. In radiopharmaceutical therapy,

reviews should consider

patient outcome (survival, acute and late side effects, etc.), and

the effect of introducing new

radiopharmaceuticals on efficiency and cost. The nuclear medicine facility

should have a system for

the on-going collection of relevant data to support such reviews.

Records

4.259. Records should be in place to demonstrate on-going compliance

with radiation protection

requirements. The BSS, paragraphs 3.183 to 3.185, specify requirements

for keeping personnel

records, records of calibration, dosimetry and quality assurance, and

records of medical exposure.

These records should be kept for the period specified by the country’s

regulatory body. In the absence

of such a requirement, a suggested period for keeping records is 10

years. In the case of children,

records should be kept for a longer time.

RADIATION PROTECTION OF THE PUBLIC

Introduction

4.260. Public exposure may arise from the performance of nuclear medicine, to

persons in and around

the nuclear medicine facility, but also in the wider public domain. The latter

can occur as a result of

the release from the nuclear medicine facility of patients with some remaining

radioactivity. Persons

who may be so exposed fall into three categories – those who work at the

nuclear medicine facility

but not in a role that is directly involved in the use of radiation, those who

are visitors to the facility,

and the wider public. Radiation exposure of carers and comforters

while performing that role is

considered occupational exposure and not public exposure and is not

covered by this section. See

paras. 4.232 – 4.236 for guidance on carers and comforters. In addition there

is the possibility, albeit

low, of public exposure from pathways associated with the discharge of

radioactive waste.

4.261. The requirements of the BSS for public protection, paragraphs 3.117 to

3.123, 3.125 to 3.127,

and 3.135 to 3.137, apply to nuclear medicine facilities. This

sub-section contains guidance very

specific to nuclear medicine facilities. For more general and

comprehensive guidance on radiation

protection of the public, reference should be made to the IAEA Safety Guide

Radiation Protection of

the Public [24].

Non-occupationally exposed workers and visitors

4.262. Non-occupationally exposed workers are those persons who work

at the nuclear medicine

facility but not in a role that is directly involved in the use of

radiation, for example non-nuclear

medicine ward nurses, clerical staff, and cleaning personnel. It also includes

those persons who work

at the wider medical facility where the nuclear medicine facility is

located. These persons are to be

afforded the same level of radiation protection as any member of the public, as

required by the BSS

paragraph 3.78.

4.263. Visitors to the nuclear medicine facility include those persons who will

be undergoing nuclear

medicine procedures, for the time during the visit when their treatment or

diagnostic procedure is not

taking place – for example, while they are sitting in the “cold” waiting room.

Similarly for carers and

comforters – any exposure other than that arising from the nuclear medicine

procedure with which

they are helping will be public exposure. Other visitors, including

persons delivering goods or

supplies, sales personnel, accompanying persons and escorts, and other patients

in the facility, are also

considered members of the public.

External exposure and contamination

4.264. The primary means for protecting the public (non-occupationally exposed

workers and visitors)

from external exposure is to ensure that the shielding of the nuclear medicine

facility (see paras. 4.31

– 4.35) is sufficient so that public exposure resulting from being in

any immediate adjacent areas,

including rooms above and below, accessible by either

non-occupationally exposed workers or

visitors would be in compliance with the public dose limits, and

preferably less than any dose

constraint that the regulatory body may have applied (see Section 2 paras. 2.16

and 2.46.)

4.265. Patients that have been administered radiopharmaceuticals may expose

members of the public

in the nuclear medicine facility and upon release. For the latter situation

(release) see paras. 4.243 to

4.245. In the nuclear medicine facility, the RPO should establish rules to

ensure that the exposure of

any member of the public will be less than the public dose limit

and, preferably, lower than any

applicable dose constraint. At the design stage of the nuclear medicine

facility, consideration should

given to the respective flow of patients and visitors in the facility so that

their contact or proximity is

minimized, thereby reducing the potential for both external exposure and spread

of contamination.

Control of access

4.266. Following adequate shielding, access to areas where radiation is being

used should be control

to provide forcontrolling doses to visitors and non-occupationally exposed

workers. This is effective

against both external exposure and contamination. Visitors should not be

allowed to enter controlled

areas, in particular radiopharmaceutical therapy wards. Exceptionally, a

visitor may enter, but he/she

should be accompanied to some controlled areas by a staff member who knows the

protection and

safety measures for the controlled area. The nuclear medicine facility should

have written procedures

specifying when such exceptions can take place and who may do the

accompanying. Similarly, the

facility should have established the rules regarding non-occupationally exposed

workers, especially

regarding access to controlled and supervised areas. Particular attention, in

all cases, should be made

with respect to potentially pregnant women.

4.267. Controlled and supervised areas should be clearly identified to help

prevent inadvertent entry.

This includes areas such as toilets designated for nuclear medicine patients.

Further control can be

afforded by the use of keys (or passwords) to restrict access to

the control panels of medical

radiological equipment to only authorized persons.

Members of the public in the wider public domain

4.268. Usually there are no restrictions with respect to public exposure for

the release of patients that

have undergone diagnostic nuclear medicine procedures. Patients should be

advised on measures to

enhance elimination of the residual radioactivity (such as hydration

and frequent voiding) and to

avoid prolonged contact with sensitive members of the public (young children,

pregnant women), if

appropriate.

4.269. The exposure of other persons, in the wider public domain, by

patients who have received

radiopharmaceutical therapy can occur through external irradiation of

persons close to the patient,

such as on public transport, and through internal contamination of persons as a

result of excreted or

exhaled radionuclides. The RPO of the nuclear medicine facility should

establish rules to ensure that

the exposure of any member of the public, following release of a

radiopharmaceutical therapy patient,

will be less than the public dose limit and, preferably, lower than any

applicable dose constraint. As

stated in para. 4.245, the patient should have been given written instructions

that include means for

avoiding external and internal exposure of the public. An acceptable

method to estimate the

acceptable retained activity for patients being discharged is described in

para. 4.244. Results of the

calculations should be recorded. When deciding on the appropriate discharge

activity for a particular

patient, the licensee and RPO should take into account the transport and the

living conditions of the

patient, such as the extent to which the patient can be isolated from other

family members and the safe

management of the patient’s excreta and body fluids. Detailed

guidance on release of

radiopharmaceutical therapy patients and public radiation protection is given

in Refs [18, 261].

Death of a patient who has undergone a nuclear medicine procedure

4.270. Precautions may be required after the death of a patient to whom

radiopharmaceuticals have

been administered, particularly in the case of radiopharmaceutical

therapy. This applies to the

immediate handling of the dead patient, both in the hospital and in home or

other place, but also with

respect to autopsy, embalming, burial or cremation. The radiation

protection precautions should be

determined by the RPO, based on a generic safety assessment of the need for

monitoring personnel

who carry out these procedures, the need for monitoring the premises and the

need for minimizing

external radiation exposure and the potential for contamination. In addition to

whole body monitoring,

finger monitoring may be required for autopsy and embalming personnel,

as contamination and

radioactive waste are likely to be generated. A particular problem is the

cremation of patients injected

with bone-seeking radiopharmaceuticals such as ⁸⁹Sr for pain management

of skeletal metastases.

Because of the relatively long half-life of this radionuclide (50 days), the

crematorium should store

the ashes until adequate decay is achieved before releasing them to the family.

Detailed guidance is

given in Refs [18, 261]. Other considerations, e.g. cultural o legal,

may prevail over the radiation

protection considerations.

Radioactive waste

4.271. Another potential pathway for public exposure is radioactive waste and

hence there should be

systems and procedures in place to manage radioactive waste and its discharge,

as stated in the BSS,

requirement 31 and paragraphs 3.131 to 3.134. Detailed guidance on the

management of radioactive

waste, applicable to nuclear medicine facilities, is given in Ref [283].

4.272. Most radioactive waste from nuclear medicine is short lived

radionuclides, and it is feasible to

consider them as non-radioactive waste either directly or after some

time for decay. A formal

mechanism should be in place, including rigorous control measures, to

demonstrate compliance with

regulatory requirements in respect of release of radioactive waste

from regulatory control. Further

guidance is given in Ref [283].4.273. Since waiting for decay until the

waste meets the regulatory

criteria for clearance or authorized discharge is an essential method in

nuclear medicine, a room for

interim storage of radioactive waste should be available. The room should be

locked, properly marked

and ventilated. Records should be kept from which the origin of the

waste can be identified. The

process requires grouping (segregation) radionuclides according to the expected

time for their decay

(initial activity and physical half-life) and their physical form. Examples of

different physical forms

include: vials that may contain residual radioactivity,

biological waste which may undergo

decomposition, infectious waste requiring sterilization, broken

glassware, syringes, and needles

requiring collection in separate containers to prevent personnel being injured,

radionuclide generators,

bed linen and clothing from hospital wards (therapeutic applications),

and liquid scintillation

solutions. Containers to allow segregation of different types of radioactive

waste should be available

in areas where the waste is generated. The containers should be

suitable for their purpose (for

example, in volume, shielding and leak tightness).

4.274. In practice, it is mainly ¹³¹I and the waste from

radiopharmaceutical therapy patients that

require special precautions. Appropriate storage of radioactive

materials to allow for decay will

minimize the environmental impact of the release. The majority of diagnostic

studies are performed

using ⁹⁹ᵐTc, which has a physical half-life of 6 h. Following storage of 2.5

days (10 half-lives, i.e. a

decay of a factor of more than 1000) most of this waste can be treated

conventionally. The technetium

generators contain ⁹⁹Mo with a half-life of 2.75 days; depending on their

initial activity, the decay

time at the nuclear medicine facility is 1.5–2 months.

