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Permitting medical device manufacturers to submit bulk summary reports of adverse events to the U.S. Food and Drug Administration (FDA), rather than reporting individual cases, often fails to promptly detect potential safety signals, finds a study published by The BMJ. This is a public health concern, argue the researchers, and they call for immediate improvements to better protect patient safety and meet FDA standards.

U.S. regulations require medical device makers to report malfunctions and adverse events to the FDA's Manufacturer And User Facility Device Experience (MAUDE) database within 30 days to inform safety measures, such as product recalls, as part of the postmarket surveillance process.

MAUDE requires complete and accurate reporting to be effective, but earlier programs, notably the Alternative Summary Reporting (ASR) program, let manufacturers submit millions of adverse events as bulk summaries rather than as individual reports in order to "reduce the burden on industry."

Although the FDA ended the ASR program in 2019 due to concerns that it masked safety signals, similar summary reporting exemptions remain in use, but their accuracy, completeness and compliance with FDA rules are unclear.

To address this, researchers analyzed all adverse event summary reports submitted to MAUDE over a six-year period (July 2019 to June 2025) for evidence of incomplete device problem identification, undercounting of adverse events, failure to correctly identify reports as summary reports and delays in serious adverse event reporting.

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