ASN Report 2022

an incorrect atmospheric pressure value discovered during the machine quality controls. ASN had already alerted the centres to this type of error by circular letter of 19 May 2016, and drawn up recommendations for calibrating the treatment beams; ∙ an error in the computer modelling of the treatment table led to a position error situated at the head of the patient in the computerised dosimetric planning system; 134 patients were concerned. Most of the events reported in 2022 concern patient radiation protection, and the majority of them are not expected to have any clinical consequences. As in the preceding years, these events always highlight organisational weaknesses concerning: ∙ the management of movements of patients’ files; ∙ the validation steps, which are not explicit enough; ∙ the keeping of patients’ files in a manner that provides an overall view and gives access to the required information at the right time. Variations in practices within a given centre, frequent task interruptions, a high and uncontrolled workload affecting the length of working hours, or the deployment of a new technique or practice, all constitute situations that disrupt work activities and weaken the safety measures defined in the quality management system. It is therefore essential to assess these measures regularly and to draw lessons from the malfunctions that occur. ASN has noted a significant and regular drop in ESR notifications in radiotherapy since 2015 (see point 2.7 Graph 12). This drop can probably be partly attributed to the setting up of organisations that have rendered treatment preparation smoother and safer (complete dematerialisation with lists of “record and verify” tasks, harmonisation of medical protocols, delineation assistance software, automatic application of dosimetry shifts, monitoring of preparation times, etc.), and the integration of lessons learned from events. The setting up of audits to assess the performance of the radiotherapy treatment process (auditing of files, tracking times), observance of the identity monitoring rules or the effectiveness of an improvement measure can also explain this drop in ESR reporting, even if these procedures are still far from being widely implemented. However, at the same time the ASN inspectors observe a drop in the ESR reporting culture with a reduction in the number of internally recorded adverse events that are analysed (fewer feedback analysis committee meetings organised) and more analyses of superficial events but rarely investigating their root causes. The inspectors also note a lack of integration of the lessons learned from the analysis of reported events at national level and shortcomings in communication, which is top-down only in some centres. The drop in reported ESRs in radiotherapy is one of the themes of a seminar organised by ASN for 15 March 2023 entitled “Quality-safety approach in radiotherapy: what lessons have been learned after more than 15 years of application?” Among the adverse events declared in 2022 is a growing number of cyber attacks (3 radiotherapy centres, 1 in 2021 and 2 in 2022, and 1 nuclear medicine centre in 2022). These attacks paralyse the computer system and cause serious disruptions in the organisation of treatments. In view of the risks of reduced chances of success for patients whose treatments are interrupted or errors in treatment delivery due to potential data losses, these cyberattacks generate stress for the treatment teams and the patients alike. Although cyber security does not fall under the competence of ASN, these situations are nevertheless brought to ASN’s attention and form the subject of a report if they cause an ESR. These cyber attacks call into question current practices of “all-electronic” patient records. The SFRO has just initiated a reflection, in which ASN is involved, with the aim of issuing recommendations to anticipate and limit the risks associated with cyber attacks in a context of growing digitisation of data (relevance of keeping paper documents, reviewing backup procedures in the event of loss of digital data, etc.). GRAPH Percentage conformity of external-beam radiotherapy facilities in the management of events in 2022 2 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2022 2021 2020 2019 2018 Reporting culture and organisation Analysis, defining corrective actions, building on lessons learned Assessing corrective action effectiveness 218 ASN Report on the state of nuclear safety and radiation protection in France in 2022 • 07 • Medical uses of ionising radiation 07

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