ASN Report 2018

Nuclear-based medical activities: the main risks ACTIVITIES PATIENTS MEDICAL PROFESSIONNELS 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 remote-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 On the basis of this classification, ASN considers that its oversight must focus in priority on external-beam radiotherapy, brachytherapy, nuclear medicine and fluoroscopy-guided interventional practices. As from 2018, ASN began implementing a new inspection strategy in the medical field based on systematic verifications of the regulatory provisions concerning radiation protection of the workers, the patients and the public. These verifications concern a limited number of inspection points, combined with indicators for conducting regional and national assessments. This approach is supplemented by deeper investigations focusing on specific themes defined on an annual or multi-year time frame. In view of the experimental nature of this new inspection strategy, the radiation protection situation in the medical environment has been assessed essentially on the basis of the indicators associated with the inspection points. 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 of the Labour Code). 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 technical decisions (see points 4, 5 and 6). 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 5211‑12 to R 5211‑24). The CE marking, which certifies conformity with these essential requirements, is mandatory. Additional requirements shall be issued in 2019 by Ministerial Order (currently under preparation). The radiopharmaceutical drugs (RPD) used in nuclear medicine are covered by a marketing authorisation (MA) delivered by ANSM (French Health Products Safety Agency) or by 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 (Art. R. 1333‑45 to R.1333‑80). The principles of justification of procedures and optimisation of the doses delivered are the basis of these regulations. However, contrary to the other applications of ionising radiation, the principle of dose limitation does not apply to patients due to the need to adapt the dose delivered to 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 . Through a decision subject to approval by Ministerial Order, ASN undertook as of 2017 to update and supplement the regulatory framework with specific provisions regarding optimisation, quality assurance, training and qualification. Table 1 ASN report on the state of nuclear safety and radiation protection in France in 2018  205 07 – MEDICAL USES OF IONISING RADIATION 07