ITR treatments can be administered either by mouth (e.g. capsule of iodine-131) or by systemic route (intravenous injection or via a catheter). Some treatments – depending on the administered activity or the nature of the radionuclide used – require patients to be hospitalised for several days in specially fitted-out rooms in the nuclear medicine department to ensure the radiation protection of the personnel, of people visiting the patients and of the environment. The radiological protection of these rooms is adapted to the nature of the radiation emitted by the radionuclides, and the contaminated urine of the patients is collected in tanks. Forty-five nuclear medicine departments have a combined total of 170 ITR rooms for therapeutic purposes (see Graph 5 above). Until recently, ITR was a minority technique among the therapeutic strategies in cancerology, but today it is undergoing an increasing number of clinical tests, particularly in oncology. It raises many questions regarding radiation protection of the patients, their family circle and the medical staff, as well as the fitting out of nuclear medicine departments and the management of waste and effluents. The use of these new treatments therefore necessitates deeper knowledge of the specific radiation protection issues, as from the clinical research phase. For this reason, in 2023 ASN referred the matter to the GPRP, initiated discussions with the nuclear medicine actors and became involved in the European SimpleRad project (Study on the implementation of Euratom and EU legal bases with respect to the therapeutic uses of radiopharmaceuticals) which aims to improve the understanding of the links and interdependencies between the European pharmaceutical legislation and the Euratom requirements with regard to radiation protection. Medical dispensaries On account of the ongoing reform of healthcare licences (see point 2.3), the authorisation for level A holders requires that a radiopharmacist be attached to the medical dispensary if the nuclear medicine department is located in a site that has a dispensary. For the holders of level B, the radiopharmacist duties are ensured and 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 non-profit 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, which came into effect 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 marked 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. GRAPH Overview of the national nuclear medicine base in 2023 5 0 10 20 30 40 50 60 Strasbourg Division Paris Division Orléans Division Nantes Division Marseille Division Lyon Division Lille Division Division Dijon Châlons-enChampagne Division Caen Division Bordeaux Division Licensed centres Departments with out-patient therapies Departments with therapies with hospitalisation and ITR rooms ITR rooms 224 ASN Report on the state of nuclear safety and radiation protection in France in 2023 • 07 • Medical uses of ionising radiation
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