ASN Report 2020

1.3.2 Medical devices and radiopharmaceuticals Medical devices 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 R. 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. The new European Regulation 2017/745 will enter into effect on 26 May 2021 and its implementation will extend until May 2027. It will concern implantable medical devices (such as the microspheres used in nuclear medicine). The RPDs used in nuclear medicine are covered by a Marketing Authorisation (MA) delivered by the French Health Products DIFFICULTIES ENCOUNTERED BY PERSONS/ENTITIES RESPONSIBLE FOR NUCLEAR ACTIVITIES IN APPLYING THE REGULATORY OBLIGATIONS Faced with a large number of difficulties, the persons/ entities responsible for nuclear activities were unable to meet all their regulatory obligations. ASN anticipated these difficulties as of March 2020. It worked with the learned societies (representing the radiotherapists, medical physicists and nuclear medicine physicians), the medical device manufacturers and maintenance companies, and the institutions (Ministry of Health, Ministry of Labour, the French Health Products Safety Agency – ANSM, the French High Council for Public Health – HCSP, and the French National Cancer Institute – INCa) to define the measures to take in the area of radiation protection. The various learned societies issued recommendations for adapting the organization of patient management that are compatible with the dual constraints of radiation protection and health aspects (grouping Covid‑19 patient appointments at the end of the day, management of the nuclear medicine department waiting room) and allowing for possible tensions due to a lack of medical staff (absence). For example, for the simplest radiotherapy treatments, the presence of three radiographers for two accelerators was tolerated, whereas the regulations require two radiographers per accelerator. Similarly, a collegial reflection was also conducted on medical device quality controls, defining the absolutely vital controls to perform in the interim period until it is possible to carry out all the required controls. Alongside this, in addition to the regulatory measures taken by the Government (Ordinance 2020-306 of 25 March 2020) which eased certain requirements concerning, for example, the deadlines imposed on those responsible for nuclear activities for performing certain checks or training in application of the Public Health Code or the Labour Code (radiation protection controls, radiation protection refresher training validity period), the ANSM issued information mentioning the possibility of adapting the frequency of the third-party quality controls, of internal and external audits and of internal controls. THE IMPACT OF COVID‑19 ADAPTATION OF METHODS OF INSPECTION IN HEALTH CARE CENTRES Nuclear activity licenses issued by ASN in the medical sector The Covid‑19 pandemic has obliged health care centres to adapt the organisation of patient management to be compatible with the twofold radiation protection and health constraints. The departments thus had to use equipment or premises under conditions not covered by the licenses to possess and use radioactive sources. For example, the Computed Tomography (CT) scanners of the nuclear medicine or radiotherapy departments were used for diagnostic purposes (chest scan in particular), in the management of patients suspected of being infected by Covid‑19. Similarly, the radiation- protected Internal Targeted Radiotherapy (ITR) rooms in nuclear medicine or even formerly Pulsed Dose-Rate (PDR) rooms in brachytherapy were used to accommodate Covid‑19 patients because they have the advantage of being single rooms and having air filtering systems suited to the viral risk insofar as they are under negative pressure. We can mention, for example, the validation by a radiologist and a medical physicist of the new use of a nuclear medicine or radiotherapy CT scanner for diagnostic purposes, or the reinforcement of room contamination verifications. Furthermore, the license application examination and issuing methods were adapted: reduction in the number of documents required when filing the application, in the license validity period and in the application examination time. It was thus possible to issue licenses to hold and use a CT scanner within 24 hours when circumstances so required. Inspections In order to continue its oversight while ensuring the safety of the ASN staff and the personnel met during the inspection, ASN defined new inspection methods as of April 2020. Depending on the situations of the centres, the inspections were conducted either on site in the conventional manner, or entirely remotely or through a combination of the two methods. The documents to be provided and the document verification points prior to the inspection were defined by adapting them to the nuclear activities (radiotherapy, Fluoroscopy-Guided Interventional (FGI) practices, nuclear medicine, Computed Tomography). The interchanges that are usually held on a face-to-face basis, such as the synthesis meetings, were organised by video conference. THE IMPACT OF COVID‑19 ASN Report on the state of nuclear safety and radiation protection in France in 2020 211 07 – MEDICAL USES OF IONISING RADIATION 07