ASN Report 2020

3.3.1 Radiation protection of medical professionals The occupational radiation protection measures deployed in 2020 by the brachytherapy departments were considered satisfactory on the whole, even if these results must be put into perspective given the small number of inspections performed in 2020. Out of the 16 inspected centres possessing high-activity sources, 13 have put in place enhanced training in emergency situations and have organised simulated emergency situation exercises. ASN considers that these efforts must be continued to reinforce the radiation protection training of workers in cases where licenses to hold high-activity sources were delivered in 2020. 3.3.2 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, with one exception where the variations in medical physicist staff numbers led to the postponement of medical procedures. 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 2020 has shown that the majority of brachytherapy departments inspected have deployed the quality management system, with the support of the external-beam radiotherapy departments. The prospective risks analysis is considered satisfactory in only half of the centres inspected. Although some progress is noted with respect to 2019, the data collected concern fewer centres (a quarter of the centres compared with two-thirds in 2019). The effectiveness of the corrective actions put in place following adverse events is considered satisfactory in about 45% of the centres inspected, a result comparable with that of 2019. Progress is therefore still required in this respect. The prior validation of HDR brachytherapy treatments is formalised in 65% of the case, which is a significant improvement on 2019 (52%). While on the subject, ASN underlines the risks associated with the use of high-activity sealed sources (Graph 8). 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 an ANSM decision defining the baseline requirements for the quality controls of brachytherapy devices, the quality controls implemented result from the past practices and are based on the recommendations of the manufacturers or medical professionals. Maintenance of the HDR and PDR afterloaders is ensured by the manufacturers, particularly when the sources are replaced. The brachytherapy units rely on these verifications to guarantee correct operation of the devices. Verifications of source activity are also carried out at each source delivery and removal operation. 3.3.3 Management of sources Management of the brachytherapy sources is satisfactory. All the centres inspected record the tracking of source movements, transmit the source inventory to the IRSN and store the sources waiting to be loaded or collected in a suitable place. The Order of 29 November 2019 sets the obligations concerning the protection of ionising radiation sources and batches of radioactive sources of categories A, B, C and D against malicious acts The requirements concerning the protection barriers and their resistance time for category A, B and C sources shall be enforceable as from 1 July 2022. With the exception of just one centre inspected in 2020, the organisational structures in place enable the category of each source or batch of sources to be identified, which is an improve­ ment on 2019. However, the majority of the centres (92%) have still not issued the necessary authorisations to its personnel to access the high-activity sealed sources. Progress has been noted regarding the safeguarding of access to high-activity sources, with 44% of the centres inspected in 2020 having put in place appropriate measures to prevent unauthorised access to these sources. ASN nevertheless remains attentive to the progress still to be made and inspection of this obligation shall remain a priority in 2021 for the centres holding high-activity sealed sources. GRAPH 7 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 2020 Strasbourg Division Paris Division Orléans Division Nantes Division Marseille Division Lyon Division Lille Division Dijon Division Châlons-en- Champagne Division Caen Division Bordeaux Division 0 2 4 6 8 10 12 14 16 Licensed centres HDR centres Authorisations issued ASN Report on the state of nuclear safety and radiation protection in France in 2020 221 07 – MEDICAL USES OF IONISING RADIATION 07