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. 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). However, no trace of these radionuclides has been detected in water intended for human consumption (see chapter 1). 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 (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) 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 RPDs, 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 of 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. 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 es– sential 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. Moreover, the new European regulation EU 2017/745 entered into application on 26 May 2021 and its implementation extends until 27 May 2025 (date limit for putting on the market or commissioning MDs under the old regulation). This new European regulation reinforces patient safety, through a better clinical assessment of the MDs, and transparency, thanks to the European database on medical devices –Euramed), 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, RPDs 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 Committe for analysing new techniques and practices using ionising radiation. 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 risks and to produce recommendations and conclusions with regard to patient and worker radiation protection. Its first work, still in progress, focuses on intraoperative radiotherapy, the gyroscopic radiosurgery platform Zap-X (which obtained the “CE” marking in January 2021) and new radionuclides in nuclear medicine. 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 abovementioned 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 examination of submitted documents, but in limited number. Thus, since 1 July 2021, the ASN on-line services portal allows heads of nuclear activities to register their activities. The list of medical activities subject to registration has been defined on the basis of the radiation protection risks by ASN resolution 2021-DC0704 of 4 February 2021. This system is applicable to computed tomography and to FGIPs, activities with radiation protection risks. Conventional radiology and dental radiology will continue to come under the notification system. The licensing system is maintained for external-beam radiotherapy, brachytherapy and diagnostic and therapeutic nuclear medicine. 206 ASN Report on the state of nuclear safety and radiation protection in France in 2021 07 – MEDICAL USES OF IONISING RADIATIONS
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