ASN Report 2020

Compliance with ASN resolution 2017-DC-0591 Facilities equipped with a CT scanner coupled with a gamma- camera or a PET camera must comply with the provisions of ASN resolution 2017-DC-0591 of 13 June 2017 (5) . Compliance with ASN resolution 2008-DC-0095 Like all facilities producing waste and effluents contaminated by radionuclides, they must comply with the provisions of ASN resolution 2008-DC-0095 of 29 January 2008 (6) . Premises must be dedicated to these activities, as must specific equipment for monitoring the conditions of effluent discharges (tank filling levels, leakage alarm systems, etc.). The compliance of the facilities for collecting the effluents and wastes produced by nuclear medicine units must be verified regularly (see point 4.3.3.). 4.3  Radiation protection situation in nuclear medicine 37 nuclear medicine departments, which represents 15% of the facilities, were inspected in 2020. As a result of the inspection adaptations due to the pandemic, 13 inspections were carried out remotely, including 5 which nevertheless included a short on-site visit. 4.3.1 Radiation protection conformity of nuclear medicine professionals From the radiological viewpoint, the personnel are subjected to a risk of external exposure – in particular on the fingers – due to the handling of certain radionuclides (case with fluorine-18, iodine-131 or yttrium-90) when preparing and injecting RPDs, and a risk of internal exposure through accidental intake of radioactive substances. The results concerning radiation protection of professionals (see Graph 10) show that the radiation protection measures implemented by nuclear medicine departments are generally satisfactory with regard to the appointing of a Radiation Protection Expert-Officer (RPE-O) dedicated to this activity (valid certificate issued by the employer in all the inspected departments), the analysis of the dosimetric results of the medical staff, and the consistency between the delimiting of restricted areas and the results of the working environment verifications. Two lines for improvement have nevertheless been identified, namely updating of personnel training (in 70% of the departments), all the staff concerned received this training less than three years ago, and coordination with outside contractors (only 24% of the departments have established coordination measures with all outside contractors and 32% with more than 50% of them). Alongside this, the radiation protection technical verifications have been carried out over the last two years at the regulatory frequency for all the sources and devices and for the radioactivity measuring and detection devices, in nearly 90% of the 37 depart­ ments inspected. Only two of the 22 departments concerned by nonconformities had not corrected them. 4.3.2 Radiation protection of nuclear medicine patients Since ASN resolution 2019-DC-0667 of 18 April 2019 on diagnostic reference levels (7) came into effect, ASN has been assessing the 5. ASN resolution 2017-DC-0591 of 13 June 2017 setting the minimum technical design rules to be met by premises in which X-ray emitting devices are used. 6. ASN resolution 2008-DC-0095 of 29 January 2008 setting the technical rules for the elimination of effluents and wastes which are or could be contaminated by radionuclides due to a nuclear activity, taken in application of the provisions of Article R. 1333‑12 of the Public Health Code. 7. 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. new requirements concerning the quality of collection of doses, their analysis and the optimisation put in place where necessary. The inspections carried out were satisfactory in 54% of the departments. However, 19% of the departments had not optimised their practices even though this was necessary. In four departments the requirements were only partially implemented. The external quality controls of the last two years have moreover been carried out on all the medical devices at the required regulatory frequency and the nonconformities discovered have been remedied in 92% of the departments. In two departments, not all the devices concerned had undergone the quality controls. The organisation put in place to integrate medical physicists and specify their duties and time of presence on site is only fully defined in 65% of the departments. In 35% of cases the medical physics organisation described in the Medical Physics Organisation Plan (POPM) was judged insufficient with regard to the risks the activity involves. 4.3.3 Protection of the general public and the environment Implementation of the requirements concerning protection of the public and the environment is judged acceptable in the majority of the inspected centres (see Graph 11). Thus, 87% des services have a dedicated and protected deliveries area that complies with the requirements of ASN resolution 2014- DC-0463 of 23 October 2014. In 90% of the departments the activity concentration of the effluents discharged after decay complies with the regulatory limits (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). Nevertheless, progress is expected: ∙ in non-nuclear medicine departments that use unsealed sources (19 such departments inspected in 2020), given that less than half of them carried out the non-contamination verifications required by the protocol at the end of therapeutic procedures; ∙ in the verification and traceability of the tank leak detector operating checks which are only fully ensured in 27 of the 37 departments inspected. 4.3.4 Significant events in nuclear medicine Out of the 37 departments inspected, 64% have a system for recording adverse events. These latter departments analysed the events and reported them to ASN when necessary. Six departments did not have an events recording system, and two had not reported any events. 132 ESRs were reported in 2020, a reduction of nearly a quarter compared with 2019. This drop is probably a consequence of the health crisis, which has led to a reduction in the number of examinations carried out. As in the preceding years, most of the reported events (70%) concerned the patients who had undergone a nuclear medicine procedure. The majority of the reported events have no expected clinical consequences. ASN Report on the state of nuclear safety and radiation protection in France in 2020 227 07 – MEDICAL USES OF IONISING RADIATION 07