Riskregister för livscykelhantering av medicintekniska produkter

Sammanfattning

Medical devices are associated with inherent risks that may vary in severity and emerge throughout the product lifecycle. Several regulatory frameworks and standards describe how these risks should be managed, emphasizing the importance of structured and systematic risk management throughout the lifecycle of medical devices. Despite these requirements, healthcare organizations often lack clear and consistent methods for organizing and managing risks related to medical devices. The aim of this project was to identify relevant risk types for the lifecycle management of medical devices and investigate how these can be structured within a risk register for the medical device department of Region Skåne. The project was carried out at the Medical Device and IT department within Region Skåne (Digitalisering IT och MT). The project was based on a literature study of relevant standards and regulatory frameworks, including ISO 14971, ISO 13485, and MDR, in order to establish a theoretical foundation for risk management of medical devices. A workshop was conducted with physicians, subject matter experts in medical technology and patient safety, and other stakeholders within Region Skåne. The workshop results were analyzed, condensed, and compared with applicable standards and regulatory requirements to identify and validate relevant risk types. The results indicate a clear need for structured and systematic risk management within organizations using medical devices. The proposed risk types were primarily connected to different stages of the medical device lifecycle and may support improved categorization, traceability and follow-up of risks within a lifecycle-oriented risk register.