The ESRs mainly concern women who were unaware of their pregnancy (113 notifications). A slight decrease in the number of ESR notifications has been observed since 2021 (from 147 ESRs in 2021 to 113 in 2024), when a specific “Patient safety” bulletin was produced and issued in order to improve the organisational measures to reduce the number of events. The analysis of the notified ESRs shows that checking for pregnancy when registering the appointment, checking-in and installing the patient can be further improved. The в-HCG level is not always assayed, and is sometimes incorrectly interpreted or not consulted. Urinary self-tests are little used. The other causes of ESRs are linked to shortcomings in the patient management process (errors in identity monitoring, in the anatomical region exploration protocol, in examination scheduling). Among the ESRs notified in 2024, one was particularly noteworthy in view of the size of the cohort of patients concerned nationally in several paediatric or neonatology departments (see box below). SUMMARY In CT, ASN’s oversight focuses essentially on compliance with the requirements of ASN resolution 2019-DC-660 of 15 January 2019, particularly concerning formalisation of the principle of justification and optimisation. The departments must still embrace the quality assurance procedures and the associated tools (formalisation of the justification and optimisation process, specific work tasks qualification, lessons learned from significant events, etc.). Efforts must also continue in the formalisation of the procedures by type of medical procedure, taking into account the persons at risk, and for the procedures performed remotely in the teleradiology context. The analysis of doses with regard to existing diagnostic reference levels and the procedures that are not subject to DRLs can be improved. ASN notes that teleradiology is progressing constantly with technical and organisational constraints linked to communication and consultation issues that are underestimated by the centres (software interfaces, communication problems) which are liable to foster the occurrence of ESRs if the service is not managed properly. In 2025, ASNR will publish the results of a study it has initiated on this subject in order to identify the radiation protection risks. 2.6 Human body product irradiators 2.6.1 Description The irradiation of products from the human body is used in particular to prevent post-transfusion reactions in blood-transfusion patients. The blood bag is irradiated with a dose of about 20 to 25 grays. Since 2009, irradiators with sources have been gradually replaced by X-ray generators which have been subject to notification to ASN since 2015. In 2023, the installed base of irradiators comprises 135 devices equipped with X-ray generators. 2.6.2 Technical rules applicable to facilities A blood product irradiator must be installed in a dedicated room designed to provide physical protection (against fire, flooding, break-in, etc.). Access to the device, which must have a lockable control console, is limited to the persons authorised to use it. The fitting out of premises accommodating irradiators equipped with X-ray generators must comply with the provisions of ASN resolution 2017-DC-0591 of 13 June 2017. 2.7 Significant radiation protection events The number of ESRs notified to ASN in the medical sector (827) in 2024 has risen by more than 20% compared with 2023 (655) (see Graph 13 next page). This significant increase is mainly accounted for by the number of ESRs notified in nuclear medicine. ASN reiterates the importance of notifying ESRs in order to establish shared learning from experience and improve radiation protection. Graphs 13 and 14 illustrate how the number of ESRs has evolved by activity category since 2010. Graphs 15 and 16 illustrate the breakdown of the number of ESRs in 2024 by area of exposure (environmental impact, exposure of the general public, exposure of patients, exposure of professionals) and by category of medical activity compared with the average number of ESRs over the preceding ten years. Accidental modification of exposure settings on a mobile radiology device During a dosimetric study of bedside X-ray examinations of infants hospitalised in the Bordeaux University Hospital, the medical physics team detected exposures higher than those expected for this type of examination and in November 2023 notified an ESR to ASN in accordance with the regulations in effect. This ESR was the subject of an incident notification published on the ASN website in January 2024. The retrospective analysis of these doses recorded by the Dose Archiving and Communication System (DACS) showed that a cohort of nearly 250 children was concerned between 2022 and 2023. The exposures, which represented a few tens of microsieverts, induce no clinical consequences and require no particular monitoring. They can be explained by the combination of a design particularity of the mobile radiology device (FDR Nano – Fujifilm) and inadequate knowledge of the steps for stopping and restarting this medical device. As a result, pulmonary X-ray constants for adults defined by the manufacturer (85 kilovolt – kV and 1,575 milliampere-seconds – mAs) are selected automatically by default whereas the operators thoughtthey were using paediatric X-ray constants. In effect, if the exposure conditions are defined while the tube power switch is in the off position, they are not transmitted and when the tube is switched on the default values take effect. If the correspondence of the exposure parameters between the “image” console and the “X-ray controller” is not verified, the X-ray image is taken using the default parameters defined by the manufacturer. The dose received during this X-ray exposure is therefore not the appropriate dose. In the wake of the Bordeaux hospital incident, more than ten other hospital centres informed ASN that they were in the same situation with a cohort of children who had received inappropriate doses. These serial events led ASN to produce an “Experience feedback”’ sheet through its WG on lessons learned in imaging. It aims to draw the attention of the centres to the particular way this device functions, to the possible adverse effects if the instructions are not observed and to recommend possible measures to take pending correction by the manufacturer. This sheet was sent to more than 200 healthcare facilities and was published on the ASN website on 22 April 2024. Moreover, the ANSM has urged the manufacturer to modify the device’s human-machine interface to prevent use of the default exposure parameters. The modifications were made in autumn 2024 and a new software version correcting this problem is currently being put in place in the entire French installed base. ASN Report on the state of nuclear safety and radiation protection in France in 2024 241 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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