Although the RNAs are given advance notice of the majority of routine inspections (see chapter 3), unannounced inspections may be carried out. Six unannounced inspections were thus carried out in 2024 covering all the inspected activities (two in FGIPs, two in nuclear medicine, one in radiotherapy and one in computed tomography – see point 2.1.3). Furthermore, inspections may be carried out in the commissioning context when installing new MDs or for new facilities, and when investigating ESRs. 1.5 Significant radiation protection events It is mandatory for ASN to be notified of ESRs pursuant to the Public Health Code (Articles L. 1333-13, R. 1333‑21 and 22) and the Labour Code (Article R. 4451‑74 – see chapter 3, point 3.3). In the medical field, ESRs have been notified to ASN since 2007. Notifying these events makes it possible, after analysing them, to give feedback to the medical professionals with a view to continuous improvement of radiation protection. An on-line services portal has been provided at teleservices.asn.fr to enable all the medical professionals to file their notifications on line. This portal is integrated in the adverse public health events reporting portal managed by the Ministry responsible for health. Depending on the type of event reported, the notification is sent automatically to ASN (regional division and Department of ionising radiation and health – DIS), to the ARS for all events concerning the patient and to the ANSM for events relating to medical devices vigilance or drug safety monitoring. The methods of notification and of codifying the significant events notification criteria defined in ASN Guide No. 11 are soon to be updated. The ASN-SFRO scale for rating events concerning patients undergoing radiotherapy or brachytherapy treatment remains unchanged. The aim of this scale, developed in collaboration with the French Society for Radiation Oncology (SFRO), is to inform the public about radiation protection events affecting patients in the course of a radiotherapy or brachytherapy treatment, taking into account, in addition to the confirmed consequences, the potential effects of the event and the number of patients exposed (see chapter 3). In addition to this, the incident notices are published on asn.fr. To meet its obligation to inform health professionals of the lessons learned from the analysis of events that could affect the health of the persons mentioned in Article L. 1333-13, when these events have relevance from the patient radiation protection viewpoint (Article R. 1333-74 of the Public Health Code), ASN regularly produces information media: ∙“Learning from experience” sheets further to an ESR to rapidly inform the medical professionals potentially concerned in order to prevent the event from occurring in another centre; ∙“Patient safety - Paving the way for progress” bulletins, published since March 2011. The “Patient safety” bulletin offers a thematic presentation of the good practices of medical departments and the recommendations developed by the professional organisations of the discipline concerned and the health and radiation protection institutions; ∙circular letters addressed to the RNAs to draw their attention to particular points that have caused ESRs, to disseminate the lessons learned from these events and/or to make known its recommendations on the subject. To produce the first two types of information media, ASN is assisted by two multidisciplinary Working Groups (WGs) in the fields of radiotherapy and imaging respectively. Documents of this type are published on the ASN website in the section “Espace professionnels”, sub-section “Retour d’expérience”. The circulars are published in the sections devoted to each medical activity, under the sub-section “Lettres circulaires”. All of these communication media, over and beyond fulfilling ASN’s obligation, are produced with particular care in order to stimulate the interest of the medical professionals and encourage the sharing of lessons learned from experience. Refer to point 2.7 below for further information on the work of these WGs. 2 Nuclear-based medical activities 2.1 External-beam radiotherapy Radiotherapy, along with surgery and chemotherapy, is one of the key techniques employed to treat cancerous tumours. Radiotherapy uses ionising radiation to destroy malignant cells and also dysfunctional non-malignant cells. We distinguish external-beam radiotherapy, where the source of radiation (particle accelerator or a sealed radioactive source in the case of Gamma knife®) is external to the patient, from brachytherapy, where a sealed radioactive source is placed as close as possible to the cancerous lesion, either via the natural cavities or by catheters (see point 2.2). The radiation sessions are always preceded by the preparation of a treatment plan which serves to set the conditions for achieving a high dose in the target volume while preserving the surrounding healthy tissues. The treatment plan defines the dose to deliver, the target volume(s) to treat, the organs at risk to be protected, the ballistics of the radiation beams and the predicted dose distribution (dosimetry). Preparation of the treatment plan requires close cooperation between the radiation oncologist, the medical physicist and, if necessary, the dosimetrists. TABLE 2 Inspection frequency by nuclear-based medical activity Nuclear-based medical activity Routine frequency External-beam radiotherapy Every 4 years Brachytherapy Every 4 years Diagnostic nuclear medicine Every 5 years Therapeutic nuclear medicine on out-patient basis (e.g. iodine < 800 Megabecquerels – MBq, synoviortheses, etc.) Every 4 years Therapeutic nuclear medicine with complex therapies using iodine >800 MBq, lutetium-177, yttrium-90 and hospitalisation Every 3 years Fluoroscopy-guided interventional practices with risks Every 5 years approximately(*) Computed tomography (emergencies or paediatrics with radiation protection risks) Sampling: about twenty facilities per year * Depending on ASN’s knowledge of the radiation protection situation in the facilities, based in particular on the inspections carried out when issuing a registration. ASN Report on the state of nuclear safety and radiation protection in France in 2024 217 Medical uses of ionising radiation 07 01 02 03 04 05 06 08 09 10 11 12 13 14 15 AP
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