A major problem in healthcare today is the manual handling of administrative work. Few processes are automated and healthcare professionals are forced to spend a lot of time on paperwork, which means that their time with patients suffers. This has a major negative impact on patient safety. In addition, these manual processes mean that it is often not possible to trace implants in the care process. The purpose of this thesis is to investigate the effect that the implementation of traceability of implantable pacemakers can have on patient safety, on the working environment of healthcare professionals as well as on the financial incentives of hospitals. To answer the questions, a qualitative research strategy was used where first a scientific literature review was conducted; thereafter, interviews were conducted with healthcare professionals from clinics for implantation of active implants, as well as with professionals in the regulation of medical devices and the manufacture of pacemakers; later a regulatory document review was conducted. Lastly, based on the findings obtained, a proposal was formulated for a solution of a digital traceability process. The key results that could be found were that the methods and opportunities for conducting traceability in hospitals in Sweden differ. In addition, the results showed that in many places in the European and Swedish regulations, requirements were made for traceability to be conducted in hospitals, however, information and guidance are lacking on how traceability can be conducted in an efficient manner. Many interviewees also experienced this void of guidance documents and had a unanimous view that an effective digital traceability system would have an entirely positive impact on patient safety, on the healthcare environment's working environment and on hospitals' financial incentives. In summary, a guidance regulatory document is required to standardize traceability processes. In addition, an essential aspect of the possibilities for creating effective digital traceability systems is that there is collaboration at several levels to reach consensus and interoperability between healthcare systems. / Ett stort problem inom sjukvården idag är den manuella hanteringen av administrativt arbete. Få processer är automatiserade och sjukvårdspersonalen tvingas lägga mycket tid på pappersarbete, vilket gör att deras tid med patienter blir lidande. Detta har stor negativ påverkan på patientsäkerheten. Dessutom medför dessa manuella processer att det ofta inte går att spåra implantat i vårdprocessen. Syftet med detta examensarbete är att undersöka vilken effekt införandet av spårbarhet av implanterbara pacemakers kan ha på patientsäkerheten, på sjukvårdspersonalens arbetsmiljö samt på sjukhusens ekonomiska incitament. För att besvara frågeställningarna användes en kvalitativ forskningsstrategi där först en litteraturöversikt utfördes. Därefter genomfördes intervjuer med vårdpersonal inom mottagningar för implantering av aktiva implantat, samt med yrkesverksamma inom regleringen av medicintekniska produkter samt tillverkning av pacemakers. Efter detta utfördes en literaturstudie. Slutligen, baserat på de resultat som erhölls, formulerades ett förslag på en lösning av en digital spårbarhetsprocess. De nyckelresultat som kunde återfinnas var att metoderna och möjlig-heterna för att bedriva spårbarhet på sjukhus i Sverige skiljer sig åt. Dessutom visade resultaten att det på många ställen i de Europeiska och Svenska regelverken ställdes krav på att spårbarhet ska bedrivas på inom sjukvården, däremot så fattas information och vägledning om hur spårbarhet kan bedrivas på ett effektivt sätt. Många intervjudeltagare upplevde också detta tomrum av vägledande dokument och hade en enad uppfattning om att ett effektivt digitalt spårbarhetssystem enbart skulle ha positiv inverkan på patientsäkerheten, på vårdpersonalens arbetsmiljö samt på sjukhusens ekonomiska incitament. Sammanfattningsvis krävs det vägledande regulatoriska dokument för att standardisera processerna för spårbarhet. Dessutom är en väsentlig aspekt av möjligheterna för att skapa effektiva digitala spårbarhetssystem att det sker ett samarbete på ett flertal nivåer för att nå konsensus och interoperabilitet mellan sjukvårdens system.

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.