Study: Nearly one-third of device adverse event reports were late or missing data

More than 1 million medical device adverse event reports sent to the US Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between September 2019 and December 2022 were late or had missing or invalid date data, according to findings from a cross-sectional study published in the BMJ.

Reports that were late or had missing date data accounted for nearly 30% of all reports to MAUDE during the three-and-a-half-year study period.

“The MAUDE database is crucial for identifying emerging medical device safety issues, so when information about deaths and injuries are not reported in a timely manner, it creates the possibility for otherwise preventable patient harm,” Alexander Everhart of Washington University School of Medicine in St. Louis, MO, and the study’s lead author, told Focus.

MAUDE is the main postmarket safety surveillance tool for medical devices and more than 95% of reports come from device manufacturers. FDA requires manufacturers to submit adverse event reports within 30 days of being notified of an event and within 5 working days for certain high-risk events. (RELATED: FDA finalizes malfunction reporting requirement guidance for lower-risk devices to ease burdens, Regulatory Focus 28 August 2024)

The study evaluated all initial reports from manufacturers to MAUDE between 1 September 2019 and 31 December 2022. The researchers were primarily interested in the report time, the period between when a manufacturer was notified of an event and when they reported it to the FDA. They also investigated the types of events and the distribution of late reports by device manufacturer.

“We conducted this study because we had heard anecdotal reports about late adverse event reporting from manufacturers, but we didn’t know how widespread the practice was. Prior studies had found concerning patterns of late reporting from pharmaceutical manufacturers, but no studies had been conducted examining medical devices,” Everhart said.

The study included 4.4 million initial medical device reports from 3,028 manufacturers. The reports related to 2.8 million malfunctions, 1.5 million injuries, and 13,587 deaths.

The majority of initial reports – 71% – were submitted within the FDA’s 30-day requirement. In total, 4.5% were submitted between 31 and 180 days, 9.1% were more than 180 days late, and 15.5% contained missing or invalid dates that suggested “negative report times,” the researchers wrote.

While most reports were submitted on time, about two-thirds of late reports were sent to the FDA more than 6 months after manufacturers first learned about the events, Everhart noted.

Most late reports were concentrated among a small number of device makers. Just 3 manufacturers (0.1%) accounted for 54.8% of late reports. Becton Dickinson accounted for 25.2% of all late reports, Medtronic accounted for 19.5%, and Dentsply accounted for 10.1%.

“Reporting delays could stem from manufacturers knowingly withholding important safety information from the public, as has been previously reported. 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,” the researchers wrote. “Nonetheless, late reporting is not permitted under existing regulations, regardless of intent. Withholding safety information may cause avoidable patient harm given the role the MAUDE database currently has in identifying emerging safety issues.”

The researchers also observed that late reports of adverse events were often released in “large batches.” For instance, 7% of late reports in the study were from a single glucose monitor. The device had a steady flow of on-time reports during the study period followed by all its late reports being released in the same month that the company issued a recall for the device. “Since so much late reporting occurs in big spikes, it seems like FDA can’t really stop it until after it happens,” Everhart said.

Everhart and colleagues proposed a menu of policy actions to address late reporting by device manufacturers, starting with utilizing existing enforcement authority – from seizure to criminal prosecution – to encourage compliance.

FDA, or a non-government organization, could also routinely publish a list of the manufacturers or devices associated with a large portion of late reports. “Such a list could help to inform patient and clinician decision making regarding medical device selection, as well as spur manufacturers to submit timely reports for the sake of avoiding negative media attention,” the researchers wrote.

Another option to be to move away from a passive approach to postmarket surveillance and instead integrate unique device identifiers into administrative claims and electronic health records to provide active device surveillance.

“We hope our study informs changes to the way we perform medical device surveillance in the United States. Ideally, the US would employ a more prospective and comprehensive approach to collecting safety data, rather than relying on manufacturers and others to report to the FDA,” Everhart said.

BMJ study

Study: Nearly one-third of device adverse event reports were late or missing data

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