A new universal, standardized implant database for product identification: a unique tool for arthroplasty registries

• Published in: Archives of orthopaedic and trauma surgery 2015-07, Vol.135 (7), p.919-926
• Main Authors: Blömer, Wilhelm, Steinbrück, Arnd, Schröder, Christian, Grothaus, Franz-Josef, Melsheimer, Oliver, Mannel, Henrich, Forkel, Gerhard, Eilers, Thomas, Liebs, Thoralf R., Hassenpflug, Joachim, Jansson, Volkmar
• Format: Article
• Language: English
• Subjects: Arthroplasty, Replacement - standards; Germany; Humans; Joint surgery; Libraries; Medicine; Medicine & Public Health; Orthopaedic Surgery; Orthopedics; Product Surveillance, Postmarketing - standards; Prostheses and Implants - standards; Prosthesis Failure; Quality Assurance, Health Care; Registries - standards; Transplants & implants
• ISSN: 0936-8051; 1434-3916
• DOI: 10.1007/s00402-015-2238-2

Introduction Every joint registry aims to improve patient care by identifying implants that have an inferior performance. For this reason, each registry records the implant name that has been used in the individual patient. In most registries, a paper-based approach has been utilized for this purpose. However, in addition to being time-consuming, this approach does not account for the fact that failure patterns are not necessarily implant specific but can be associated with design features that are used in a number of implants. Therefore, we aimed to develop and evaluate an implant product library that allows both time saving barcode scanning on site in the hospital for the registration of the implant components and a detailed description of implant specifications. Materials and methods A task force consisting of representatives of the German Arthroplasty Registry, industry, and computer specialists agreed on a solution that allows barcode scanning of implant components and that also uses a detailed standardized classification describing arthroplasty components. The manufacturers classified all their components that are sold in Germany according to this classification. The implant database was analyzed regarding the completeness of components by algorithms and real-time data. Results The implant library could be set up successfully. At this point, the implant database includes more than 38,000 items, of which all were classified by the manufacturers according to the predefined scheme. Using patient data from the German Arthroplasty Registry, several errors in the database were detected, all of which were corrected by the respective implant manufacturers. Conclusions The implant library that was developed for the German Arthroplasty Registry allows not only on-site barcode scanning for the registration of the implant components but also its classification tree allows a sophisticated analysis regarding implant characteristics, regardless of brand or manufacturer. The database is maintained by the implant manufacturers, thereby allowing registries to focus their resources on other areas of research. The database might represent a possible global model, which might encourage harmonization between joint replacement registries enabling comparisons between joint replacement registries.