IRRS follow-up mission to France - October 2017

48 For the implementation of this provision, ASN has published a decision on quality management systems in radiotherapy (2008) and is preparing a new decision on medical imaging (to be published in 2018). Quality control (QC) of equipment is a part of QA. This new decision is part of the National Cancer Plan (2014-2019). For eachmedical device emitting ionizing radiation, internal QChas to be achieved by the Medical Physicist and an external QC has also to be completed by specific bodies appointed by the DG of the French National Agency for Medicines and Health Products Safety (ANSM), in charge of the control of medical devices. The frequency and the modalities of QC are defined by ANSM. ASN inspectors check the practical implementation of this regulation (QC and maintenance) and, if necessary, communicate to ANSM if the QC has not been performed. A protocol between ANSM and ASN defines the means of collaboration between both authorities. The ASN responsibilities in this field have been strengthened by Ordinance n°2016-128. In addition, a specific requirement underlined the ASN legal competence to control the practical use of medical devices emitting ionizing radiation (HPC, Article L. 1333-30). A decree is in preparation that will allow bodies appointed by ASN (for the technical control of radiation protection) to check the practical implementation of provisions related to QC and maintenance (R.1333-134), particularly for medical practices that are rarely inspected by ASN (i.e. conventional and dental radiology). Calibration of patient dosimetry is covered by the ministerial order of 20 November 2007. This is performed by accredited bodies following NF EN ISO/CEI 17020 and NF EN ISO/CEI 17025. The calibration of sources is covered by the ASN resolution 2010-DC-0175 and is performed by bodies appointed by ASN following NF EN ISO 17025. The reference laboratory is the LNE (Laboratoire National d’Essai). Recommendation 14: France is currently working on the transposition of the European directive 2013/59/Euratom into the national legislation. Legislative terms have been defined in the Ordinance n°2016-128. A decree in preparation aims at modifying the Public Health Code (R. 1333-40.I and II) to add a requirement to evaluate the doses delivered to patients during interventional radiology practices on a regular basis and to transmit the corresponding results to IRSN. Therefore, in future, interventional radiology practices will be included in the existing process to define and update DRLs. For practices deemed to be of importance in terms of radioprotection, ASN will issue DRLs on a regular basis, taking into account the analyses performed by IRSN on the data received. Status of the finding in the initial mission Suggestion 23 (S23) is closed on the basis of progress made and confidence in the effective completion of the review of the regulatory framework, and in particular, concerning the role and the responsibilities of the MoH. Recommendation 13 (R13) is closed on the basis of progress made and confidence in the effective completion as the legislation has been completed in order to ensure that the radiological QA requirements will be fully implemented for all medical practices. Recommendation 14 (R14) is closed on the basis of progress made and confidence in the effective completion as provisions have been made in such a way that interventional radiology practices will be included in the existing process to define and update DRLs.