A review of the inspections carried out over the 2019‑2023 period and covering all the departments reveals the following trends: ∙ The notification culture and the organisation for managing the reports are considered satisfactory for all the departments inspected in recent years, with ratings of 100% in 2021 and 2022, and 92% in 2023. ∙ The analysis, the defining of corrective actions and capitalising on them are considered satisfactory in two thirds of the departments, with a situation that is less satisfactory in 2023 (the rate has diminished over the last three years, from 87% in 2021 to 78% in 2022 and 69% in 2023). ∙ The assessment of corrective action effectiveness has been progressing since 2019. While only a quarter of the departments assessed the effectiveness of corrective actions in 2019, more than three quarters of the inspected centres did so in 2023. ∙ Most of the departments inspected over the period from 2019 to 2023 have a validation procedure for HDR treatments (ranging from two thirds to over three quarters of the centres). ∙ The authorisation process is being deployed, but there are still disparities between the medical and paramedical personnel, given that it is applied mostly for the paramedical staff. Maintenance and quality controls – The majority of the centres have an inventory of the MDs and a register for recording maintenance operations and quality controls. In the absence of regulatory baseline requirements for the quality controls of brachytherapy devices, the quality controls implemented are based on the recommendations of the manufacturers or learned societies. Guide of the European Society Radiation Oncology (ESTRO) Booklet No. 81 and Guide No. 36 of the French Society of Medical Physics (SFPM). Maintenance of the afterloaders (for HDR and PDR applications) – This is ensured by the manufacturers, particularly when replacing sources. The brachytherapy departments rely on these verifications to guarantee correct operation of the devices. The source activity is verified at each delivery, and verifications are also carried out on source removal. ASN notes that the verifications performed by the departments can sometimes prove insufficient when a new device is received, and draws attention to the need to clearly define these verifications taking into account the manufacturer’s requirements, particularly for HDR brachytherapy. As the doses delivered at each brachytherapy session are about 4 to 10 Gy, errors in treatment delivery can have serious consequences for the health of the patient. 2.2.3.6 Significant events in brachytherapy Eight ESRs concerning brachytherapy were reported in 2023 under criterion 2.1 (exposure of patients undergoing therapeutic treatment), all rated level 1 on the ASN‑SFRO scale. One ESR in brachytherapy rated level 1 on the ASN-SFRO scale concerned a cohort of patients (about one hundred) in three different healthcare facilities. The event was reported after the manufacturer gave notification of a roundoff error in the software leading to an imprecision in the space between the computed tomography slices imported for the dosimetric planning of the treatments. This event also led to a medical devices vigilance notification to the ANSM. This imprecision could have resulted in a dose error of about 5 to 10% on each brachytherapy treatment fraction in certain conditions of use. The manufacturer proposed corrective measures involving the software parameter settings. The analysis of these events underlines that the control of risks in brachytherapy must be based on appropriate quality controls and the implementation of organisational measures to better manage informing of the patient, the sources and emergency situations. Furthermore, one event concerns the potential exposure of workers linked to the contamination of tongs and a soaking tank by radium-224 during a brachytherapy procedure involving the temporary implantation of Alpha DaRT™ sources. The tongs used to implant the sources came into contact with the sources during their insertion into the tumour. On arrival in the hospitalisation sector at the end of the procedure, the tongs were placed in the disinfection tray instead of the decontamination tray. When the tray was checked, it was found to be contaminated. This event occurred in a context of incomplete risk mapping and an incomplete protocol, leading the personnel to underestimate the contamination risk, and poor management of discarded and reusable instruments. In brachytherapy, the inspections carried out in 2023 in nearly a quarter of the brachytherapy units, considered alongside those carried out over the 2019-2022 period, enabling all the departments to be covered, confirm that the radiation protection rules are properly applied. ASN does however find that the management of high-activity sealed sources is less satisfactory in 2023, with less than half the centres having put in place enhanced training in emergency situations and organised situation simulation exercises, particularly for the management of jammed source situations. The training effort for professionals in possession of a high-level source must be maintained and reinforced for certain centres. ASN observes that deployment of the new requirements concerning safeguarding access to high-activity sources, which came fully into force in 2022, continues to progress, in particular regarding measures to prevent unauthorised access to these sources. However, some centres are faced with difficulties when bringing into compliance necessitates major works. Furthermore, ASN underlines the importance of having an active events recording system so that malfunctions can be identified as rapidly as possible, equipment quality controls can be formalised, performed and recorded, while ensuring that these latter comply with professional standards and the manufacturer’s recommendations. Lastly, ASN underlines the challenges concerning resources and skills that must be met in the coming years in order to maintain the brachytherapy activity. SUMMARY 222 ASN Report on the state of nuclear safety and radiation protection in France in 2023 • 07 • Medical uses of ionising radiation
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