REGISTRIES OF MEDICAL DEVICES IN THE EUROPEAN UNION
Author(s)
Niederländer CS, Wahlster P, Kriza C, Schaller S, Kolominsky-Rabas PUniversity of Erlangen-Nuremberg, Erlangen, Germany
Presentation Documents
OBJECTIVES: In early 2012, there were a number of serious events in the implant area. A recent example are the defective breast implants of the French company Poly Implant Prothese. The second incident concerns 'metal on metal' (MoM) hip implants. These events raised public awareness and started a scientific discussion in academia and politics on safety issues and monitoring medical devices. Apparently, there is a big lack in the surveillance of medical devices. Therefore, the objective of this work is to detect existing implant registries in the European Union. METHODS: A systematic review of the literature was carried out to identify different types of implant registries in the European Union Member States (EU MS). The systematic search for implant registries was performed in the databases PubMed, Medline, CRD York. All results up to April 2012 were considered. RESULTS: Ninety-nine registries in the EU MS for different types of implants were identified. As demonstrated, most registries exist in the field of cardiac implants and arthroplasty (34 and 30 within Europe). The distribution of implant registries showed variation in the different EU MS. For a lot of implant categories, none or very few registries could be identified. Some countries run more registries than others (UK 15, Portugal 1). CONCLUSIONS: The results show that there is only a limited number of reviews on registries and a centralized monitoring system in the EU MS is missing. Our results reveal a lack of transparency concerning number, aim, structure and quality of registries. This is crucial, as registries work as an early warning systems for identifying and notifying patients at risk. [The research is supported by the German Federal Ministry of Education and Research (BMBF), project grant No. 01EX1013B as part of the Centre of Excellence for Medical Technology].
Conference/Value in Health Info
2012-11, ISPOR Europe 2012, Berlin, Germany
Value in Health, Vol. 15, No. 7 (November 2012)
Code
PHP26
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes
Disease
Multiple Diseases