ASN Report 2021

With regard to the radiation protection risks, the ASN inspections focus on radiation protection of workers (organisation of radiation protection, delimiting restricted areas, ambient dosimetry, staff dosimetry) and patients (analysis of DRLs, quality control of medical devices, control of dispensing of RPDs,) and source management (circuit followed by unsealed sources, from delivery to disposal, such as the delivery reception premises, storage tanks and effluent discharges). In 2021, 79 nuclear medicine departments were inspected, representing 33% of the facilities. Despite continuation of the epidemic, inspections that were unable to be done in 2020 were carried out in 2021. Just one inspection was carried out remotely, under the adaptation of inspection methods to the pandemic situation. 2.3.3.1 Radiation protection of nuclear medicine professionals From the radiological viewpoint, the personnel are subjected to a risk of external exposure –in particular on the fingers– due to the handling of certain radionuclides (case with fluorine-18, iodine-131, gallium-68 or yttrium-90) when preparing and injecting RPDs, and a risk of internal exposure through accidental intake of radioactive substances. The results concerning radiation protection of professionals (see Graph 5) show that the radiation protection measures implemented by nuclear medicine departments are generally satisfactory with regard to the appointing of a Radiation Pro– tection Expert-Officer (RPE-O) dedicated to this activity (valid certificate issued by the employer in all the inspected depart– ments), the analysis of the dosimetric results of the medical staff, and the consistency between the delimiting of restricted areas and the results of the working environment verifications. Two lines for improvement have nevertheless been identified: the updating of personnel training in occupational radiation protection (all the medical professionals concerned have been trained within the last three years in only 61% of the departments,) and coordination with outside contractors, for which less than one third of the nuclear medicine departments (28%) have established a prevention plan with all the intervening outside contractors. 4. Order of 23 May 2019 approving ASN resolution 2019-DC-0667 of 18 April 2019 concerning the methods for evaluating ionising radiation doses delivered to patients during a radiology procedure, fluoroscopy-guided interventional or nuclear medicine practices, and the updating of the corresponding diagnostic reference levels. Alongside this, the radiation protection technical controls have been carried out over the last two years at the regulatory frequency for all the sources and devices and for the radioactivity measuring and detection devices, in 93% of the 79 departments inspected. Only four of the 21 departments concerned by nonconformities had not corrected them on the day of the inspection. 2.3.3.2 Radiation protection of nuclear medicine patients Since ASN resolution 2019-DC-0667 of 18 April 2019 on Diagnostic Reference Levels (DRLs)(4) came into effect, ASN has been assessing the new requirements concerning the quality of recording of doses, their analysis and the optimisation put in place where necessary. The inspections carried out were satisfactory in 78% of the departments. However, 22% of the departments had not optimised their practices even though this was necessary (exposure levels significantly higher than the DRLs) The external quality controls of the last two years have moreover been carried out on all the medical devices at the required regulatory frequency and the nonconformities discovered have been remedied in all the inspected departments. The organisation put in place to integrate medical physicists and specify their duties and time of presence on site is fully defined in 83% of the inspected departments (see Graph 6). On the other hand, in 15% of the cases the Medical Physics Organisation Plan (POPM) was incomplete, and in one department the medical physics organisation described in the POPM was deemed inadequate in view of the risks associated with the activity (insufficient medical physics resources to fulfil tasks such as recording and analysing the doses for the CT scanner). Along with this, further to the publication of two ASN resolutions, 2019-DC-0660 and 2021-DC-0708 laying down the quality assurance obligations for medical imaging and therapeutic procedures respectively, ASN observes commitment and significant investment on the part of the medicine departments in the deployment of quality management systems and notes a good events reporting culture in the majority of the inspected departments. GRAPH Conformity of the inspected facilities with regard to radiation protection of patients in 2021 6 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Organisation of medical physics Complete management of NRD (recording, analysis, optimisation if necessary) Complete management of annual external quality controls ASN Report on the state of nuclear safety and radiation protection in France in 2021 219 07 – MEDICAL USES OF IONISING RADIATIONS 08 07 13 04 10 06 12 14 03 09 05 11 02 AP 01

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