ASN Report 2018

Regulatory work in progress in the area of patient radiation protection EXISTING TEXT WORK IN PROGRESS Quality assurance in radiotherapy Resolution 2008-DC-0103  of 1 July 2008 Updating planned in 2020 Quality assurance inmedical imaging Resolution approved in February 2019 Diagnostic reference level Order of 24 October 2011 Draft resolution presented for public consultation in November 2018 Continuous training of health professionals in the protection of persons exposed for medical purposes Resolution 2017-DC-0585  of 14 March 2017 Draft amending resolution presented for public consultation in July 2018 Qualifications of physicians involved in the exercise of nuclear-based medical activities Resolution 2011-DC-0238  of 23 August 2011 Updating planned in 2019 2. ASN resolution 2018-DC-0649 of 18 October 2018 defining, in application of 2° of Article R. 1333‑109 and Article R. 1333‑110 of the Public Health Code, the list of nuclear activities subject to the notification system and the information that must be indicated in these notifications. 3. 213,204 cancer patients were treated by radiotherapy in 2016: 117,196 in the public sector and 96,008 in the private sector. 1.3.4  –  The administrative procedures Decree 2018‑434 of 4 June 2018 introducing various nuclear- related provisions has brought the clarifications necessary for the implementation of the new system of procedures applicable in small-scale nuclear activities in application of Article L. 1333‑7 of the Public Health Code: a third system baptised «registration» (it is a «simplified» licensing system) may be put in place in addition to the notification and licensing systems that exist for certain activities. In view of the risks (Table 1), ASN has adopted the following changes: ∙ ∙ The existing list of medical activities subject to notification has been maintained by ASN resolution 2018-DC-0649 of 18 October 2018 (2) ; conventional radiology and dental radiology continue to be covered by the notification system. ∙ ∙ The new registration system expected in 2019 should be applied to computed tomography and the use of radionuclides in medical biology laboratories (see point 4.1.2.), currently subject to licensing, and to fluoroscopy-guided interventional practices which involve radiation protection risks (in the meantime, the latter are still simply subject to notification). ∙ ∙ The licensing system shall be maintained for external-beam radiotherapy, brachytherapy and diagnostic and therapeutic nuclear medicine. 2 —  External-beam radiotherapy 2.1  ̶  Description of the techniques Alongside surgery and chemotherapy, radiotherapy is one of the key techniques employed to treat cancerous tumours. Some 200,000 patients (3) are treated each year, representing nearly four million irradiation sessions. Radiotherapy uses ionising radiation to destroy malignant cells (and non-malignant cells in a small number of cases). The ionising radiation necessary for the treatments is produced by an electric generator or emitted by radionuclides in sealed sources. We thus have external- beam radiotherapy, where the source of radiation produced by a particle accelerator or radioactive sources (Gamma knife® for example) is external to the patient, and brachytherapy, where the source is placed as close as possible to the area to treat. According to the information gathered from the French National Radiotherapy Observatory (source: INCa, 2017), the radiotherapy facilities comprise 505 particle accelerators in 173 radiotherapy centres subject to an ASN license. ASN issued 114 licenses in 2018. The majority of these cases concerned the updating of an existing license. Graph 5 shows the distribution of the pool of facilities under ASN oversight and the licenses issued, updated or renewed in 2018. Eight hundred and ninety-five radiation oncologists were listed in SFRO (French Society for Radiation Oncology) directory in 2017. The irradiation sessions are always preceded by preparation of a treatment plan which precisely defines the dose to be delivered, the target volume(s) to be treated, the volumes at risk to be protected, the irradiation beam setting and the estimated dose distribution (dosimetry) for each patient. Preparation of this plan, which aims to set conditions for achieving a high dose in the target volume while preserving surrounding healthy tissues, requires close cooperation between the radiation oncologist, the medical physicist and, when applicable, the dosimetrists. In the vast majority of treatments, irradiation is ensured using linear particle accelerators with an isocentric arm emitting beams of photons produced at a voltage varying from 4 to 25 megavolts (MV) or electrons with an energy level of between 4 and 25 megaelectronvolts (MeV) and delivering dose-rates that can vary from 2 to 6 grays per minute (Gy)/min. It should be noted that some latest-generation linear accelerators can deliver much higher dose rates, of up to 25 Gy/min (in the case of photon beams). Table 2 206  ASN report on the state of nuclear safety and radiation protection in France in 2018 07 – MEDICAL USES OF IONISING RADIATION