4.275. 18F is the most commonly used radionuclide in PET. The short

physical half-life of 110

minutes generally allows discharge within 24 hours.

4.276. Management of radioactive waste containing longer-lived radionuclides

should consider initial

activity and half-life. The nuclear medicine facility’s RPO should give advice

in these situations.

4.277. Following the above considerations, a summary of practical advice for

specific situations in

nuclear medicine can be given:

(a) Technetium generators. There are two options: (1) returning to the

supplier after use, ensuring

compliance with regulations for transport of radioactive materials (see paras.

4.298 – 4.300),

and (2) waiting for decay. After 1.5–2 months, the generator can

be dismantled and the

elution column removed, as the material is considered non-radioactive. Labels

should then be

removed.

(b) Used syringes and needles. These can be collected in a shielded container

in the rooms used

for preparation and injection of radiopharmaceuticals. When the container is

full, it should be

sealed and the expected date of release from regulatory control be marked on

it. After this

time, the external dose rate can be monitored. The container can be released

from regulatory

controlwhen the external ambient dose equivalent rate is the same as the

background or in line

with national/local regulations.

similar procedure should be

established as for the syringes, but segregation based on the

physical half-life is needed.

Caution should be exercised in storing waste containing very low

levels of longer lived

residues such as ⁶⁸Ge (half-life 271 days) as these could over time accumulate

to activities

where they should be considered as radioactive waste and could

require prolonged storage

before release from regulatory control.

(d) Gloves and cover paper. These should be collected in plastic

bags in the rooms used for

preparation and injection of radiopharmaceuticals. When a bag is filled, it

should be sealed.

After waiting for decay or with appropriate monitoring, they can be released

from control and

treated as ordinary waste.

(e) Sealed sources for calibration of activity meters, quality control

of gamma cameras and

counters, and anatomical marking of images are released from

regulatory controlas

determined by the RPO in accordance with national regulations and

authorization by the

regulatory body (clearance).

(f) Small activities of ³H and ¹⁴C in organic solutions can usually be treated

as non-radioactive

waste. In certain instances, because of their potential toxicity, special

precautions may apply,

and appropriate bio-hazard precautions taken.

(g) Patients’ excreta, such as urine with ¹³¹I. For diagnostic

patients there is no need for

collection of excreta and ordinary toilets can be used. For therapy patients,

policies vary for

different countries, but in principle follow the dilution and decay

methodologies to meet

national or local requirements. Some precautions may be required where sewerage

systems

allow rapid processing of effluent with subsequent usage for

irrigation of land used for

growing vegetables.

Monitoring and reporting

4.278. The BSS, requirement 32 and paragraph 3.137, sets out the requirements

that should be met by

the nuclear medicine facility with respect to monitoring and

reporting. In the nuclear medicine

facility, procedures should be in place to ensure that:

is assessed;

(d) The requirements regarding discharge of radioactive materials to

the environment are

satisfied;

(e) Appropriate records of the results of the monitoring programmes are kept.

4.279. The programme for monitoring public exposure arising from nuclear

medicine should include

dose assessment in the areas in and surrounding the nuclear medicine facility,

which are accessible to

the public. This can be achieved from the shielding calculations in the

planning stage, combined with

area monitoring and contamination monitoring at the initial operation of the

facility and periodically

thereafter. Records of these assessments should be kept for typically 7-10

years, but in any case for a

period that meets any relevant regulatory requirements.

PREVENTION AND MITIGATION OF ACCIDENTS

Safety assessments

4.280.To comply with the BSS requirements for safety assessment (BSS,

paragraphs 3.29 to 3.36), ,

the the registrant or licensee should conduct a safety assessment applied to

all stages of the design and

operation of the nuclear medicine facility. The safety assessment report

should be submitted to the

regulatory body if required. Basically, the safety assessment deals

with determining ‘what can go

wrong’ and how it can be prevented and, in case it occurs, how it can be

mitigated. Section 2, paras

2.148 – 2.152, describes general considerations for facilities using

ionizing radiation for medical

purposes.

4.281. The safety assessment should be systematic and contain

information on identification of

possible events leading to accidental exposure (see Appendix I for a summary of

typical causes and

contributing factors to accidental exposures in nuclear medicine). The safety

assessment should not

only cover these events, but also aim at anticipating other events

that have not previously been

reported. Clearly the safety assessment should be documented.

4.282. The safety assessment should be revised when:

(d) New or modified radiopharmaceuticals, equipment, or their accessories are

introduced;

(e) Operational changes occur, including workload;

(f) Operational experience or information on accidents or errors

indicates that the safety

assessment is to be reviewed.

4.283. Safety assessments in nuclear medicine include consideration of

all the steps in the use of

radiopharmaceuticals for diagnosis and treatment in the nuclear medicine

facility. The steps include

ordering, transport and receipt of radiopharmaceuticals, unpacking,

storage, preparation and

administration of the radiopharmaceuticals to the patient, examination or

treatment, care of therapy

patients with high amounts of radioactivity, and storage and handling of

radioactive waste.

Accident prevention

4.284. Accident prevention is clearly the best means for avoiding

potential exposure and the BSS,

paragraphs 3.39 to 3.41, set out requirements based on good engineering

practice, defence in depth,

and facility-based arrangements, to achieve this. Design considerations

for the nuclear medicine

facility, medical radiological equipment and ancillary equipment are described

in paras 4.7 to 4.58.

4.285. The licensee should incorporate:

(a) Defence in depth measures to cope with identified events, and evaluation of

the reliability of the

safety systems (including administrative and operational procedures, equipment

and facility design).

For example, theft of sources can be minimized through multiple layers of

security including having

sources locked up in a safe within a locked room, in an area that has a

restricted access with camera

surveillance and is routinely patrolled.

(b) Operational experience and lessons learned from accidents and errors. This

information should be

incorporated into the training, maintenance and quality assurance programmes.

Mitigation and contingency plans

4.286. On the basis of events identified by the safety assessment for

the nuclear medicine facility,

contingency plans should be prepared for events associated with

potential exposure, including

allocation of responsibilities and resources, the development and

implementation of procedures, and

the provision of training and periodic retraining of the relevant

staff in executing the mitigation

measures. Contingency plans in a nuclear medicine facility should, as

a minimum, cover the

following:

(a) Predictable incidents and accidents, and measures to deal with them;

(b) The persons responsible for taking actions, with full contact details;

emergency procedures (for

example, nuclear medicine physicians, medical physicists, nuclear medicine

technologists, the

RPO);

(d) Equipment and tools necessary to carry out the emergency procedures;

(e) Training and periodic rehearsals;

(f) Recording and reporting systems;

(g) Immediate measures to avoid unnecessary radiation doses to patients, staff

and the public;

(h) Measures to prevent access of persons to the affected area;

(i) Measures to prevent spread of contamination, including leakage from fume

hoods and room

ventilation systems.

4.287. Kits should be kept readily available for use in a nuclear medicine

incident. These may include

the following:

(a) Protective clothing, for example overshoes and gloves;

(b) Decontamination materials for the affected areas, including absorbent

materials for wiping up

spills;

(d) Warning notices and barrier tape;

(e) Portable monitoring equipment;

(f) Bags for waste, tape, labels and pencils.

4.288. The exposure of workers involved in such nuclear medicine events cannot

be considered an

unexpected exposure and whether deliberate or not should be

controlled, and the dose limits for

workers in planned exposure situations should apply.

4.289. For medical exposure, potential exposure when it does occur is manifest

as an unintended or

accidental medical exposure. Means for preventing or minimizing unintended and

accidental medical

exposures in nuclear medicine are described in para. 4.246 – 4.249, and the

ensuing investigation and

corrective actions are described in paras, 4.250 – 4.255.

4.290. The BSS, paragraphs 3.43 to 3.44, sets out the requirements for

emergency preparedness and

response. It is unlikely that emergency exposure situation can arise from

nuclear medicine practice,

but if the safety assessment identified the need, an emergency plan should be

prepared according to

the requirements in the GSR Part 7 and guidelines by the regulatory authority

[7].

Lost sources

4.291. It is critical for this type of event that an up-to-date inventory

exists (see para. 4.55) so that it

can be determined immediately when a source is missing, what its type and

activity are, when and

where it was last known to be, and who last took possession of it.

A proactive attitude is

recommended for the case that sources are ordered and not received at the

expected time. Making a

check for the arrival of a source at the expected receipt time should be part

of the procedures. The

actions to be part of the contingency plans in this case include:

(a) Obtain assistance from the RPO when needed.

(b) Conduct a local search.

theft in the facility is

suspected.

(d) If the source is not found, call the supply company and inform them of the

loss so that they

can trace the shipment and find out where the radioactive material is.

(e) If not found, report the loss of the material according to the

rules given by the regulatory

body.

Damage to radionuclide generators

4.292. Radionuclide generators, such as for ⁸²Rb, ⁹⁹ᵐTc and ⁶⁸Ga, contain a

relatively large amount of

activity. In the event of a generator being damaged, the measures to be taken

should include:

(a) Evacuate the area immediately and institute measures to prevent entry to

the area.

(b) Inform the RPO, who should confirm the spillage, define the safety

boundaries and supervise

the decontamination and monitoring procedures, including when restrictions to

enter the area

can be lifted.

regulatory body.

