Every hip counts The central implant registry is intended to increase safety for patients. It was a scandal: In 2010, it became known to the general public that the French manufacturer Poly Implant had been producing inferior breast implants for years. As a result, hundreds of women had to have the silicone-containing, often defective preparations removed. Poly Implant revealed gaps in the control system of medical devices that are only gradually being closed. As recently as the end of 2018, a network of journalists discovered the "Implant Files": gaps in the approval of implants, without which modern high-performance medicine is inconceivable. Pacemakers, vascular prostheses, stents, cochlear and retinal implants: there is hardly an area in which medical devices cannot support or replace bodily functions. "The legislator has now reacted to the abuses," says Prof. Henning Windhagen, Director of the Orthopedic Clinic of the Hannover Medical School (MHH) at the DIAKOVERE Annastift. He points to the significantly tightened approval procedure for medical devices at the EU level. Another advance is the current 16 voluntary implant registries for pacemakers and other implants maintained by medical societies more. "Products can remain in the patient's body for decades. Without registries, long-term effects are almost impossible to detect," says Windhagen. A shining example is the Endoprostheses Register Germany (EPRD), established in 2012. According to Windhagen, almost 716 of 1,200 German hospitals that insert around 450,000 endoprostheses, i.e. artificial hip and knee joints, each year now report the data of patients - if they agree. "That's still 66.7 % of the implants inserted that are recorded in this way," says Windhagen. The importance of data collection is shown by the more than 45,000 endoprosthetic operations performed each year in which, according to the EPRD, old implants are exchanged for new ones without the real reasons being known. Another example is thousands of hip replacements used until about 2010, in which the ball and joint alike were made of extremely hard cobalt chrome. "With the register, doctors would have been able to identify the problems with this design much earlier," Windhagen is certain. His advice to patients: Only have operations performed in hospitals that report to the EPRD and are also part of the German Endoprosthetics Centers (EPC) network. Experts such as Windhagen believe that the statutory minimum volumes are not sufficient, not to mention the fact that hospitals tend to disregard them, as the German medical journal "Ärzteblatt" reported in June 2019. "A single surgeon should be able to perform at least 50 operations a year, as specified in the EPCs, and at least 100 operations in the case of complicated procedures, for example due to congenital deformities," says Windhagen. Another advantage of the EPCs is the co-pilot concept: "A specialist must assist an experienced surgeon for two years before he or she can lead an operation," Windhagen explains. In order to close the remaining gaps in the registration of implants, the establishment of a central registry based in Cologne is to start in 2020. It will merge the existing voluntary registries, cover additional implant groups and introduce a reporting requirement: Clinics will then have to report every "installation" of an implant and patients will have to agree to data transmission. "Ultimately, this is in the interest of patients," Windhagen says. HAZ/NP Safety Weeks 07.11.2019