Abstracts ASN Report 2019

׏ِ ב ِ א xƺƳǣƬƏǼ ƳƺɮǣƬƺɀ ƏȇƳ ȸƏƳǣȒȵǝƏȸȅƏƬƺɖɎǣƬƏǼɀ 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 ĸĴĿŇĻ łķĸ Ҏ ŅŇļĶĿĸņ ӈӅӄӄіӄӅׇŇł ӈӅӄӄіӅӇҏє Ļĸ ŀĴŅľļŁĺё which certifies conformity with these essential requirements, is ŀĴŁķĴŇłŅŌє ňŅŇĻĸŅ Ňł ŇĸĶĻŁłĿłĺļĶĴĿ ķĸʼnĸĿłŃŀĸŁŇņё ŇĻĸ ŅķĸŅ łĹ ӄӈׇ ĴŅĶĻ ӅӃӄӃׇĿĴŌļŁĺ ķłŊŁ ŇĻĸ ĸņņĸŁŇļĴĿ ŅĸńňļŅĸŀĸŁŇņ ĴŃŃĿļĶĴĵĿĸ to medical devices has been modified to reinforce the provisions concerning the display of the dose during imaging procedures. The RadioPharmaceutical Drugs (RPDs) used in nuclear medicine are covered by a Marketing Authorisation (MA) delivered ĵŌ ŅĸŁĶĻ ĸĴĿŇĻ ŅłķňĶŇņ ĴĹĸŇŌ ĺĸŁĶŌ Ҏ ҏ łŅ ĵŌ ŇĻĸ European Medicines Agency (EMA). Pending delivery of an MA, they can be granted a Temporary Authorisation for Use (ATU) ҂ŇĻĸ ŅĸŁĶĻ ʼnĸŅņļłŁ łĹ ĶłŀŃĴņņļłŁĴŇĸ ňņĸ҂ ŊĻļĶĻ ĶĴŁ ĵĸ ĹłŅ 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 Ҏ ŅŇļĶĿĸņ єׇӄӆӆӆіӄӈӅׇŇł єׇӄӆӆӆіӄӉӇҏє ׏ِ ב ِ « ב ƏƳǣƏɎǣȒȇ ȵȸȒɎƺƬɎǣȒȇ Ȓǔ ȵƏɎǣƺȇɎɀ Justification and optimisation – The protection of patients undergoing medical imaging examinations or therapeutic procedures using ionising radiation is regulated by specific ŃŅłʼnļņļłŁņ łĹ ŇĻĸ ňĵĿļĶ ĸĴĿŇĻ łķĸ Ҏ ŅŇļĶĿĸņ єׇӄӆӆӆіӇӈׇŇł єׇӄӆӆӆіӋӃҏє łŊĸʼnĸŅё ĶłŁŇŅĴŅŌ Ňł ŇĻĸ łŇĻĸŅ ĴŃŃĿļĶĴŇļłŁņ łĹ ionising radiation, the principle of dose limitation does not apply to patients because of the need to adapt –for each individual patient– the delivered dose 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 ĵŌ ŇĻĸ ŅĸŁĶĻ łĶļĸŇŌ łĹ ĴķļłĿłĺŌ Ҏ ҏ ĴŁķ ŇĻĸ ŅĸŁĶĻ łĶļĸŇŌ łĹ ňĶĿĸĴŅ ĸķļĶļŁĸ ĴŁķ łĿĸĶňĿĴŅ ŀĴĺļŁĺ Ҏ ҏ helps physicians to choose the most appropriate examination ӆє ŅĸņłĿňŇļłŁ ӅӃӄӋі іӃӉӇӌׇłĹ ӄӋׇ ĶŇłĵĸŅ ӅӃӄӋׇķĸĹļŁļŁĺё ļŁ ĴŃŃĿļĶĴŇļłŁ łĹ Ӆխ łĹ ŅŇļĶĿĸ єׇӄӆӆӆіӄӃӌׇĴŁķ ŅŇļĶĿĸ єׇӄӆӆӆіӄӄӃׇłĹ ŇĻĸ ňĵĿļĶ ĸĴĿŇĻ Code, the list of nuclear activities subject to the notification system and the information that must be indicated in these notifications. 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 ňŁķĸŅŇłłľ Ĵņ łĹ ӅӃӄӊׇŇł ňŃķĴŇĸ ĴŁķ ņňŃŃĿĸŀĸŁŇ ŇĻĸ ŅĸĺňĿĴŇłŅŌ framework with specific provisions regarding optimisation, quality assurance, training and qualification. ׏ِ ב ِ ג ƳȅǣȇǣɀɎȸƏɎǣɮƺ ȵȸȒƬƺƳɖȸƺɀ ĸĶŅĸĸ ӅӃӄӋіӇӆӇׇłĹ Ӈׇ ňŁĸ ӅӃӄӋׇļŁŇŅłķňĶļŁĺ ʼnĴŅļłňņ ŁňĶĿĸĴŅі related provisions has brought the clarifications necessary for the implementation of the new system of procedures applicable in ņŀĴĿĿіņĶĴĿĸ ŁňĶĿĸĴŅ ĴĶŇļʼnļŇļĸņ ļŁ ĴŃŃĿļĶĴŇļłŁ łĹ ŅŇļĶĿĸ єׇӄӆӆӆіӊׇłĹ the Public Health Code: a third system baptised “registration” (it is a “simplified” licensing system) may be put in place in addition to the notification and licensing systems that exist for certain activities. In view of the risks (Table 1), ASN has adopted the following changes: Ҋ The existing list of medical activities subject to notification ĻĴņ ĵĸĸŁ ŀĴļŁŇĴļŁĸķ ĵŌ ŅĸņłĿňŇļłŁ ӅӃӄӋі іӃӉӇӌׇłĹ ӄӋׇ ĶŇłĵĸŅ ӅӃӄӋ (3) , conventional radiology and dental radiology continue to be covered by the notification system. Ҋ The preparation of the conditions of application of the new registration system in the medical sector progressed well in ӅӃӄӌє Ň ņĻłňĿķ ĵĸ ĴŃŃĿļĸķ ļŁ ĶłŀŃňŇĸķ ŇłŀłĺŅĴŃĻŌ ĴŁķ Ňł fluoroscopy-guided interventional practices involving radiation exposure risks (in the meantime, these practices remain subject to simple notification). Ҋ The licensing system shall be maintained for external-beam radiotherapy, brachytherapy and diagnostic and therapeutic nuclear medicine. Á n0 ׏ ڙ Nuclear-based medical activities: the main 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 ژא ɎȒ ژב ƳƺȵƺȇƳǣȇǕ Ȓȇ the procedures ژא ɎȒ ژב ƳƺȵƺȇƳǣȇǕ Ȓȇ the procedures 1 Diagnostic nuclear medicine ׏ ژ ɎȒ ژא ƳƺȵƺȇƳǣȇǕ Ȓȇ the procedures ژא ɎȒ ژב ƳƺȵƺȇƳǣȇǕ Ȓȇ 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 ASN Report on the state of nuclear safety and radiation protection in France in 2019 203 ׎ ٲ ו MEDICAL USES OF IONISING RADIATION 07