ASN Report 2020

5. Fluoroscopy-Guided Interventional practices 5.1  Overview of the techniques and the equipment FGI practices group all the imaging techniques using ionising radiation to perform invasive medical or surgical procedures for diagnostic, preventive and/or therapeutic purposes, and surgical and medical procedures using ionising radiation for the purpose of guidance or verification. The equipment The equipment items used 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. 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 high-resolution spatial images. Practitioners can also use the subtraction method to obtain images, after injecting a contrast agent. Surgeons have recently started to use CT scanners, sometimes mobile or rail-mounted, in the operating theatre. This type of equipment helps the practitioner perform the procedure by providing multi-plane images allowing virtual navigation. These scanners however are not equipped with the latest dose-reduction technologies. The personnel most often work in the immediate proximity of the patient and are also exposed to higher dose levels than in other interventional practices. In these conditions, given the exposure risks for both the operator and the patient, practices must be optimised to reduce doses and ensure the radiation protection of operators and patients alike. The health care centres On the basis of the code of the common classification of medical procedures and the activity data reported by the health care centres to the Agency for Information on Hospital Care (AIHC), 903 centres performing FGI practices involving risks (with regard to radiation protection) in one or more disciplines have been inventoried. The distribution of the number of centres by category of Fluoroscopy-Guided Interventional practice is shown in Graph 12. In 2020, the ASN regional divisions issued 450 acknowledgements of notification of Fluoroscopy-Guided Interventional procedures. 5.2  Technical rules for the fitting out of medical rooms The rooms in which fluoroscopy-guided intervention procedures 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 mentioned in point 4.2. Few centres are compliant with this resolution because the signalling and safety systems are often absent; as for the technical reports, of those that do actually exist, many are incomplete. ASN has noted that interventional radiology departments comply with this resolution to a greater extent than operating theatres. 5.3  Radiation protection situation in Fluoroscopy-Guided Interventional practices For several years now, significant radiation protection events have been regularly reported to ASN in the area of FGI practices. Although these events represent just a small proportion of all the medical events reported to ASN, they most often have serious consequences with the occurrence of tissue damage (radiodermatitis, necrosis) in patients having under-gone particularly long and complex interventional procedures. In addition to these events, which underline the major radiation exposure risks for the patients, are those concerning professionals, whose exposure can lead to the exceeding of regulatory limits, particularly at the extremities (fingers). On account of the radiation exposure risks, ASN carries out a large number of inspections in this sector. In 2020, 144 centres representing 238 departments were inspected. These inspections were carried out in interventional imaging departments (rooms dedicated to interventional vascular and osteoarticular radiology, to neuroradiology and to cardiology) and in surgical departments (operating theatre) performing Fluoroscopy-Guided Interventional procedures. 55% of the inspections in 2020 were carried out in operating theatre departments. Fifty-nine centres were inspected entirely remotely and 15 by a remote inspection followed by a short on-site visit. Characteristics of the inspected departments 238 departments underwent an inspection, with the following breakdown: ∙ of the 131 operating theatre departments inspected in 2020, 121 had at least one mobile C-arm, 8 had fixed arms and 2 had a mobile CT scanner. To adapt to the departments’ organis­ ational constraints on account of the Covid‑19 pandemic, ASN inspected 53 departments entirely remotely and 17 by a remote inspection followed by a short on-site visit; ∙ the 107 interventional imaging departments inspected were broken down as follows: 37 cardiology – coronary angiography departments, 29 cardiology – rhythmology departments, 34 vascular and osteoarticular interventional radiology departments and 7 neuroradiology departments. Eighty-two had at least one fixed C-arm, 14 had mobile C-arms and 11 had fixed CT scanners; ∙ 42 departments were inspected entirely remotely and 23 by remote inspection followed by a short on-site visit. More than 76% of the inspected interventional imaging departments have fixed C-arms, whereas in the operating theatres the physicians mainly use mobile C-arms (92%) to guide their surgical procedures. Furthermore, operating theatres are being equipped with ever-more efficient and sophisticated medical devices. These are mobile CT scanners or fixed C-arms in “hybrid” rooms which combine the characteristics of a conventional surgical room with those of an interventional imaging room; this combination enables the surgeon to perform “mini-invasive” surgery with 2D and 3D imaging. Fixed CT scanners coupled to fixed C-arms are also beginning to be installed in health care centres. 5.3.1 Radiation protection of medical professionals In interventional imaging departments and in operating theatres The radiation protection of professionals is judged satisfactory, particularly with the appointing of a RPE-O in about 93% of the departments inspected and the implementation of radiological zoning in the facilities in 84% of the services inspected. For the remaining 7%, there is either no internal RPE-O or the external RPE-O is not present during the FGI procedures as required by ASN resolution 2009-DC-0147 of 16 July 2009. ASN Report on the state of nuclear safety and radiation protection in France in 2020 229 07 – MEDICAL USES OF IONISING RADIATION 07