More than 1.2 Million Medical Device Adverse Event Reports were not submitted to the us food and Drug Administration (FDA) With the Deadline Set by Federal Regulations, Finds Anna Analysis of Recent Data Published by The bmj,

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

The Researchers WARN that Late Adverse Event 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 made or contributed to a death

Under Federal Law, Manufacturers must Submit Adverse Event Reports to the FDA’s Manufacturer and User Facility Device Experience (Maude) Database with DATABASE with DAYS OF BCES OF BCES OF

However, mude has known limitations, and some media reports have described manufacturers withhlding reports from maude years years beyond this deadline.

To Investigate This Further, A Team of Us Researchers Analyzed Manufacturer Reports received by the FDA over the FDA over the Three-AA-AA-AHALF-Year Period (1 September 2019 to 31 December 2022), Measuring the defense 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 ware of deaths, 1,552,268 of injuries, and 2,866,693 of Malfunctions from 3,028 Unique Manufacturers and 88,4448 Unique Devices.

Of the inclined reports, 71% (3,146,957) of Adverse Events Within 30 Days (On Time), 4.5% (197,606) Were Reported Between 31 and 180 Days (Late), and 9.1% (402,891) WERE AFTER Days (Late).

A Total of 1,004 Deaths was reported late, as was 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 number numbers of late reports were crucial to patient, including information pumps and glucose monitors.

Almost One in Six (685,094) Reports Had Missing or Invalid Date Data Data provided by the manufacturer. Among reports with no missing or invalid report time, 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 Cauded by Late Reporting, Or Determine White Manufcturers Report Late and Theirs Underling motivations for doing so.

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

“The findings from this study collectively show that whose mude database often informs FDA Safety Actions, this data source is incomplete for undertanding Medical Device Safety Safety Safety to Late 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.” Researches in a linked editorial.

“The maude database can be a useful adjunct to active surveillance efforts, particularly if some of the problems of the problems identified by this study are reacted,” Ya Write. “But Ultimately, Support for Active Survelance Using Data from Routine Health Encounters is essential to improve the safety of medical devices for Patients.”