FDA’s Deadline Ignored in Nearly 30% of Device Safety Reports

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Timeliness is among the known issues of the MAUDE passive surveillance system

by
Nicole Lou, Senior Staff Writer, MedPage Today
March 12, 2025

The FDA has allowed a substantial amount of late reports and undated reports into its Manufacturer and User Facility Device Experience (MAUDE) safety database, researchers confirmed.

During a 3.5-year period in 2019-2022, there were over 4.4 million initial adverse event reports to the FDA, of which 4.5% had been submitted late (31-180 days after the manufacturer was notified of the safety event) and 9.1% very late (past 180 days). Another 15.5% of reports had missing or invalid date data logged by the manufacturer — leaving 71% of reports ultimately meeting MAUDE’s 30-day deadline.

“Withholding safety information may cause avoidable patient harm given the role the MAUDE database currently has in identifying emerging safety issues,” according to investigators led by Alexander Everhart, PhD, of Washington University School of Medicine in St. Louis.

“Reporting delays could stem from manufacturers knowingly withholding important safety information from the public … At the same time, delays could also represent the time required for manufacturers to verify adverse events and gather additional information before reporting events to the FDA. Nonetheless, late reporting is not permitted under existing regulations, regardless of intent,” the authors stressed in their manuscript, published in The BMJ.

MAUDE is the FDA’s central postmarket safety surveillance tool for U.S. medical devices. Most reports are made by manufacturers, which are required by regulation to report within 30 days of becoming aware of events.

Everhart and colleagues noted the known limitations of the database. “MAUDE relies on external individuals and organizations to report adverse events, rather than systematically and prospectively collecting safety and outcome data. Moreover, reporting is at times inaccurate and incomplete; key clinical details can be omitted from reports, and reports describing patients ‘expiring’ or ‘dying’ are often categorized as injuries or malfunctions rather than deaths.”

In the present study, MAUDE logged over 13,500 deaths, 1.5 million injuries, and 2.8 million device malfunctions.

Notably, late death reports were disproportionately more common if they were associated with a device with FDA breakthrough designation. “This finding is concerning because breakthrough devices may have less developed premarket evidence supporting their safety and efficacy, meaning any late reporting for breakthrough devices could have an outsized public health impact relative to late reporting for non-breakthrough devices,” according to Everhart’s team.

As a whole, the late reports tended to be released in large batches and in short time periods, “consistent with media reports of manufacturers only reporting important safety information after recall initiation or other high-profile events,” the investigators wrote. “MAUDE is an incomplete data source for understanding medical device safety issues, due partly to the timeliness of its reports.”

They suggested that there are better ways to collect real-world safety data without relying on manufacturers to do the reporting.

“[U]ltimately, support for active surveillance using data from routine health encounters is essential to improving the safety of medical devices for patients,” according to William Feldman, MD, DPhil, MPH, and Aaron Kesselheim, MD, JD, MPH, both of Brigham and Women’s Hospital and Harvard Medical School in Boston.

Although the FDA has recently engaged in more active surveillance of some medical products — using electronic medical records and insurance claims — these efforts are hampered by unique device identifiers (UDIs) not being routinely recorded.

“Unlike pharmaceutical claims, which contain standardized national drug codes for each prescription filled and thereby link the product dispensed to a given manufacturer, device claims with missing UDIs do not have such linkages. Lawmakers from both parties, including Senators Elizabeth Warren (Democratic party, Massachusetts) and Charles Grassley (Republican party, Iowa), have long pushed for inclusion of UDIs as fields in Medicare claims,” Feldman and Kesselheim wrote in an accompanying editorial.

A major setback to these efforts came in 2023, when federal advisors on the National Committee on Vital and Health Statistics declined to recommend a UDI addition to Medicare claims forms.

Meanwhile, the FDA continues to lack the funding for a nationwide active device surveillance program.

For the present work analyzing MAUDE’s passive surveillance, Everhart’s group had probed more than 4.4 million initial adverse event reports submitted during the study period. They found 98% that met criteria for inclusion in the study. These covered reports from 3,028 unique manufacturers for 88,448 unique medical devices.

Three manufacturers and 13 medical devices were responsible for 54.8% of late reports. Sitting in the top ten devices by proportion of late reports were infusion pumps from Becton Dickinson, glucose monitoring systems from Abbott and Dexcom, insulin pumps from Medtronic, artificial pancreas device systems from Medtronic, and a dental implant from Biohorizons.

Study authors acknowledged that they only looked at initial reports, excluding summary reports and those missing manufacturer names, having undeclared event types, or missing device classes. Misreporting was a possibility in the database, and unreported adverse events on MAUDE went wholly undetected.

It was beyond the scope of the study to identify harms caused by late reporting.