3 Synthesis and prospects On the basis of the inspections carried out in 2023 and an analysis of the period 2019-2023 enabling the entire base of facilities to be covered, ASN considers that the state of radiation protection in the medical sector is being maintained at a good level, relatively comparable from one year to the next, although with a number of persistent shortcomings which led it to adopt an enforcement approach in the area of FGIPs in 2023. It underlines the progress in the area of clinical audits, with the first experiments started in 2023 in radiotherapy and radiology, but encourages their extension to the most risk-prone activities, giving priority to radiosurgery and therapeutic nuclear medicine. ASN nevertheless detects several signals that could lead to a deterioration in the current situation: ∙ a widespread finding of diminished resources with strained staffing levels for radiographers, medical practitioners and medical physicists, with the development temporary work and tasks being performed by personnel without the required qualifications; ∙ the recourse, in imaging, to services insufficiently mastered to assist the centres’ RPE-Os and medical physicists, liable to lead to a loss of radiation protection skills and a lack of flexibility for the implementation of the regulatory radiation protection requirements (training, verifications, etc.); ∙ the emergence of mobile radiology and the constant growth of teleradiology, with centres underestimating the technical and organisational constraints associated with this method of working (communication problems, software interfacing); ∙ the complexification of organisational structures, with resource sharing and the risk of diluting responsibilities, in a context of reforms in the healthcare licences and the buying out of centres; ∙ conflictual situations in a context of overstretched human resource or organisational changes brought to ASN’s knowledge during inspections or via the system for collecting alerts from whistle-blowers. In this context, ASN draws the attention of decision makers to the need to assess the impact of these changes on the organisational set-ups and the work of those involved and to precisely define their roles and responsibilities so that the radiation protection requirements are satisfied. In radiotherapy, although the safety fundamentals are in place, the LFE procedures are losing momentum with less detailed ESR analyses and less frequent CREX meetings, underlining the need to give renewed meaning to these procedures in order to maintain both the interest of the medical professionals and the collective dynamic. The repetition of target errors (laterality and positioning errors in particular) reported in 2023, once again emphasises the need to regularly assess the barriers put in place by taking greater advantages of the LFE at national level. ASN insists on the importance of the prospective risk analysis when making technical and organisational changes. ASN communicated a methodology for performing the prospective risk analysis in its “Patient safety” bulletin of September 2023. The inspections in brachytherapy confirm that the radiation protection rules are duly taken into account, but the drive to reinforce training in emergency situations involving source jamming must be maintained over time. ASN underlines the challenges to maintaining the resources and skills necessary for this activity in the years to come. The inspections in nuclear medicine find that radiation protection is duly taken into account, while at the same time underlining the need to continue deploying the quality assurance procedures to ensure the safety of the drug administration process, particularly for therapeutic procedures, and for procedures involving children in view of the reported ESRs. Alongside this, the formalisation of the coordination of prevention measures with the outside contractors (for maintenance, cleaning services, private physicians, etc.), personnel training and analysis of the DRLs are still areas for improvement. In the area of FGIPs, and more particularly in the operating theatre, regulatory nonconformities persist over the years regarding the technical rules for fitting out facilities, the occupational and patient radiation protection training requirements and the coordination of prevention measures during concomitant activities, particularly when private physicians are involved. These deviations have led ASN to give one centre formal notice to comply with the rules concerning radiation protection of the staff and the fitting out of the rooms used for interventional procedures. ASN observes moreover that the centres are turning increasingly to RPOs, either as specialised contributors to assist a RPE-O, or as an RPA and that this outsourcing, if it is not adequately managed, leads to a dilution of the responsibilities of the RNAs and poorer assimilation of, or even a deterioration in radiation protection. In 2024, ASN will continue its inspections in the priority sectors, namely radiotherapy, radiosurgery, nuclear medicine, FGIPs and computed tomography, in line with the inspections performed in 2023. Particular attention will be devoted to the signals mentioned previously and the weak points identified in 2023 (training, analysing events and learning lessons from the reported ESRs, coordination of prevention measures during concomitant activities, bringing the facilities into compliance with the fitting out rules, maintenance), and the implementation of the quality assurance obligations and change management. Unannounced inspections shall be carried out if necessary. In radiotherapy and nuclear medicine, on the basis of the lessons learned from the ESRs reported over the last few years, specific inspections on the mastering of the accelerator calibration process and the verification of non-contamination shall be carried out in 2024, with the assistance of IRSN. With regard to FGIPs, ASN will conduct targeted inspections of private practitioners who, although they are not RNAs and do not own the equipment they use, have radiation protection obligations for themselves and as employers of personnel classified on account of exposure to ionising radiation. On the regulatory front, ASN will revise ASN resolution 2019-DC-0667 of 18 April 2019 setting the DRL values, to update the values for mammography procedures and will continue the preparatory work for the revision of ASN resolution 2008-DC-0095 of 29 January 2008 laying down the technical rules applicable to the disposal of effluents and waste contaminated by radionuclides. 238 ASN Report on the state of nuclear safety and radiation protection in France in 2023 • 07 • Medical uses of ionising radiation
RkJQdWJsaXNoZXIy NjQ0NzU=