The Importance and Use of Registries for Performance and Safety Information on Medical Implants

It is estimated that at this moment approximately 500,000 different medical devices are marketed in the European Union. Devices have to be safe and effective, and comply with the essential requirements as laid down in European Directives for medical devices. Early detection of device problems is pivotal for authorities overseeing and enforcing this legislation. Clinical (device) registries are an important source of such information. They may contain relevant data to identify products with a lower than expected reliability and are able to identify patients who have been implanted with an inadequate implant. Therefore, the main objective of this thesis was to examine the usability of a number of currently available and accessible registries for information on implant performance and complications of implant therapy. For the studies described in this thesis, existing registries have been used: a utilization register on pacemakers (CPPR-SPRN) and a national hospital discharge records database (LMR). The data in our studies clearly support the vital role registries on implants and implant therapies play in modern day health care. In addition, registries may fulfil a need as source for the formation of study cohorts and providing a reliable denominator for observational studies regarding implant use.