Two areas for improvement come back as a matter of course each year. The first concerns the updating of personnel training in occupational radiation protection (in 64 %, in 2022 of the departments all the staff concerned received their training less than three years ago), a requirements for which ASN notes a slight regression over the last two years. The second area for improvement, also recurrent, is the coordination of the prevention measures with outside contractors, with about one-third of the nuclear medicine departments having drawn up a prevention plan with all their outside contractors (35% in 2022). Alongside this, the radiation protection technical verifications were carried out at the required regulatory frequency for all the sources and devices in 86% of the departments inspected in 2022, a percentage that remains relatively constant from one year to the next. The same goes for the periodic verifications of radiation measurement and monitoring devices which are compliant in 87% of the departments inspected in 2022. 2.3.3.2 Radiation protection of nuclear medicine patients Since resolution 2019-DC-0667 of 18 April 2019 on the Diagnostic Reference Levels(6) came into effect, ASN assesses the new requirements concerning the quality of dose recording, analysis and optimisation, if this proves necessary. The inspections carried out show better results for the last two years with more than 70% of the departments implementing a complete optimisation process (see Graph 6). Only 12% of the departments in 2022 had not optimised their practices even though this was necessary (exposure levels significantly higher than the DRL). Management of the external quality controls of medical devices has also been improving steadily over the last few years. In 2022, 95% of the departments carried out the quality controls of all their medical devices at the required regulatory frequency, and the identified nonconformities have been remedied (see Graph 6). The organisation in place to allow the involvement of a medical physicist, identify their duties and quantify the time of presence on site is also found to be better defined in the last two years and deemed satisfactory in more than 80% of the departments (82% in 2022 – see Graph 6). However, in 10% of cases, the Medical Physics Organisation Plan (POPM) was incomplete and the medical physics organisation described in the POPM was considered inadequate in 2022. In 8% of the centres inspected, the medical physics resources were found inappropriate with regard to the risks associated with the activity, and tasks such as dose recording and analysis for the CT scanner were not carried out. Lastly, further to the publication of two ASN resolutions 2019-DC-660 and 2021-DC-0708 setting the quality assurance obligations in medical imaging and for therapeutic procedures respectively, ASN observes a high level of commitment and investment on the part of the medicine departments in the deployment of the quality management systems and notes that the events-reporting culture is present in the majority of the services inspected but must be further developed. 2.3.3.3 Protection of the public and the environment Compliance with the requirements concerning protection of the general public and the environment was checked in all the inspected centres. More than 90% of the departments (92% in 2022) have a dedicated and protected deliveries area (see Graph 7) that complies with the requirements of ASN resolution 2014-DC-0463 of 23 October 2014. About 20% the departments inspected each year (18% in 2022) have difficulties in meeting the regulatory 6. Order of 23 May 2019 approving ASN resolution 2019-DC-0667 of 18 April 2019 concerning the methods for evaluating ionising radiation doses delivered to patients during a radiology procedure, fluoroscopy-guided interventional or nuclear medicine practices, and the updating of the corresponding diagnostic reference levels. limits set for the activity concentration of effluents discharged after letting the effluents decay (10 becquerels per litre – Bq/L – for contaminated effluents after storage, or 100 Bq/L for effluents from the rooms of patients treated with iodine-131 - see Graph 7). Improvements have been observed these last two years in the verification of the storage tank leak detectors in the retention trays and in the formalising of checks, with more than 80% complying with the regulations (81 % in 2022). In 5% of the cases, documentation tracking (registers) must be improved; the frequencies defined in the EWMP are not observed and the traceability of checks is insufficient. Four departments inspected in 2022 were found deficient in the inspection of the leak detectors. Lastly, ASN notes an improvement over the last two years in the performance of the contamination checks at the end of therapeutic procedures when carried out outside the nuclear medicine departments; the checks are performed satisfactorily by 90% of the services inspected (96% in 2022). 2.3.3.4 Significant events reported in nuclear medicine Out of the 79 departments inspected, 73% have a system for recording adverse events. These latter departments analysed the events and reported them to ASN when necessary. However, 20% of the inspected departments had not reported their ESRs to ASN, primarily due to the personnel’s lack of awareness of events reporting (ESRs not recorded or not reported). After dropping for the last two years in succession, the number of ESRs reported in 2022 totalled 191, a figure that has been gradually increasing over the last 10 years. As in the preceding years, most of the reported events (>70%) concerned patients who had undergone a nuclear medicine procedure. The majority of the reported events have no expected clinical consequences, in view of the activities injected (see Graph 8). Significant events concerning patients (140 ESRs, or >70% 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, wrong activity injected) or identity monitoring errors (RPD administered to the wrong patient), and result from organisational and human malfunctions, usually in high workload situations. Although most of the departments have put in place events recording systems in application of ASN resolution 2019-DC-0660, the experience feedback procedures need to be improved in the large majority of the departments, particularly to further the analyses and to assess the robustness of the corrective actions. In 2022, 11 ESRs that occurred during therapeutic procedures were reported, five linked to complications associated with the use of yttrium-90 microspheres, the others concerning errors in the handling or injection of RPD (lutetium-177 and iodine-131). Significant events concerning medical professionals (10 ESRs, i.e. 5% of the reported ESRs) Ten events concerning nuclear medicine professionals were reported in 2022. They result from contaminations that led to internal exposures due to the malfunctioning of an extraction hood, and external exposures (surface contaminations as a result of handling errors or reception of a broken vial). One event concerned the irradiation of a radiographer when X-ray emission was triggered accidentally at the same time as the contrast agent was injected. 224 ASN Report on the state of nuclear safety and radiation protection in France in 2022 • 07 • Medical uses of ionising radiation 07
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