2.3.3.3 Protection of the public and the environment More than 90% of the departments inspected over the 2019-2024 period (93% in 2024) have a dedicated and protected delivery room in compliance with the requirements of ASN resolution 2014-DC-0463 of 23 October 2014, and 86% of these departments have no particular difficulties in complying with the statutory effluent discharge limits (10 becquerels per litre – Bq/L – for the contaminated effluents after interim storage, or 100 Bq/L for effluents from the rooms of patients treated with iodine-131) set for the activity concentration of effluents discharged after radioactive decay (see Graph 8). However, two points which had improved over the last three years regressed slightly in 2024. The first concerns the contamination checks at the end of procedures performed outside the department (activities such as looking for sentinel lymph nodes in the operating theatre), which are still not performed systematically in 20% of the departments inspected, while pointing out that the small number of departments concerned (10) out of those inspected in 2024 may explain this figure. The second point concerns the obligation to verify the storage tank leak detectors in the retention trays which is carried out to a lesser extent than last year (76% of the departments inspected were compliant compared with 87% in 2023). Regarding this latter point it has been observed that the transfer of alarms to an entity external to the nuclear medicine department outside working hours, although judicious in principle, is not always adequately addressed. The inspections have also revealed that the Effluent and Waste Management Plans (EWMPs) do not always contain all the required elements such as the discharge authorisation, often signed tardily with the manager of the public wastewater drainage network, and the setting of a maximum permissible value at the outlet of the centre. ASN also notes that the RNAs have difficulties in implementing the new regulations concerning the verifications to be carried out under the Public Health Code which are applicable since 1 January 2023. The main difficulty is linked to the definition of the requirements (scope of the verification action) of the Order, for the approved organisations and healthcare centres alike. 2.3.3.4 Significant events notified in nuclear medicine Out of the 69 departments inspected, most of them have a system for recording adverse events. For the majority of events notfied to ASN, the proposed action plan is appropriate but shortcomings are sometimes observed in the analysis of their root causes. On the other hand, several inspected departments had not notified certain ESRs to ASN, primarily due to the personnel’s lack of awareness of events notification. The number of ESRs notified in 2024 totals 324, a great increase compared with 2023 (+61%) and double the number notified in 2019 (see point 2.7). This change results very probably from an increase in the number of procedures in nuclear medicine, a discipline that developing strongly, whether for diagnostic purposes – with PET scans in particular – or therapeutic purposes, but can also be explained by greater adoption of the quality assurance approach by the centres, which integrates the notification of ESRs. This trend must not mask the fact that failures tonotify events are still observed occasionally. As in the preceding years, the majority of the reported events (73%) concern patients (see Graph 9). Significant events concerning patients (237 ESRs, i.e. 73% of the notified ESRs) The large majority of ESRs concerning nuclear medicine patients occur in the course of diagnostic procedures (70%). Most of these ESRs have no expected clinical consequences, in view of the activities injected. They result mainly from drug preparation or administration errors leading to injection of the wrong RPD or an inappropriate RPD activity (53% of the ESRs concerning patients, a figure that is stable compared with 2023). They result from organisational and human malfunctions, usually in high workload situations. Seven of these ESRs in 2024 concerned children and also resulted from preparation and injection errors. The other ESRs which occurred during diagnostic procedures are most often linked to an error in the examination requests, in the physician’s prescription or their treatment (16%) or a problem that arose during image acquisition (16%) (failure, incorrect protocol, etc.). One ESR received particular attention given the number of patients concerned (70) and led to the publication of an incident notification on the ASN website. It involved the delivery of higher- than-planned doses in scintigraphy examinations due to incorrect utilisation of the dose calibrator used to measure the activities to be injected into the patients. Contamination of a nuclear medicine department employee O n 20 December 2024, when a preparation technician was manipulating a syringe containing technetium-99m, the needle came off the syringe causing a few drops to be projected onto the technician’s arm resulting in cutaneous contamination. A contamination check and a decontamination procedure were implemented by the centre’s RPE-O. The dosimetric evaluation carried out considering the worst-case assumptions led to a dose exceeding one quarter of the maximum annual dose to the extremities for a worker. ASN therefore rated this event level 1 on the INES scale, as specified in the incident notification it published on its website. The centre’s analysis of the event enabled corrective actions to be defined (fitting all the syringes with special connectors, drafting of a procedure for treating a medical professional contaminated during the injection process, and systematic wearing of anti-spray protective glasses during injection), the implementation of which shall be verified by ASN during its inspections. GRAPH 9 Breakdown (in %) of ESRs in nuclear medicine in 2024 5% 3% Others 73% 68% Patients 5% 7% Workers 10% 13% Sources, waste, effluents 7% 9% Public In red: average of the number of ESRs notified during the 10 preceding years. ASN Report on the state of nuclear safety and radiation protection in France in 2024 231 Medical uses of ionising radiation 07 01 02 03 04 05 06 08 09 10 11 12 13 14 15 AP
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