BACKGROUND: The medical device and in vitro diagnostic industries are evolving with innovative, high-tech devices. New European regulations aim to create a sustainable, innovation-friendly regulatory framework. RESEARCH DESIGN AND METHODS: This study is a retrospective analysis of complaints and incidents reported to the Regional Health Coordination Agency in 2023 in the Friuli Venezia Giulia region (Northeast Italy), in collaboration with IRCCS Burlo Garofolo. Safety and usability metrics were used to proactively and reactively monitor the quality and safety of hospital medical devices. RESULTS: A total of 132 reports (57 incidents, 75 complaints) involving 101 different medical devices (0.5% of all ARCS devices) were analyzed
24 reports classified as complaints were actually incidents. Risk class IIA and European Medical Device Nomenclature (EMDN) A devices were the most frequently reported. The analysis highlighted the need for improved compliance with reporting guidelines, proactive post-market surveillance, and enhanced institution-specific training programs to reduce risk and improve device performance. CONCLUSIONS: Proactive and reactive surveillance of medical devices in hospitals can be a useful tool to improve the safety and effectiveness of medical devices in real-world settings. Refining local reporting practices and improving user education will ultimately improve patient safety and outcomes, as well as hospital expenditure.