Traceability of Medical Devices Used During Surgeries : A Study of the Current Traceability System at the Karolinska University Hospital in Solna and Research of Improvement

Sammanfattning: The last few decades' development of technology has greatly affected healthcare. The implementation of technology in healthcare has advanced and improved it immensely, but it has also brought a new level of complexity. One of the modern issues introduced to healthcare is the traceability of medical devices. The main reason why traceability is becoming a more important matter in regards to healthcare is because of patient safety. Patient safety is one of the greatest priorities in healthcare but is constantly challenged by new innovations. Enabling traceability of medical devices is a part of the process of ensuring patient safety. The aim of this master thesis project was to research how medical devices used in surgeries are traced and how the routine can be improved. The idea of this thesis was based on the application of two new regulations, Regulation (EU) 745/2017 and Regulation (EU) 746/2017, both with the purpose of improving traceability. Qualitative methods such as observations, surveys, and interviews were used for this project. To gain multiple perspectives on the issue, different target groups were defined for the collection of data. The qualitative data was then analysed and conclusions based on the data could be drawn. The results of this project showed that the current traceability routine is lacking and that there is a lot of potential for improvements. The computer systems that manages information regarding medical devices can enable proper traceability if combined with other systems. Improvements of features in the systems are suggested, as well as an idea of an integrated system that combines functionalities of other software. Some of the project's challenges are discussed and suggestions for how to further develop the research are presented.