In addition, 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 laying down the minimum technical design rules to be satisfied by premises in which electrical devices emitting X-rays are used. Management of waste and effluents from nuclear medicine departments The management of waste and effluents potentially contaminated by radionuclides must be described in a management plan which includes, more specifically, the conditions of monitoring of discharged effluents in accordance with Article R. 1333‑16 of the Public Health Code and ASN resolution 2008-DC-0095 of 29 January 2008. 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 departments must be verified regularly. Revision of this resolution began at the end of 2020 and will also lead to an update of ASN Technical Guide No. 18 of 26 January 2012. One of the 15 recommendations of the Working Group report “Discharging of effluents containing radionuclides from nuclear medicine units and research laboratories into the sewage network” published in June 2019 on asn.fr introduces the notion of setting “contractual” or “management” guidance levels, if applicable, in the discharge license mentioned in Article L. 1331-10 of the Public Health Code. These guidance levels, whose value would be specific to each centre, are management levels which, in the event of a drift in the measurement results, must trigger an investigation and, if necessary, corrections in the centre’s effluents collection and disposal system. ASN has asked IRSN(6) to propose a measurement protocol and provide the centres with a method to use the results to define their own “local” guidance levels, which could figure in the discharge licenses between the centre producing these discharges and the sewage managers. IRSN submitted its reports(7) to ASN in 2023; the IRSN recommendations shall be analysed as part of the revision of ASN resolution 2008-DC-0095 of 29 January 2008. 2.3.3 Radiation protection situation in nuclear medicine The nuclear medicine facilities installed base in 2023 comprises 252 licensed nuclear medicine departments, of which 45 practice high-activity ITR requiring hospitalisation in a radiation-proof room and 134 practice moderate-activity ITR on an out-patient basis. One hundred forty-three nuclear medicine licences were issued during 2023, 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 6. Referral CODEP-DIS-2020-013834 – Request for expert assessment concerning the definition of a measurement protocol and a method of utilising the results in order to establish local guide levels for environmental discharges containing radionuclides coming from nuclear medicine departments and research laboratories. 7. IRSN Report No. 2023-00061 – Guide levels for the discharge of radionuclides concerning the defining of a measurement protocol and a method of utilising results in order to establish local guide levels for environmental discharges containing radionuclides coming from nuclear medicine departments: situation analysis and proposals. IRSN Report No. 2023-00241 – Guide levels for the discharge of radionuclides concerning the defining of a measurement protocol and a method of utilising results in order to establish local guide levels for environmental discharges containing radionuclides coming from research laboratories: situation analysis and proposals. that differ depending on whether they concern diagnostic or therapeutic procedures. In this context, the inspection frequency is five-yearly 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. 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 2023, 61 nuclear medicine departments were inspected, representing 24% 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, leading them to have recourse to telemedicine. 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. 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 in 2023 find that occupational radiation protection requirements are taken into account less well than in the preceding years (see Graph 6 next page). The observed deviations concern the appointing of a Radiation Protection Expert (RPE-O) dedicated to this activity (valid certificate issued by the employer in all the inspected departments), failures to verify the risk of atmospheric contamination or non-contamination of areas adjacent to rooms in which radionuclides are handled, application of the provisions concerning the delimiting of restricted areas consistently with the verifications of the work environments and the radiation protection technical controls. The latter verifications were carried at the required regulatory frequency for all the sources and devices in 62% of the departments inspected in 2023, a percentage that is significantly lower than in the preceding years. Furthermore, only 45% of the departments inspected had carried out compliance work further to the nonconformities found at the last verifications. However, nearly all of the departments inspected in 2023 monitor and analyse the dosimetric results of their staff. ASN Report on the state of nuclear safety and radiation protection in France in 2023 225 • 07 • Medical uses of ionising radiation 07 05 15 08 11 04 14 06 13 AP 03 10 02 09 12 01
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