Institute of Physics and Engineering in Medicine IR(ME)R Implications for clinical practice in diagnostic imaging, interventional radiology and diagnostic nuclear medicine June 2020 Contents Foreword 3 1 Introduction 5 2 Duty holder roles and responsibilities 7 3 Employer’s procedures, document control and audit 18 4 Training 24 5 Entitlement 30 6 Referral process 36 7 Justification and authorisation 40 8 Optimisation 48 9 Diagnostic reference levels 51 10 Patient dose assessment and recording 55 11 Clinical evaluation 57 12 Identification of the individual to be exposed 59 13 Pregnancy and breastfeeding enquiries 61 14 Communicating benefits and risks 67 15 Children and young people 71 16 Carers and comforters 74 17 Health screening and individual health assessment 80 18 Non-medical imaging exposures (using medical radiological equipment) 83 19 The role of the medical physics expert (MPE) 86 20 Equipment and quality assurance (QA) 89 21 Accidental or unintended exposures 95 22 Nuclear medicine licensing 102 23 Research 104 References 109 Appendix 1: Glossary 114 Appendix 2: Abbreviations used in this document 118 Appendix 3: Key things to consider when writing employer’s procedures 120 Appendix 4: Example template for a local training record 125 Appendix 5: Example template for individual scope of practice 126 Appendix 6: Group entitlement 128 Appendix 7: Example pregnancy flow chart 129 Appendix 8: Working party membership 130 www.rcr.ac.uk IR(ME)R 3 Implications for clinical practice in diagnostic imaging, interventional radiology and diagnostic nuclear medicine Foreword Ionising radiation has been used for over 100 years in medical imaging, greatly helping patient diagnosis and treatment. Continual advances in technology have led to the increasing use of ionising radiation in many patient pathways. The benefits of using ionising radiation for diagnosis and treatment need to be weighed against the risks associated with the detrimental effects of the radiation dose. Regulations provide a framework for the safe use of ionising radiation in medical and non-medical imaging using medical radiological equipment. Guidance is required to help interpret these regulations. The Ionising Radiation (Medical Exposures) Regulations 2017 and Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018 came into force on 6 February 2018 replacing IR(ME)R 2000 and the Medicines (Administration of Radioactive Substances) Regulations 1978. The updated regulations retain the four duty holders identified in IR(ME)R 2000: the employer, referrer, practitioner and operator. The responsibilities of each duty holder are defined in the regulations. The principles of justification, optimisation and adequate training of practitioners and operators remain fundamental to the updated regulations, with some new requirements included. This guidance seeks to explain how the requirements of the regulations should be interpreted and used in practice. It explains the principles and requirements of IR(ME)R, providing clinical scenarios to enable practical interpretation of the regulations. This document has been written in support of all staff groups involved in medical and non-medical exposures within clinical settings, both in the NHS and the independent sector, research laboratories, universities and sports facilities, where appropriate. This guidance also applies to those services using ionising radiation outside of radiology and nuclear medicine departments such as cardiology and orthopaedics. Specific guidance is available for dental exposures and therefore is not covered in this guidance. The inclusion of diagnostic nuclear medicine into this document complements the updated radiotherapy IR(ME)R guidance, which now includes molecular radiotherapy. Every effort has been made to provide a consistent approach across the two guidance documents with shared working across the disciplines of diagnostic imaging, nuclear medicine and radiotherapy. This guidance has been produced by a working party, which included representatives from: § British Institute of Radiology § British Society of Paediatric Radiology § Institute of Physics and Engineering in Medicine § Medical Exposures Group, Public Health England § Royal College of Radiologists § Society and College of Radiographers www.rcr.ac.uk IR(ME)R 4 Implications for clinical practice in diagnostic imaging, interventional radiology and diagnostic nuclear medicine We would like to thank members of the working party (Appendix 8) for their time and expertise in developing this document and acknowledge the radiotherapy IR(ME)R working party for their contribution and shared working. Particular thanks should go to Dr Peter Riley, who chaired the working party. Sadly, Peter passed away during