Medical dispensaries On account of the ongoing reform of healthcare authorisations (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, 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 radio- active 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. 7. 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. 8. 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. 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-DC0591 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(7) 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 network administration managers. IRSN submitted its reports(8) 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 (see point 2.3.3.3). Inspections on the theme of contamination verifications Three inspections carried out in nuclear medicine departments during 2024 included a part dedicated to the verification of noncontamination using IRSN’s measuring means. The atmospheric and surface contamination measurements were taken using air samplers and contamination meters and by laboratory analysis of smear samples. The measurement and sampling points were determined by the IRSN experts based on the plans of the department and its activities on the day the measurements were taken. They concerned both key places in the department and measurement points in adjacent rooms (pre-injection waiting room, corridor in a non-restricted area, etc.). The first returns from these measurement campaigns indicate generally good control of the contamination risk in the departments inspected. The analysis reports are then communicated to the RNA so that they can be taken into account when defining measurement points that will be subject to statutory verifications. This initiative will be applied in several other nuclear medicine departments in 2025. 228 ASN Report on the state of nuclear safety and radiation protection in France in 2024 Medical uses of ionising radiation
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