2.3.3 Radiation protection situation in nuclear medicine The nuclear medicine facilities installed base in 2024 comprises 253 licensed nuclear medicine departments, of which 109 practice exclusively a diagnostic activity. Among the departments involved in therapy, 46 have the capacities to practice high-activity ITR requiring hospitalisation in a radiation-proof room, whereas the other departments practice exclusively ITR therapy in non-radiation-proof rooms, mainly on an out-patient basis, whether for treatments with moderate-activity iodine-131 or for certain treatments with lutetium-177. During 2024, 139 nuclear medicine licences were issued, including: equipment changes or commissioning (PET scanners in particular), increases in the activity of radioisotopes already used, license extensions to allow the use of new radionuclides, and licences to perform clinical studies with new RPDs (such as actinium-225 and holmium-166). ASN inspections in nuclear medicine are scheduled applying a graded approach that takes into account the breakdown of the types of procedures performed in the departments, with risks that differ depending on whether they concern diagnostic or therapeutic procedures. In this context, the inspection frequency is fiveyearly for departments that only perform diagnostic examinations, four-yearly for departments performing diagnostic examinations and out-patient therapeutic procedures (delivery of iodine with activities below 800 MBq, synoviortheses, etc.) and three-yearly for the departments performing complex therapies using iodine with delivered activities exceeding 800 MBq, lutetium-177, yttrium-90 (with hospitalisation in a room that may or may not be radiation-proof). This means that about a quarter of the national installed base is inspected each year. These frequencies will change as from 2025 to take into account the reform of healthcare licenses, which has separated nuclear medicine departments into two categories (level A and level B) on the basis of their risks. Consequently, level-B nuclear medicine departments will be inspected every three years whereas level-A departments will be inspected every five years (see point 1.3.3). With regard to the radiation protection risks, the ASN inspections focus on radiation protection of workers (organisation of radiation protection, delimiting restricted areas, ambient dosimetry, staff dosimetry) and patients (analysis of DRLs, quality control of medical devices, control of dispensing of RPDs,) and source management (circuit followed by unsealed sources, from delivery to disposal, such as the delivery reception premises, storage tanks and effluent discharges). In 2024, 69 nuclear medicine departments were inspected, representing 27% of the facilities. During these inspections the centres mentioned staffing problems, particularly with radiographers (recruitment difficulties, high turnover), and difficulties in recruiting practitioners in certain regions. The progressive reform of the healthcare licences also raises the question of whether there are enough radiopharmacists, as they must now assist the level-A nuclear medicine departments. Given the development of ITR, the number of medical physicists is also a focus of attention. ASN endeavours to question the centres about the adequacy of their resources, particularly when new projects are underway and in a context of increasing activity. ASN conducted inspections in 2024 with experts from IRSN using measuring equipment to check control of the contamination risk by the RNAs (see box previous page). 2.3.3.1 Radiation protection 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, gallium-68 or yttrium-90) when preparing and injecting RPDs, and a risk of internal exposure through accidental intake of radioactive substances. The inspections carried out in 2024 give mixed results regarding the way occupational radiation protection requirements are taken into account, compared with the previous years (see Graph 6). The monitoring and analysis of occupational exposures are stagnating in the inspected departments whereas progress was observed in the preceding years (77 % of the inspected departments comply with these measures as opposed to over 90% in the previous years). The other deviations observed concern deficiencies in the verification of the risk of atmospheric contamination or checks for contamination in areas adjacent to places in which radionuclides are handled, in the application of measures concerning the marking out of regulated zones in keeping with workplace verifications, and the verifications of work equipment and sealed sources. The distinct drop in conformity observed in the latter verifications in 2023 persists, with only 64% of the departments inspected being able to prove that the verifications were carried out at the required statutory frequency for the all the sources and equipment items. Furthermore, only 38% of the departments inspected had carried out compliance work further to the nonconformities found at the last verifications. Lastly, a recurrent area for improvement is still the coordination of the prevention measures with outside contractors, with only slightly more than one-third of the nuclear medicine departments having drawn up a prevention plan with all their outside contractors. On the other hand, the requirement to designate a Radiation Protection ExpertOfficer (RPE-O) dedicated to nuclear medicine is well respected (valid certificate issued by the employer in all the departments inspected), and the refreshing of radiation protection training of the medical professionals has distinctly improved in 2024 after the decline observed in the last few years (in 78 % of the departments inspected, the training of all the medical staff concerned dates back less than three years, compared with 59% in 2023). 2.3.3.2 Radiation protection of nuclear medicine patients The ASN inspectors note a clear improvement in the optimisation approach, with 82% of the departments deploying a complete DRL management system, compared with 68% in 2023 (see Graph 7), even if difficulties are still observed from time to time, to the extent that some departments have no optimisation approach whatsoever. Management of the third-party quality controls of MDs has returned to a satisfactory level following the regression observed in 2023, since 89% of the inspected departments had carried out the quality controls on all their MDs at the required regulatory frequency (see Graph 7). The organisation put in place to integrate medical physicists, identify their duties and quantify their time of presence on site is satisfactory in 80% of the departments (see Graph 7). This organisation can still be improved however in some departments inspected in 2024, where the Medical Physics Organisation Plan (POPM) is incomplete and the medical physics organisation described in the POPM is considered inadequate. Lastly, following the publication of two ASN resolutions 2019-DC-0660 and 2021-DC-0708, laying down the quality assurance obligations in medical imaging and for therapeutic procedures respectively, ASN notes a strong commitment and significant investment on the part of the medical departments in the deployment of the QMS’s. Deployment of the authorisation process is continuing, even if this year ASN still observes disparities between the medical and paramedical personnel, given that it is applied mostly for the paramedical staff. Although the events notification culture exists in a large proportion of the departments inspected, it must be improved and even reinforced, particularly regarding the analysis of events. ASN once again observed this year that ESRs had not been notified by some centres. ASN Report on the state of nuclear safety and radiation protection in France in 2024 229 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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