Permitting medical device manufacturers to submit bulk summary reports of adverse events to the US 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 today.
This is a public health concern, argue the researchers, and they call for immediate improvements to better protect patient safety and meet FDA standards.
US 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) programme, 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 programme 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 analysed 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.
A total of 6,308 summary reports were submitted to the FDA during the study period containing 159,503 adverse events, mostly involving high risk devices.
Of these, 57% identified no device or use problem, 38% reported insufficient information, 11% were incorrectly identified as non-summary reports, 7% incorrectly listed one event in the 'number of events' field, and 55% exceeded the FDA's 30-day reporting deadline.
The researchers acknowledge the inherent limitations of passive adverse event reporting and the lack of publicly available information on the specific requirements governing summary reporting exemptions.
However, they say identifying and correcting the existing flaws highlighted in this study are vital, particularly given that the number of summary reports submitted to the FDA - and the number of adverse events contained within them - more than doubled between 2020 and 2024.
"Immediate improvements are needed to better protect patient safety and adhere to transparency principles outlined by the FDA," they write. "Making serious adverse event reports fully visible and accessible is critical to patient safety."
In a linked editorial, Koji Todaka at Kyushu University Hospital in Japan, says these findings raise concerns about transparency in a system intended to support public scrutiny of medical device safety.
To preserve public trust in postmarket surveillance, he says regulators should require accurate and timely summary reporting, standardised device identification, and clear links to registries. He also suggests that researchers integrate spontaneous reports, registries, and linked healthcare data rather than treating any single source as definitive.
He also notes that the FDA is currently transitioning to a new Adverse Event Monitoring System (AEMS), designed to consolidate existing reporting systems and publish adverse event reports in real time.
"Transparency builds trust, evidence improves safety, and both are essential to effective postmarket surveillance and safer medical devices," he concludes.
