ASN Report 2017

101 ASN report on the state of nuclear safety and radiation protection in France in 2017 Chapter 03  - Regulations Radiotherapy quality assurance The quality assurance obligations of radiotherapy centres were specified by ASN resolution 2008-DC-0103 dated 1st July 2008, which mainly concerns the Quality Management System (QMS), the management’s commitments as stipulated in the QMS, the documentary system, staff responsibility, the assessment of the risks faced by the patients during the radiotherapy process, and the identification and handling of undesirable situations or malfunctions, whether organisational, human or equipment-related. The medical imaging quality assurance obligation also appears in the Public Health Code. Faced with the regular rise in the doses of ionising radiation delivered to patients over the past decade, ASN should be publishing a resolution in 2018 to clarify the corresponding requirements. The draft resolution was submitted for public consultation from 2nd December 2017 to 2nd February 2018. This action is part of Cancer Plan 3 adopted by the Minister responsible for Health in January 2014. Maintenance and quality control of medical devices The internal and external maintenance and quality control of medical devices using ionising radiation (Articles R. 5211-5 to R. 5211-35 of the Public Health Code) were made mandatory by the Order of 3rd March 2003 setting out the list of medical devices subject to the maintenance and quality control obligation. External quality control is entrusted to organisations approved by the Director General of the French National Agency for the Safety of Medication and Health Products who is responsible for issuing a decision defining the acceptability criteria, the monitoring parameters and the frequency of the inspections on the medical devices concerned. The published decisions can be consulted on www.ansm.sante.fr . Training and information Additional major factors in the optimisation approach are the training of health professionals and the information of patients. ASN resolution  2017-DC-0585 of 14th March 2017 introduced new conditions for the continuous training of professionals in the radiation protection of persons exposed to ionising radiation for medical purposes. These new conditions replace those defined by the Order of 18th May 2004 concerning training programmes for the radiation protection of patients exposed to ionising radiation (this Order should soon be repealed). The new training system will be implemented after approval of the professional guides required by this resolution, scheduled for early 2018. To ensure the traceability of information, the report on the procedure, written by the medical practitioner carrying out the examination, must provide information justifying the procedure and the operations carried out as well as the data used to estimate the dose received by the patient (Order of 22nd September 2006 on the dosimetry data to be included in the report of a procedure using ionising radiation). Finally, with regard to information, before carrying out a diagnostic or therapeutic procedure using radionuclides (nuclear medicine), the physician must give the patient oral and written guidelines on radiation protection that are of use to them, their friends and relations, the public and the environment. In the case of a therapeutic nuclear medicine procedure, this information - which is provided in writing – gives advice on day to day living such as to minimise external exposure of the patient’s friends and family and the risk of any contamination, for example by specifying the number of days during which contact with the spouse and children must be limited. Recommendations (French High Council for Public Health, learned societies) were sent out by ASN in January 2007, with the goal of harmonising the content of the information already given to patients by the nuclear medicine units. 2.2.3 Radiological examination with no direct medical indication With the decree under preparation, the existing expression “forensic applications of ionising radiation” which was felt to be too vague, is replaced by the expression “radiological examination with no direct medical indication” (Articles R. 1333-75 to R. 1333-77 of the Public Health Code). The examination categories concerned are explicitly defined (examples: preventive examinations carried out for occupational medicine or sports medicine purposes, or for inspections to identify objects or narcotic products hidden in the human body). For this type of examination, the principles of individual and generic justification, and optimisation are applicable. 2.3 Protection of persons exposed to a natural source of ionising radiation 2.3.1 Protection of persons exposed to radon The regulatory framework applicable to the management of the radon risk in premises open to the public will be overhauled by the decree under preparation: ཛྷ ཛྷ The radon monitoring obligation applies in geographical areas in which radon of natural origin is likely to be measured in high concentrations and in premises in which the public is likely to stay for extended periods (areas with high radon potential). ཛྷ ཛྷ The measurements are taken by organisations approved by ASN. They must be repeated every ten years and whenever works are carried out to modify the ventilation or radon- tightness of the building. ཛྷ ཛྷ The reference level is set at 300 Bq/m³. The geographical areas in which radon measurements are mandatory are the 31 départements mentioned in the Order of 22nd July 2004 concerning management of the risk related to radon in premises open to the public. A new map, showing individual municipalities, will be sent out by order during the first half of 2018 (see chapter 1). The “premises open to the public” categories concerned are teaching establishments, including buildings for boarders, establishments accepting groups of children less than six years old, health care, social and medico-social facilities with in-patient capacity, spas and penitentiaries.