Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data.

Abstract

Digital health interventions (DHIs) use digital technologies to deliver and support healthcare. When registered as medical devices incidents associated with them have to be reported. This study examines errors and incidents involving software-based medical devices as recorded in the U.S. Food and Drug Administration's MAUDE database. Using natural language processing methods, specifically BERTopic clustering and large language model-based classification, we analysed narrative reports to identify