International conference on patient radiation protection in radiotherapy With the support of the World Health Organisation (WHO), the IAEA and the European Commission, and the participation of a large number of professional bodies and associations and patients’ associations, ASN organised the first international conference on patient radiation protection in the field of radiotherapy, held in Versailles from 2 to 4 December 2009. Among the major conclusions, the prime position of radiotherapy in the treatment and curing of cancers was reasserted; operator training had to be reinforced and the first utilisations of these techniques should undergo an independent assessment by the professionals. Systems for notifying significant events should be developed with the aim of analysing events and establishing incident learning systems; the involvement of patients and their associations was found to be desirable in the assessment of treatment quality and safety and in the areas of risk management and communication. A special issue of Contrôle magazine is available in PDF format on the asn.fr website The notification of significant events to ASN Radiation safety oversight is based on incident reports which are sent to the authorities by the health professionals. Two radiation safety oversight systems coexist in the field of radiotherapy: • medical devices vigilance, which comes under the remit of the AFSSAPS (French Health Products Safety Agency), concerns the incidents or risks of incidents involving medical devices during their use. The Public Health Code now specifies that the persons/entities responsible for a “nuclear activity” are subject to an obligation to notify ASN and the State representative in the département of “any incident or accident in the area of radiation protection that could jeopardise peoples’ health by exposure to ionising radiation”; • the obligation for health professionals involved in the treatment or follow-up of patients exposed to ionising radiation for medical purposes, who are aware of an incident or accident linked to this exposure, notify it without delay to ASN and the Director General of the Regional Health Agency – ARS (Act of 21 July 2009). Quality assurance obligations The errors committed at Épinal included a lack of preparation of the operators for the change of software and protocol, and failure to inform the public. ASN has tightened the regulations since then by detailing the quality assurance obligations. The aim of the regulatory requirements is to develop the safety culture and the integration, in the organisation of the radiotherapy departments, of management of the risks run by patients. For the radiotherapy centres, the main obligations concern the setting up of a quality management system (QMS), a senior management commitment under the QMS; the accountability of the personnel; the analysis of the risks run by the patients during the radiotherapy process; keeping a record of and addressing adverse situations or dysfunctions, from the organisational, human and material aspects. To accompany these regulatory changes, ASN has published a Guide to the management of safety and quality of radiotherapy treatments, and a Guide to the self-assessment of the risks run by external-beam radiotherapy patients (available in PDF format on the ASN website). “The Épinal accident sent shockwaves through the world of radiotherapy, which until then had been considered very safe. The international conference on patient radiation protection that we organised in 2009 provided the opportunity to review the state of knowledge of the risks associated with radiotherapy. It ended with a moment of intense emotion when the chairman of an association of victims of the Épinal accident gave his testimonial before more than 200 people on the pain experienced by the victims. This was followed by a debate on the informing of patients, which highlighted the shortcomings in the doctor-patient dialogue. The Chairman of the French Society of Radiation Oncology (SFRO) then pointed out that the physicians unfortunately were not well trained in discussing things with patients and each person did the best they could.” Jean-Luc Godet Director of the Ionising Radiation and Health Department of ASN from 2006 to 2019 Nuclear accidents and developments in nuclear safety and radiation protection • 25
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