ASN Report 2021

3 // Synthesis and prospects Although the year 2021 was also marked by the Covid-19 pandemic, the disturbances in the health care system did not lead ASN to cut back its inspection programme. More specifically, the inspection frequencies defined according to the risks entailed by the various nuclear activities in the medical sector were duly respected. Twenty percent of the inspections were conducted remotely, either entirely or in part. On the basis of the inspections carried out in 2021, ASN considers that, despite the impact of the Covid-19 pandemic on the functioning of the health services, the radiation protection situation in the medical field is comparable with that of the 2019 and 2020, reflecting the fact that the departments have been able to adapt and maintain a good standard of radiation protection. Thus, no major deficiency was detected in the areas of radiation protection of medical professionals, patients, the public or the environment. Nevertheless, due to the pandemic, lateness in performing the radiation protection technical verifications for the FGIPs has been observed, leading to noncompliance with the regulatory frequencies. In addition to this, the coordination of prevention measures when third-party interventions are involved, particularly those of private practitioners, must be reinforced in nuclear medicine and FGIPs. Lastly, raising awareness in operating theatre personnel –users who are not ionising radiation specialists, such as surgeons– remains necessary for a better perception of the risks and embracing of radiation protection measures in this sector where, moreover, the work to bring the premises into conformity is progressing too slowly. The events reported to ASN highlight that the formalising of practices, the explanation of validations, the supervision of maintenance services and the reporting of adverse events are essential to enhance the safety of practices. In 2022, ASN will continue its inspections in radiotherapy, nuclear medicine, FGIPs and computed tomography, in line with the inspections carried out in 2021, paying particular attention to the vulnerabilities identified in 2021 (frequency of radiation protection verifications, coordination of prevention measures during third-party interventions, notably those of private practitioners, training in the radiation protection of workers and patients and in the use of the equipment, bringing operating theatres into conformity with the fitting-out rules in effect) and the updating of the new quality assurance obligations for therapeutic nuclear activities which came into effect in July 2021 (ASN resolution 2021-DC-0708 of 6 April 2021). With regard to its regulatory role, in 2022 ASN will continue revising resolution 2008-DC-0095 of 29 January 2008 setting out the technical rules for the elimination of effluents and waste contaminated by radionuclides, along with its contribution to the regulatory work conducted by the Minister responsible for health concerning the duties of medical physicists, the organisation of medical physics and the deployment of clinical audits. ASN will also start the updating of resolution 2010-DC-0192 of 22 July 2010 relative to the detailed content of the information that must be included in first-time license or license-renewal applications. Lastly, the fast development of new radionuclides and vectors in nuclear medicine, of new, ever-more efficient and sophisticated medical devices, of new practices and clinical indications in the various medical nuclear activity sectors, remains a major concern for ASN. Working in collaboration with the various institutional actors of the health sector, the learned societies, and assisted by its groups of experts and the Canpri in particular, ASN will work to identify the radiation protection risks, to promote and facilitate –in an innovation-driven context– safe operating frameworks, paying particular attention to the generic justification of these new techniques in order to assess the radiation protection benefits for patients. 230 ASN Report on the state of nuclear safety and radiation protection in France in 2021 07 – MEDICAL USES OF IONISING RADIATIONS

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