thresholds beyond which tissue damage occurs (radiodermatitis, necrosis) in patients having undergone particularly long and complex interventional procedures. In addition to these events, which underline the major radiation exposure risks for the patients, are those concerning professionals, whose exposure can lead to the exceeding of regulatory dose limits, particularly at the extremities (fingers) and the lens of the eye. Ever more efficient and sophisticated techniques are developing in environments with little experience of the radio- logical risk. In this context, it is essential to optimises the doses, as much for the patients as for the personnel. This is why ASN’s inspections focus in particular on the rules for the fitting out of premises, the delimiting and signalling of restricted areas, dosimetric and medical monitoring of the personnel, the provision of Personal Protective Equipment (PPE). Concerning patients, particular attention is paid to the optimisation of doses delivered to the patient (putting in place DRLs and dose analysis), personnel training in patient radiation protection and the use of the MDs. Application of ASN resolution 2019-DC-0660 of 15 January 2019 laying down the quality assurance obligations in medical imaging using ionising radiation helps the centres manage the risks arising from ionising radiation. As FGIPs are numerous, varied, and performed in many different departments (neuroradiology, interventional cardiology, interventional radiology and operating theatres) within a given centre, the inspection programme is established so that all the departments performing radiation-risk procedures are inspected every five years. Nevertheless, the progress made in certain centres, the checks carried out when examining the FGIP registration applications, and the need to focus inspections more on the departments that are falling seriously behind in fulfilling the regulatory radiation protection obligations have led ASN to adjust the inspection frequency. Inspection prioritisation is based on the number of procedures performed within a centre, the nature of the procedures which determine the radiation protection risks for the patients and medical staff, the condition of the facilities, (compliance with facility fitting out rules and persistence of nonconformities), the radiation protection culture of the teams and the situational factors (ESRs, vulnerabilities identified in previously inspected centres). This is why, since 2018, ASN prioritises its inspections in operating theatres, where the radiation protection culture is less firmly anchored than in interventional imaging departments. In 2024, 171 centres were inspected corresponding to 115 departments. As in 2023, the operating theatre complexes of the university hospital centres and the largest hospital centres, represent 73% of the inspections, and the departments licensed by the ARS (licensed for treatments in cardiac rhythmology, interventional cardio- logy and neuroradiology) were prioritised. Furthermore, and for the first time, ASN conducted inspections in 2024 of employer private practitioners performing own- account procedures in operating theatres or interventional rooms. This is because these practitioners are responsible for the health and safety obligations with respect to the risk associated with ionising radiation for themselves and their employees. During the year 11 private practitioners were inspected by the various regional divisions of ASN. During these inspections ASN finds differences between the procedures for which the structure is registered with ASN and those effectively practised. In effect, the FGIP offering in the inspected centres changes frequently because it depends on the specialists the centres are able to recruit (mobility, lack of personnel in certain specialities). At present, only 65% of the interventional radiology departments and 44% of the operating theatres have rooms conforming to the requirements of the above- mentioned ASN resolution 2017-DC-0591 of 13 June 2017 setting the technical fitting out rules and have drawn up a conformity report. These percentages have varied little over the last five years. The centres still mention financial difficulties and technical difficulties in particular in meeting the signalling requirements in the restricted areas, particularly with the emergence of new technologies that make electrical network modifications necessary. ASN observed moreover that several medical centres were using medical devices without a registration record. This situation renders the centres liable to legal penalties and compromises the traceability and safety of the devices. ASN reminds the RNAs of their obligation to submit registration applications at least six months before commissioning or renewing medical devices. This period is necessary to guarantee rigorous processing of the applications. Noting the absence of an administrative act authorising the exercise of its activities and recurrent failures to comply with the regulations, ASN served formal notice on one hospital to submit a registration application. The hospital has now taken action to regularise its situation. 2.4.3.1 Radiation protection of medical professionals ASN considers the level of occupational radiation protection to be satisfactory, particular regarding the integration of the results of verifications for the delimitation of zones, with 84% of zones correctly delimited in the operating theatres and 87% in the interventional imaging department in 2024. These levels of conformity are nevertheless slightly lower than in 2023. Virtually all the centres inspected (99% of the departments inspected) have appointed an RPE. The finding concerning the lack of training of the medical professionals in occupational radiation protection in 2024 is identical to the preceding years. This is a recurrent issue, particularly in operating theatres, where only 12% of the medical personnel (as opposed to 24% in interventional imaging departments) and 27 % of the paramedical personnel (same percentage as in interventional imaging departments) are trained. Although this percentage is higher than in 2023, the level of training in occupational radiation protection remains a subject of concern to which the RNAs should devote particular attention. ASN observes in 2024, as in 2023, significant use of Radiation Protection Organisations (RPOs), either as a specialised contributor to assist an internal RPE-O, or as an RPE. The use of RPOs can partly explain the difficulties in training the personnel due to the lower organisational flexibility of outsourced training sessions. Furthermore, calling upon an RPO necessitates supervision of this service with strong internal mobilisation and an interlocutor who is capable of following through with the radiation protection questions, because the on-site presence of the RPO’s personnel is often very limited. Without close involvement of the centres, the RPO’s will use standard documents that ignore the departments’ particularities. They are moreover often poorly known or unknown to the teams, who have difficulties in assimilating them. Yet compliance with and assimilation of the occupational radiation protection requirements is dependent on a high degree of involvement of the people who ensure in particular the correct implementation of radiological zoning, the radiation protection verifications and the occupational radiation protection training courses. Coordinating prevention measures with outside contractors, including private practitioners, is also an area for progress in interventional imaging departments and operating theatres alike. The percentage of inspected departments having formalised ASN Report on the state of nuclear safety and radiation protection in France in 2024 235 Medical uses of ionising radiation 07 01 02 03 04 05 06 08 09 10 11 12 13 14 15 AP
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