Spillage of small amounts of radioactivity

4.293. After a spillage of a small amount of radioactivity, for

example low volumes of non-toxic

radiopharmaceuticals which are easily removed, such as 10 MBq of ⁹⁹ᵐTc or ¹⁸F,

the following actions

should be taken:

(a) Use protective clothing and disposable gloves.

(b) Quickly blot the spill with an absorbent pad to keep it from spreading.

(d) Wipe with a tissue from the edge of the contaminated area towards the

centre.

(e) Monitor the tissue for residual activity, for example using a

contamination monitor or

performing a wipe test.

(f) Continue the cycle of cleaning and monitoring until the measurements

indicate that the spill

has been removed, trying to keep the volume of contaminated waste as small as

possible. In

some cases, such as with short-lived radionuclides, it may be simpler to

“quarantine” the area

for sufficient time to allow decay – e.g. cover the spill site, such as with a

laboratory coat, and

prevent access to the area.

(g) Use a plastic bag to hold contaminated items. Suitable bags should be

always available, as

well as damp paper towels.

(h) If the decontamination process is not successful, the RPO should be

contacted.

(i) Monitor all people involved in the spill for contamination when leaving

the room, particularly

the monitoring of shoes if the spill was on the floor.

Spillage of large amounts of radioactivity

4.294. After a spillage of a large amount of radioactivity, for

example if a patient undergoing ¹³¹I

therapy vomits shortly after administration, the following actions should be

taken:

(a) Throw absorbent pads over the spill to prevent further spread of

contamination.

(b) All people not involved in the spill should leave the area immediately.

clean-up.

(d) Monitor all people involved in the spill for contamination when leaving

the room.

(e) If clothing is contaminated, remove and place it in a plastic bag labelled

‘RADIOACTIVE’.

(f) If contamination of skin occurs, wash the area immediately.

(g) If contamination of an eye occurs, flush with large quantities of water.

(h) When the contamination is contained, the procedures outlined for cleaning

small spills may

be followed, taking particular care that the contaminated waste bags are

appropriately labelled

and stored.

Medical emergencies involving patients who have received therapeutic

radiopharmaceuticals

4.295. There may be medical emergencies, such as in the case of a stroke or

cardiac arrest, involving

immediate care of patients who have been administered large amounts of

radioactive material (e.g. of

the order of several GBq of ¹³¹I) for radiopharmaceutical therapy. In these

cases dose rates near the

patient are high, and attendant medical personnel may receive significant

doses. However, the dose

will be acceptable because the procedure is lifesaving. Measures should

be used to minimize such

doses. All members of the emergency team should wear impermeable protective

gloves. Medical staff

should be informed and trained on how to deal with such patients.

Rehearsals of the procedures

should be held periodically.

Need for urgent patient attention, including surgery

4.296. Radiation protection considerations should not prevent or delay

lifesaving operations in the

event that surgery is required on a patient who has been

administered radiopharmaceuticals. The

following precautions should be observed:

(a) Notify the operating room staff.

(b) Modify operating procedures under the supervision of the RPO to

minimize exposure and

spread of contamination.

(d) Rotate personnel as needed if the surgical procedure is lengthy.

(e) Measure personnel doses.

Fires, earthquakes and other disasters affecting the nuclear medicine facility

4.297. The normal facility drill should be observed, providing for safe

evacuation of patients, visitors

and staff. When the first responders (for example the fire brigade) attend,

they should be informed of

the presence of radioactive material. No one, other than emergency responders,

should re-enter the

building until it has been checked for contamination by the RPO or by the

radiation safety staff of the

agency in charge of emergency response.

SAFETY IN THE TRANSPORT OF RADIOACTIVE MATERIALS

4.298. The BSS paragraph 2.25 sets out the requirements for the transport of

radioactive materials,

invoking in particular the IAEA Regulations for the Safe Transport of

Radioactive material [283]. The

IAEA Regulations for the Safe Transport of Radioactive material use the defined

terms “consignor” to

mean any person, organization or government that prepares a

consignment for transport, and

“consignee” to mean any person, organization or government that is

entitled to take delivery of a

consignment. “Consignment” is also a defined term, meaning any package or

packages, or load of

radioactive material, presented by a consignor for transport.

4.299. The licensee of a nuclear medicine facility may be both a consignee and

a consignor, and hence

may have responsibilities for both receipt and shipment of

radioactive materials. Receipt of

radioactive materials will be a regular occurrence for all nuclear medicine

facilities. Shipments may

take place when the facility has a cyclotron or laboratory that sends

radiopharmaceuticals to other

sites, or when expired generators, old sealed calibration sources or

radioactive liquids (for example

¹⁴C solutions) should be returned to the supplier or disposed off-site, as

applicable.

4.300. The detailed requirements for the safe transport of radioactive

material, including general

provisions, activity limits and classification, requirements and controls for

transport, requirements for

radioactive material and for packagings and packages, test

procedures, and approval and

administrative requirements, are given in the IAEA Regulations for the Safe

Transport of Radioactive

material [284]. Emergency arrangements during the transport of

radioactive material should be in

place, in line with the requirements in the GSR Part 7 and guidelines by the

regulatory authority [7].

The licensee and the RPO of the nuclear medicine facility should be familiar

with these regulations to

ensure that their transport of radioactive materials will be in compliance.

5. SPECIFIC RECOMMENDATIONS FOR RADIATION PROTECTION AND

SAFETY IN RADIATION THERAPY

INTRODUCTION

5.1. This chapter covers radiation therapy, the branch of clinical medicine

that uses ionizing radiation

(teletherapy and brachytherapy), either alone or in combination with

other modalities, for the

treatment of patients with malignancies or other diseases. It includes

responsibility for the treatment

decision, treatment preparation and planning, treatment delivery, follow-up and

supportive care of the

patient as an integral part of the multidisciplinary management of patients.

Treatment using unsealed

sources is covered in Section 4. Imaging studies used in treatment preparation,

planning, verification

and delivery are covered in Section 3, with appropriate cross-references.

5.2. External beam radiation therapy (teletherapy) is mainly performed

with linear accelerators

(Linacs), superficial and orthovoltage units, tomotherapy units

incorporating a CT, or radioactive

source based equipment (primarily using cobalt-60). In the case of Linacs, both

photons and electrons

are widely used and, for each, a range of energies can be utilized. External

beam radiation therapy can

be delivered using a wide range of techniques including: 2D, 3D conformal

radiotherapy (3DCRT),

intensity modulated radiotherapy (IMRT), stereotactic radiosurgery (SRS),

stereotactic radiotherapy

(SRT), volumetric-modulated arc therapy (VMAT), Rapid Arc, and

intraoperative radiotherapy

(IORT). More recently, proton and heavy ion therapy has become available in

some facilities.

5.3. Brachytherapy can be performed by implanting radioactive sources

directly into the patient or

using after-loading devices that allow for the sources – either manually or

remotely – to be placed into

catheters that then are inserted in the body. Techniques can be

interstitial, intracavitory, surface or

intraoperative and a range of sources are used. Low dose rate (LDR), medium

dose rate (MDR), high

dose rate (HDR) and pulsed dose rate (PDR) brachytherapy techniques are used.

5.4. The generic term “medical radiation facility” is used widely in Section 2

to mean any medical

facility where radiological procedures are performed. In Section 5,

the narrower term “radiation

therapy facility” is used to cover any medical radiation facility

where radiation therapy is being

performed. A radiation therapy facility may be a radiation therapy department

inside a wider hospital

or medical centre, or it may be a stand-alone facility.

5.5. The defined term “radiological procedure” is used in the BSS to cover all

imaging and therapeutic

procedures using ionizing radiation. In a radiation therapy facility

both imaging and therapeutic

radiological procedures occur, and this should be borne in mind when reading

the following guidance

in Section 5. In cases where the guidance is specific to one of either imaging

or treatment, additional

qualifiers, such as “imaging” or “treatment”, are used.

5.6. The health professionals that can take on the role of the

radiological medical practitioner in

radiation therapy depend inter alia on national laws and regulations.

Most typically this will be a

radiation oncologist, but may also include other specialists – for example,

neurosurgeons in the case

of stereotactic radiosurgery.

5.7. Section 2 of this Safety Guide provides general guidance on the

framework for radiation

protection and safety in medical uses of radiation, including roles

and responsibilities, education,

training, qualification and competence, and the management system for

protection and safety. This is

relevant to radiation therapy and reference to Section 2 should be made as

indicated or needed.

SAFETY OF MEDICAL RADIATION FACILITIES AND MEDICAL RADIOLOGICAL

EQUIPMENT

Radiation therapy facilities

Location and site

5.8. A radiation therapy facility should be located on a site that gives ready

access for in-patients and

outpatients, and that at the same time makes fulfilling radiation protection

requirements as simple as

possible. Operational efficiency, initial cost, as well as provision

for future expansion and/or

increased workload, should be considered when locating a new radiation therapy

facility. Radiation

therapy facilities are often located on the periphery of the hospital

complex to minimize radiation

protection problems arising from treatment rooms being adjacent to high

occupancy areas. The option

of being able to construct rooms below ground level, with the

potential for a reduced need for

substantial shielding, may also influence the choice of site. Further guidance

on location and site of

radiation therapy facilities is given in Refs [285 – 288].

