ASN Report 2020

Safety Agency (ANSM) or by the European Medicines Agency (EMA). Pending delivery of an MA, they can be granted a Temporary Authorisation for Use (ATU) – the French version of compassionate use – which can be for named patients or cohorts. 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). 1.3.3 Radiation protection of patients Justification and optimisation – The protection of patients undergoing medical imaging examinations or therapeutic procedures using ionising radiation is regulated by specific provisions of the Public Health Code (Articles R. 1333‑45 to R. 1333‑80). The principles of justification of the procedures and optimisation of the delivered doses constitute the cornerstone of this regulation. However, contrary to the other applications of ionising radiation, the principle of dose limitation does not apply to patients, because of the need to adapt the delivered dose for each individual patient according to the therapeutic objective or to obtain an image of adequate quality to make the diagnosis. The Guide to Good Medical Imaging Examination Practices produced by the French Society of Radiology (SFR) and the French Society of Nuclear Medicine and Molecular Imaging (SFMN) helps physicians to choose the most appropriate examination according to the symptomatology, the suggested diagnoses and the patient’s medical history. It takes into account the proof of the level of diagnostic performance of the examinations in each of the situations (analysis of international publications), whether the examination involves radiation or not, and if so, the corresponding doses. No technique is universal; a technique that gives good results for one organ or function of that organ may be less effective for another organ, and vice versa . ASN continues to update, and if necessary supplement, the regulatory framework with specific provisions regarding optimisation, quality assurance, training and qualification. 1.3.4 Administrative procedures Decree 2018-434 of 4 June 2018 provided the details necessary for implementation of the new system of procedures applicable to small-scale nuclear activities: in application of Article L. 1333-7 of the Public Health Code, a third and “simplified” authorisation system called “registration” will be put in place as of 2021, in addition to the existing notification and licensing systems. The list of medical activities subject to registration has been defined on the basis of the radiation exposure risks (Table 1) by ASN resolution 2008-DC-0103 of 1 July 2008. This system will thus be applied to computed tomography and FGI practices, activities involving radiation exposure risks. Conventional radiology and dental radiology will continue to come under the notification system. The licensing system shall be maintained for external- beam radiotherapy, brachytherapy and diagnostic and therapeutic nuclear medicine. TABLE 2 Regulatory work in progress in the area of patient radiation protection EXISTING TEXT WORK IN PROGRESS Quality assurance in radiotherapy Resolution 2008-DC-0103 of 1 July 2008 Undergoing updating revision Qualif ications of physicians or dental surgeons who performprocedures using ionising radiation for medical or research purposes involving humans, to the qualif ications required to be designated coordinating physician of a nuclear activity for medical purposes or to request a license or registration as a physical entity Resolution 2020-DC-0694 of 8 October 2020 Undergoing approval List of medical activities usingmedical devices emitting ionising radiation subject to the registration system and the requirements relative to these activities Resolution 2021-DC-0704 of 4 February 2021 Undergoing approval TABLE 1 Classification of nuclear-based medical activities according to the radiation exposure risks ACTIVITIES PATIENTS MEDICAL PROFESSIONALS PUBLIC AND ENVIRONMENT External-beam radiotherapy 3 1 1 Brachytherapy 2 2 2 Internal targeted radiotherapy 3 2 3 Fluoroscopy-guided interventional practices 2 to 3 depending on the procedures 2 to 3 depending on the procedures 1 Diagnostic nuclear medicine 1 to 2 depending on the procedures 2 to 3 depending on the procedures 2 Computed Tomography 2 1 1 Fluoroscopy-guided procedures on remotely-controlled table in radiology department 1 1 1 Conventional radiology 1 1 1 Dental radiology 1 1 1 1: no risk or low risk – 2: moderate risk – 3: high risk 212 ASN Report on the state of nuclear safety and radiation protection in France in 2020 07 – MEDICAL USES OF IONISING RADIATION