1.3.4 The particularities of patient radiation protection Justification and optimisation – The protection of patients undergoing medical imaging examinations or therapeutic procedures using ionising radiation is regulated by specific provisions of the Public Health Code (Art. R. 1333‑45 to R. 1333‑80). The principles of justification of the procedures and optimisation of the delivered doses constitute the cornerstone of this regulation. The principle of dose limitation does not apply to patients due to the need to adapt the delivered dose to the diagnostic or therapeutic end-purpose for each patient. ASN ensures that this regulatory framework is updated through specific provisions with regard to optimisation, quality assurance, training and qualification as described below. The required qualifications – The use of ionising radiation on the human body is restricted to physicians and dental surgeons having the necessary skills to perform these procedures (Article R. 1333‑68 of the Public Health Code). ASN updated and specified the necessary qualifications in October 2020. This aim of the updating is to adapt the regulatory provisions to the developments in the techniques and conditions of practise. ASN resolution 2020‑DC-0694 of 8 October 2020, approved by Order TABLE Classification of nuclear-based medical activities according to the radiation protection risks ACTIVITIES PATIENTS PROFESSIONALS PUBLIC AND ENVIRONMENT External-beam radiotherapy 3 1 1 Brachytherapy 2 2 2 Internal targeted radiotherapy 3 2 3 Fluoroscopy-guided interventional practices 2 to 3 depending on the procedures 2 to 3 depending on the procedures 1 Diagnostic nuclear medicine 1 to 2 depending on the procedures 2 to 3 depending on the procedures 2 Computed tomography 2 1 1 Fluoroscopy-guided procedures on remotelycontrolled table in radiology department 1 1 1 Conventional radiology 1 1 1 Dental radiology 1 1 1 1: no risk or low risk – 2: moderate risk – 3: high risk 1 PATIENT RADIATION PROTECTION: THE JUSTIFICATION PRINCIPLE As the first principle of radiation protection enshrined in the Public Health Code, justification aims to ensure that the patient derives benefit from the examination or treatment received, as compared with the risks inherent to exposure to ionising radiation and in view of the alternative techniques that do not involve exposure to ionising radiation. It ties in with the medical notion of relevance, which means endeavouring to perform “the right procedure for the right patient at the right time”, taking into account the benefit-risk trade-off. The clinical assessments conducted for putting onto the market medical devices, RPDs or derogation processes enabling patients to have early access to an innovative treatment are determining factors in the application of the justification principle (see point 1.3.2). Application of the principle of justification is materialised by the publication of guides defining the medical indications justifying the procedures involving exposure to ionising radiation in the various applications (radiology, nuclear medicine, radiotherapy). To this end, the Minister responsible for health or the organisation he/she designate (the HAS) draws up, in collaboration with the health professionals, and distributes a guide defining the medical indications justifying the procedures involving exposure to ionising radiation, especially those used the most frequently (Article R. 1333‑47 of the Public Health Code). These guides have to be updated periodically according to the changes in techniques and practices and are distributed to the practitioners requesting and performing the procedures. In view of the radiation protection risks, the updating of these guides, particularly in radiotherapy, is a priority for ASN. The individual justification of the procedure for each patient is based on consideration these professional guides. Justification is the joint responsibility of the “referring” physician and the “performing” physician. In application of Article R. 1333‑52 of the Public Health Code, prior to referral for and performance of a procedure, the physician or dental surgeon checks that it is justified by referring to the guide or the documents mentioned in Article R. 1333-47. In the event of disagreement between the referring physician and the performing physician, the decision lies with the latter. In imaging, the Guide to good use of medical imaging examinations produced by the French Society of Radiology (SFR) and the French Society of Nuclear Medicine and Molecular Imaging le (SFMN) was updated in 2021 and transformed into a website baptised ADERIM (Aid to Referral for Radiology and Medical Imaging Examinations), intended primarily for general practitioners. Its serves to guide the referring physician in choosing the most appropriate examination for exploring the pathology concerned. It features an indication recommendation (indicated, not indicated, or even counter-indicated), the level of proof of the recommendation and the level of exposure to ionising radiation resulting from the examination. Its aim is to reduce the exposure of patients by eliminating unjustified imaging examinations and by giving preference if necessary to the use of non-irradiating techniques when available. In external-beam radiotherapy and brachytherapy, the Guide to recommendations for the practise of external-beam radiotherapy and brachytherapy (Recorad) produced by the French Society for Radiation Oncology (SFRO), was revised in February 2022. It presents recommendations aiming to optimise, harmonise and render uniform the practises. ASN Report on the state of nuclear safety and radiation protection in France in 2021 207 07 – MEDICAL USES OF IONISING RADIATIONS 08 07 13 04 10 06 12 14 03 09 05 11 02 AP 01
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