ASN Report 2018

4.2  ̶  Layout rules for nuclear medicine facilities Given the radiation protection constraints involved in the use of unsealed radioactive sources, nuclear medicine units are designed and organised so that they can receive, store, prepare and then administer unsealed radioactive sources to patients or handle them in laboratories (radioimmunology for instance). Provision is also made for the collection, storage and disposal of radioactive wastes and effluents produced in the facility, particularly the radionuclides contained in patients’ urine. • Compliance with ASN resolution 2014-DC-0463 Nuclear medicine units must satisfy the rules prescribed by ASN resolution 2014-DC-0463 of 23 October 2014 relative to the minimum technical rules of design, operation and maintenance to be satisfied by in vivo nuclear medicine facilities. This resolution details in particular the rules for the ventilation of nuclear medicine unit premises and the rooms accommodating patients receiving, for example, treatment for thyroid cancer with iodine-131. ASN published its Guide No. 32 clarifying certain aspects of this resolution in May 2017. Compliance was required by 1 July 2015 for nuclear medicine facilities and by 1 July 2018 for internal targeted radiotherapy rooms. However, departments licensed before 1 July 2015 which did not meet these requirements had to comply with them if they underwent major modifications. Since 1 July 2015, the ASN division radiation protection inspectors have assessed the compliance of the facilities during inspections: ∙ ∙ For the radionuclide handling rooms, the rooms in the nuclear medicine sector and the provisions for lung examinations, the data show that the virtually all the departments comply with the requirements concerning the ventilation system, with the exception of the ventilation system for lung examinations which is not always independent of the system for the rooms in the nuclear medicine sector. ∙ ∙ For the ITR rooms, a first compliance assessment had been carried out before July 2018 on the basis of the inspections conducted between 2015 and 2017: the inspectors at the time found that about half of the structures were noncompliant (independent ventilation and negative pressure). The verifications shall be continued in 2019. • Compliance with ASN resolution 2017-DC-0591 Furthermore, the facilities equipped with a CT scanner coupled with a gamma-camera or a PET camera must comply with the provisions of ASN resolution 2017-DC-0591 of 13 June 2017 (4) . • Compliance with ASN resolution 2008-DC-095 Like all facilities producing waste and effluents contaminated by radionuclides, they must comply with the provisions of ASN resolution 2008-DC-0095 of 29 January 2008 (5) setting the technical rules that the disposal of effluents and waste contaminated by radionuclides must meet. Premises must be dedicated to these activities, as must specific equipment for monitoring the conditions of effluent discharges (tank filling levels, leakage alarm systems, etc.). The compliance of the facilities intended to accommodate the effluents and wastes produced by nuclear medicine departments is verified regularly (see point 4.3.3.). 4. ASN resolution 2017-DC-0591 of 13 June 2017 setting the minimum technical design rules to be met by premises in which devices emitting X-rays are used. 5. Order of 23 July 2008 approving ASN resolution 2008-DC-0095 of 29 January 2008 setting the technical rules to be met for the elimination of effluents and waste contaminated by radionuclides, or liable to be so contaminated owing to a nuclear activity, issued in application of the provisions of Article R. 1333-12 of the Public Health Code. 4.3  ̶  Radiation protection situation in nuclear medicine Sixty-nine nuclear medicine departments, i.e. 30% of the facilities, were inspected in 2018. 4.3.1  –  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 or yttrium-90) when preparing and injecting radiopharmaceuticals, and a risk of internal exposure through accidental intake of radioactive substances. The results for radiation protection of the medical professionals (Graph 10) show that the radiation protection measures deployed by the nuclear medicine departments are on the whole satisfactory. It is noted, for example, that all the inspected departments have appointed an RPE-O dedicated to this activity, with a valid certificate delivered by the employer. Two areas for improvement have nevertheless been brought to light, namely the refreshing of personnel training and, above all, the coordination with outside companies (only 30% of departments have established coordination measures with all these companies). 4.3.2  –  Radiation protection of nuclear medicine patients The radiation protection of nuclear medicine patients can also be considered satisfactory in the departments inspected in 2018. Thus, in more than 90% of the departments that perform therapy or diagnostic procedures using iodine-131 (43 of the 69 departments inspected), a printed information leaflet is given to the patient in accordance with the order of 21 January 2004 and the recommendations of the SFMN (French Society of Nuclear Medicine). The external quality controls of the last two years have been carried out on all the medical devices at the correct frequency and any nonconformities discovered have been remedied in nearly 90% of the departments. In all the other cases, either the control has not been carried out at the regulatory frequency, or it has not covered all the devices concerned. ASN inspection in the Morvan Hospital in Brest – September 2018 218  ASN report on the state of nuclear safety and radiation protection in France in 2018 07 – MEDICAL USES OF IONISING RADIATION