“The Épinal accidents played a major role in our relations with the medical sector. Our rigorous intervention enabled us to establish a close collaboration with the French Society for Radiation Oncology (SFRO). Patients died at Épinal, but many of the survivors suffered horrific and often irreversible damage. And this happened in Épinal, barely 60 km from the major radiotherapy centre of Nancy, a very large centre where the Épinal hospital radiotherapists, had they recognised their shortcomings and been organised, could have ‘realigned’ their practices.” André-Claude Lacoste ASN Chairman from 2006 to 2012 A chain of dysfunctions The effects of the accident were minimised by the hospital personnel concerned. The authorities were not informed of the true nature of the problems within the required time. Moreover, there were no organisational barriers serving to prevent this accident and manage its health consequences. ASN-SFRO scale for classifying nuclear incidents and accidents in the medical field and radiation protection events, developed in July 2007 by ASN in collaboration with the French Society for Radiation Oncology (SFRO). Like the INES scale, the criteria for classifying an event concern not only the confirmed consequences but also the potential effects of the events. Event 0 Event 1 Incident 2 Incident 3 Accident 4 For example, patient identification error with a patient treated for the same pathology (can be compensated for). Dose or volume error: for example, dose error or target error during one session, that cannot be compensated for over the duration of the treatment. Dose higher than the recommended doses, or irradiation of a volume that can lead to unexpected but moderate complications. Dose or irradiated volume higher than tolerable doses or volumes. Dose or irradiated volume very much higher than tolerable doses or volumes. Dose (or irradiated volume) very much higher than normal, leading to complications or sequels incompatible with life. No symptoms expected. Moderate, unexpected or unpredictable acute or latent effect of grade 2, with minimal or zero deterioration in quality of life. Severe, unexpected or unpredictable acute or latent effect of grade 3. Serious, unexpected or unpredictable acute or latent effect of grade 4. Death. Event with no consequences for the patient. Event with dosimetric consequence, but no expected clinical consequence. Event causing or likely to cause moderate deterioration of an organ or function. Event causing severe deterioration of one or more organs or functions. Serious event jeopardising life, complication or disabling sequel. Death. Accident 5to7 EVENTS (unplanned, unexpected) CAUSES CONSEQUENCES (grades CTCAE V3.0) APPLICATION OF THE ASNSFRO SCALE Radiotherapy uses ionising radiation to destroy cancer cells. The ionising radiation necessary for the treatments is either produced by an electric generator or emitted by radionuclides in sealed sources. There are two different techniques: external-beam radiotherapy (the radiation source is external to the patient), and brachytherapy (the source is introduced into the patient and positioned as close as possible to the area to treat). 409 patients were concerned by the radiation overdoses between 2001 and 2006. They were all treated for prostate cancer and 66 of them suffered severe complications. It is the cohort of 24 patients treated from 2004 to 2005 which was the most severely affected, with ten deaths. If several patients die: – the minimum level 5 is increased to 6 if the number of patients is greater than 1 and less than or equal to 10; – the minimum level 5 is increased to 7 if the number of patients is greater than 10. If the number of patients is greater than 1, a + sign is added to the chosen level (example: 3 becomes 3+). Nuclear accidents and developments in nuclear safety and radiation protection • 23
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