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 radio- logy 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 major medical equipment items will have to comply with the Installation Conditions (ICs – they detail the levels of the procedures in particular) set for each of them by the provisions of Chapter III of Title III of Book I of the 6th Part of the Public Health Code (Articles R. 6123-1 to R. 6123-212). These ICs are also associated with 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.). These TOCs are detailed by the provisions of Chapter IV of Title II of Book I of the 6th Part of the Public Health Code (Articles D. 6124-1 to D. 6124-501). The implementation of this reform will continue to modify the organisational structures in place, notably by encouraging cooperation between healthcare organisations. These groupings can lead the holder of a nuclear activity or activities licence to ask ASN to modify or even to revoke the license (change of RNA, development or change of agreements, etc.). For example, in nuclear medicine certain devices may be shared between healthcare facilities; in external-beam radiotherapy, the radiosurgery activity may be attached to a neurosurgery department and no longer to a radiotherapy department. Nuclear medicine departments are divided into two categories: category A departments which do not perform therapeutic procedures and category B departments which do perform therapeutic procedures among others. ASN is 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). To adapt the regulatory provisions to the technical changes and conditions of professional practice, ASN published resolution 2020-DC-0694 of 8 October 2020, approved by the Order of 5 July 2021, which came into effect in July 2021. It repeals the resolution of 23 August 2011 (2011-DC-0238) and updates the qualifications required for physicians and dental surgeons who perform procedures using ionising radiation for medical purposes or human subject research. 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; ∙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 (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 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 services 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 of the Public Health Code, 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 have been introduced progressively since 2023 on the initiative of the General Directorate for Health (DGS) in the areas of imaging and radiotherapy initially, with the backing of the professional organisations and national councils concerned. ASN participates in the steering committees set up by the DGS to monitor implementation TABLE 1 Classification of nuclear-based medical activities according to the radiation exposure risks Activities Patients Professionals Public and environment External-beam radiotherapy 3 1 1 Brachytherapy 2 2 2 Internal targeted radiotherapy 3 2 3 Fluoroscopy-guided interventional practices 2 to 3 depending on the procedures 2 to 3 depending on the procedures 1 Diagnostic nuclear medicine 1 to 2 depending on the procedures 2 to 3 depending on the procedures 2 Computed tomography 2 1 1 Fluoroscopy-guided procedures on remotely controlled table in radiology department 1 1 1 Conventional radiology 1 1 1 Dental radiology 1 1 1 1: No risk or low risk – 2: Moderate risk – 3: High risk ASN Report on the state of nuclear safety and radiation protection in France in 2024 215 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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