5.9. In addition to on-site considerations, surrounding environment should be

also considered. This

includes presence of, and implications for, adjacent residential or

industrial areas, and the level of

general public access to, and use of, the area. This relates to ensuring that

public exposure outside –

and above and below if there are occupied areas – the radiation

therapy facility is consistent with

public exposure requirements.

5.10. When considering expansion of an existing radiation therapy facility

consideration should be

given to the areas beside, above and below the proposed expansion site.

5.11. For physical security purposes, radiation therapy facilities

using sealed radioactive sources

should be located in areas where access by members of the public to the rooms

where sources are

used and stored can be restricted.

Design of rooms within the radiation therapy facility – general considerations

5.12. A typical radiation therapy facility consists of 5 main

functional areas: reception, clinical

consulting areas, external beam radiation therapy, brachytherapy,

and imaging and treatment

planning. Within these areas there are several types of rooms and,

depending on the treatment

modalities being provided, may include rooms or areas for patient

imaging, treatment simulation,

treatment planning, treatment control, treatment delivery, mould preparation,

and patient examination,

as well as patient changing cubicles, public waiting rooms, operating

theatres and source storage and

preparation rooms. Provisions for the incorporation of radiation safety

features into these areas and

rooms are best made at the facility design stage. (See para. 2.73). Because

the structural shielding of

radiotherapy facilities is very heavy, care should be taken that the shielding

weight can be supported

by the building structure, especially in cases when machines are

replaced by higher energy ones, such

as is the case of a cobalt-60 unit being replaced by a linear accelerator. The

layout should take into

account workload and staff and patient flow, both within the radiation therapy

facility and, in cases

where the radiation therapy facility is part of a larger hospital or

medical centre, with other

departments and wards of the wider facility. Wherever possible,

treatment rooms should be

surrounded with rooms that have low or controlled occupancy. Physical signage

giving information

on where different areas are located and designating hazardous areas is

beneficial here and should be

preferably in both word and picture format. Colour coding of

different areas is also very helpful.

General guidance on radiation therapy facility design is given in Refs. [285 –

289].

5.13. The three factors relevant to dose reduction for workers and the public

(namely, time, distance

and shielding) should be combined in the design to optimize

occupational and public radiation

protection.

5.14. Access to the radiation therapy facility and its treatment,

imaging, consultation and patient

preparation rooms should be considered. This includes provision for the

delivery of equipment and for

ease of access for patients undergoing clinical assessment and daily

treatment. Patients may arrive in

wheelchairs or on trolleys or beds.

5.15. As a general rule, the design of the radiation therapy facility should

make provisions for safety

systems or devices associated with the equipment and room. This

includes ventilation, electrical

wiring related to emergency ‘off’ switches, as well as standby lighting, safety

interlocks and warning

signals.

5.16. A reliable and stable power supply should be available for all

modern equipment and

information technology systems. An emergency diesel generator alone is

generally not sufficiently

stable to power a linear accelerator or orthovoltage unit and should

not be used in this way.

Uninterruptible power supply (UPS) or battery backup systems should be

installed to capture the

active information at the time of an outage and to power down all software in a

controlled manner.

Servers should be programmed to automatically shut down when the

power supply is interrupted.

Diesel generators could be used to run systems that depend only on

timers, such as in the case of

cobalt-60 teletherapy units.

5.17. The design of the facility should include an air conditioning system

sufficient to maintain the

temperature in the treatment room within the parameters defined by the

equipment manufacturers.

5.18. Room lights should be dimmable so that the alignment lasers and the field

defining lights can be

seen easily to facilitate patient set up. It is useful to be able to control

the treatment and imaging room

lights and lasers from the control pendant in the respective room. When the

field light is switched on,

the room lights should dim to a pre-set (but adjustable) level, and the

alignment lasers should also be

switched on. Since fluorescent lights do not dim very satisfactorily,

it is recommended that

incandescent lights are used for the dim level. Four alignment lasers are

recommended. Three lasers

projecting across: two aligned with the gantry positions of 90° and

270°, and one mounted in the

ceiling directly above the isocentre. A fourth laser should project a sagittal

line along the gantry axis.

This laser is usually mounted on an angled bracket on the wall

opposite the gantry. The laser

switching should be controlled from the hand pendant, but it is also useful to

be able to switch them

off independently for quality control tests.

5.19. In addition to interlocks, as described in para 5.29, signs and warning

lights should be placed at

the entrances of controlled areas to prevent inadvertent entry (see also para.

5.287 on control of public

access). The BSS, paragraph 3.90, requires the use of the symbol of the

International Organization for

Standardization (ISO) [59]. An illuminated warning sign should be displayed at

the entrance to the

maze or treatment room as well as several inside the treatment room. It should

be possible to see a

warning sign from any position within the treatment room. These signs should be

interlocked with the

treatment unit control. The illuminated signs may have two or three stages. For

a two stage sign, the

first stage will be illuminated when there is power to the treatment unit,

and the second stage will

illuminate when the beam or the source is on. For a three stage sign, stage one

will be illuminated

when there is power to the treatment unit, stage two will light when the

treatment unit is programmed

to deliver a radiation beam and stage three will illuminate when the beam or

the source is on. Other

possibility is that the warning lights flash when the beam is on. Other rooms

which are also controlled

areas, such as imaging, simulator and source storage rooms, also should have

appropriate signs and

warning lights.

5.20. Radiation therapy facilities that use radioactive sources should

implement technical measures so

that unauthorized access to sources can be detected in a timely fashion,

including afterhours. These

technical measures should be independent of any interlocks that terminate the

radiation beam during

normal operation. Such measures could include a video camera that

provides continuous remote

surveillance of the device, a photoelectric beam or motion detector

system installed in the maze

and/or treatment room, or a door interlock. If these devices indicate

the potential presence of an

unauthorized person, an alarm should indicate this locally and remotely so that

personnel can respond

in a timely fashion. Further guidance on security provisions for teletherapy

sources, and HDR, PDR,

MDR and LDR brachytherapy sources is given in Ref. [286]. See also para. 5.84.

5.21. Firefighting equipment should be available in all areas. For example, in

brachytherapy this is in

order to preserve the integrity of radioactive sources in the event

of a fire. Further guidance is

available in Ref [287].

Design of rooms within the radiation therapy facility – treatment rooms for

external beam radiation

therapy and afterloading brachytherapy

5.22. External beam radiation therapy and HDR/PDR brachytherapy should be

carried out within the

radiation therapy facility in treatment rooms designed for that purpose.

5.23. A shielded treatment room should not be shared between HDR brachytherapy

and external beam

radiation therapy, as this can negatively influence procedure flow and

efficiency. Further guidance is

given in Ref [285].

5.24. The size of the treatment room will depend on many factors, including the

treatment equipment

and the intended techniques of the treatments. The room should be

large enough to allow full

extension of the couch in any direction, with sufficient space for staff to

walk around it. The design

should also take account of the need for larger treatment rooms to allow for

specific procedures. For

example, total body irradiation (TBI) will require a larger treatment

distance to one wall; IORT

procedures require additional support staff and equipment, and the

room may need to be larger.

Imaging systems for image guided radiation therapy (IGRT), especially

CT-on-rails, also need extra

space. Easy access for patients on a bed or trolley, correct storage of

accessory equipment such as

electron applicators or breast positioning boards, and ease of patient

positioning and staff movement

during the setup procedures may be better facilitated with a larger

room. Careful placement of

accessory equipment within the room can help minimize the walking distance for

each patient set up.

Further guidance is given in Refs [285 – 287].

5.25. Care should be taken when a new machine or unit is to be introduced into

an existing treatment

room or bunker. The room size and shielding specification should be

consistent with the new

equipment and practices. This can be particularly relevant in the case of IMRT

or the installation of a

non-isocentric unit, for instance.

5.26. Some current or future equipment integrations, such as MRI/Cobalt/ MRI or

MRI/Linac/ MRI,

may have particular requirements that should be considered in the

room design to ensure both

efficient and effective operation and radiation safety.

5.27. The treatment and imaging room designs should include an open access

conduit for the control

panel, and monitoring and dosimetry equipment cables. This duct should

not be aligned with the

primary beam.

5.28. Entrance to the treatment room may be through a shielded door or via a

maze or a combination

of both. A maze reduces the need for a heavy shielded door and provides a route

for ventilation ducts

and electrical conduits without compromising the shielding. However a

maze requires more room.

More guidance on mazes and entrances is given in Refs [286, 287, 289].

5.29. Access to the treatment room should be furnished with a visible signal

indicating whether the

radiation source is ‘on’ or ‘off’. An interlock barrier to prevent

unauthorized access should be

provided. This could include a light beam or a physical barrier such as a gate

or door. Preferably two

such interlock barriers should be in place. The interruption of irradiation

should be maintained until

the interlock is reset after it has been verified that no person but the

patient is inside the room and that

the patient setup has not changed. After an interruption, provided no

operating parameters are

changed or reselected, it should be possible to resume irradiation,

but only from the equipment’s

control panel. See also para. 5.68.

5.30. The design should be such that access to the treatment (and imaging)

rooms should be visible to

the operators at all times. Further, the controls should be installed in such a

way that access to the

treatment room can be monitored at all times.

5.31. A safety system, such as the ‘last man out button’, should be in place to

ensure that all staff have

left the room prior to treatment commencement.

5.32. One or more emergency off switches should be conveniently placed inside

the treatment room,

in addition to those on the control panel and the equipment itself,

to allow interruption of the

irradiation from inside the treatment room.

