ASN Report 2017

283 ASN report on the state of nuclear safety and radiation protection in France in 2017 Chapter 09  - Medical uses of ionising radiation 5.5.1 Radiation protection of nuclear medicine professionals On completion of the inspections performed in 2016, ASN had observed that virtually all the nuclear medicine departments had defined and implemented means of protection (lead- shielded cases or trolleys) aiming to limit the exposure of workers and the public when radiopharmaceuticals had to be transported for utilisation outside the nuclear medicine department, for example in a neurology department or an interventional radiology room. ASN had nevertheless considered that weaknesses subsisted: ཛྷ ཛྷ This was because the working environment analyses were not carried out for all the jobs and did not always include the internal exposure of the workers. ཛྷ ཛྷ Only 69% of the departments carried out all of the internal technical controls at the required frequencies. ཛྷ ཛྷ The continuous training of workers in radiation protection remained incomplete for newly hired personnel, nuclear physicians, physicians performing procedures from time to time (cardiologists) and the cleaning services personnel. ཛྷ ཛྷ Shortcomings were still observed in the coordination of the general prevention measures which the nuclear medicine departments were to provide when an outside company was required to work in the facility. Only 34% of the departments had formalised the coordination of the prevention measures. ཛྷ ཛྷ In 80% of the departments with ITR rooms, protection equipment had been made available to the workers (gloves, masks, sometimes coveralls, overshoes and caps covering hair and, if necessary, lead aprons). 5.5.2 Radiation protection of patients in nuclear medicine ASN observed that the external quality verifications of the medical devices were now carried out in virtually all the nuclear medicine departments inspected and that the information relative to the dispensing and recording of staff training in patient radiation protection was available in nearly 80% of these departments. With regard to the utilisation of automated systems for preparing and injecting radiopharmaceuticals, which are becoming common practice for the handling of fluorine-18, particularly for injecting the patient, nearly all personnel had received training in routine use and in the event of a malfunction. The utilisation protocols however were not always subject to strict quality assurance procedures and the points to check were not all formalised. The other weaknesses observed concerned the following points: ཛྷ ཛྷ With regard to optimisation, although the diagnostic reference levels were systematically recorded and forwarded to IRSN, only 10% of the inspected departments analysed the values recorded to assess their practices. ཛྷ ཛྷ The utilisation protocols for CT scanners coupled with gamma cameras were only optimised in 62% of the inspected facilities and iterative image reconstruction software was available in less than 50% of the facilities. ཛྷ ཛྷ The marking efficiency checks (percentage of the radiopharmaceutical actually marked by a radionuclide), provided for in the commercialisation authorisation for each radiopharmaceutical, were carried out in 75% of the departments inspected. 5.5.3 Protection of the general public and the environment ASN has observed a steady improvement in the quality of the effluent and waste management plans produced by nuclear medicine departments, which are now implemented in all the departments. There are nevertheless still some shortcomings: ཛྷ ཛྷ Only 86% of the inspected departments are in compliance with ASN resolution 2008-DC-0095 of 29th January 2008. ཛྷ ཛྷ The accessible pipes which carry contaminated effluents are identified and signalled in 74% of the facilities. ཛྷ ཛྷ Periodic checks were carried out at the outflow from the centre at frequencies varying according to the facilities inspected (in 2016, out of 63 departments inspected, 89% perform a check at least once per year and 3% have never performed checks). ཛྷ ཛྷ 65% of the departments had been issued an authorisation to discharge contaminated effluents from the manager of the public sewage network (the number of departments with an authorisation has nevertheless been increasing since 2014). With regard to the implementation of the recommendations issued in ASN’s circular letter of 17th April 2012 drawing up the lessons learned from several ESRs involving leaks in pipes carrying liquid effluents contaminated by nuclear medicine radionuclides, the following findings were made: ཛྷ ཛྷ In 63% of the facilities, the department’s pipeline networks and, where applicable, the ITR rooms, had been mapped. ཛྷ ཛྷ In 49% of the departments, the condition of the pipes and tanks was monitored. ཛྷ ཛྷ In about 40% of the departments, an intervention protocol and a reflex response sheet in the event of tank leakage had been drawn up. 5.5.4 Nuclear medicine facilities ASN resolution 2014-DC-0463 of 23rd October 2014 relative to nuclear medicine facilities set requirements for the ITR rooms with entry into effect on 1st July 2018 (dedicated rooms, independent ventilation system and under negative pressure). Among the 20 departments inspected having at least one ITR room (from 1 to 7 rooms), 5% of the rooms, at present not dedicated exclusively to patients to whom radionuclides have been administered for therapeutic purposes, were to be brought into compliance before 1st July 2018. The same goes for half of the rooms which, on the day of the inspections, were not ventilated with negative pressure. 5.5.5 Notified events in nuclear medicine One hundred and forty-eight ESR were notified in 2017, representing an increase of 28% over 2016. It is probable that the opening of ASN’s on-line notification portal in 2017 contributed to this increase due to the simplification of the procedure. As in the preceding years, most of the notified events concerned patients examined for diagnostic purposes (63%). Significant events concerning patients (98 ESRs, i.e. 66% of the notified ESRs) The majority of these ESRs were linked to errors in the administration of radiopharmaceuticals to a patient (interchanging of syringes or patients), errors in prepared