In addition, a set of safety systems informs the operator of the machine operating status (exposure in progress or not) and switches off the beam in an emergency or if the door to the irradiation room is opened. The bunker with shielding baffle remains the reference insofar as it reduces the shielding required at the ventilation duct and electrical duct inlets and provides greater security in the event of failure of the door motorisation system or if anyone gets accidentally locked inside. However, if the space available to the licensee is limited, which compromises the installation of the accelerator, a smaller shielding baffle, or even none at all, can be envisaged under certain restrictive conditions. Furthermore, with the arrival of self-shielded MDs such as the ZAP-X®, the centres can envisage installation and operating conditions other than those existing in the radiotherapy and radiosurgery departments, subject to compliance with the same regulatory requirements in the two types of facility (see point 2.1.1). 5. In 2021, 214, 000 cancer patients were treated by radiotherapy by 4.3 million treatment sessions (source: INCa Observatory). 2.1.3 Radiation protection situation in external-beam radiotherapy The installed base of external-beam radiotherapy facilities in 2023 comprises 565 particle accelerators installed in 174 radiotherapy centres subject to ASN licensing (see Graph 1 above). More than 214,000 patients(5) are treated each year, which represents 4.3 million radiation sessions (in 2021). The French Radiotherapy Observatory (INCa), lists 901 radiotherapists (headcount in 2021). In 2023, ASN notes a upward trend in the number of radiotherapy department relocations in order to enlarge them and purchase new accelerators. ASN issued 121 licenses in 2023, which represents a 5% increase on 2022. These applications are either for new facilities (about 21%) 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 further increase in the coming years. GRAPH Breakdown, by ASN regional division, of the number of centres and external-beam radiotherapy accelerators inspected and the number of new licenses or license renewals issued by ASN in 2023 1 0 10 20 30 40 50 60 70 80 90 100 110 Strasbourg Division Paris Division Orléans Division Nantes Division Marseille Division Lyon Division Lille Division Dijon Division Châlons-enChampagne Division Caen Division Bordeaux Division Licensed centres Accelerators New licences or licence renewals ASN carried out two unannounced inspections concomitantly on 3 July 2023 in two radiotherapy centres of the Ramsay Santé group, the Iridis Clairval and the Beauregard centres in Marseille. The main purpose of these inspections was to check that the human resources present on the sites matched the required criteria for ensuring the treatments, particularly radiotherapists, medical physicists and radiographers at the console of each accelerator in each centre. Furthermore, given the particularity of the centres established on two geographically close sites enabling the medical professionals to move from one centre to the other, the work tasks qualification required by article 7 of ASN resolution 2021-DC-0708 was checked, as was the knowledge of the work environment. Further to these inspections, ASN made demands concerning in particular: • the measures taken to recruit radiographers and a health executive, and well as the mode of functioning of the department according to the number of radiotherapists and radiographers; • the training and qualification of the medical professionals in order to include the different irradiation techniques; • knowledge of the work environment and identification of the organisational particularities; • the methods of assessing newly recruited staff; • the analysis of certain recurrent malfunctions noted internally, and the methods of selecting adverse events that must undergo a systemic analysis. These unannounced inspections, which are part of ASN’s inspection arsenal, are a useful complement to the announced inspections for verifying compliance with certain regulatory requirements such as the presence of qualified medical professionals in sufficient numbers. The type of inspection also allows work situations to be observed over a limited period of time without entailing preparatory work for the licensee. ASN CARRIED OUT TWO UNANNOUNCED INSPECTIONS IN TWO RADIOTHERAPY CENTRES OF THE RAMSAY SANTÉ GROUP IN MARSEILLE 214 ASN Report on the state of nuclear safety and radiation protection in France in 2023 • 07 • Medical uses of ionising radiation
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