1.5 Significant radiation protection events It is mandatory to report ESRs to ASN in application of the Public Health Code (Articles L. 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 reported to ASN since 2007. Reporting these events makes it possible, after analysing them, to give feedback to the medical professionals with a view to continuous improvement of radiation protection. The on-line Teleservices portal at asn.fr has been provided to enable all the medical professionals to file reports on line. This portal is integrated in the “one-stop vigilance portal” managed by the Ministry responsible for health. Depending on the type of event reported, the notification is sent automatically to ASN (regional division), to the Regional Health Agency (ARS) for all events concerning the patient, while events relating to medical devices vigilance or drug safety monitoring (RPD) are sent to the ANSM. A draft ASN resolution on “Procedures for reporting significant events and codifying the reporting criteria” was submitted for public consultation in 2022, along with the updated Guide No. 11 for the medical sectors, which details the event reporting procedures. The resolution and guide should be published in the course of 2023. 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). Moreover, the incident notices are published on asn.fr. To encourage sharing of the lessons learned from experience feedback from medical professionals, ASN publishes the newsletter Patient safety – Paving the way for progress, first issued in March 2011, sheets on Experience feedback from ESRs, and circular letters addressed to the heads of nuclear activities. Produced by multidisciplinary working groups coordinated by ASN, the newsletter offers a thematic deciphering, good practices by medical departments and the recommendations developed by the learned societies of the discipline concerned and the health and radiation protection institutions. The “Experience feedback” sheet, for its part, draws attention to a specific ESR reported to ASN to prevent it from occurring in another centre. 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 non-malignant cells. The ionising radiation necessary for the treatments is produced by an electric generator or emitted by radionuclides in sealed sources. We distinguish external-beam radiotherapy, where the source of radiation (particle accelerator or a radioactive source such as Gamma knife®) is external to the patient, from brachytherapy, where the source is placed as close as possible to the cancerous lesion. 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 volumes 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. The main radiation protection risk is linked to the dose delivered to the patient; the change of treatment techniques with the development of hypofractionated radiotherapy (see point 2.1.1), which consists in delivering higher doses during a given session, makes it all the more crucial to control delivery of the dose. This is why ASN’s oversight focuses on both the ability of the centres to control delivery of the dose to the patient and to learn lessons from the malfunctions that could occur. Implementation of the treatment quality and safety management system, skills management, mastery of the equipment, ESR recording and follow-up are the focal points of the ASN inspections. As technical, organisational and human changes have been identified as potential risk-generating situations, particular attention is also given to change management during the inspections. 2.1.1 Description of the techniques Several external-beam therapy techniques are currently used in France. The SFRO considers three-dimension conformal radiotherapy to be the basic technique in its Guide to recommendations for the practise of external-beam radiotherapy and brachytherapy (Recorad), updated in February 2022. This technique TABLE Inspection frequency by area of 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 Every 5 years Computed tomography (emergencies or paediatrics) Sampling: about twenty facilities per year 2 ASN Report on the state of nuclear safety and radiation protection in France in 2022 213 • 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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