More than 200,000 patients(4) are treated each year, which represents nearly 4.2 million radiation sessions. The French radiotherapy observatory (French National Cancer Institute – INCa), lists 901 radiation oncologists in 2021. ASN issued 115 licenses in 2022, which represents a 35% increase on 2021. These applications are either for new facilities (about 15%) or changes of devices (accelerators or simulation scanners). As the installed base of accelerators is aging (age > 10 years) and can represent 20 to 30% of the base in certain regions, licence renewal applications could increase in the coming years. ASN moreover observes a rise in numbers of stereotactic treatments in radiotherapy departments across the country, with an increase in extra-cranial stereotactic indications (lung, liver, spine, bones, ENT). This activity presents radiation protection risks and requires skills of a high standard and greater control of the doses delivered. The safety of radiotherapy treatments has been a priority area of ASN oversight since 2007 on account of the high doses delivered to the patient. The inspection programme for the 2020‑2023 period places the emphasis on the ability of the centres to deploy a risk management approach. Skills management, the implementation of new techniques or practices and the mastery of the equipment are also examined in depth, depending on the centres. ASN has continued its graded approach to inspection: ∙ by reducing, in the light of the progress made in the control of treatment safety, the average frequency of inspections, which since 2020 has been reduced to once every four years (instead of the previous three-yearly frequency), enabling all the centres to be inspected every four years; ∙ by maintaining a higher frequency for the centres presenting vulnerabilities or risks, particularly for some centres having necessitated tightened inspections. ASN conducted 48 inspections in 2022, representing 25% of the French centres. Out of the 48 inspections, 9 were conducted in combined mode, that is to say both on site and remotely. This results from the experience acquired over the previous two years where inspections were conducted remotely on account of the Covid-19 pandemic. By analysing documents and general points at their desk, inspectors can devote more time when on site to visiting the facility and interviewing the personnel. 2.1.3.1 Radiation protection of external-beam radiotherapy professionals When the radiotherapy facilities are designed in accordance with the rules in force, the radiation protection risks for the medical staff are limited due to the protection provided by the facility. The results of the inspections conducted in 2022 reveal no difficulties in this sector: ∙ radiation protection advisors have been designated in all the centres inspected; ∙ all the radiation protection technical controls have been carried out at the required regulatory frequency. 2.1.3.2 Radiation protection of radiotherapy patients The assessment of the radiation protection of radiotherapy patients is based on the inspections focusing on implementation of the treatment quality and safety management system, made compulsory by ASN resolution 2021-DC-0708 of 6 April 2021. Since 2016, in the course of its inspections ASN verifies the adequacy of the human resources, and in particular the presence of the medical physicist and the internal organisation procedures 4. In 2020, 204,062 people with cancer were treated by radiotherapy in 4,093,819sessions (source: INCa Observatory). 5. Association of continuous training in oncology. for tracking and analysing adverse events – or malfunctions – recorded by the radiotherapy centres. A medical physicist is effectively present during the treatments in 100% of the inspected centres. All the centres have a medical physics organisation plan, but the quality of the plans varies from one centre to another. The ASN inspectors observe that the authorisation process is being deployed, but with disparities between the medical and paramedical personnel, given that it is applied to a greater extent for the paramedical staff. ASN was invited to give a presentation of ASN resolution 2021-DC-0708 of 6 April 2021 on personnel authorisation at a day event organised by the AFCOR(5) in September 2022. Furthermore, the analysis of compliance with regulatory requirements concerning the management of events over the 2018‑2022 shows that a constant proportion of departments complied with the regulations over the last 3 years, with significant disparities depending on the requirements concerned (see Graph 2): ∙ The detection of adverse events, their reporting (internally or to ASN) and their recording are deemed satisfactory on the whole, with rates varying between 80% and 88% over the period in question. ∙ The analysis of adverse events, the defining of corrective actions and building on the lessons learned, seem to be stabilising after an initial phase of progress, with about 74% of the inspected centres carrying out these steps satisfactorily over the period in question. ∙ The improvement in practices resulting from Incident Learning Systems (ILS’s) and assessing the effectiveness of the corrective actions still represent the weak spot of these events analysis procedures, with the percentage of satisfactory situations remaining stationary at between 27% and 36% for the 2018‑2022 period, with no dynamic for progress in this respect (see Graph 2). These procedures must involve representatives of all the staff contributing to the treatment of patients, but the lack of personnel availability, especially medical personnel, limits their effectiveness. Furthermore, regular assessment of the corrective actions implemented and updating of the prospective risks analysis on the basis of the lessons learned from the events reported internally, which is obligatory pursuant to the above-mentioned resolution 2021-DC-0708 of 6 April 2021, are vital in order to improve treatment quality and safety. In effect, the only way of testing the long-term robustness of the measures taken is to assess the corrective actions. The addition of check points, for example, can constitute a “false security” if they cannot be implemented by the professionals for various reasons. Moreover, the analysis of events can reveal that the safety barriers in place have not been effective, like those for ascertaining that the treatment has been delivered to the correct side, which should lead to a review of the prospective risk analysis and a team reflection to find more effective protection measures. The ability of a centre to deploy a risk management procedure was again subject to specific investigations in 2022. These investigations reveal that: ∙ Although the requirements for quality and safety management in radiotherapy departments are satisfied in the majority of cases, there are still disparities between centres. Thus, the prospective risk analysis is only complete or updated in half the inspected centres, mainly due to lack of training or resources, or to a change in the operational quality manager. ASN Report on the state of nuclear safety and radiation protection in France in 2022 215 • 07 • Medical uses of ionising radiation 07 01 08 13 AP 04 10 06 12 14 03 09 05 11 02
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