More than 1.2 million medical device side-effect reports not submitted within legal timeframe, analysis finds

More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) within the deadline set by federal regulations, finds an analysis of recent data published by The BMJ.

Of these late reports, more than 400,000 were submitted more than six months after the manufacturer was notified of an adverse event.

The researchers warn that late adverse event reporting may prevent early detection of patient safety concerns.

Most medical devices in the US are approved on the condition that manufacturers report to the FDA when they learn that any of their devices have malfunctioned or may have caused or contributed to a death or serious injury.

Under federal law, manufacturers must submit adverse event reports to the FDA’s Manufacturer And User Facility Device Experience (MAUDE) database within 30 days of becoming aware of them.

However, MAUDE has known limitations, and some media reports have described manufacturers withholding reports from MAUDE years beyond this deadline.

To investigate this further, a team of US researchers analyzed manufacturer reports received by the FDA over the three-and-a-half-year period (1 September 2019 to 31 December 2022), measuring the difference between the date a manufacturer reported that they were notified of an event and the date the FDA received the report.

Of 4,432,548 included reports, 13,587 were of deaths, 1,552,268 of injuries, and 2,866,693 of malfunctions from 3,028 unique manufacturers and 88,448 unique devices.

Of the included reports, 71% (3,146,957) of adverse events were reported within 30 days (on time), 4.5% (197,606) were reported between 31 and 180 days (late), and 9.1% (402,891) were after 180 days (late).

A total of 1,004 deaths were reported late, as were 198,051 injuries and 401,442 malfunctions.

More than 50% of late reports were attributable to three manufacturers and 13 medical devices. Many of the devices with large numbers of late reports were crucial to patient care, including infusion pumps and glucose monitors.

Almost one in six (685,094) reports had missing or invalid date data provided by the manufacturer. Among reports with no missing or invalid report times, higher risk devices had higher percentages of late reports: 22.4% for class III (high risk) devices vs. 6.9% for class I (low risk) devices.

The researchers point to some limitations including possible misreporting of dates by manufacturers, being unable to identify harms caused by late reporting, or determine why manufacturers report late and their underlying motivations for doing so.

However, they stress that late reporting is not permitted under existing regulations, meaning greater policy attention is warranted regardless of the cause.

“The findings from this study collectively show that while the MAUDE database often informs FDA safety actions, this data source is incomplete for understanding medical device safety issues due to late adverse event reporting from manufacturers,” they write. “Besides impacting how policy makers, clinicians, and patients make medical decisions, this may affect future device development.”

“This study adds to a growing body of literature on the important limits of passive surveillance, not only for medical devices but also for pharmaceuticals and other products regulated by the FDA,” say researchers in a linked editorial.

“The MAUDE database can be a useful adjunct to active surveillance efforts, particularly if some of the problems identified by this study are rectified,” they write. “But ultimately, support for active surveillance using data from routine health encounters is essential to improving the safety of medical devices for patients.”

More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) within the deadline set by federal regulations, finds an analysis of recent data published by The BMJ.

Of these late reports, more than 400,000 were submitted more than six months after the manufacturer was notified of an adverse event.

The researchers warn that late adverse event reporting may prevent early detection of patient safety concerns.

Most medical devices in the US are approved on the condition that manufacturers report to the FDA when they learn that any of their devices have malfunctioned or may have caused or contributed to a death or serious injury.

Under federal law, manufacturers must submit adverse event reports to the FDA’s Manufacturer And User Facility Device Experience (MAUDE) database within 30 days of becoming aware of them.

However, MAUDE has known limitations, and some media reports have described manufacturers withholding reports from MAUDE years beyond this deadline.

To investigate this further, a team of US researchers analyzed manufacturer reports received by the FDA over the three-and-a-half-year period (1 September 2019 to 31 December 2022), measuring the difference between the date a manufacturer reported that they were notified of an event and the date the FDA received the report.

Of 4,432,548 included reports, 13,587 were of deaths, 1,552,268 of injuries, and 2,866,693 of malfunctions from 3,028 unique manufacturers and 88,448 unique devices.

Of the included reports, 71% (3,146,957) of adverse events were reported within 30 days (on time), 4.5% (197,606) were reported between 31 and 180 days (late), and 9.1% (402,891) were after 180 days (late).

A total of 1,004 deaths were reported late, as were 198,051 injuries and 401,442 malfunctions.

More than 50% of late reports were attributable to three manufacturers and 13 medical devices. Many of the devices with large numbers of late reports were crucial to patient care, including infusion pumps and glucose monitors.

Almost one in six (685,094) reports had missing or invalid date data provided by the manufacturer. Among reports with no missing or invalid report times, higher risk devices had higher percentages of late reports: 22.4% for class III (high risk) devices vs. 6.9% for class I (low risk) devices.

The researchers point to some limitations including possible misreporting of dates by manufacturers, being unable to identify harms caused by late reporting, or determine why manufacturers report late and their underlying motivations for doing so.

However, they stress that late reporting is not permitted under existing regulations, meaning greater policy attention is warranted regardless of the cause.

“The findings from this study collectively show that while the MAUDE database often informs FDA safety actions, this data source is incomplete for understanding medical device safety issues due to late adverse event reporting from manufacturers,” they write. “Besides impacting how policy makers, clinicians, and patients make medical decisions, this may affect future device development.”

“This study adds to a growing body of literature on the important limits of passive surveillance, not only for medical devices but also for pharmaceuticals and other products regulated by the FDA,” say researchers in a linked editorial.

“The MAUDE database can be a useful adjunct to active surveillance efforts, particularly if some of the problems identified by this study are rectified,” they write. “But ultimately, support for active surveillance using data from routine health encounters is essential to improving the safety of medical devices for patients.”