Traceability of Single-Use Medical Devices through the Hospital Supply Chain. Reflections and Recommendations for Implementation of Single-Use Medical Devices Traceability

Abstract: There is an increased need for complete medical device traceability in the healthcare industry. The two main reasons are the healthcare industry's global supply chain and decentralised adverse events reporting, where different laws apply for each country and where each country has their own database for incidents without international governance. The idea of improving traceability procedures in the surgical department at Karolinska University Hospital was formed in the light of a near miss event where guidelines regarding incident management of a Single-Use Medical Device (SUMD) were not followed properly. Hence, this thesis project will investigate the issue of finding an effective way to trace SUMDs at Karolinska University Hospital, in order to improve the incident management process and suggest improvements of patient safety at other Swedish hospitals as well. The collection of data consisted of different data sources; observations at the research site and interviews with relevant participants. By employing multiple sources to this study, a more holistic approach could be achieved. In addition to observing the current situation of device registration, it was of importance to ask individuals with competence and different perspectives on the issue of traceability of SUMDs. To answer the research questions, the acquired data was categorized into the different identified cornerstones of traceability of SUMDs. These were registration process, perioperative supply chain and incidents management. Each section was divided into an investigation of the current process, issues and suggested improvements, in order to clearly answer to the research questions. Furthermore, these acquired answers and insights, from observations and interviews, were translated and summarized to form a basis for the results. Based on the data acquisition and compilation from the different perspectives, key findings and themes are presented in the results. The thesis proposal include a visual representation that show the physical flow of a SUMD from the point of being delivered to the hospital by the distributor, through different entities where registration occur, until it is either discarded or saved for incidents reporting. In order to avoid many of the current issues and to realize the acquired suggestions from this thesis, interoperability between the systems within the healthcare organization as well as between the different entities throughout the entire supply chain is an essential part of the solution, which should be further studied.