Registries of implantable medical devices in Europe

Abstract

Background: In early 2012, a number of serious events in the implant area raised public awareness and started a discussion on safety issues and monitoring medical devices in academics and politics. Apparently, there is a lack in the surveillance of medical devices. Therefore, the objective of this work is to detect and classify implant registries in Europe.

Methods and findings: A systematic search of literature was carried out to identify the different types of registries. Furthermore, to characterize the implant registries by different criteria a medical device classification system was established. One hundred and one European registries were found. Most registries exist in the field of cardiac implants and arthroplasty (38 and 29) and their distribution showed variation within Europe. For a lot of implant categories, none or very few registries could be identified. Some countries run more registries than others. There are a lot of differences in aim and structure among the registries.

Conclusion: There is only a limited number of reviews on registries and a centralized monitoring system in Europe is missing. Our results reveal a lack of transparency concerning number, aim, structure and quality of registries. This is crucial, as registries work as early warning systems for identifying and notifying patients at risk.

Keywords: Implants; Medical device registry classification; Medical devices; Patient safety; Registry; Registry structure; Safety in health care.