5.33. Adequate systems, audio-visual devices or other means should be provided

to allow staff to have

communication with and a clear and full view of the patient. Oral communication

from the control

panel should be possible with the patient in the treatment (and imaging) room

using an intercom or

other communication system.

5.34. When using sealed sources a power fail-safe radiation area

monitor (audio-visual) should be

visible upon entering the room.

5.35. Provision should be made in each treatment room to enable the safe

removal of the patient in the

event of a power outage (e.g. availability of flashlights or torches). This

also means manual operation

of heavy doors should be possible.

5.36. Enclosed patient changing cubicles should not be located within the

treatment room.

Design of rooms within the radiation therapy facility – rooms for manual

brachytherapy

5.37. Typical radiation safety features for rooms used for the

storage and preparation of sealed

radioactive sources for manual brachytherapy include:

(a) The room should be provided with a lockable door to

control access and maintain source

security (see also paras. 5.11 and 5.84).

(b) There should be shielded storage (e.g. a safe) for all

sources, the outer surface of which

should be made of fireproof materials. The safe should be located

near the preparation

workbench to reduce the exposure of personnel during handling and

transfer of sources if

applicable.

Each compartment should

be marked so as to permit immediate and easy identification of its contents

from the outside

with a minimum of exposure.

(d) Sources should be readily identifiable by sight. When

radioactive sources of the same

appearance but of different activities or activity distribution are

used, they should be

distinguishable, e.g. by different coloured threads or beads.

(e) The workbench should be provided with L block shielding,

and with a lead glass viewing

window and a magnifying glass.

(f) The working surface for source preparation should be smooth and

seamless to avoid losing

small sources such as ¹⁹²Ir wire fragments or small ¹²⁵I seeds.

(f) The source handling area should be well illuminated and a

magnifying glass in a fixed

mounting should be available for viewing, in order to handle sources

efficiently and with a

minimum of radiation exposure.

(g) Devices for handling sources, typically forceps, should be

available. They should be as long

as practicable, compatible with efficient source handling. A device

should be provided for

threading sources expeditiously with the fingers protected by distance.

(h) The source storage and preparation laboratory should have a

sink with a filter or trap to

prevent sources being lost into the sewerage system.

(j) There should be a clear indication of the radiation level in terms

of ambient dose equivalent.

This should be achieved either by an area radiation monitor that should be

visible on entering

the room and during any handling of the unshielded sources, or by a survey

meter that should

be available and in use during source handling.

(k) Hand carried transport containers should be provided with

long handles. The lid of the

container should be securely fastened to prevent tipping and dropping

of sources during

transport. Containers should bear the radiation symbol as well as a warning

sign.

(l) Space should be available for source transport trolleys.

5.38. It is preferable that patients’ rooms be single and adjacent

to one another. Where this is not

possible, appropriate shielding between patients is necessary to

minimize to the external exposure

from other patients in the room. Within patients’ rooms, whenever possible

movable shielding for the

nurses and potential visitors should be provided (see also para. 5.146).

5.39. The treatment room should contain a shielded storage container

(large enough to accept the

applicators if necessary) and a remote handling tool (forceps) in the event of

a dislodged source.

5.40. An area monitor should be placed at the entrance so as to detect when a

source or a patient with

a source is leaving the room or the controlled area. In order to

ensure that after the treatment no

source remains within the patient, clothes or bed linen, or anywhere in the

area, a portable monitor

should be available for monitoring these items.

Design of rooms within the radiation therapy facility – imaging and other

non-treatment rooms

5.41. Patient preparation and imaging areas where radiation is used,

such as simulator rooms (CT,

PET-CT, conventional), together with their console areas and patient

changing areas should be

designed to ensure that requirements for occupational and public protection are

met. Details are given

in the appropriate sub-sections of Sections 3 and 4, paras. 3.8 –

3.15 and paras. 4.7 – 4.27,

respectively, and further guidance is given in Ref [285, 287].

Design of rooms within the radiation therapy facility – shielding

considerations

5.42. Radiation therapy facilities typically require significant shielding,

especially for the treatment

rooms, to ensure that the requirements for occupational and public radiation

protection are met. The

nominal design dose in occupied areas is derived by the process of

constrained optimization, i.e.

selecting a source related dose constraint, with the condition that

the individual doses from all

relevant sources be well below the dose limits for the persons occupying the

area to be shielded. The

following paragraphs (5.43 to 5.50) highlight some considerations with respect

to shielding design,

but a full discussion and details on methodologies and data for shielding

calculations for treatment

rooms are presented in Refs. [286, 290, 291].

5.43. Care should be taken to avoid multiplication of conservative

assumptions which can lead to

unrealistic overestimates of required shielding. Typical conservative

assumptions are: workload, use

and occupancy factors are overestimated; and the persons to be protected are

permanently in the most

exposed place of the adjacent room. A balanced decision should be

achieved and accumulation

avoided of overly conservative measures that may go beyond optimization.

5.44. However, from the other perspective, since corrections or

additions after radiation therapy

facilities are completed can be difficult and expensive, it is also

advisable that the design includes

consideration of possible future needs for new equipment and changes in

practice or use, increased

workloads, and changes in the occupancy of adjacent, above and below spaces.

5.45. The design and specification for the radiation shielding should

be performed by a medical

physicist or RPO to ensure that the required level of occupational and public

radiation protection is

achieved. The medical physicist or RPO should be involved from the

very beginning because

shielding requirements may influence decisions on where to site treatment and

imaging rooms, and

the type of building construction. The medical physicist or RPO should be

provided with all relevant

information regarding the proposed medical radiological equipment and

its use, type of building

construction, and occupancy of nearby areas. The shielding assumptions and

specifications should be

documented and signed off by the medical physicist or RPO and all

documentation, including

calculations, should be archived for the lifetime of the facility.

Depending on a Member State’s

regulatory requirements, it may also be necessary to submit the final

shielding specifications to the

radiation protection regulatory body for review prior to construction.

5.46. The shielding of the radiation treatment room should be so constructed

that the integrity of the

radiation protection is not compromised by joints, by openings for

ducts, pipes or other objects

passing through the barriers, or by conduits, service boxes, or other

structural elements embedded in

the barriers.

5.47. Treatment room door and/or maze design for high-energy

machines requires special

consideration to ensure adequate radiation protection without sacrificing

operational efficiency.

5.48. Whenever and wherever possible, there should be site visits by the

medical physicist or RPO

during construction to ensure that there has been, from the radiation safety

perspective, the correct

positioning of the joins in the structure and to ensure that the concrete has

been poured to avoid gaps

or cracks in the shielding and that the ducting does not go through the primary

shielding or is aligned

with the primary beam.

5.49. A final assessment of the adequacy of the shielding should be

performed by the medical

physicist or RPO after construction or installation of the equipment has been

completed.

5.50. Shielding considerations for imaging and simulator rooms, depending on

the modalities used,

are given in Sections 3 and 4, paras. 3.17 – 3.23 and 4.31 – 4.35,

respectively.

Medical radiological equipment, software and ancillary equipment

5.51. This sub-section considers medical radiological equipment,

software and ancillary equipment

used in a radiation therapy facility, including for diagnosis, simulation,

treatment planning, treatment

delivery, verification and follow up. For treatment pre-planning and

simulation, the equipment used

may include C-arms, conventional simulators, CT scanners, PET-CT,

SPECT-CT, MRI, and

ultrasound units. Medical radiological equipment used for external beam therapy

includes superficial

units (including units using Grenz or Bucky rays), orthovoltage units,

gamma-ray teletherapy units,

linear accelerators, and proton or heavy ion accelerators. While the

radiological equipment used for

external beam therapy falls into two main camps – linac-based and cobalt-based

– the techniques used

and hence how the equipment is constructed, its features and

configurations vary enormously

depending on whether treatment is via conventional external beam radiation

therapy, SRS, stereotactic

body radiation therapy (SRBT), 3-dimensional conformal radiation therapy, IMRT,

VMAT, intensity

modulated arc therapy (IMAT), Rapid Arc, or some other technique.

Some hybrid external beam

radiation therapy units incorporate imaging systems, such as

radiography, fluoroscopy, CT, cone

beam CT or MRI, and can perform IGRT. Brachytherapy may be manual

or remote and is

characterized by contact, intracavitary, or interstitial applications,

which may be temporary or

permanent. Almost all brachytherapy is performed with sealed

radioactive sources but electronic

brachytherapy systems with miniature X ray tubes are available [292, 293].

Radiation therapy with

unsealed sources is covered in Section 4.

5.52. The requirements for medical radiological equipment and its

software are given in the BSS

paragraphs 3.49 and 3.162. The International Electrotechnical Commission

(IEC), through its

Technical Committee 62 on Electrical equipment in medical practice and in

particular Sub-committee

62C on Equipment for radiotherapy, nuclear medicine and radiation

dosimetry, has published

international standards applicable to medical radiological equipment

used in radiation therapy.

Current IEC standards relevant to radiation therapy include the following Refs

[289, 294 – 310]. For

those relevant to the X ray based imaging systems used in radiation therapy see

Section 3 para. 3.27,

and for those relevant to radiopharmaceutical based imaging used in radiation

therapy, see Section 4

para. 4.40. It is recommended that the IEC website is visited to

view the most up-to-date list of

standards: http://www.iec.ch . The International Organization for

Standardization (ISO), through its

Technical Committee 85 on Nuclear energy, nuclear technologies, and

radiological protection and in

particular Sub-committee 2 on Radiological protection, publishes international

standards applicable to

medical radiological equipment used in radiation therapy. Current ISO standards

relevant to radiation

therapy include the following Refs [311 – 313]. It is recommended that the ISO

website is visited to

view the most up-to-date list of standards: http://www.iso.org .

