Makers Drag Feet Reporting Medical Device Side Effects: Study

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Medically reviewed by Carmen Pope, BPharm. Last updated on March 18, 2025.

By Dennis Thompson HealthDay Reporter

TUESDAY, March 18, 2025 -- Other people could be having problems with the same insulin pump, dental implant or glucose monitor that you use -- and you might not find out in a timely manner.

That’s because medical device manufacturers frequently fail to promptly report side effects caused by their wares to federal regulators, a new study says.

About 3 in 10 adverse event reports for medical devices did not come in to the U.S. Food and Drug Administration (FDA) within the required 30-day deadline, researchers reported in The BMJ.

“Many of the devices with large numbers of late reports were crucial to patient care, including devices like infusion pumps used in hospitals and continuous glucose monitors used by patients in ambulatory settings,” wrote the research team led by Alexander Everhart, an instructor with the Washington University School of Medicine in St. Louis.

“Late reporting … could preclude identification of patient safety concerns in a timely manner,” researchers noted.

The trade group Medical Device Manufacturers Association did not respond to a request for comment regarding the new study.

Under federal law, device makers must submit adverse event reports they receive from patients to the FDA’s Manufacturer And User Facility Device Experience (MAUDE) database within 30 days, researchers said in background notes.

To see whether this is happening, researchers analyzed more than 4.4 million manufacturer reports received by the FDA between September 2019 and December 2022, tracking the difference between the date that a manufacturer said they were notified of an event and the date the FDA received the report.

About 71% of adverse events were reported on time, while nearly 5% were reported up to six months late and 9% more than six months late, results show.

About 1,000 deaths linked to medical devices were reported late, as were more than 198,000 injuries and more than 400,000 malfunctions, researchers noted.

More than 50% of late reports came from three manufacturers regarding 13 medical devices, researchers said.

These devices included infusion pumps, glucose monitors, insulin pumps and dental implants.

“Reporting delays could stem from manufacturers knowingly withholding important safety information from the public, as has been previously reported,” researchers wrote. “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,” researchers wrote. “Withholding safety information may cause avoidable patient harm given the role the MAUDE database currently has in identifying emerging safety issues.”

Sources

  • The BMJ, news release, March 12, 2025

    • Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

    Source: HealthDay

    Posted : 2025-03-19 00:00

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