Abstracts ASN Report 2021

ASN resolution 2021-DC-0703 of 4 February 2021 establishing the list of nuclear activities using sources of ionising radiation for industrial, veterinary or research purposes (other than research involving humans) subject to the registration system, and the binding requirements applicable to these activities A third administrative system, registration, was introduced into the Public Health Code by Decree 2018-434 of 4 June 2018; it corresponds to a simplified authorisation and applies to nuclear activities not needing specific individual requirements. Resolution 2021-DC-0703 implementing Articles L. 1333-8 and R. 1333‑113 (et seq.) of the Public Health Code, notably specifies: ∙ the list of nuclear activity categories now subject to the registration system and previously requiring authorisation (appendix 1); ∙ the practicalities for submitting an initial application, a modification application or registration renewal application, and the list of information and documents to be provided for a registration application (appendix 2); ∙ the general requirements specific to the different nuclear activity categories (appendix 3) which are binding on the nuclear activity manager and any breach of which can be punished; ∙ the interim provisions applicable to authorised activities switching from the authorisation system to the registration system. In the absence of any modification to the authorised nuclear activity, the authorisations issued before the date this resolution enters into force Act as the registration up until their expiry date (an initial registration application shall be submitted no later than six months before the authorisation expiry date). It entered into force on 1 July 2021, after publication of its approval order of 15 June 2021 in the Official Journal. ASN resolution 2021-DC-0704 of 4 February 2021 establishing the list of medical activities using medical devices emitting ionising radiation subject to the registration system and the requirements relative to these activities Transposition into French law of Directive 2013/59/Euratom (known as the “BSS” Directive) led to modification of the Public Health Code. This was notably done through publication of Decree 2018‑434 of 4 June 2018 introducing various provisions concerning nuclear activities. This resolution modifies and repeals ASN resolution 2018-DC-0649 of 18 October 2018 implementing 2° of Article R. 1333-109 and Article R. 1333-110 of the Public Health Code, setting the list of nuclear activities subject to the notification system and the information to be mentioned in these notifications. This results in a significant change concerning fluoroscopyguided interventional practices. Article 12 of the resolution concerning the interim provisions applicable to fluoroscopyguided interventional practices requires that “for fluoroscopyguided interventional practices which have been notified to ASN, a description of the types of procedures carried out, according to the list given in Article 1, along with the references of the notification concerned, shall be transmitted within twelve months following entry into force of this resolution”. To enable this information to be transmitted to ASN, a notification form was created. The facilities are asked to notify their activities via an online form available on the Framaforms website. 1. Ordinance 2016-128 of 10 February 2016 for the legislative part and Decree 2018-434 of 4 June 2018 for the regulatory part. The registration is only valid if it complies with the specific general requirements concerning the medical devices emitting X-rays used (maintenance, loan for test purposes, organisation of patient radiation protection for fluoroscopy-guided interventional practices). The provisions to be implemented are formally set out in the quality management system put into place pursuant to ASN resolution 2019-DC-660 of 15 January 2019. It entered into force on 1 July 2021, after publication of its approval order of 15 June 2021 in the Official Journal. ASN resolution 2021-DC-0708 of 6 April 2021 setting quality assurance obligations for procedures using ionising radiation for therapeutic care purposes Following the transposition of Directive 2013/59/Euratom(1), ASN entirely revised the regulatory arrangements regarding the quality assurance obligations for medical procedures utilising ionising radiation. ASN resolution 2021-DC-0708 applies to the four therapeutic fields using ionising radiation, preparatory and monitoring computed tomography examinations and research involving humans: ∙ external radiotherapy, including contact therapy and preoperative radiotherapy; ∙ brachytherapy; ∙ therapeutic nuclear medicine (Targeted Internal Radiotherapy); ∙ radiosurgery. The resolution repeals resolution 2008-DC-0103 of 1 July 2008 and expands the scope of procedures using ionising radiation for therapeutic purposes subject to the quality assurance obligation. The requirements are harmonised with the medical imaging sector (resolution 2019-DC-0660). This resolution prescribes new applicable quality assurance requirements: ∙ extension of quality assurance obligations to therapeutic nuclear medicine (art. 1). The following points must be formalised: ∙ the procedures for training of professionals in radiation protection of patients and the use of a new medical device or a new technique (art. 7); ∙ the tasks to be performed by an internal procedure for qualification on the workstation by new arrivals, for all professions or when changing positions or medical devices (art. 7); ∙ project management for any change affecting the quality and safety of patient care (medical devices, information systems, premises, treatment practices, etc.) by means of a procedure (art. 8); ∙ the respective responsibilities of the ordering party and the service provider if the activity is out-sourced (subcontracted tasks, medical devices or operations concerned, technical measures taken), for example in the form of a contract (art. 3); ∙ the responsibilities, authorities and delegations of professionals, including in the event of intervention by external service providers (art. 5). The quality management system shall make provision for the performance of the audits defined. It entered into force three months after publication of its approval order of 17 May 2021 in the Official Journal. 36 ABSTRACTS – ASN Report on the state of nuclear safety and radiation protection in France in 2021 REGULATORY NEWS