5.53. Guidance on X ray based medical radiological equipment used for

imaging as part of pre-

treatment simulation, IGRT or for follow-up assessment, as described in para

5.51, is given in Section

3, paras. 3.26 – 3.39.

5.54. As the licensee takes responsibility for the radiation safety of medical

radiological equipment to

be used in the radiation therapy facility, he/she should impose purchasing

specifications that include

conditions to meet relevant international standards of the IEC and

ISO and/or equivalent national

standards. In some countries there may be a medical devices agency or similar

organization that gives

type approval to particular makes and models of medical radiological equipment.

Radiation sources,

including radioactive material, equipment and accessories, should be purchased

only from suppliers

who meet national requirements for such dealings.

5.55. Displays, gauges and instructions on operating consoles of medical

radiological equipment, and

accompanying instruction and safety manuals, may be used by staff who may not

understand, or who

have a poor understanding of, the manufacturer’s original language. In such

cases, the accompanying

documents should comply with IEC and ISO standards and should be

translated into the local

language. Software, either used in conjunction with medical

radiological equipment or as part of

treatment planning (see also para. 5.75) should be designed so that it can be

easily converted into the

local language resulting in displays, symbols and instructions that will be

easily understood by the

staff. The translations will require a quality assurance process to

ensure accuracy of the technical

content to avoid operating errors. The same should apply to maintenance

and service manuals and

instructions for maintenance and service engineers and technicians, if these

persons do not have an

adequate understanding of the original language.

5.56. Procedures for the purchase, installation, acceptance,

commissioning, use, maintenance and

quality control of all equipment (hardware and software) should be developed

with the involvement of

a medical physicist together with other radiation therapy professionals as

appropriate (for example,

medical radiological practitioner, medical radiation technologist,

biomedical engineer, information

technology specialist) and the radiation therapy facility’s radiation

protection committee and quality

assurance committee.

5.57. For medical radiological equipment in use, specific criteria of

acceptability should be defined in

order to indicate when remedial action should be taken, including, if

appropriate, taking the

equipment out of service. Examples of remedial and suspension criteria are

given in Ref. [193]. A

strategy or transition period for replacement based on social and economic

factors is helpful. See also

paras. 5.224 – 5.243 on quality assurance programmes for medical exposure.

Design features of medical radiological equipment – general considerations

5.58. The design of medical radiological equipment should be such

that its performance is always

reproducible, accurate and predictable, and that it has features that

facilitate staff in carrying out the

requirements in the BSS for operational considerations of optimization

of patient protection (BSS,

paragraph 3.163 - 3.164). Many design features contribute to the performance of

medical radiological

equipment and should be considered when purchasing such equipment, as

indicated briefly in the

following paragraphs. Further details on design features and

performance standards of medical

radiological equipment used in radiation therapy are given in Refs [294 – 299,

301 - 309, 311]. See

also later paragraphs on quality assurance and acceptance testing, and in

particular para. 5.236.

5.59. Medical radiological equipment should include provisions for selection,

reliable indication and

confirmation (when appropriate and to the extent feasible) of operational

parameters such as type of

radiation, indication of energy, beam modifiers (such as filters and wedges),

treatment distance, field

size, beam orientation and either treatment time or pre-set dose.

5.60. As noted in para. 5.52, radioactive sources for either teletherapy or

brachytherapy should meet

relevant international standards [311- 313].

5.61. Units under software control that are designed to operate within certain

tolerances should have

interruption mechanisms that stop the radiation when the tolerances

are exceeded (for example,

tumour tracking and respiratory gating). The equipment design should include

the ability to override

the software control, but only by appropriate persons that have been

authorized by the radiation

therapy facility’s licensee. When dynamic treatments are interrupted

due to being outside defined

tolerances, there should be a system/method available to resume and complete

the treatment.

5.62. Medical radiological equipment using radioactive sources should be

fail-safe in the sense that

the source will be automatically retracted to its shielded position in the

event of an interruption of

power and will remain shielded until the beam control mechanism is

reactivated from the control

panel.

5.63. Medical radiological equipment used for radiation therapy should

be provided with safety

systems capable of preventing its use by unauthorized personnel. A key should

be required to energize

the system, access to which should be restricted to authorized staff.

5.64. External beam radiation therapy equipment containing radioactive sources

and high dose rate

brachytherapy (HDR/PDR) equipment should be provided with a device to return

sources manually to

the shielded position in the case of a failure of the source to retract. For

SRS and SBRT units it should

be possible to close the shielding door manually.

5.65. The design of safety interlocks should be such that operation

of the medical radiological

equipment during maintenance procedures, if interlocks are bypassed, can be

performed only under

direct control of the maintenance personnel using appropriate devices, codes or

keys.

5.66. Record and verify systems (RVSs) and their related interfaces with

imaging systems, treatment

planning systems, treatment delivery systems, and image and administrative data

storage systems (e.g.

PACS, RIS, OIS) should be systematically verified for all their functionalities

and data integrity. The

RVSs should be able to store complete sets of information, including

the patient’s identification,

prescription, treatment plan, and field parameters, allowing this information

to be entered and called

upon accurately for each treatment. The details about the treatment equipment,

including coordinates,

scales, and angles conventions used, beam energies, available field sizes, and

other parameters and

limitations should be entered, or their entry supervised, by the medical

physicist. The system should

be subject to periodic quality assurance because, if these parameters are

incorrectly introduced into

the RVS, systematic treatment errors will occur. Detailed guidance on RVSs is

given in [309, 314].

5.67. Data transfer and data integrity, including patient information, should

be maintained throughout

the radiation therapy facility’s network. Thus the information technology

specialist should be familiar

with the radiation therapy process and work in close cooperation with the

radiological oncology team

(radiological medical practitioner, medical radiation technologist and medical

physicist).

Design features of medical radiological equipment – external beam therapy

5.68. Medical radiological equipment used for external beam therapy should meet

the specifications

given in relevant IEC standards [294 – 297, 301, 302, 305, 306, 308] and should

follow the guidance

on design specifications and performance in Refs [285, 315 - 317], as

appropriate. In addition to the

recommendations given in paras. 5.58 – 5.67, the following considerations

should also be included:

(a) Safety interlocks or other means designed to prevent the

clinical use of the machine in

conditions other than those selected at the control panel should be provided.

(b) Equipment design should permit interruption of the treatment from

the control panel; after the

interruption, resumption of treatment should be possible only from the control

panel.

including devices that indicate

clearly and in a fail-safe manner whether the beam is ‘on’ or ‘off’. See also

para. 5.19.

(d) The radiation field within the treatment area in the absence of any

radiation beam modifiers

(such as wedges or multileaf collimators) should be as uniform as practicable

and the non-

uniformity be stated by the supplier. The non-uniformity of flattening filter

free (FFF) beams

also should be specified by the supplier.

(e) The design of the unit should lead to exposure rates outside the

treatment area due to radiation

leakage or scattering being kept as low as reasonably achievable.

(f) If primary shielding is incorporated into the equipment,

electrical or mechanical interlocks

should be provided to avoid the beam being directed towards secondary

barriers if the

primary shielding is not intercepting the beam.

5.69. Manufacturers should design accelerators to minimize neutron

production, for example by

avoiding the use of aluminium and other materials which have a high

neutron-capture cross section.

Design features of medical radiological equipment – brachytherapy

5.70. Medical radiological equipment used for brachytherapy should meet the

specifications given in

Refs [298] and should follow the guidance in [285, 318], as appropriate.

5.71. Both LDR and HDR sources should be accompanied by a source certificate

specifying:

(a) The source strength in terms of reference air kerma rate

(RAKR) or the air kerma rate

constant defined by the ICRU [300]. See also para. 5.206(b));

(b) The quality control tests applied to the source.

5.72. Applicators for brachytherapy should be manufactured specifically for the

source to be used or

be compatible with it. Use of reusable LDR radioactive

sources after the working lifetime

recommended by the manufacturer should be continued only after leak

testing by the medical

physicist or RPO and approval by the regulatory body.

5.73. Where manual brachytherapy sources incorporating ²²⁶Ra or encapsulated

¹³⁷Cs are still in use,

efforts should be made to replace them as soon as practicable with modern

afterloading systems. In no

case should sources be left in applicators (pre-loaded applicators) in between

clinical procedures, to

avoid encapsulation and/or applicator rupture due to radiation damage.

5.74. Sources using beta emitters, such as ⁹⁰Sr and ¹⁰⁶Ru in

ophthalmic applicators, should be

provided with low atomic number shielding to minimize bremsstrahlung while they

are in storage and

in preparation for use.

Design features of treatment planning systems

5.75. The capabilities of treatment planning systems (TPS) have evolved in

parallel with advances in

computers and computing. Depending on the TPS, these capabilities may include

complex three- or

four-dimensional image manipulation and dose calculations. The design features

of the TPS should

meet the clinical goals of the radiation therapy facility. TPSs should meet the

standards given in Ref

[307], and should follow the guidance on TPSs, including specifications and

performance given in

[285, 320 - 322].

