operating theatre. Simple and practicable instructions must be favoured in a context of multiple risks and a complex environment. The signalling systems moreover count among the most effective prevention measures, as does the wearing of appropriate Personal Protective Equipment (PPE) and dosimeters by each operator, from the moment a restricted area is delimited due to the risk of exposure to ionising radiation. Some centres are equipped with operating halls that constitute technical platforms allowing procedures to be performed simultaneously with the sharing of certain members of staff. Compliance with the regulatory requirements, particularly those concerning signalling, can be more complicated in these halls. 2.4.3 Radiation protection situation in fluoroscopy-guided interventional practices For some years now ASN has been receiving regular reports on ESRs in the area of FGIPs, but their number remains low for the number of procedures performed. In the course of its inspections, ASN still finds that the medical professionals lack knowledge of the criteria for reporting significant events, even though the doses administered in some centres are high and sometimes exceed the dose 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 radiological 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 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 2023, 210 medical departments were inspected in 139 centres. As in 2022, the operating theatre complexes of the university hospital centres and the largest hospital centres, represent 65% of the inspections, and the departments licensed by the ARS (licensed for treatments in cardiac rhythmology, interventional cardiology and neuroradiology) were prioritised. 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, 65% of the interventional imaging departments and 40% the operating theatres have rooms conforming to the requirements of 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. After several years without improvement despite the compliance commitments made by the centres, ASN deployed an enforcement approach in 2023 (see box above). 2.4.3.1 Radiation protection of medical professionals The radiation protection of the medical professionals is considered satisfactory with regard firstly to the implementation of radiological zoning of the facilities (91% of the inspected departments), with a better assimilation of the notions of zoning in the operating theatres over the last five years, and secondly the appointing of an RPE-O (98% of the inspected departments). Nevertheless the lack of training of medical professionals in occupational radiation protection has been a recurrent finding in inspections over the last five years. The situation in interventional imaging departments is better in 2023, but it has further deteriorated in the operating theatres. Only 5% of the operating theatres have trained all their medical personal and 19% have trained all their paramedical personnel; for interventional imaging departments these figures are 36% and 40% respectively. ASN thus notes a drop in the number of operating theatres that have trained all their personnel in the space of five years, and the proportion is very small. Yet this training is essential to understand of the radiation protection risks and identify the risk situations, and to be capable of implementing the prevention measures to ensure the safety of the personnel. The centres explain this situation by a lack of availability of the medical staff and/or a lack of mobilisation due to a certain amount of repetitiveness in the content delivered in ASN exercised its powers of sanction in 2023 in the areas of FGIPs by issuing formal notice to the Bordeaux University Hospital to carry out the continuous training in patient radiation protection of the medical professionals concerned in order to comply with the provisions of Article R. 1333-68 of the Public Health Code and those of ASN resolution 2017-DC-0585 of 14 March 2017 amended. This centre was also given formal notice to comply with the fitting out rules for interventional procedure rooms defined in ASN resolution 2017-DC-0591 of 13 June 2017. COMPLIANCE NOTICES SERVED BY ASN ON A CENTRE IN THE AREAS OF FGIPS IN 2023 230 ASN Report on the state of nuclear safety and radiation protection in France in 2023 • 07 • Medical uses of ionising radiation
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