Postmarket Surveillance of Orthopaedic Implants using Web-technologies
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In the European Union (EU) between 8-12 % of patients admitted to hospitals, suffer harm from the healthcare they receive every year. There are many reasons for this, e.g. surgical error, error in diagnostics and medical device failures etc. (European Commission, 1994). Currently there is no publicly available central system to log/archive failures of medical devices inside of Europe. Under the EU's medical device directive, surgeons are requested to report failures to the nation's relevant government department. In Norway, they have Helsedirektoratet, which covers this role. The Ministry of Health and Care Service administrate Helsedirektoratet (Helsedirektoratet, 2014). In the U.S., the Food and Drug Administration (FDA) has implemented such a system called MAUDE (Manufacturer And User Facility Device Experience) (FDA, 2014). In this Open Data search engine, surgeons and even the public can search data and information regarding all the failures collected in the system. At Haukeland University Hospital in Bergen, the Biomaterial Research Group are implementing a retrieval centre where the goal of the centre is to promote surgeons to send failed knee and hip prosthesis to Bergen, so that they can be reported directly to Helsedirektoratet. The goal of the retrieval centre is to discover bad prosthesis, cements or bad surgery techniques as early as possible to avoid complications and to improve the treatment of patients. They would like to have a system similar to MAUDE, so that both surgeons and potentially the public could view all the failures collected in a reduced format. In addition to this, they want to be able to gather relevant data from several external sources (Helse Bergen, 2014). A high-level prototype has been created in this project. The prototype gathers relevant medical data from the retrieval centre's local database containing failed hip- and knee-prosthesis records, as well as data from three different external sources. The external sources are MAUDE, Clinical Trials and PubMed which are publicly available web-based databases. The system is generating summaries and statistics based on user searches towards the different sources. The prototype is a web application that presents the functionalities and a design alternative for such a system, as well as to promoting Open Data for health research. The system will be a proof of concept as a proposition to generate further funding, with the goal of reaching the entire European Union.