Design features of simulators and imaging equipment

5.76. The role of radiation therapy simulators, as distinct from imaging

devices, has changed in recent

years with wide bore CT scanners becoming more prevalent and integral to the

treatment planning and

follow-up. Where more conventional simulators are used these should meet the

specifications given in

IEC standards [299, 303, 304] and should follow the recommendations of Refs

[285, 323]. The CT

scanners used as virtual simulators should be designed so that

patients can be simulated in the

treatment position. As noted above in para. 5.53, guidance on medical

radiological equipment used for

imaging as part of radiation therapy, either pre-treatment, during treatment

(IGRT) or for follow-up, is

given in Section 3, paras. 3.26 – 3.39 and Section 4, paras. 4.44 – 4.50, with

specific guidance for

IGRT in Ref [324].

5.77. Guidance applicable to C-arm imaging devices used in

brachytherapy is given in Section 3,

paras. 3.36 – 3.37.

Ancillary equipment

5.78. The radiation therapy facility should have equipment, instruments and

test objects for dosimetry

and quality control which may include ionization chambers (thimble, plane-

parallel and well-type),

solid-state detectors, detectors for small-field dosimetry,

electrometers, thermometers, barometers,

phantoms, geometry and mechanical test tools. Further guidance

on appropriate equipment,

instruments and test objects is given in [285, 298, 310, 317, 325, 326].

5.79. The radiation therapy facility should have a mould room (also known as a

patient preparation

area or workshop) that is equipped to prepare beam modifiers, positioning aids

and immobilization

devices (e.g. blocks, compensators, bolus, etc.). Immobilization devices

are now more commonly

prepared in the simulation area and multileaf collimators remove the

requirement for shielding blocks

in most of the cases. Where blocks are still prepared, electronic transfer of

data from the TPS to the

automatic cutting and milling machines would represent an advantage in terms of

accuracy.

5.80. In addition to laser positioning beams, the radiation therapy

facility may need to have other

positioning devices, including surface optical scanners, RF systems, GPS

transmitters and ultrasound

units.

5.81. For manual brachytherapy, the radiation therapy facility should

be equipped with radiation

safety and source handling equipment including a magnifying glass,

source manipulators (such as

forceps, tweezers or tongs), clippers or wire-cutters, and several shielded

containers.

5.82. For afterloading brachytherapy, the radiation therapy facility

should be equipped for source

handling in the case of a failure of the afterloading unit, including: a

storage container present in the

treatment room, to serve as an emergency source container in case of

failure of the afterloader in

retracting the source; a remote manipulator; and a rod mounted GM detector for

source localization.

5.83. The radiation therapy facility should be equipped with radiation

monitoring instruments (area

detectors and portable/survey meters), including Geiger counters,

ionization chambers with

electrometers or scintillators. For accelerators with energies of 15 MV and

above, access to a neutron

measuring instrument may be needed.

Security of sources

5.84. The objective of source security is to ensure continuity in the control

and accountability of each

source at all times in order to meet the requirement in BBS paragraph 3.53. In

the radiation therapy

facility the sources include sealed sources used in teletherapy and

brachytherapy, and sealed sources

used for calibration or QC tests. Situations that are particularly critical

with respect to source security

in the radiation therapy facility include receipt of sources, storage

of sources, and movement of

sources within the facility. The radiation therapy facility licensee should

develop procedures to ensure

the safe receipt and movement of radioactive sources within the institution and

establish controls to

prevent theft, loss, unauthorized withdrawal of radioactive materials

or entrance of unauthorized

personnel to the controlled areas. An inventory of sources should be

maintained, with procedures in

place to check and confirm the sources are in their assigned locations and are

secure.

Maintenance

5.85. The BSS (BSS, para 3.15(i) and 3.41) gives requirements for maintenance

to ensure that sources

meet their design requirements for protection and safety throughout

their lifetime and to prevent

accidents as far as reasonably practicable. Therefore the licensee of

the radiation therapy facility

should establish the necessary arrangements and coordination with the

manufacturer’s representative

before initial operation and on an on-going basis. This can be

achieved through a maintenance

contract (preventive and corrective) with the manufacturer, or by

in-house staff or third party

contractor only if appropriately trained and authorized (see also Section 2,

para. 2.112).

5.86. Maintenance includes not just the medical radiological equipment

and its hardware, but also

software, networks, data bases and other supporting systems in the

radiation therapy facility, for

example, PACS, HIS and RIS.

5.87. In addition to the guidance in Section 2, paras 2.110 - 2.111, the

licensee of the radiation therapy

facility should ensure that the process of removal from, and return

to, clinical service of radiation

therapy medical radiological equipment for maintenance or source exchange

includes:

(a) A record of maintenance carried out should be kept for each item of

equipment: this should

include information on any defects found by users (a fault log), remedial

actions taken (both

interim and subsequent repairs) and the results of testing before equipment is

reintroduced to

clinical use.

(b) Where maintenance of the therapy and imaging equipment or treatment

planning equipment

may affect the accuracy of the physical or clinical dosimetry or the

safe operation of the

equipment, a radiation therapy medical physicist should perform

specific tests or

measurements in order to determine that the equipment is operating

satisfactorily before it is

used to treat patients (see BSS paragraph 3.167(b)).

5.88. The electrical and mechanical safety aspects of the medical

radiological equipment are an

important part of the maintenance programme, and can have direct or

indirect effects on radiation

safety. This work should be performed by appropriately authorized

persons who understand the

specifications of the medical radiological equipment. Electrical and mechanical

maintenance should

be included in the QA programme at a frequency recommended and preferentially

performed by the

manufacturer of the medical radiological equipment. Servicing should

include a written report

describing the findings. These reports should be archived as part of the QA

programme.

OCCUPATIONAL RADIATION PROTECTION

Introduction

5.89. In radiation therapy radiological procedures, as described in

paras. 5.1 to 5.6, occupationally

exposed individuals are usually the medical radiation

technologists, the radiological medical

practitioners (typically the radiation oncologists) and the medical physicists.

In some radiation therapy

facilities, other health professionals such as nurses may also be considered

occupationally exposed.

5.90. Additional occupationally exposed personnel may include

dosimetrists and biomedical or

service engineers and some contractors, depending on their role.

5.91. Other radiation therapy facility workers such as social workers,

dieticians, physiotherapists,

patient porters, orderlies, assistants, cleaners and other service support

personnel, for whom radiation

sources are not directly related to their work, require the same level of

protection as members of the

public, as stated in the BSS paragraph 3.78.

5.92. This sub-section contains guidance very specific to radiation

therapy. For more general and

comprehensive guidance on occupational radiation protection, including

guidance on radiation

protection programmes, assessment of occupational exposure and providers

of dosimetry services,

applicable to all areas of radiation use (including non-medical uses),

reference should be made to the

IAEA Safety Guide Occupational Radiation Protection [23].

Arrangements under the radiation protection programme

Classification of areas

5.93. Various areas and rooms in a radiation therapy facility should

be classified as controlled or

supervised areas, in line with the requirements given in BSS paragraphs 3.88 to

3.92. All other rooms

and areas, not so-designated, are considered as “public domain” and levels of

radiation in these areas

should be low enough to ensure compliance with the dose limits for public

exposure.

5.94. In a radiation therapy facility, all treatment rooms for

external beam radiation therapy and

remote afterloading brachytherapy, operating theatres used during

brachytherapy procedures with

radioactive sources, brachytherapy patient rooms, radioactive source storage

and handling areas, and

rooms where imaging or simulation procedures are performed meet the criteria

for controlled areas

and should be so designated.

5.95. Supervised areas may include the areas surrounding brachytherapy

patients’ rooms or around

radioactive source storage and handling areas.

5.96. The area around the control panel for all medical radiological

equipment used in radiation

therapy should be classified as either a controlled or a supervised

area, even though the radiation

levels may be very low due the shielding design. In either case, this area

should have restricted access,

among other things to avoid distraction of staff which may lead to

accidental medical exposure of

patients.

5.97. In order to avoid uncertainties about the extent of controlled

and supervised areas, the

boundaries should, when possible, be walls and doors, partitions or

other physical barriers, clearly

marked or identified with ‘radiation area’ signs.

Local rules and procedures – general

5.98. The BSS, in paragraph 3.93, establishes a hierarchy of preventive

measures for protection and

safety with engineered controls, including structured and ancillary

shielding, specific physical

barriers, signs and interlocks, being supported by administrative

controls and personal protective

equipment. To this end, and as required in the BSS paragraph 3.94, written

local rules and procedures

should be established in a radiation therapy facility. Their purpose is to

ensure protection and safety

for workers and other persons. These local rules and procedures should include

measures to minimize

occupational radiation exposure during both normal work and unusual

events. The local rules and

procedures also should cover the wearing, handling and storing of personal

dosimeters, and specify

investigation levels and ensuing follow-up actions (see also paras. 5.155 –

5.167).

5.99. Since all personnel involved in using radiation in radiation therapy

should know and follow the

local rules and procedures, the development and review of these local rules

and procedures should

include representatives of all health professionals involved in radiation

therapy.

5.100. Equipment (hardware and software) should be operated in a manner that

ensures satisfactory

performance at all times with respect to both the tasks to be accomplished and

radiation safety. The

manufacturer’s operating manual is an important resource in this respect, but

additional procedures

should be also considered. The final documented set of operational

procedures should be approved by

the radiation therapy facility’s licensee, and incorporated into the

facility’s quality management

system (see Section 2, paras. 2.136 – 2.147).

