LES ACTIVITÉS NUCLÉAIRES : RAYONNEMENTS IONISANTS ET RISQUES POUR LA SANTÉ ET L’ENVIRONNEMENT organised within the medical dispensary of the site and the RPD preparation room within the nuclear medicine department, called the “nuclear pharmacy”, forms part of the medical dispensary. In 2020, there were 105 nuclear pharmacies in the nuclear medicine departments in public healthcare institutions and nonprofit private healthcare institutions, such as the cancer centres. The radiopharmacist is primarily responsible for managing the RPD circuit (procurement, possession, preparation, control, dispensing and traceability) and the quality of preparation. The ANSM published a guide to Good preparation practices on 20 September 2023, replacing the guide dating from 2007. The equipment In addition to the cameras installed in the nuclear medicine departments, radiation-proof enclosures are installed in the departments to permit safe handling of unsealed sources. Automated or semi-automated devices are also used in the preparation and injection of RPDs labelled with fluorine-18 and gallium-68. 2.3.2 – Technical rules applicable to nuclear medicine facilities The radiation protection constraints specific to nuclear medicine are linked to the use of radionuclides in unsealed sources. The departments are designed and organised for the reception, storage and handling of these unsealed radioactive sources with a view to their administration to patients or in the laboratory (in the case of radioimmunology). Provision is also made for the collection, storage and disposal of radioactive wastes and effluents produced in the facility, particularly the radionuclides contained in patients’ urine. Compliance with the technical design, operating and maintenance rules of nuclear medicine departments Nuclear medicine departments must satisfy the rules prescribed by ASN resolution 2014-DC-0463 of 23 October 2014 relative to the minimum technical rules of design, operation and maintenance to be satisfied by in vivo nuclear medicine facilities. This resolution details in particular the rules for the ventilation of nuclear medicine department premises and the rooms accommodating patients receiving, for example, treatment for thyroid cancer with iodine-131. Guide No. 32 detailing certain aspects of this resolution was published by ASN in May 2017 and was updated in February 2020. 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. This work takes into account regulatory changes, the results of studies carried out and working groups set up since that time, as well as OEF from waste and effluent inspections. 2.3.3 – Radiation protection situation in nuclear medicine The nuclear medicine facilities installed base in 2025 comprises 254 licensed nuclear medicine departments, of which 118 practice exclusively a diagnostic activity. Among the departments involved in therapy, 42 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 2025, 139 nuclear medicine licences were issued, including equipment changes or commissioning (PET scanners in particular), increases in the activity of radioisotopes already used, licence extensions to allow the use of new radionuclides, and licences to perform clinical studies with new RPDs (mainly actinium-225). ASNR 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 Bordeaux Caen Châlons-enChampagne Dijon Lille Lyon Marseille Nantes Orléans Paris Strasbourg 0 10 20 30 40 50 60 31 27 17 5 13 9 3 3 1 2 4 8 6 9 7 16 31 3 26 31 28 10 6 6 13 7 11 5 1 13 4 3 11 2 1 22 23 21 3 8 14 7 57 19 7 Licensed centres Departments with out-patient therapies Departments with therapies with hospitalisation in ITR rooms ITR rooms GRAPH 5 Overview of the national nuclear medicine base in 2025 208 ASNR Report on the state of nuclear safety and radiation protection in France in 2025
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