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 ensured by IRSN (chapter 3). The environmental gamma radiation does not reveal any exposure exceeding the 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 state of the French environment from 2018 to 2020). However, no trace of these radionuclides has been detected in water intended for human consumption (see chapter 1). Furthermore, the bibliographical study conducted by IRSN(3) in 2021 reveals that the estimated radiological impact on the population of radioactive discharges from nuclear medicine departments into sewage systems is low (doses evaluated at below 1 μSv/year for people living in the vicinity of wastewater treatment plants). 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. 4451‑135). In order to protect the public and the workers, the facilities that use medical devices emitting ionising radiation must also satisfy the technical rules defined in the ASN resolutions (see technical rules described in point 2). The monitoring of sources (radioactive sources including RadioPharmaceutical Drugs (RPD), 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) which concern the acquisition, distribution, import, export, sale, transfer and recovery and disposal of the sources. More specifically, the sources must be declared, registered or licensed if they are not exempted, they must be inventoried, recovered when expired/disused, and be subject to financial guarantees of recovery. 1.3.2 Medical devices and radiopharmaceuticals The radionuclides used in nuclear medicine can be classified in two categories: ∙ the RPD, subject to obtaining a Marketing Authorisation (MA), issued by either the French Health Products Safety Agency (ANSM) or the European Medicines Agency (EMA); ∙ medical devices, which are required to obtain the “CE” marking (for example, implantable medical devices, such as microspheres marked with yttrium-90). 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 by two conditions of access, namely compassionate access and early access. 3. 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. Medical Devices (MD) emitting ionising radiation (electrical devices and particle accelerators) used in nuclear-based medical activities must meet the essential requirements defined in the Public Health Code (Articles 5211‑12 to R 5211‑24). 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 medical devices has been modified to reinforce the provisions concerning the display of the dose during imaging procedures. In addition, the new European regulation EU 2017/745 entered into application on 26 May 2021 and its implementation is planned for 2028. This new European regulation reinforces patient safety, through a better clinical assessment of the MDs, and improves transparency, thanks to the European Database on Medical Devices – EUDAMED), also accessible to the general public, which helps to improve collaboration between the competent European authorities. To facilitate early access of patients to innovative and useful technologies which do not yet have the “CE” marking, the French National Authority for Health (HAS) has instituted an “innovation pass”, conditional on the deployment of a clinical study to confirm the substantial health benefit of the new technology. The clinical assessments conducted for putting onto the market MDs, RPD or derogation processes allowing patients to receive an innovative treatment are determining factors in the application of the justification principle (see point 1.3.4). On 8 July 2019, in order to plan ahead for the radiation protection risks associated with the introduction of new techniques and emerging practices using ionising radiation, ASN created “Canpri”, a Committee for analysing new techniques and practices using ionising radiation (see chapter 2). Chaired by ASN and comprising 16 experts and representatives of French health institutions, Canpri’s aim is to identify new techniques and practices in the medical field, analyse their radiation protection implications and to produce recommendations and conclusions with regard to patient and worker radiation protection. Its work focuses on intraoperative radiotherapy, the ZAP-X® gyroscopic platform for stereotactic intracranial radiotherapy and radiosurgery, the new radionuclides in nuclear medicine and Flash therapies. The Canpri will issue its first opinion, which will concern the ZAP-X®. gyroscopic platform, in 2023. 1.3.3 Administrative system As part of the recasting of the classification of the different nuclear activities introduced by Decree 2018-434 of 4 June 2018 stipulating diverse provisions in the nuclear field, ASN wanted to implement a more graded and proportionate approach to the risks. Three authorisation systems are now in place, namely licensing, notification and, since 1 July 2021, a simplified system called “registration”. Notification is a simple procedure which does not require the submission of any supporting documents. It is particularly suited to the nuclear activities that present the lowest risks for people, patients and the environment. Licensing serves to regulate the activities presenting the greatest risks, for which ASN checks, when examining the application file, that these risks have effectively been identified by the applicant and that the barriers intended to mitigate their effects are appropriate. Registration also involves the submission of documents for examination, but fewer in number. Thus, since 1 July 2021, the ASN On-line services portal allows persons/entities responsible for nuclear activities to register their 210 ASN Report on the state of nuclear safety and radiation protection in France in 2022 • 07 • Medical uses of ionising radiation 07
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