ASN Report 2017

282 ASN report on the state of nuclear safety and radiation protection in France in 2017 Chapter 09  - Medical uses of ionising radiation departments and showed the same shortcomings with regard to the risks incurred by the patients and the management of adverse events. The following findings were made: ཛྷ ཛྷ All the centres inspected had designated an operational quality manager and defined the person’s missions, objectives and the means at their disposal. ཛྷ ཛྷ All the centres inspected had formalised the mapping of the processes. ཛྷ ཛྷ 17 of the centres inspected had defined treatment quality and safety objectives, but 3 centres did not follow them all or did not update them all. ཛྷ ཛྷ The study of the risks run by patients in brachytherapy was carried out in the majority of the inspected centres but in six of them it was not updated. ཛྷ ཛྷ All the inspected centres made improvement proposals following the adverse events analysis, but six centres did not keep track of their implementation. ཛྷ ཛྷ All the inspected centres had put in place a management review and eight of them also carried out internal audits and process reviews. Maintenance and quality controls In 2016, the majority of the centres had an inventory of medical devices and a register for recording maintenance operations and quality controls. In the absence of a decision from the ANSM (Health Products Safety Agency) defining the quality controls for brachytherapy devices, the nature of the quality controls always resulted from past practices and was based on recommendations provided by the device manufacturers or the professionals. Maintenance of the HDR and PDR afterloaders was ensured by the manufacturers. More specifically, the manufacturers performed the afterloader operating verifications when replacing the sources. The brachytherapy units relied on these verifications to guarantee correct operation of the devices. The source activity was verified at each delivery and source removal verifications were also carried out. 5.4.3 Management of sources Management of the brachytherapy sources was satisfactory. All the centres inspected in 2016 recorded the tracking of source movements, transmitted the source inventory to IRSN and stored the sources waiting to be loaded or collected in a suitable place. Twenty-one percent of the centres inspected in 2016 stored expired sealed sources pending their removal. 5.4.4 Emergency situations Two events involving the jamming of an iridium-192 source in a PDR or HDR afterloader, which occurred in 2013 and 2016, led to the exposure of a worker and a patient. These events emphasised the importance of training the personnel in emergency measures. This training must focus in particular on the emergency measures to implement in the event of loss of control of a high-activity source (jamming of the source, for example). However, exercises to prepare for and assess intervention methods were still very rare. There was progress in compliance with requirements concerning increased training in occupational radiation protection for the use of high activity sealed sources, but further efforts were still necessary so that, in each centre, all the personnel concerned could receive this training (14 of the 20 centres inspected had provided this training for all the personnel). 5.4.5 Notified events in brachytherapy 10 ESRs were notified in brachytherapy in 2017. These events concerned patient identity errors, afterloader positioning errors, source management deficiencies (loss of iodine seeds, discovery of orphan source) and dose errors. Among the dose errors, one event was rated level 2 on the ASN-SFRO scale. A dose of 20 grays in two 10-gray sessions was delivered, whereas the total dose prescribed was 10 grays to be delivered in two 5-gray sessions. This error resulted from incorrect manual entry of the dose per session in the R&V (record and verify) system. Analysis of the event revealed organisational deficiencies in the defining and planning of tasks. The procedures were imprecise with regard to the points to check and the brachytherapy appointment schedule did not take account of the schedules of the physicians and physicists. With regard to the management of sources, a loss-of-sources ESR was rated level 1 on the INES scale because an incident of this type had occurred previously and the checks carried out failed to prevent it from recurring. In this particular case, three grains of radioactive iodine (iodine-125) used for brachytherapy treatments of the prostate were lost, then detected when they activated a radiation portal monitor at the entrance to a waste disposal site. The checks carried out with a radiation detector in the intervention room and on leaving the centre failed to detect the three grains which had fallen into a bin for potentially infectious clinical waste. This event revealed a lack of rigour in the end-of- intervention checks. 5.4.6 Summary Despite the encouraging findings of the inspections in the last few years, ASN considers that efforts must still be made to reinforce the radiation protection training of workers when high-activity sources are involved. 5.5 Radiation protection situation in nuclear medicine Since 2013, the inspection frequency is established each year applying a graded approach to oversight by distinguishing: ཛྷ ཛྷ those facilities in which only diagnostic procedures are performed, where an inspection is carried out every five years instead of every three years; ཛྷ ཛྷ the departments practising a therapeutic activity, with or without patient hospitalisation in a radiation-shielded room, for which a three-year frequency is maintained. Sixty-seven nuclear medicine departments were inspected in 2016 (i.e. about 29% of the departments). Among these departments, 44 had a nuclear pharmacy authorised by the ARS and 20 had at least one ITR room (from 1 to 7 rooms) out of a total of 48 rooms. In 2017, 72 departments were inspected.