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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 fur angewandte Qualitatsforderung 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 fur Qualitatssicherung 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. |
