Radiation protection technical verifications ASN notes that the verification programme for work equipment and radiation protection instrumentation is drawn up and implemented in 56% of the interventional imaging departments and 53% of the operating theatres. When nonconformities had been identified, they had been corrected or were in the course of being corrected on the date of inspection in 78% of the cases. 2.4.3.2 Radiation protection of patients Of the departments performing FGIPs inspected in 2024, 74% call upon a medical physicist and have a POPM describing the organisation for involving a medical physicist, whose duties and times of presence on site are defined according to the centre’s activities. This figure has remained relatively stable over the 2019-2024 period. Recourse to outside contractors for medical physics services continues to expand in private sector centres and public hospitals alike. The outsourcing of medical physics duties is largely delegated to special advisors who intervene on site as and when required. ASN points out that close collaboration between operators and the medical physicist and regular presence of the physicist in the departments lead to optimised use of the equipment, with the setting up of protocols adapted to the procedures, recording of delivered doses and evaluation with regard to the locally-defined dosimetric reference levels. ASN notes that the external medical physicists working under a service contract are rarely present on the sites, including when the presence of a medical physicist is required by the regulations, for example during medical device acceptance tests and the setting up of optimised protocols under article 10 of ASN resolution 2021-DC-0704 of 4 February 2021. The training of physicians in patient radiation protection is a recurring weak spot: about 15% of the operating theatres have trained all the physicians. The medical personnel in the interventional imaging departments medical are trained to a greater extent, with 38% of the departments having trained all their medical personnel, an improvement compared with 2023 (31%). Over the last five years, 60% of the interventional imaging departments on average have collected, analysed and optimised the doses. ASN notes a broadly stable situation in 2024, with 65% of the interventional imaging departments meeting these obligations compared with 69% of those inspected in 2023. On the other hand, only 36% of the operating theatres satisfied these optimisation requirements in 2024. ASN finds the same weakness in the application of the optimisation principle 11. Improving patient monitoring in interventional radiology and fluoroscopy-guided procedures – reducing the risk of deterministic effects of 21 May 2014. in setting machine parameters and optimising the protocols used. The training time for the medical staff is insufficient and the recurrent shortage of paramedical personnel does not facilitate the scheduling and following of training courses. Nevertheless, reference levels for the most common examinations are being developed locally more and more often. This approach makes it possible, among other things, to set alert levels for triggering appropriate medical monitoring of the patient according to the dose levels delivered to the patient. Patient dose archiving and analysis systems are also deployed and facilitate the development of these reference levels and the programming (or adaptation) of local alert levels per machine and by type of procedure. These systems are an asset for tracking the doses previously received by the patient and for patient monitoring, and they contribute to the optimisation of the dose delivered. ASN is regularly alerted by situations of noncompliance with the required qualifications in the operating theatre. The shortage of radiographers in operating theatres means that nurses are required to operate devices emitting ionising radiation under the responsibility of the physicians. ASN is also questioned about the scopes of intervention and the patient radiation protection training obligations of State-Registered Operating Theatre Nurses (SROTNs) and State-Registered Nurses (SRNs). ASN reiterates that devices emitting ionising radiation may only be operated by radiographers whose training in patient radiation protection is current and under the responsibility of a physician. With regard to SROTNs, they now have new prerogatives and can, under the responsibility of a surgeon, assist in certain interventional procedures (performed under mobile C-arm unit in the operating theatre, not requiring a protocol adjustment and delivering a dose of less than 10 grays per square centimetre – Gy/cm2 (Dose Area Product – DAP – at end of procedure) without being authorised to operate or set the parameters of the medical device. They must also have a specific work tasks qualification and be current in their patient radiation protection training (ASN resolution approving the patient radiation protection continuous training guide for SROTNs). With regard to SRNs, they can only operate devices emitting ionising radiation under the responsibility of a physician in the context of a cooperation protocol approved by the ARS in accordance with the Article of Act 2019-774 of 24 July 2019 on the organisation and transformation of the health system or under the provisions of Decrees 2019-678 of 28 June 2019 and 2024-954 of 23 October 2024 relative to the conditions of performance of certain professional procedures by nurses in the operating theatre. Patient monitoring if the skin exposure threshold defined by the HAS(11) is exceeded is formalised to a greater extent in the interventional imaging departments (81%) inspected in 2024 than in the operating theatres (65%); interventional imaging departments are more frequently concerned by procedures leading to such exposure levels than the operating theatres. Although the nonconformities detected during the external quality controls of the medical devices have been or are in the processing of being corrected, persistent situations of human resource shortages within several external quality control organisations have been reported. These difficulties have led to significant delays in the quality controls, sometimes compromising their regularity and effectiveness. Given this context, ASN calls for increased vigilance in order to guarantee the continuity and quality of these quality controls which are essential for patient safety and the correct functioning of the MDs. 2.4.3.3 Significant events notified in relation with fluoroscopy-guided interventional practices An events recording system is in place in more than 69% of the inspected sites performing FGIPs. In 2024, 32 significant events were notified (compared with 26 in 2023) and concern: ∙overexposures of patients (14 ESRs); ∙exposures of medical staff (12 ESRs); ∙one overexposure of patient and professionals (1 ESR); ∙exposure of foetuses in women unaware of their pregnancy at the time of the procedure (5 ESRs). ∙one malfunction of lighted signalling systems in an operating theatre (1 ESR). In two of these ESRs, the amplifiers generated radiation without any external input, triggering the untimely emission of X-rays. These two incidents lasted 6 seconds (s) and 20 s respectively, the first being stopped by activation of the emergency stop control, the second highlighting the failure of the safety mechanisms that are supposed to prevent such untimely activations. These events underline the need for an in-depth analysis of the technical causes and a tightened verification of the built-in safety systems in order to prevent the recurrence of these anomalies with potential harmful consequences for the radiation protection of staff and patients. The majority of patient overexposures are due to long and complex procedures (in interventional neuroradiology, urology, digestive tract surgery, fitting Implantable Venous Access Devices – IVAD, also called implanted ports). ASN Report on the state of nuclear safety and radiation protection in France in 2024 237 Medical uses of ionising radiation 07 01 02 03 04 05 06 08 09 10 11 12 13 14 15 AP
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