the later stages of the development of this document. The radiology community owe him a great debt for this document. In recognition of all his valuable work as an interventional radiologist and on radiation safety the RCR has issued this document in memoriam to Dr Riley. We hope this document will support the diagnostic and nuclear medicine communities to implement IR(ME)R in their practice. Stewart Redman Radiation Protection Adviser to The Royal College of Radiologists www.rcr.ac.uk IR(ME)R 5 Implications for clinical practice in diagnostic imaging, interventional radiology and diagnostic nuclear medicine 1. This guidance document is intended to provide a practical approach to implementing Introduction the Ionising Radiation (Medical Exposure) Regulations 2017 (IR(ME)R) for all staff groups delivering a range of diagnostic imaging, interventional radiology and diagnostic nuclear medicine services.1 This guidance also applies to the implementation of the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018 and any reference to ‘IR(ME)R’ can be taken to refer to these regulations also, unless specifically stated.2 Within the UK responsibility for healthcare is devolved and different approaches may be taken in each of the four nations. Typical scenarios and examples have been included within text boxes to provide practical advice on aspects of the regulations. These are taken from information provided to the working party by several hospital trusts or health boards and are not intended to be prescriptive. A glossary of terminology used in this guidance is included in Appendix 1. The Regulations IR(ME)R implements the medical exposure provisions from the European Council Basic Safety Standards Directive 2013/59/Euratom (BSSD).3 The BSSD takes into account the recommendations from the International Commission on Radiological Protection (ICRP) publication 103.4 IR(ME)R includes new requirements relating to the following: § Reporting of accidental and unintended exposures (Chapter 21) § Introduction of non-medical imaging exposures using medical radiological equipment which replaced and expanded upon medico-legal exposures (Chapter 18) § Introduction of a formal recognition scheme for medical physics experts (Chapter 19) § Introduction of licensing for employers and practitioners for the administration of radioactive substances to persons for diagnosis, treatment or research (Chapter 22) § Existing equipment requirements moved from the Ionising Radiations Regulations 1999 and new equipment requirements from BSSD added (Chapter 20).5 IR(ME)R places obligations on specific duty holders and provides a framework intended to protect individuals from the hazards associated with medical and non-medical exposures involving ionising radiation. The responsibility for compliance with IR(ME)R lies with the employer and each of the entitled duty holders. The roles and responsibilities of all duty holders are explained in Chapter 2 (Duty holder roles and responsibilities). IR(ME)R applies to medical exposures and specific types of non-medical exposures listed in Table 1.1 [Regulation 3]. www.rcr.ac.uk IR(ME)R 6 Implications for clinical practice in diagnostic imaging, interventional radiology and diagnostic nuclear medicine Table 1.1: Types of exposure Exposure Examples Medical exposures § Patients, as part of their medical § X-ray imaging, computed diagnosis or treatment tomography (CT), fluoroscopy, interventional radiology, dual- energy X-ray absorptiometry (DXA), mammography § Nuclear medicine imaging, positron emission tomography/computed tomography (PET-CT), non-imaging nuclear medicine examinations § Individuals as part of health § Imaging a group or population for a screening programmes disease (eg, NHS Breast Screening Programme) § Individuals participating in research § Patients taking part in clinical trials programmes § Carers and comforters § Individuals who provide support and comfort to a patient within a controlled or a supervised area (where access is normally restricted, or systems of work are in place to exclude members of the public) § Asymptomatic individuals § Investigations to exclude disease on individuals with no symptoms Non-medical exposures § Individuals undergoing non-medical § Health assessment for employment, imaging using medical radiological immigration or insurance purposes equipment § Radiological age assessment § Identification of concealed objects within the body This document should be read in conjunction with IR(ME)R and other published guidance.6 www.rcr.ac.uk IR(ME)R 7 Implications for clinical practice in diagnostic imaging, interventional radiology and diagnostic nuclear medicine 2. Responsibility Duty holder roles The responsibility for compliance with IR(ME)R lies