Chapter 108 - Legal metrology framework for medical devices

Abstract

Medical devices (MDs) are sophisticated electronic systems whose performances vary depending on the production quality and the environmental conditions in which they are used (European Commission, n.d.-a). Safety and performance of MDs are defined by international standards issued by prominent worldwide organizations and national regulatory bodies (International Organisation for Standardization – ISO, n.d.; International Electrotechnical Commission, n.d.). Although, production process of MDs is regulated by various international and national legal frameworks and procedures (World Health Organisation, n.d.), safety and quality of MD performance in real settings are still not defined. That is the reason why, despite the existence of regulations for MDs unfortunate incidents are not uncommon around the world. Existing frameworks are mostely based on postmarket surveillance performed by manufacturers and distributors, or local health technology assessment (HTA) units. This is done through the establishment of databases for reporting incidents involving MDs. That practice is adopted in United States. The Food and Drug Administration (FDA) (n.d.) receives thousands of reports each year detailing the deaths, serious injuries, and malfunctions associated with MDs. These incidents are, in United States, reported either by healthcare institution or by manufacturer to central database of incidents called Manufacturer and User Facility Device Experience (MAUDE) (Food and Drug Administration (FDA), n.d.). In the Europe, as part of IDABC (Interoperable Delivery of European eGovernment Services to public Administrations, Businesses, and Citizens) program, information system for exchanging legal information related to the application of European Union Directives on medical devices [European Union database on Medical Devices (EUDAMED)] was established (European Commission, n.d.-c). Nowadays, most manufacturers recommend different preventive maintenance procedures for preoperative checking of MD as only method of assessment during usage. All of this suggests that evidence-based performance and safety inspection of MDs already used in health care should be adopted to ensure safety and performance reliability of MDs. Performance inspection regulations exist for other devices with measuring function (electricity meters, gas meters, scales) and it is conducted periodically based on metrological procedures so measurements are traceable to international standards. Therefore, this chapter gives an overview of key elements for legal metrology framework for inspection od MD safety and performance that can be part of various HTAs protocols.