Design and Implementation of a Digital Traceability System of Implantable Pacemakers in the Care Process

Abstract: 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.