ASN Report 2023

or positioning errors), reported in 2023, once again recalls the need for regular evaluation of the barriers put into place, taking greater advantage of national OEF. ASN stresses the importance of the advance risk assessment when technical and organisational changes are made. In this respect, ASN shared a risk assessment methodology in its “Patient safety” bulletin of September 2023. In brachytherapy, the inspections confirm that the radiation protection rules are well taken into account, but the enhanced training effort for emergency situations in the event of a source blockage must be maintained on a long-term basis. ASN underlines the challenges in the coming years linked to maintaining the resources and skills needed for this activity. In nuclear medicine, the inspections show that radiation protection is satisfactorily addressed, while underlining the need to deploy quality assurance procedures to secure the drugs administration process, in particular for therapeutic procedures as well as for those concerning children, in the light of the ESRs reported. In addition, formalised coordination of prevention measures with outside contractors (for maintenance, upkeep of the premises, the intervention of private practitioners, etc.), personnel training and analysis of the Diagnostic Reference Levels (DRL) are still areas in which progress could be made. In the field of FGIPs and more particularly in the operating theatre, regulatory nonconformities persist as the years go by, whether the technical rules for the layout of installations, radiation protection training requirements (worker and patient training) and coordination of prevention measures during concomitant activities, notably for interventions by private practitioners. As a result of these deviations, ASN served formal notice on one facility requiring that they comply with the rules regarding radiation protection of professionals and the layout of rooms in which interventional procedures are carried out. ASN also observed that the centres are increasingly calling on Radiation Protection Organisations (OCR), either as specialists for internal RPE support missions, or as Radiation Protection Adviser (RPA), and that if insufficiently well managed, this subcontracting leads to a dilution of the responsibilities of the person/entity Responsible for a Nuclear Activity (RNA) with less consideration for and even deterioration of radiation protection. In 2024, ASN will continue its inspections in the priority sectors such as radiotherapy, radiosurgery, nuclear medicine, FGIP and computed tomography, following on from the checks carried out in 2023. Particular attention will be paid to the weak signals previously mentioned and to the weak points identified in 2023 (training, OEF approach and lessons learned from reported ESRs, coordination of prevention measures during concomitant activities, work to ensure compliance of installations with layout rules, maintenance), as well as implementation of the quality assurance and change management obligations. If necessary, unannounced inspections will be carried out. 1. SimpleRad – EANM EARL – Research4Life: earl.eanm.org/simplerad/ In radiotherapy and in nuclear medicine, on the basis of the lessons learned from the ESRs reported in recent years, specific inspections will be carried out by ASN in 2024 on the accelerators calibration programme and verification of non-contamination, in collaboration with the French Institute for Radiation Protection and Nuclear Safety (IRSN). With regard to FGIPs, ASN will carry out targeted inspections on the private practice physicians who, although not RNA, and not owners of the equipment on which they work, do have radiation protection obligations both for themselves and as an employer of personnel classified in terms of exposure to ionising radiation. In regulatory terms, ASN will in 2024 revise resolution 2019-DC-0667 of 18 April 2019 setting DRL values to update the values for mammography procedures and will continue the work to prepare for revision of resolution 2008-DC-0095 of 29 January 2008 setting the technical rules to be met for elimination of effluents and wastes contaminated by radionuclides. Finally, the deployment of new techniques and practices in therapy (radiotherapy, Internal Targeted Radiotherapy – ITR) remains a subject of particular attention for ASN, which will aim to promote all actions designed to improve assessment of the radiation protection issues and allow a better demonstration of their advantages over the existing techniques. On this point, ASN will continue its work with the various institutional players in the health field and the learned societies, and will call on the Advisory Committees of Experts (GPEs), in particular the Committee for the analysis of new techniques and practices using ionising radiation (Canpri), notably flash radiotherapy and adaptive radiotherapy. In nuclear medicine, against the backdrop of the emergence of new vectors and radionuclides for therapeutic purposes, and the projected growth in the number of patients eligible for these new treatments, with limited out-patient treatment resources and infrastructures, ASN underlines the importance of anticipating the radiation protection issues for the patient and their entourage, the workers, as well as in terms of layout of the facilities and effluent and waste management. To this end, it referred the matter to the Advisory Committee for Radiation Protection (GPRP), and is following European work being done under the SimpleRad(1) project and maintains dialogue with the nuclear medicine players to recall the regulatory framework and examine that it is keeping pace with the changes made. ASN Report on the state of nuclear safety and radiation protection in France in 2023 27 ASN assessments

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