LES ACTIVITÉS NUCLÉAIRES : RAYONNEMENTS IONISANTS ET RISQUES POUR LA SANTÉ ET L’ENVIRONNEMENT the resolution of 23 August 2011 (2011-DC-0238) and updates the qualifications required for physicians and dental surgeons who perform procedures using ionising radiation for medical purposes or human subject research. It also sets the requirements for designating physicians coordinating a medical nuclear activity and to apply for a license or registration as a natural person. The quality assurance obligations – To control the doses delivered to patients and thereby contribute to improved treatment safety, the obligations of the RNAs with regard to quality assurance for all medical activities involving ionising radiation are now governed by two ASN resolutions: ∙resolution 2019-DC-0660 of 15 January 2019 in medical imaging, that is to say in nuclear medicine for diagnostic purposes, in dental and conventional radiography, in computed tomography and for FGIPs; ∙resolution 2021-DC-0708 of 6 April 2021 for therapeutic procedures, that is to say external-beam radiotherapy, including contact therapy and intraoperative radiotherapy, brachytherapy, nuclear medicine for therapeutic purposes (ITR) and radiosurgery. These resolutions oblige the RNA, with requirements proportionate to the radiation protection risks, to formalise the work instructions associated with the operational implementation of the two general principles of radiation protection (justification for the procedures and dose optimisation), and those concerning Operational Experience Feedback (OEF), the training and authorisation of professionals and, for therapeutic procedures, the prospective risk analysis. The above-mentioned resolution 2021-DC-0708 of 6 April 2021 updates and tightens the quality assurance requirements, particularly when there is an organisational or technical change, and when services are outsourced. A clinical peer review figures among the quality assurance obligations. The principle of the clinical peer review has been written into Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation. Transposed into French law in Article R. 1333-70 of the Public Health Code, the peer-reviewed clinical audit, which is included in the quality assurance system provided for in Article L. 1333-19 of the Public Health Code defines it as “the evaluation method which, in accordance with criteria determined by the quality assurance framework, guarantees to the patient the competence of the medical and care team, the quality of care and the safety of procedures, including the radiation protection of patients”. These audits are carried out internally by a multi-professional team trained in auditing, and if necessary, by an external team, depending on the risks incurred by patients. A trial phase of clinical audits by a team of peers from outside the centres being audited has been initiated from 2023, at the instigation of the French General Directorate for Health (DGS), in the fields of conventional radiology and radiotherapy. It ended at the end of 2025. These external clinical audits will initially focus on the fields of X-ray imaging and radiotherapy, with the support of the relevant professional bodies and national professional organisations. The aim of these initiatives, which are currently voluntary, is to assess good imaging practice and the appropriateness of the procedures performed. ASNR participates in the steering committees set up by the DGS to monitor implementation of these clinical peer reviews. Deployment of the pilot phase in radiotherapy continued in 2025. The assessment conducted at the end of 2024 on about ten volunteer radiotherapy centres is broadly positive as regards review preparation on the part of the reviewers, the reviewed centres and the subjects addressed during the reviews, such as justification of the procedure (patient radiation protection). In radiology, by the end of the 3rd quarter of 2025, just under 80 imaging facilities were audited. The results of the first 60 audits have been positive, both in terms of the feedback received from the structures audited and the observations made, enabling them to progress as part of a continuous improvement process. The results communicated by the National Professional Council for Radiology and Medical Imaging (G4) show an average of almost 20 non-compliances per site, mainly relating to documentation. Imaging facilities have room for improvement in terms of formalising their practices, not always analysing Diagnostic Reference Levels (DRLs), providing ongoing training for practitioners in patient radiation protection, and under-equipping facilities with Dose Archiving and Communication Systems (DACS), even though these are generally compulsory when they carry out interventional practices. The audits show compliance rates with room for improvement regarding the justification of referrals (73% compliant), and high compliance rates with regard to the drafting of both the referral request by the referring physician (94% compliant) and the procedure report by specialist physicians in radiology and medical imaging (95% compliant). The audits have proved to be useful in raising awareness of existing recommendations and ensuring that they are applied by professionals, and that they complement government controls, including ASNR inspections. They would benefit from being refocused on clinical professional practices (relevance of procedures and optimisation process) and priority operational issues, rather than on document compliance, which can be managed by other means. At the end of these experimental phases, a national review will be carried out by the Ministry of Health to extend these clinical audits nationwide, to ensure an overall increase in their quality and relevance, in accordance with Council Directive 2013/59/Euratom of 5 December 2013. A decree should then specify the procedures for carrying out these audits, including the frequency. 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 remotely controlled table in the 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 TABLE 1 Classification of nuclear-based medical activities according to the radiation exposure risks ASNR Report on the state of nuclear safety and radiation protection in France in 2025 195 01 05 02 03 04 09 06 10 07 11 13 08 12 A / Z
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