Summary
A BMJ editorial argues that FDA adverse-event reports can flag medical-device safety concerns, while clinical registries help measure risk. It cites a cross-sectional study that found frequent errors and delays in MAUDE summary reports.
A BMJ editorial published on 14 October 2026 argues that medical-device safety monitoring needs both public adverse-event reports and clinical registries. It points to a linked cross-sectional study that found substantial problems with summary reports submitted to the US Food and Drug Administration’s MAUDE database, while emphasising that the two surveillance approaches serve different purposes.
Why reports and registries answer different questions
MAUDE—the Manufacturer and User Facility Device Experience database—collects reports of suspected problems with medical devices. Such reports can alert regulators, clinicians and researchers to a possible hazard, including one not identified before a device entered clinical use. But reports may be incomplete, submitted late or uncertain about whether the device caused the event. They also do not reliably show how many patients received the device.
That missing denominator matters: a collection of reports alone cannot reliably show how often a problem occurs among people using a device or support sound comparisons between devices. Clinical registries take a different approach. They systematically collect standardised information about a defined group of patients, making it possible to relate outcomes to the number exposed and, in some cases, follow patients over time.
The editorial gives examples of both roles. Registries have identified safety trends, including higher revision rates for metal-on-metal hip replacements. Spontaneous reports can also surface patterns that warrant investigation; the editorial describes reports of pacemaker failures before a manufacturer recall. Together, the systems can help identify a concern and then assess its frequency and significance.
What the MAUDE assessment found
The cross-sectional study discussed in the editorial examined the accuracy, completeness and timeliness of publicly available summary reports submitted to MAUDE from 2019 to 2025. More than 6,000 reports represented about 160,000 adverse events, mostly involving high-risk cardiovascular devices. Fifty-seven per cent of the reports lacked meaningful information about the device problem. In 423 reports (7%), a single event was listed incorrectly, undercounting 11,902 adverse events. More than half—55%—missed reporting deadlines.
The study assessed summary reporting, not the quality of clinical registries. The editorial therefore argues for improving reporting and connecting information sources, rather than treating registry surveillance as a substitute for public reports. Its recommendations include accurate, timely summaries, standardised device identification and transparent links to registries where appropriate.
The editorial also says the FDA is transitioning to a new adverse-event monitoring database intended to consolidate existing reporting systems and publish reports in real time. It was commissioned and, according to its BMJ record, was not externally peer reviewed.