IRRS follow-up mission to France - October 2017

47 11. ADDITIONAL AREAS 11.1. CONTROL OF MEDICAL EXPOSURES 2014 MISSION RECOMMENDATIONS, SUGGESTIONS S23 Suggestion: The Government should consider undertaking a review of the regulatory framework for the control of medical exposure to ensure there are no gaps and that the organizations involved are properly coordinated. R13 Recommendation: ASN should take the necessary steps to ensure that the radiological QArequirements, as set out in the PHC, are implemented for all medical practises. These requirements should assure that there are no gaps in the QC of equipment used for medical exposure and that calibrations of patient dosimetry and sources are traceable to a standard dosimetry laboratory. R14 Recommendation: ASN should establish DRLs for interventional radiology, and assure for local review of practice if patient doses fall substantially below national DRLs. Changes since the initial IRRS mission Suggestion 23: Based on the conclusions of a first action plan on medical imaging (covering the period 2012 to 2017), ASN has developed a second national Radiation Protection action plan which will be published in January 2018. It has been sent (27 September 2017) for approval to the Ministry of Health (MoH) and is focusing on the justification and the optimization of medical imaging practices. The coordination of this action plan will be done by ASN. In regards to radiotherapy, there is no such plan but the coordination will continue to be done by INCA (Institut National du Cancer). Regarding the setting of referral guidelines, a new decree modifying the Public Health Code (PHC) will establish the MoH as the organisation in charge of the validation of guidelines, which are prepared by the medical scientific societies. New practices involving the use of ionising radiation can be validated on a “case by case” basis by the MoH by a specific order (R.1333-36.2 and R.1333-36.3). For these practices, the collection of patient data and the assessment of the justification as requested by the MoH will have to be done. In order to ensure coherence, ASN is setting up a survey committee with all stakeholders whose role will be to examine new innovative practices and new techniques, which were not previously validated. Recommendation 13: Ordinance n°2016-128 issued on 10 February 2016 clarified and strengthened the regulatory framework of QA for medical practices. QA was mandatory for all medical practices since 2003 but effectively only in place in radiotherapy. The new provision requires: “Article L. 1333-19.-I.-Procedures using ionizing radiation performed for medical diagnosis, therapeutic treatment, screening, prevention or biomedical research purposes are subject to a quality assurance obligation from the justification of the choice of procedure and optimization of the doses delivered to the patients through, to the procedure results report.”