Maintenance and quality control of medical devices

Maintenance and quality control, both internal and external, of medical devices using ionising radiation (articles R. 5211-5 to R. 5211-35 of the Public Health Code) have been mandatory since publication of the order of 3 March 2003. Outside quality control is entrusted to organisations approved by the Director General of the AFSSAPS who is responsible for issuing a decision to define the acceptability criteria, the monitoring parameters and the frequency of the inspections on the medical devices concerned.

Four decisions were published:
- decision of 2 March 2004 concerning outside quality control of external radiotherapy installations;
- decision of 2 March 2004 concerning electron accelerators for medical uses and tele-cobalt therapy devices.
– decision of 20 April 2005 setting the quality control procedures for bone mineral density test devices using ionising radiation;
– decision of 7 October 2005 concerning monitoring of mammography installations, modified by a decision of 16 December 2005.

Furthermore greater knowledge of the radiology appliances in use will be needed to further external quality control and assess how effective it is. Therefore a new ownership notification procedure was set up in 2004 for radiological equipment.

Training and information

Additional major factors in the optimisation approach are the training of health professionals and informing patients. Work is continuing on finalising the mechanism introduced in March 2003, through statutory channels.

Thus the objectives and content of training programmes for practitioners conducting procedures using ionising radiation, or who assist in these procedures, were defined in the order of 18 May 2004. This patients radiation protection training is already part of initial medical training programmes and extends to other medical professions involved in these procedures; on-the-job training, currently being devised by learned societies and professional bodies, will also be offered to working practitioners.

As regards the traceability of the data on the application of justification and optimisation, the report on the procedure, written by the medical practitioner carrying out the examination, must provide the information justifying the need for the exposure, the operations carried out and the data used to estimate the dose received by the patient. An order is awaited that will specify the nature of this data in detail.

Finally, before carrying out a diagnostic or therapeutic procedure using radionuclides, the physician must give the patient oral and written guidelines on radiation protection that are of use to him/herself, his/her relations, the public and the environment. In the event of a therapeutically-oriented nuclear medicine procedure, this information, issued in a written document, provides lifestyle hints to enable potential contamination to be minimised and states, for example, for how many days contacts with the spouse and children should be reduced. Recommendations (the French High Council on Public Health, or learned societies) are awaited to harmonise the content of information already given out.

In the medico-legal field, ionising radiation is used in a wide variety of sectors such as occupational medicine, sports medicine or for investigative procedures required by the courts or insurance companies. The principles of justification and optimisation defined apply both to the person requesting the examinations and to the person performing them.

In occupational medicine, ionising radiation is used for medical supervision of workers (whether or not professionally exposed to ionising radiation, for example workers exposed to asbestos). A working group set up by the ASN is examining the justification and optimisation of various procedures currently conducted, some of which are required by the regulations. The conclusions of this work will be available during the course of 2006.

For medical supervision of high-level athletes, radiographic examinations are stipulated in the regulations (order of 11 February 2004). On the basis of the work of an expert group, tasked jointly by the Minister for Sport, the Directorate-General for Health and the ASN with evaluating the justification for these examinations, a modification to this order is planned for 2006.