ASN Annual report 2024

having declared the FGIPs(10) they practice. Based on available information, the most widely practised procedures in the centres are those performed on the digestive and visceral system, in urology, and on the musculoskeletal system (some 450 centres concerned). The equipment The equipment items used in FGIPs are either fixed C-arm devices installed in the interventional imaging departments in which vascular specialities (neuroradiology, cardiology, etc.) are carried out, or mobile C-arm radiology devices used chiefly in operating theatres in several surgical specialities such as vascular surgery, gastroenterology, orthopaedics and urology. More and more medical techniques are using the characteristics of these mobile C-arm radiology devices to guarantee the patients an optimal treatment offering. To give an example, a mobile C-arm radiology device coupled with a shock wave generator can be used in the operating theatre to perform “lithotripsy”, a procedure which breaks up kidney stones into small fragments which can then be eliminated naturally via the urinary system. The detectors present on the devices with C-arms are image intensifiers or flat panel detectors. These devices employ techniques that use fluoroscopy and dynamic radiography (called “photofluorography”, or “cineradiography”) intended to produce images with high spatial and temporal resolution. Practitioners can also use the subtraction method to obtain images, after injecting a contrast agent. A growing number of manufacturers are developing new innovative technologies with increasing use of Artificial Intelligence (AI). The 10. Form that the centres had to fill out with the information requested in paragraph I of article 12 of ASN resolution 2021-DC-0704 relative to the registration system in the medical field «For fluoroscopy-guided interventional practices having been notified to ASN, a description of the types of procedures performed in accordance with the list figuring in article 1 (of the resolution), and the references of the notification concerned, must be submitted within twelve months following entry into effect of this resolution (before 1 July 2022). centres practising FGIPs are equipped with ever-more efficient and sophisticated medical devices. “Hybrid” operating room facilities, which combine the characteristics of a conventional operating theatre with those of an interventional imaging room, are continuing to develop. These operating rooms contain fixed or mobile C-arm units and fixed or mobile scanners. This combination enables the surgeon to perform “mini-invasive” surgery with 2D and 3D imaging. Given that the delivered dose levels are higher than in other interventional procedures, practices must be optimised in order to reduce the exposure doses for both the patients and the operators, who often work in the immediate proximity of the patient. ASN also observes the use of CBCT devices in the departments performing FGIPs. 2.4.2 Technical rules for the fitting out of medical rooms The rooms in which FGIPS are carried out, operating theatres and interventional imaging rooms, must be organised in accordance with the provisions of ASN resolution 2017-DC-0591 of 13 June 2017 laying down the technical design rules to be satisfied by rooms in which electrical devices emitting X-rays are used. The design rules for the rooms, set by the above resolution, aim to protect the workers by limiting their exposure to ionising radiation. The arrangements must make it possible for any member of personnel entering a room in which an electrical device emitting X-rays is present and used, to assess the risk in order to take appropriate radiation protection measures on entering or when inside the room. With regard to signalling systems, they are obligatory at the point of access to the operating rooms and inside the rooms when a device is present and to signal the emission of radiation. It is important to point out that many medical and non-medical staff members intervene in the operating theatre. Simple and practicable instructions must be favoured in a context of multiple risks and a complex environment. The signalling systems moreover count among the most effective prevention measures, as does the wearing of appropriate personal protective equipment and dosimeters by each operator, from the moment a restricted area is delimited due to the risk of exposure to ionising radiation. Some centres are equipped with operating halls that constitute technical platforms allowing procedures to be performed simultaneously with the sharing of certain members of staff. Compliance with the regulatory requirements, particularly those concerning signalling, can be more complicated in these halls. 2.4.3 Radiation protection situation in fluoroscopy-guided interventional practices For some years now ASN has been receiving regular reports on ESRs in the area of FGIPs, but their number remains low for the number of procedures performed. In the course of its inspections, ASN still finds that the medical professionals lack knowledge of the criteria for reporting significant events, even though the doses administered in some centres are high and sometimes exceed the dose 0 100 200 300 400 500 600 700 800 900 1,000 Other FGIPs FGIP on the musculoskeletal system FGIP in urology FGIP in visceral or digestive system FGIP in vascular domain FGIP in cardio-rhythmology FGIP in cardio-coronary FGIP on the spine Intracranial FGIP 238 361 435 513 89 383 171 488 978 GRAPH 10 Breakdown of the number of centres by category of fluoroscopy-guided interventional practices in 2024 234 ASN Report on the state of nuclear safety and radiation protection in France in 2024 Medical uses of ionising radiation

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