Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data

Medical devices increasingly include software components, which facilitate remote patient monitoring. The introduction of software into previously analog medical devices as well as innovation in software-driven devices may introduce new safety concerns—all the more so when such devices are used in patients’ homes, well outside of traditional health care delivery settings. We review four key mechanisms for post-market surveillance of medical devices in the United States: (1) post-market trials and registries; (2) manufacturing plant inspections; (3) adverse event reporting; and (4) recalls. We use comprehensive regulatory data documenting adverse events and recalls to describe trends in the post-market safety of medical devices based on the presence or absence of software. Overall, devices with software are associated with more reported adverse events (i.e., individual injuries and deaths) and more high-severity recalls, as compared to devices without software. However, in subgroup analyses of individual medical specialties, we consistently observe differences in recall probability but do not consistently detect differences in adverse events. These results suggest that adverse events are a noisy signal of post-market safety and not necessarily a reliable predictor of subsequent recalls. As patients and health care providers weigh the benefits of new remote monitoring technologies against potential safety issues, they should not assume that safety concerns will be readily identifiable through existing post-market surveillance mechanisms. Both health care providers and developers of remote patient monitoring technologies should therefore consider how they might proactively ensure that newly introduced remote patient monitoring technologies work safely and as intended.