More Than Algorithms: an Analysis of Safety Events Involving ML-enabled Medical Devices Reported to the FDA

Objective: To examine the real-world safety problems involving machine learning (ML)-enabled medical devices.

Materials And Methods: We analyzed 266 safety events involving approved ML medical devices reported to the US FDA's MAUDE program between 2015 and October 2021. Events were reviewed against an existing framework for safety problems with Health IT to identify whether a reported problem was due to the ML device (device problem) or its use, and key contributors to the problem. Consequences of events were also classified.

Results: Events described hazards with potential to harm (66%), actual harm (16%), consequences for healthcare delivery (9%), near misses that would have led to harm if not for intervention (4%), no harm or consequences (3%), and complaints (2%). While most events involved device problems (93%), use problems (7%) were 4 times more likely to harm (relative risk 4.2; 95% CI 2.5-7). Problems with data input to ML devices were the top contributor to events (82%).

Discussion: Much of what is known about ML safety comes from case studies and the theoretical limitations of ML. We contribute a systematic analysis of ML safety problems captured as part of the FDA's routine post-market surveillance. Most problems involved devices and concerned the acquisition of data for processing by algorithms. However, problems with the use of devices were more likely to harm.

Conclusions: Safety problems with ML devices involve more than algorithms, highlighting the need for a whole-of-system approach to safe implementation with a special focus on how users interact with devices.