Information System for Postmarket Surveillance of Total Joint Prostheses

Abstract

The storage, integration and presentation of clinical data is an important aspect of any modern medical research. The Biomaterials research group at the Haukeland University Hospital uses both their own locally generated clinical data and external registry data to examine retrieved joint implants. This thesis describes the design and implementation of a database and an application for use at the Biomaterials lab. Its goal was to enable an integrated storage and retrieval system that would combine information from different data sources used by the researchers.As a solution to this challenge, a system prototype was developed that would enable further integration of these information systems into a multi-user environment. The system allows importing registry data and matching it with local data, viewing and editing of this information and exporting the integrated data for further statistical analysis.To guide the research project and improve traceability, the design science paradigm was followed. For the development phase, elements from agile methodologies such as user stories and sprints were applied.An evaluation consisting of both user testing and heuristic evaluation was carried out and generated constructive feedback and positive responses.The prototype demonstrates the feasibility of combining these data sources in a single database and the future possibility of exposing parts of this information to external users through a web application.Future integration of external sources could improve the information management of biobank data for postmarket surveillance of medical devices.i