Healthcare System Stakeholders

Abstract

In order for a medical device to be marketable in Europe it must bear the CE mark. CE certification is granted if the device conforms to specific safety and performance requirements. Monitoring is conducted by so-called »Notified Bodies«. Manufacturers can select any one of these certification bodies to certify a medical device. In Germany, the certification procedure for endoprostheses is regulated in the Medical Device Directive 93/42/EEC and is implemented through the Medical Devices Act and further decrees. Up to now, the AQUA Institute for Quality Improvement and Research in the Healthcare System (AQUA-Institut für angewandte Qualitätsförderung und Forschung im Gesundheitswesen) has been responsible for external inpatient quality assurance which is mandatory in Germany. The institute publishes detailed reports concerning the quality outcomes of patient care, which both hospitals and patients can use for comparisons with other establishments. As of 2016, the Institute for Quality Assurance and Transparency in the Healthcare System (Institut für Qualitätssicherung und Transparenz im Gesundheitswesen (IQTiG)), which was founded by the Federal Joint Committee, has assumed this responsibility. The German arthroplasty registry »Endoprosthenregister Deutschland« was initiated in 2013 and aims to document quality outcomes of knee and hip arthroplasty across Germany. The purpose of the registry is to enable the tracking of typical service lives of implants used and to investigate reasons for undesired treatment outcomes. The validity of the registry is still limited as about only half of the hospitals that perform arthroplasty currently contribute to it and only a limited number of primary hip and knee arthroplasties are recorded.

EndoCert is a certification system that was established by the German Society of Orthopedics and Orthopedic Surgery (Deutsche Gesellschaft für Orthopädie und Orthopädische Chirurgie (DGOOC)) and the German arthroplasty association »Deutsche Gesellschaft für Endoprothetik (AE)« and the Professional Association of Orthopaedic Surgeons (Berufsverband der Fachärzte für Orthopädie und Unfallchirurgie e. V. (BVOU)).

Initial results show a decline in complication rates and an improvement in outcome quality amongst a few certified institutions.

Alongside representing the interests of their members and offering basic and specialty training, medical societies also assume an important role with regard to research and towards improving the quality of healthcare. The trauma registry »TraumaRegister of the German Society for Trauma Surgery (Deutsche Gesellschaft für Unfallchirurgie (DGU))« is affiliated with hospitals specializing in trauma surgery and aims to evaluate the effectiveness of methods used in medical treatment. The German arthroplasty association »Deutsche Gesellschaft für Endoprothetik (AE)« is a division of the German Society for Orthopaedics and Trauma (Deutsche Gesellschaft für Orthopädie und Unfallchirurgie (DGOU)) and is involved in quality assurance of endoprosthetic care and in the development of new technologies.