Research: User Interface Software Errors in Medical Devices: Study of U.S. Recall Data.

The current work assessed U.S. medical device recalls during 2012-15, with the goal of under-standing the impact and nature of user interface (UI) software errors in medical devices. Based on information from the Food and Drug Administration's public and internal recall databases, 423 (~140/year) medical device recalls were identified as resulting from UI software errors, which accounted for nearly one-half of recalls caused by software errors during the same period. A total of 499 UI software errors were identified as the root causes of medical device recalls, and a detailed classification of those errors (into 20 categories) was established. This error classification can be used by device manufacturers, end users (e.g., healthcare providers), and regulatory authorities to raise awareness of the type and impact of UI software errors. The classification also provides stakeholders with an evidence-based challenge to assess and improve the quality of UI software in medical devices.