LES ACTIVITÉS NUCLÉAIRES : RAYONNEMENTS IONISANTS ET RISQUES POUR LA SANTÉ ET L’ENVIRONNEMENT make the discharging of patients having received a high activity (therapeutic application) conditional on a dose equivalent rate of about 20 microsieverts per hour (µSv/h) at a distance of 1 metre (in line with the recommendations of the GPRP in Medical Applications – October 2017. It is usually necessary to hospitalise the patient in a radiation-proof room while waiting for the activity to decay. The introduction of new RPDs will lead to the updating of the instructions for the family circle. The working group tasked with patient radiation protection (GTRPP) is working to establish recommendations for harmonising practices in nuclear medicine departments and the information to give to patients’ carers and family circle (see chapter 2). The conclusions of this work will be available in the first half of 2026. 1.2.4 – The environmental impact In nuclear medicine, the radioactive sources administered to the patients will undergo physical decay (period of time stemming from their physical-chemical properties) but also biological elimination (resulting from the biological metabolism, as with any medication). Patients having received an injection eliminate part of the administered radioactivity, mainly via the urinary tract. Nuclear medicine departments are designed and organised for the collection, storage and disposal of the radioactive waste and effluents produced in the facility, particularly the radionuclides contained in patients’ urine (see point 2.3.2), and are required to draw up an Effluents and Waste Management Plan (EWMP) detailing the collection, management and disposal arrangements. In addition, a discharge monitoring system must be put in place. The environmental impact of using ionising radiation for medical purposes is measured by the environmental radiological monitoring carried out by ASNR (see chapter 3). The measurement results are approximately equivalent to the natural background radiation. Radioactivity measurements in major rivers or wastewater treatment plants of large towns occasionally reveal the presence of artificial radionuclides used in nuclear medicine (iodine-131, for example; Assessment of the radiological condition of the French environment from 2021 to 2023). However, no trace of these radionuclides has been detected in water intended for human consumption (see chapter 1). Furthermore, the bibliographic study conducted by IRSN(4) in 2021 reveals a low radiological impact on the public of the radioactive discharges from nuclear medicine departments into the sewage systems (from its analysis of two French studies, IRSN estimates that the exposure of people living near wastewater treatment plants is less than 1 microsievert per year – μSv/year). 1.3 Regulations 1.3.1 – General regulations Protection of the personnel working in facilities that use ionising radiation for medical purposes is governed by the provisions of the Labour Code (Articles R. 4451‑1 to R. 4451‑146). In order to protect the public and the workers, the facilities that use Medical Devices (MDs) emitting ionising radiation must also satisfy the technical rules defined in the ASNR resolutions (see technical rules described in points 2.1.2, 2.2.2, 2.3.2, 2.4.2, 2.5.2 and 2.6.2 of this chapter). The monitoring of sources (radioactive sources including RPDs, devices emitting ionising radiation, particle accelerators) is subject to specific rules figuring in the Public Health Code (Articles R. 1333‑152 to R. 1333‑164). These rules concern the acquisition, distribution, import, export, sale, transfer, recovery and disposal of the sources. If the sources are not exempted, they must be notified, registered or licensed, depending on their nature. The sources are 4. IRSN Report No.2021‑00848 on the estimation of the impact on the public of effluents containing radionuclides coming from nuclear medicine departments and research laboratories. inventoried and then taken back when expired, and they can be subject to financial guarantees to ensure their recovery by the supplier. 1.3.2 – Radiopharmaceutical drugs and medical devices The radionuclides used in nuclear medicine can be classified in two categories: ∙the RadioPharmaceutical Drugs (RPDs), which like all medicinal drugs are subject to obtaining a Marketing Authorisation (MA), issued by either the National Agency for the Safety of Medicines and Health products (ANSM) or the European Medicines Agency (EMA) before they can be used in accordance with the manufacturer’s recommendations; ∙active implantable MDs (such as microspheres labelled with yttrium-90) also require their manufacturer to apply the “CE” marking in order to be placed on the market in the member states or parties to the agreement with the European Economic Community in application of Directive 90/385/EEC transposed into the French Public Health Code in Articles R. 5211-1 to R. 5211-74. Pending the obtaining of an MA, and to allow early access to medicines for patients suffering from serious or rare diseases, derogation processes have proliferated in France over the last twenty years. In order to simplify and harmonise these different processes, a reform of the access to medicines by derogation was implemented on 1 July 2021 (Decree 2021‑869 of 30 June 2021). This reform, which aims to “allow even faster access to these medicines for patients at a therapeutic dead-end”, replaces the six authorisation systems with two access pathways: compassionate access and early access. The MDs emitting ionising radiation (electrical X-ray generators, particle accelerators and yttrium-90-labelled microspheres) used in nuclear-based medical activities must meet the essential requirements defined in the Public Health Code (Articles R. 5211‑23 and R. 5211-23-1 for active implantable medical devices and R. 5211‑22 for other medical devices). The “CE” marking, which certifies conformity with these essential requirements, is mandatory. Further to technological developments, the Order of 15 March 2010 laying down the essential requirements applicable to MDs other than active implantable devices (microspheres labelled with yttrium-90), was amended on 4 October 2019 to reinforce the provisions concerning the display of the dose during imaging procedures. Furthermore, European regulation EU 2017/745 of 5 April 2017 came into force on 26 May 2021. It has been amended by European regulation EU 2023/607 of 15 March 2023 which prolongs temporary provisions. Due in particular to the effects of the Covid-19 pandemic on companies and the as yet small number of organisations notified under the above-mentioned regulation, these new provisions allow manufacturers who began a process for assessing the conformity of their MDs before 26 May 2024 under Regulation (EU) 2017/745 to continue, under certain conditions, putting these MDs on the market in accordance with Directive 90/385/EEC or Directive 93/42/EEC. The date beyond which it will no longer be possible to put on the market or put into service MDs emitting ionising radiation which do not comply with the above-mentioned directives is set at 31 December 2028 at the latest, with the exception more specifically of iodine-125 seeds used in brachytherapy and yttrium-90-labelled microspheres mentioned above which must comply with Regulation (EU) 2017/745 by 31 December 2027 at the latest. This new European regulation reinforces patient safety on the one hand through a better clinical assessment of the MDs, and transparency on the other, thanks to the European Database on Medical Devices (EUDAMED). This database is accessible to the manufacturers and the competent authorities responsible for ASNR Report on the state of nuclear safety and radiation protection in France in 2025 193 01 05 02 03 04 09 06 10 07 11 13 08 12 A / Z
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