2.2.3.2 Emergency situations and management of malfunctions Malfunctions of brachytherapy devices which can result in jams or incorrect positioning of the source can lead to overexposure –sometimes serious– of staff or patients (see point 2.2.3.5). Consequently, this type of event underlines the need to comply with the technical requirements concerning the use of these devices, and the obligations to provide training in emergency situation management and to conduct exercises. 2.2.3.3 Radiation protection of medical professionals The occupational radiation protection measures deployed in 2021 by the brachytherapy departments were considered satisfactory. Out of the 16 inspected centres possessing high-activity sources, 11 have put in place enhanced training in emergency situations and have organised situational exercises, particularly for managing situations linked to source jamming. ASN considers that these efforts must be continued in order to reinforce the radiation protection training of medical professionals where high-activity sources are held. 2.2.3.4 Radiation protection of patients As with external-beam radiotherapy, the radiation protection of brachytherapy patients is assessed from the inspections concerning the implementation of the treatment quality and safety management system. The presence of medical physicists in sufficient numbers for the activity was observed in all the centres inspected. A medical physics organisation plan is also available in all the centres inspected. The treatment quality and safety management system The qualitative result of the inspections carried out in 2021 has shown that the majority of brachytherapy departments inspected have deployed the quality management system, with the support of the external-beam radiotherapy departments. Maintenance and quality controls – The majority of the centres have an inventory of the medical devices 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 GRAPH Breakdown, by ASN regional division, of the number of brachytherapy centres, of high dose-rate brachytherapy centres and the number of new licenses or license renewals in 2021 3 Strasbourg Division Paris Division Orléans Division Nantes Division Marseille Division Lyon Division Lille Division Dijon Division Châlons-enChampagne Division Caen Division Bordeaux Division 0 2 4 6 8 10 12 14 16 Licensed centres HDR centres Authorisations issued DISCONNECTION OF AN APPLICATOR SOURCE TRANSFER TUBE On 5 August 2021, the Antoine Lacassagne Centre (Nice) reported an incident that occurred in its brachytherapy department to ASN. In January 2021, during the second HDR brachytherapy session, the medical staff detected a malfunction. It was reportedly linked to disconnection of the source transfer tube and the applicator. The source was reportedly ejected from the afterloader without reaching the target organ and remained in contact with the patient outside the treatment areas for several minutes, where a dose of between 150 and 200 grays (Gy) was reportedly administered. During a follow-up consultation of the patient in June 2021, the centre observed the presence of a lesion outside the treatment zone which could result from radiation necrosis (also called radionecrosis). The sequence of events was re-analysed and an ESR was reported to ASN. ASN conducted two inspections of the centre’s brachytherapy department, one on 10 August 2021, the other with the ARS on 2 September 2021. These inspections revealed several breaches of the regulations: no internal reporting of the incident, lack of internal communication on the malfunction, failure to report the ESR within 48 hours, staff shortages, inadequately formalised procedures, etc. This phenomenon of disconnection of the source transfer tube from the applicator, also identified as a malfunction of the medical device, was reported to the ANSM by the centre as a medical devices vigilance report. ASN moreover asked IRSN perform an expert assessment of the centre’s dosimetric reconstruction, which confirmed that the level of exposure of the skin is compatible with the onset of radiation necrosis. In view of the unintentional exposure of the patient having led to the onset of radiation necrosis, ASN rated the event level 3 on the ASN-SFRO scale. ASN Report on the state of nuclear safety and radiation protection in France in 2021 215 07 – MEDICAL USES OF IONISING RADIATIONS 08 07 13 04 10 06 12 14 03 09 05 11 02 AP 01
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