from undesirable and Significant Radiation Protection Events (ESRs), as of the first times the procedures are used for treatment. These data must be collected and analysed so that the steps to be taken to ensure safe treatment and worker protection can be defined and, if necessary, regulated, and shared with the other departments which will be using these same treatments. These must be able to plan or adapt the layout and outfitting of their premises, train their personnel, and conduct the required risk assessments for their quality management system and for occupational risk prevention. Upstream of the delivery of a radiopharmaceutical, there can be nuclear safety issues for certain radionuclides of interest, notably when their production implies the use of research reactors or specific cyclotrons, and facilities for the purification and then preparation of radiopharmaceutical drugs. These processes also require numerous intermediate shipment operations with significant time constraints owing to the short half-life of the radio- nuclides. Despite the European level coordination efforts made to secure the supply of essential radionuclides to nuclear medicine units, there are often few synthesis alternatives, which makes continuity of the available treatments vulnerable to the contingencies that can affect these facilities. Once the medical procedure has been completed, the management of effluents and waste contaminated by the radionuclides raises its own new problems. The particular 1. asn.fr/information/archives-des-actualites/premier-avis-du-canpri-et-position-sur-l-installation-et-l-utilisation-de-la-plateforme-zap-x-R 2. asn.fr/reglementation/bulletin-officiel-de-l-asnr/activites-medicales/avis/avis-n-2024-av-0445-de-l-asn-du-3-septembre-2024 case of waste contaminated by radionuclides produced at the home of patients and detected when it reaches waste collection centres, when disposed of in the household waste without adhering to decay management times, causes blocking situations or even emergencies in the waste management route and for its workers. The increase in the frequency of such events observed in 2024 is therefore of concern, given the expected increase in the number of eligible patients. The effect of the preference for out-patient treatments transfers the responsibility for managing this waste from the hospital units, which are generally organised to deal with this, to the patients when back home and the municipalities in charge of household waste management, for which operational procedures and support remain difficult to implement or may even be non-existent. Similarly to the particular case of lutetium-177, which was the subject of an ASN Circular of 12 June 2020, these issues must now be taken on-board across the disciplines, taking account of a broad range of radionuclides and vectors. This implies close collaboration between the professional organisations, the authorities (Ministry responsible for health, National Authority for Health – HAS, Health Products Safety Agency – ANSM, Authority for Nuclear Safety and Radiation Protection – ASNR), the manufacturers and promoters of clinical trials, and the health care services, to ensure a complete and coherent approach. Anticipating for improved regulation and decision-making In this context, it is essential that the decisions by all the health care system stakeholders be informed by adequate upstream consideration of the radiation protection issues. For the medical services, this entails anticipating what their future will look like in order to adapt to the needs (reception capacity, sizing, technologies, regulatory compliance, etc.) and prepare the corresponding investments, including in terms of skills. For the manufacturers of radio- pharmaceutical drugs, this for example implies limiting impurities and the presence of long half-life radionuclides, packaging the radiopharmaceuticals in an appropriate form such as to limit occupational exposure or ensure their safe dispensation. For the promoters of clinical trials, the licence application file shall include pertinent data so that the users can comply with the regulatory obligations for radiation protection of the patients and their entourage, the professionals and the environment, and carry out their risk assessment. For the manufacturers of new medical devices, it is essential that the necessary data be delivered with the equipment. To identify the new techniques and emerging practices using ionising radiation and analyse their radiation protection implications, ASN calls on Advisory Committees of Experts (GPEs) and the Committee for the Analysis of New Medical Techniques and Practices using Ionising Radiation (Canpri), with the support of the Institute for Radiation Protection and Nuclear Safety (IRSN). In 2024, ASN issued a position statement on the ZAP-X®(1), based on the opinion issued from the Canpri, as well as on pulsed fields(2), based on an opinion from the Advisory Committee of Experts for Radiation Protection (GPRP). The Canpri opinion on flash therapy is expected in 2025. Finally, ASNR will issue an opinion in 2025 on the basis of the work done by IRSN and the GPRP to draw up recommendations intended for the promoters and investigating centres to promote access to innovative care treatments. The GPE opinions were presented to the HERCA network (Heads of the European Radiological Protection Competent Authorities) for forwarding to the European Union, and the Simplerad project was also able to identify areas for improvement to enhance the interface between pharmaceutical legislation and radiological safety standards. Numerous exchanges took place with the professional organisations to make up for the lack of information on the important radiation protection data and to facilitate the collection of this information in order to allow the issue of authorisations. For ITR, ASN conducted exchanges with the ANSM to optimise and simplify the administrative approaches. In 2025, ASNR will continue its efforts to mobilise all the stakeholders and change the regulatory system, ensuring that each stakeholder assumes its responsibilities and that radiation protection issues are at the heart of the decisions in an innovative and constantly evolving health care system. ♦ NOTABLE EVENTS 2024 ABSTRACTS – ASN Report on the state of nuclear safety and radiation protection in France in 2024 19
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