ASN Report 2017

99 ASN report on the state of nuclear safety and radiation protection in France in 2017 Chapter 03  - Regulations With regard to the recovery of sources, Decree 2015-231 of 27th February 2015 concerning the management of used sealed sources, which came into force on 1st July 2015, introduced the necessary provisions to enable those in possession of sources to have the expired or end-of-life used sealed radioactive sources recovered not only by their initial supplier, but also by any other authorised supplier of radioactive sources or, as a final resort, by Andra. This modification aims to address the difficulties experienced by those in possession of sources when seeking to find the original suppliers and to take account of the cost of recovery and the monopoly situation enjoyed by certain suppliers. The conditions for the implementation and payment of the financial guarantees to be provided by the suppliers of radioactive sources are verified by ASN when it issues or renews the source distribution licenses. 2.2 Protection of persons exposed for medical purposes The radiation protection of persons exposed for medical purposes is built around two principles mentioned in 1° and 2° of Article L. 1333-1 of the Public Health Code respectively: justification of procedures and optimisation of exposure, under the responsibility of the practitioners prescribing medical imaging examinations entailing exposure to ionising radiation and the practitioners carrying out these procedures. These principles cover all the diagnostic and therapeutic applications of ionising radiation, including radiological examinations requested for screening, occupational health, sports medicine and forensic purposes. In medical imaging (see chapter 9), the final responsibility for exposure lies with the practitioners performing the exams. The rules applicable for the radiation protection of patients set out in the Public Health Code are different from those established for the protection of professionals, set out in the Labour Code, even if the competence of the physicians and professionals involved in delivering the dose must cover both domains. 2.2.1 Justification of practices A written exchange of information between the prescribing practitioner and the practitioner carrying out the procedure exposing the patient should provide justification of the benefit of the exposure for each procedure. This “individual” justification is required for each procedure. Articles R. 1333-52 and R. 1333-56 of the Public Health Code respectively require the publication of “prescription of routine procedures and examinations” guides (also called “indication guides”) and “performance of procedures” guides (called “procedure guides”). The decree under preparation introduces additional measures concerning the justification of categories of medical practices, called generic justification and based on the indication guides. Henceforth, these guides – proposed by the professionals – will be drawn up and distributed by the Minister responsible for Health (and no longer by ASN), given the possible links with the cost charged for the procedures. Handling a sealed source of gadolinium-153 used for activity meter quality controls. ASN inspection of Clémentville clinic, Montpellier, May 2017. FOCUS Justification of new medical practices If an innovative technology is used for radiotherapy, radio- surgery, diagnosis or fluoroscopy-guided interventional practices, or a new type of practice is carried out with an existing technology, the decree under preparation introduces special provisions to allow the collection and analysis of information concerning the expected benefits for the patient and the corresponding risks to be organised. If necessary, an ASN resolution could introduce specific requirements to ensure the radiation protection of patients, workers and the public. Information will be collected and analysed in accordance with the recommendations of professional best practices. The information and the corresponding analysis will be transmitted to the High Authority for Health and to ASN. These new provisions could also concern new radiopharmaceuticals which have received a license for release to market or for temporary utilisation and new implantable radioactive medical devices, provided that the radiation protection implications so warrant. ASN is tasked with setting up an “intelligence watch” on new practices and new technologies. This mission will be entrusted to a new Advisory Committee reporting to the ASN Director General. It should be in place in 2018.