ASN assessments by area for activity THE MEDICAL SECTOR On the basis of the inspections carried out in 2024 and of an analysis over the period enabling the entire base of facilities with safety implications to be covered, ASN considers that the state of radiation protection in the medical sector is being maintained at a satisfactory level, relatively comparable from one year to the next, although with a number of persistent shortcomings. ASN notes that the clinical audit experiments started at the end of 2023, in radiotherapy and radiology only, under the control of the Ministry for Health, are being deployed satisfactorily but will need to be continued before they can be generally adopted. It encourages their extension to higher-risk activities, primarily radio- surgery, as well as therapeutic nuclear medicine, and urges the National Professional Councils (CNPs) to immediately mobilise in order to construct the audit tables. It also encourages the radiotherapy units to participate in the evaluation of the new practices, similarly to that put into place for adaptive radiotherapy. It encourages the CNPs to take account of the need to update the radiation protection training guides they produced, based on the results of the evaluation of the new patient radiation protection training system published by ASN in 2024. ASN draws attention to the fact that the signals identified in 2023, and recalled below, lead to a deterioration in radiation protection culture. They are identified as a factor contributing to the occurrence of ESRs and are found during inspections to explain the fall in regulatory compliance: ∙a finding that resources are on the whole shrinking, with pressure on radiographer (MERM), medical practitioner, medical physician staffing levels, with the expansion of temporary work and the post- ponement of tasks; ∙in imaging, the use of insufficiently well-understood services to assist the Radiation Protection Expert-Officers (RPE-Os) and the medical physicians in the plants, liable to lead to a loss of radiation protection expertise and a lack of flexibility in implementing the regulation radiation protection requirements (training, verifications, etc.); ∙constant growth in teleradiology with technical and organisational constraints linked to this type of organisation that are under-estimated by the facilities (communication problem, software interface); in 2025, ASNR will publish the lessons learned from a study it conducted on this subject; ∙increasingly complex organisations, with sharing of resources and the risk of dilution of responsibilities, against a backdrop of health care authorisation reforms and buy-out of centres. ASN thus maintains its demand for vigilance on the part of the decision-makers, regarding the need to assess the impact of these changes on the organisations and on the work of the participants and to precisely define the roles and responsibilities of all parties involved, so that the radiation protection requirements are met. In radiotherapy, although the fundamentals of safety are in place, the radio- therapy departments are struggling to drive the experience feedback process, with fewer experience feedback committee meetings, insufficiently detailed ESR analyses and persistent difficulties with assessing the robustness of the corrective measures taken. The repetition of target errors (wrong-side, delineation or positioning errors in particular), the multiplication of simultaneous treatments of several locations, as well as re-irradiations, at a time when more and more patients will benefit from several radiotherapies during their lifetime, underlines the need on the one hand for regular assessment of the barriers in place, taking advantage of national Operating Experience Feedback (OEF), and, on the other, for updating of the preliminary risk assessments on the basis of local and national experience feedback. These studies are still insufficiently conducted upstream of technical and organisational changes. In brachytherapy, the inspections confirm that the radiation protection rules are well taken into account. The challenges linked to maintaining the resources and skills needed for this activity will remain in the coming years. The new requirements concerning the protection of high-level sources against malicious acts are continuing to be gradually deployed, in particular through implementing a protection policy, measures to prevent unauthorised access to these sources and the identification and control of sensitive information. The situation is gradually improving although it cannot yet be considered to be conforming. In nuclear medicine, the inspections indicate that patient radiation protection is adequately taken into account, through implementation of the optimisation principle with the collection and analysis of Diagnostic Reference Levels (DRLs), while underlining the fact that further progress is still required in the deployment of Quality Management Systems (QMS). The ESRs show that the administration processes must be regularly evaluated in order to ensure that the drug circuit is fully controlled, in particular those which could lead to errors involving several patients (use of the dose calibrator). ASN draws the attention of the entities Responsible for Nuclear Activities (RNAs) to the risk of extravasation with treatments using lutetium-177, which can lead to significant exposure on the injection site and, in collaboration with the professionals, is currently working on collecting experience feedback from the ESRs reported. It has also made available an “experience feedback” sheet concerning complications arising during liver cancer treatment by radioembolisation using yttrium-90. Particular attention must also be paid to management of the effluents (operation of the decay tank alarms) and the waste generated by the patients, linked to the emergence of new radiopharmaceuticals. Finally, despite progress regarding the training of professionals, a less satisfactory situation was observed in 2024 with regard to occupational radiation protection and monitoring of equipment and sources (analysis of dosimetry, verifications, coordination of prevention measures during concomitant activities). In the field of Fluoroscopy Guided Interventional Practices (FGIPs) and more particularly in the operating theatre, regulatory nonconformities persist, year after year, whether the technical rules for layout of facilities, radiation protection training requirements for workers and patients, and coordination of prevention measures during concomitant activities. ASN observes that the centres are increasingly calling on Radiation Protection Organisations (RPOs), and that if insufficiently well managed, this subcontracting leads to a dilution of the responsibilities of the RNAs with less consideration for ASN Assessments 28 ABSTRACTS – ASN Report on the state of nuclear safety and radiation protection in France in 2024
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