for a licence to possess and use a radioactive source or a device emitting ionising radiation. Among the changes stemming from the reform is the introduction of new healthcare activities, including interventional radiology and nuclear medicine and the reinforcing of the quality and safety approach with extension of the enforceability of the technical operating conditions of radiotherapy to neurosurgery departments. The healthcare activities and the major medical equipment items will have to comply with the Installation Conditions (ICs – they detail the levels of the procedures in particular) and the Technical Operating Conditions (TOCs – they include for example requirements concerning the composition of the teams, qualification of the personnel, fitting out of the rooms, patient follow-up methods, recourse to certain treatment methods, etc.). The entry into effect of this reform will change the existing organisational arrangements by encouraging, among other things, cooperation between the care structures, possibly making it necessary to change the nuclear activity licences issued by ASN (change of RNA, creation or modification of agreements, etc.). For example, in nuclear medicine certain devices may be shared between healthcare facilities and the radiosurgery activity may be attached to a neurosurgery department. ASN will be attentive to the impact of this reform on the nuclear activity licences and on radiation protection conditions because of these organisational changes. 1.3.4 The particularities of radiation protection of patients Justification and optimisation – The protection of patients undergoing medical imaging examinations or therapeutic procedures using ionising radiation is regulated by specific provisions of the Public Health Code (Articles R. 1333‑45 to R. 1333‑80). The principles of justification of the procedures and optimisation of the delivered doses constitute the cornerstone of this regulation. The principle of dose limitation does not apply to patients due to the need to adapt the delivered dose to the diagnostic or therapeutic end-purpose for each patient. ASN ensures that this regulatory framework is updated through specific provisions with regard to optimisation, quality assurance, training and qualification as described below. The required qualifications – The use of ionising radiation on the human body is restricted to physicians and dental surgeons having the necessary skills to perform these procedures (Article R. 1333‑68 of the Public Health Code). ASN updated and specified the necessary qualifications in October 2020. This aim of the updating is to adapt the regulatory provisions to the developments in the techniques and conditions of practise. ASN resolution 2020-DC-0694 of 8 October 2020, approved by Order of 5 July 2021, entered into effect in July 2021. It repeals ASN resolution 2011-DC-0238 of 23 August 2011 and updates the required qualifications for physicians and dental surgeons who perform procedures using ionising radiation for medical or research purposes involving humans. It also sets the requirements for designating physicians coordinating a medical nuclear activity and to apply for a license or registration as a natural person. The quality assurance obligations – To control the doses delivered to patients and thereby contribute to improved treatment safety, the obligations of the RNAs with regard to quality assurance for all medical activities involving ionising radiation are now governed by two ASN resolutions: ∙ resolution 2019-DC-0660 of 15 January 2019 in medical imaging, that is to say in nuclear medicine for diagnostic purposes, in dental and conventional radiography, in computed tomography and for FGIPs; 4. https://www.asn.fr/espace-professionnels/activites-medicales/guides-professionnels-de-formation-continue-a-la-radioprotection ∙ resolution 2021-DC-0708 of 6 April 2021 for therapeutic procedures, that is to say external-beam radiotherapy, including contact therapy and intraoperative radiotherapy, brachytherapy, nuclear medicine for therapeutic purposes (ITR) and radiosurgery. These resolutions oblige the RNA, with requirements proportionate to the radiation protection risks, to formalise the work instructions associated with the operational implementation of the two general principles of radiation protection, namely justification for the procedures and dose optimisation, and those concerning Learning From Experience (LFE), the training and authorisation of professionals and, for therapeutic procedures, the prospective risk analysis. The above-mentioned ASN resolution 2021-DC-0708 of 6 April 2021 updates and tightens the quality assurance requirements, particularly when there is an organisational or technical change, and when work processes are outsourced. A clinical peer review figures among the quality assurance obligations. The principle of the clinical peer review has been written into Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation. Transposed into French law in Article R. 1333-70 of the Public Health Code, the clinical peer review, which is included in the quality assurance system provided for in Article L. 1333-19, is the “assessment method which, in view of the criteria determined by the quality assurance baseline, gives the patient guarantees regarding the competence of the medical and healthcare team, the quality of care and the safety of the procedures, which includes patient radiation protection”. The clinical peer reviews were gradually put in place in 2023, on the initiative of the General Directorate for Health (DGS) in the areas of imaging and radiotherapy initially, with the backing of the learned societies and national councils concerned. ASN participates in the steering committees set up by the DGS to monitor implementation of these clinical peer reviews. The review grids are finalised and a pilot phase has been organised for the two areas to test the review process as a whole (organisation, documentation, etc.), and the appropriateness of the grids. After a period of recruiting and training the reviewers (physicians, medical physicists and radiographers) and finding centres willing to test the process, the first clinical reviews were carried out at the end of 2023. These pilot phases will continue during the first half of 2024. On completion of these pilot phases, the results shall be analysed in order to extend these clinical reviews to the whole of France. ASN encourages the deployment of these reviews in the sectors with high radiation protection risks which are not covered at present, namely radiosurgery and therapeutic nuclear medicine. Training in patient radiation protection – The obligations for continuous training in patient radiation protection are set in Articles L. 1333‑19, R. 1333‑68 and R. 1333‑69 of the Public Health Code. The system as a whole was revised in ASN resolution 2019-DC-0669 of 11 June 2019 amending resolution 2017-DC-0585 of 8 January 2015, further to discussions with all the National Professional Councils (CNPs) concerned. This resolution aims to clarify and enhance the teaching objectives concerning justification, to integrate new actors and to foster interfacing with the other continuous training systems. Pursuant to this resolution, 18 professional guides have been produced by the learned societies, validated by ASN and put on line on asn.fr(4). 210 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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