Medical device manufacturers are required by the U.S. Food and Drug Administration to report within 30 days any adverse safety events like malfunctions that could injure someone. The agency compiles these events in a centralized database called the Manufacturer and User Facility Device Experience (MAUDE) and uses the information to decide whether to communicate any safety concerns to the health care community and/or the public, or pursue any other regulatory actions including recalls.
But a March 2025 study highlights that manufacturers are frequently late to report such incidents, which could potentially cause patients harm. Authors of the work, published in the British Medical Journal (BMJ), reviewed some 4.4 million deaths, injuries or product malfunctions reported to the FDA between September 2019 to December 2022, finding that just 71% were reported within the required 30-day period.
More than 197,000 incidents (4.5%) were reported between 31-180 days following an incident, while over 402,000 (9.1%) were reported more than 180 days after they happened. These late reports included incidents of 1,004 deaths, 198,051 injuries and 401,442 malfunctions.
“There are two main findings that stood out to me,” said the study’s lead author, Alexander Everhart, Ph.D., in an interview with AHCJ. He is an instructor in the Division of General Medicine & Geriatrics at Washington University School of Medicine in St. Louis. “The fact that so many of these reports are coming in not on time, and when they are late, they are very late. The other thing was that there’s a lot of bunching when it comes to late reports. Manufacturers aren’t just sending in a late report every few days. It tends to come all at once, with a large proportion submitted in a single month. That suggests those manufacturers might be sitting on this information, maybe not in a nefarious way, but there’s information that they have and are just not letting the FDA know about.”
A closer look at the findings
The FDA approves medical devices sometimes based on limited clinical data, so postmarket safety surveillance is crucial, the study authors noted. “Delays in reporting may preclude regulators, clinicians and patients from learning about emerging safety issues, resulting in avoidable patient harm,” Everhart and colleagues wrote.
It’s not the first report of manufacturers potentially withholding information. While this study was not designed to identify any patient harms caused by late reporting, media outlets including ProPublica and KFF Health News have exposed the dangers of medical device malfunctions when not reported.
In the study, the manufacturers ranked by the highest total number of late reports included well-known names like Becton Dickinson, Medtronic, Dentsply, Abbott, and Boston Scientific. The top devices ranked by late reports included Becton Dickinson’s infusion pumps, Abbott’s glucose monitors, Medtronic’s insulin pumps, Biohorizons Implant Systems’ dental implants and Dexcom’s glucose monitors. Over half (54.8%) of late reports were attributed to just three manufacturers and 13 medical devices.
In response, a spokesperson for Becton Dickinson told MedTech Dive that the adverse event reports referred to in the study “were based on observations from a March 2020 inspection where the company retrospectively reviewed 2 million service records dating back to 2018. The reports were not delayed reports from customer complaints but instead were from records [Becton Dickinson] found in its retrospective analysis.”
Since then, the company has made improvements to its IT and quality management systems, the spokesperson said.
The uncertain future of device safety monitoring
There are a couple of avenues the FDA could pursue to improve timelier reporting of device issues, Everhart said. One is updating the reporting interface. He and his colleagues observed multiple instances where a manufacturer did not state when they learned about an event before reporting it, so making that information mandatory to report may help. And, while the agency relies on the goodwill of manufacturers to report this information, it could enforce it by levying fines or lawsuits against manufacturers that repeatedly submit information late.
But whether the agency will have the manpower it needs to continue monitoring device safety remains to be seen. About 180 employees from the FDA’s Center for Devices and Radiological Health — including physicians and cybersecurity experts — were laid off on Feb. 15 as part of government-wide cost-cutting measures instituted by Elon Musk and the Department of Government Efficiency, NBC News reported on Feb. 24. Some employees were later reinstated, according to NBC News,, including about two dozen people fired from the cardiac devices unit, which oversees devices like pacemakers.
The administration “has been cagey” about who has been cut, Everhart said, but “it’s very likely that the layoffs are going to disproportionately affect postmarket surveillance activities like what’s covered in my study.”
Some people re-hired have been in positions reviewing medical devices before they come to market, where personnel are funded by manufacturer user fees required to register devices or submit applications, he said. If postmarket surveillance-related positions are impacted by layoffs, “hypothetically, the FDA can’t detect these safety issues as they are evolving, and unsafe products might be on the market for a longer amount of time before we find out that there’s something wrong,” he said.
It’s very difficult for a journalist or public citizen to track real-time safety information for medical devices on their own, he said. Individuals can check the MAUDE database but the information listed for a particular device may or may not be up to date.
Story ideas
“The FDA is going through a pretty radical change like many other branches of the government right now, and it’s going to potentially negatively affect either the quality and speed of reviews before devices come to market or the ability to detect safety issues after devices come to market,” Everhart said.
To that end, journalists could find interesting stories interviewing FDA officials, even anonymously, who review device applications or safety data about how their workload has changed, he said. That could inform researchers, physicians, industry representatives and patients.
Additionally, interviewing medical device manufacturers about their experience submitting applications for FDA review, how long reviews are taking and if FDA staff have been responsive to questions, could also be enlightening.
Resources
- Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration – study from BMJ
- FDA’s Deadline Ignored in Nearly 30% of Device Safety Reports – story from MedPage Today
- Top device firms report safety data late: BMJ – story from MedTech Dive
- FDA rehires staff to its medical devices division after mass layoffs – story from NBC News
- Philips Kept Complaints About Dangerous Breathing Machines Secret While Company Profits Soared – story from ProPublica
- Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records – KFF Health News