5.101. Radiation therapy staff should understand the documented

procedures for operation of the

equipment with which they are working, including the safety features,

and should be trained, with

periodic refresher training, in what to do when things go wrong. Additional

education and training

should occur when new devices or techniques are introduced into radiation

therapy practice.

5.102. Many local rules and procedures address aspects of some or

all of occupational radiation

protection, patient radiation protection and public radiation protection,

either directly or indirectly, as

well as ensuring a successful application of the treatment. This

is the case with the following

paragraphs (5.103 to 5.142) – while placed in this section on

occupational radiation protection

because they are to be followed by workers, the local rules and

procedures often also have

significance for patient and/or public radiation protection. The following

paragraphs (5.103 to 5.142)

give recommendations that should be incorporated into the radiation therapy

facility’s local rules and

procedures.

5.103. No one should be in the treatment room during the delivery of treatment,

except the patient. All

attending personnel should be in appropriately shielded areas.

5.104. Safety features such as interlocks, presence of accessories such as the

T-bar for manual Co-60

source retraction and survey meters functionality should be checked daily prior

to patient treatment.

More detail is given in Ref [285], and see also para. 5.236 on quality control

tests in general.

5.105. Sealed sources should be subject to leak tests prior to their first use

and at regular intervals

thereafter, in conformity with international standards [312]. Leak tests should

be sufficiently sensitive

to be able to detect the presence of very small amounts of removable

contamination, for example 0.2

kBq.

5.106. Area surveys should be performed periodically around all treatment units

and check sources,

including cobalt 60-units, shielded safes and source storage facilities for LDR

and HDR sources.

5.107. Local rules for pregnant workers and persons under 18 should reflect the

guidance given in

paras. 5.178 – 5.181 and 5.182, respectively.

Local rules and procedures – external beam radiation therapy

5.108. Safe operation of external beam radiation therapy units requires

procedures for area surveys,

interlock checks, wipe tests (for sealed sources) and procedures for

contingencies such as a source

becoming stuck in the on or partially on position. Such procedures

require that the necessary

equipment be available, calibrated and in working order, including:

(a) A radiation monitor;

(b) Wipe test capabilities (for radioactive sources);

5.109. The procedures for the use of radiation monitoring equipment

should recognize that some

instruments will “lock up” in a high radiation field and give

erroneous readings, and that this

phenomenon, if it occurs, can be identified by starting the monitoring from

outside the room in which

the source is located, i.e. monitoring from the lower to the higher dose rate

areas.

5.110. The presence of other staff in the area of the control panel

should be kept to the minimum

necessary so as to avoid distraction to the medical radiation technologist, as

stated in para. 5.96.

5.111. As described in para 5.105, regular wipe tests should be

performed for sealed sources. For

external beam therapy the method to be used is the indirect wipe test of the

nearest accessible surface.

5.112. Irradiations that involve long uses of high energy X rays, such as beam

calibration, dosimetry

and quality control measurements, should be scheduled to take place at the end

of the day’s clinical

roster so that neutron activated radionuclides (especially the

longer-lived ones) can decay

significantly overnight.

Local rules and procedures – brachytherapy – general considerations

5.113. Source inventories should be maintained, giving the radionuclide,

location and activity with

reference date of each source at the facility as well as its serial

or batch number, and a unique

identifier. The unique identifier may be either a colour coded or an

alphanumeric identifier.

5.114. Sources should never be left on preparation surfaces. They

should be either in storage, in

transit or in use.

5.115. As described in para 5.105, regular wipe tests should be

performed for sealed sources. For

long-lived LDR brachytherapy sources the typical method is the direct

moist wipe test, while for

remote controlled brachytherapy the method to be used is the indirect

wipe test of the nearest

accessible surface. For an HDR/PDR unit, the wipe tests should be

only carried out on the

afterloading drive assembly and transport containers, since the source itself

has too high a dose rate to

allow this type of test.

5.116. As stated in para 5.106, area surveys should be performed

periodically around the source

storage facilities for LDR and HDR/PDR sources.

5.117. The source storage facilities should be marked to indicate

that they contain radioactive

materials, and instructions given on how to contact the radiation protection

officer, medical physicist

or other responsible radiation safety individual in the event of an emergency.

5.118. Source storage rooms should be kept locked at all times.

5.119. After every brachytherapy treatment, all brachytherapy sources should

be removed from the

patient, except in the case of permanent implants. The patient should be

monitored with a radiation

survey meter to ensure that no radioactive source remains in or on

the patient. Linen, dressings,

clothing, waste and equipment should be kept within the room where the

removal of sources takes

place until all sources are accounted for, and should be monitored with a

radiation detector. Mobile

containers and portable equipment containing radioactive sources should be

removed to storage or to

a secure place when not in use.

5.120. Sterilization processes in brachytherapy should be appropriate

for preventing damage to

sources and applicators that could affect safety.

Local rules and procedures – brachytherapy – additional for LDR sources

5.121. In the case of temporary LDR brachytherapy applications, both

manual as well as remotely

controlled, the following information should be displayed at the

entrance to the treatment room:

identification of the patient, sources, date and time of insertion

and removal, nursing required,

time/distance allowance for nurses and visitors, and concise

instructions for unplanned source and

applicator removal and for dealing with an emergency, including

contact details. A patient with a

removable source in or on his or her body should only leave the room in

exceptional circumstances

and would should be accompanied by an attendant from the radiation therapy

facility at all times.

5.122. Reusable sources should be inspected visually for possible damage after

each use, by means of

magnifying viewers and a leaded viewing window in a shielded work area.

5.123. There should be a diagram at the source storage safe that

shows the exact location of each

source within the safe, thus reducing the time taken to locate and identify a

source.

5.124. Sources should only be handled with long forceps or tongs.

5.125. When transporting sources, a mobile shielded container should be

available and the shortest

route possible should be used. The container should have a long handle and/or a

long handled trolley

should be used.

5.126. Reusable sources that come into direct contact with body

tissues will require cleaning and

sterilization after each use. This can subject the sources to

possible damage from heat, abrasion,

chemicals and mechanical stresses. Therefore, these sources should be inspected

after every use.

5.127. Work surfaces should be continuous, easy to clean and brightly lit to

make it easy to find any

sources that have been dropped.

5.128. If the source storage and preparation room is also the applicator

loading room, there should be

a sink for cleaning the applicators. However, a sink can also lead to a loss of

sources to the sewage

system when a source is left in the applicator or a patient removes a source

and puts it in the sink.

These situations are preventable by placing a filter in the sink’s drain.

Local rules and procedures – brachytherapy – additional for HDR/PDR sources

5.129. The HDR/PDR afterloader should undergo routine quality assurance tests

at the beginning of

each treatment day [327].

5.130. Among other safety checks, the couplings and transfer tubes should be

checked before each

HDR treatment, to ensure that there are no obstacles to prevent motion of the

source. Further details

on safety checks are given in Ref [327].

5.131. Emergency safety precautions require the availability of an

emergency container in the

treatment room, as well as an emergency kit containing surgical clamps and long

handled forceps for

manipulation of the source guide tubes and applicators if the source fails to

return to the safe, or for

other source retrieval actions. The emergency container should be

placed close to the patient and

should be sufficiently large that it can accept the entire applicator

assembly containing the source

removed from any patient.

5.132. Manufacturers provide suggested contingency procedures if the

source fails to return to the

safe. These generally consist of a short single page synopsis, suitable for

posting in an appropriate

place, of the necessary sequential steps involved in the emergency procedure.

They assume that the

physical integrity of the applicator is maintained. These procedures

are specific to the actual

afterloading unit, but, in general, each step assumes that if the

previous action fails to lead to

recovery, then the following actions are required. The general sequence is:

(a) Observation at the console of an error message and emergency indicators

(audible and visible

alarms);

(b) Recovery at the console (e.g. pressing an emergency ‘off’ button);

door activates the

interlock that retracts the source);

(d) Observation of radiation levels in the room (by mounted monitors or

portable survey meters);

(e) Recovery at the afterloading unit (pressing an emergency ‘off’

button on the remote

afterloading unit);

(f) Manual retraction of the source (using a hand crank);

(g) Patient survey and the afterloader survey (confirming that the source is

in the safe);

(h) Applicator removal and placement in the emergency container;

(i) Patient survey and emergency container survey (to confirm that the source

is not in the patient

and that it is in the emergency container);

(j) Removal of the patient from the vault with subsequent redundant survey

monitoring.

Local rules and procedures – remote control afterloading brachytherapy

5.133. Remote afterloading equipment requires specific contingency

procedures, as these are

especially critical for HDR brachytherapy. These procedures are dealt with in

paras. 5. 310 – 5.313. A

shielded container large enough to accommodate the largest applicator set

should be kept next to the

unit in case the source gets stuck.

Local rules and procedures – manual brachytherapy

5.134. For implants with sources of different activities, after verification of

the source strength, the

source or source holder should be marked with unique identifiers (for

example, a pre-established

colour which cannot be compromised by body fluids), to facilitate visual

recognition and prevent the

possibility of confusion between different sources or batches.

Containers utilized for transport of

radioactive sources should conform to the requirements established in the

IAEA’s Regulations for the

Safe Transport of Radioactive Material [284] – see also paras 5.318 – 5.320.

5.135. The movements of the sources from the time they leave the safe until

their return (if applicable)

should be recorded, with the signature of the person responsible for the move

(using forms or a log

book). A person should be assigned to be in charge of accountability

for the sources. This person

should keep a record of the source order and of issuance from and return to the

safe, with signatures.