Significant events concerning patients (142 ESRs, i.e. 71% of the reported ESRs) The large majority of ESRs concerning nuclear medicine patients occurred in the course of diagnostic procedures (> 90%). Most of these ESRs result from injection errors (wrong RPD or wrong activity injected in more than 50% of the ESRs) or identity monitoring errors in 30% of the cases (RPD administered to the wrong patient), and result from organisational and human malfunctions, usually in high workload situations. Five events of this type in 2023 concerned children. Nine reported events involved RPD extravasation(9). In 2023, ten events that occurred during therapeutic procedures were reported, four linked to complications associated with the use of yttrium-90 microspheres). The other ESRs concern errors in the handling or injection of RPDs (four ESRs with lutetium-177 and one with iodine-131). Significant events concerning medical professionals (13 ESRs, i.e. 6% of the reported ESRs) Thirteen events concerning nuclear medicine professionals were reported in 2023. They result from contaminations that 9. Extravasation is an inappropriate accidental and unintentional injection or leakage of drugs into the perivascular or subcutaneous spaces rather than into the targe vascular compartment. led to internal or external exposures (surface contaminations as a result of handling errors or reception of a broken vial). None of these ESRs resulted in the regulatory dose limit for the workers concerned being exceeded. Significant events concerning the public (14 ESRs, i.e. <7% of the reported ESRs) Thirteen events concerning the public result from exposure of the foetus in women unaware of their pregnancy. The doses received had no consequences for the unborn child. A “Patient safety” newsletter published in 2021 was devoted to this type of event. The 14th event involving the public concerns a high dose rate (hot spot) discovered in a corridor of a day hospital care department. Significant events concerning radioactive sources, waste and effluents (32 ESRs, i.e. 16% of the reported ESRs) These ESRs are mostly related to source losses/discoveries, the dispersion of radionuclides (resulting from overflows of radioactive effluent tanks or leaks in the effluent evacuation circuit), deliveries that do not comply with the licenses and unauthorised discharges of effluents into the environment (emptying of tanks, etc.). Difficulties have recently emerged in the management of the solid waste produced in the ITR treatments of certain prostate cancers with RPDs using lutetium-177. The patient is given instructions on leaving the nuclear medicine department regarding the management of the waste produced at home (sanitary protections, for example) in the days following treatment, including storage of their waste in the home for several weeks. At present these instructions are not harmonised nationally. Storage of this type of waste in the home can be difficult (lack of space or a suitable area). Consequently, it can happen that waste arrives at the waste treatment facilities before the time indicated in the patient’s discharge instructions has lapsed, triggering the radiation portal monitors. Solutions have been proposed by domestic waste treatment centres, such as providing patients with larger-volume collectors and having them picked up by a door-to-door service, while at the same time enhancing patient awareness. However, as these one-off solutions are costly and this is a promising type of treatment which is bound to develop, ASN draws the medical profession’s attention to the need to find long-term solutions which can be applied across the country. The inspections carried out in 2023 in nearly a quarter of the nuclear medicine departments, considered alongside those carried out over the 2019-2022 period, enabling all the departments to be covered, confirm that the radiation protection rules are properly applied in the majority of the departments. The observations made in 2023 nevertheless confirm that effluent management must be improved, even if some progress has been observed in checking the operation of tank alarms, in formalising the coordination of the prevention measures with outside contractors (for maintenance and cleaning services, services of private practitioners, etc.) and in personnel training. ASN notes that further progress is needed in the deployment of the QMS’s and in the quality of the ESR analyses. Among the reported ESRs, those concerning drug administration errors show that the drug administration process must be regularly assessed to ensure it is controlled (see the bulletin “Safeguarding the medication circuit in nuclear medicine”). Although a medical physics organisation is in place in most centres, particular attention must be devoted to it given the strong development of the therapy with the introduction of new RPDs. More generally, the increasing emergence of clinical tests involving new vectors and new radionuclides (lutetium-177, actinium-225, lead-212, holmium-166, etc.) makes it necessary to acquire deeper knowledge of the associated radiation protection risks, not only for the patients and their carers and comforters, but also for the medical professionals, the public and the environment. The work undertaken nationally by the GPRP at the request of ASN, and at European level through the SimpleRad project, should lead to recommendations to respond to new risks. SUMMARY GRAPH Breakdown (in %) of ESRs in nuclear medicine in 2023 9 71% Patients 6% Workers 7% Public 16% Sources, waste, effluents 228 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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