May 14, 2024 (by: Lawrence F Muscarella, PhD) – Hundreds of thousands of reports from device manufacturers describing an adverse event during a recent 3-and-a-half-year period were submitted to FDA late or with insufficient date informtion, a March study has found, raising questions about the safety of medical devices and the potential for undetected device risks.
In response to late reporting and other regulatory violations by device manufacturers, this article (by Dr. Muscarella) proposes a change, for the FDA’s consideration, to reduce confusion and avoid a potential clinical predicament that may arise once an FDA warning letter cites a device for violating a federal regulation.
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HIGHLIGHTS
- Nearly a third of manufacturer reports describing device-related adverse events during a recent 3-and-a-half-year period – or over 1.2 million reports – were submitted to FDA either late or had missing or invalid date information, a March study found.
- The late submission of adverse event reports to FDA can interfere with the agency’s detection of, and prompt response to, device-related safety issues, increasing the risk of patient harms.
- FDA routinely issues “warning letters” to manufacturers that may label a device “misbranded” due to one or more regulatory violations, including a company’s failure to submit adverse event reports to FDA within the required 30-day regulatory timeframe.
- Similarly, the FDA’s warning letter may state that a device is “adulterated” for certain other regulatory violations. Federal law places certain prohibitions on misbranded and adulterated devices, however.
- Once made public, an FDA’s warning letter censuring a device for one or more regulatory violations can thus cause confusion and uncertainty, among clinicians, risk managers, and patients alike, regarding the device’s use and patient disclosures due to differing interpretations of applicable laws.
- To reduce this confusion and avoid a potential clinical predicament, this article (by Dr. Muscarella) proposes that the FDA consider using similarly appropriate language, but other than declaring a device misbranded and/or adulterated, in response to certain regulatory violations (e.g., a manufacturer submitting adverse event reports late to FDA).
- Alternatively, this article suggests that the FDA’s warning letters include clear guidance directed to clinicians, risk managers and patients explaining the significance of the misbranded (or adulterated) device’s regulatory violation(s) along with a safety assessment and recommendations to prevent patient harm.
- Absent such policy changes, a key question remains that FDA warning letters and guidance documents generally do not address: what the public should know, or a patient should be told during the informed consent process, about the safety of a medical device FDA has censured (e.g., in a warning letter or via another type of FDA device communication) for violating one or more federal regulations.
May 14, 2024 (by: Lawrence F Muscarella, PhD) – Nearly a third of manufacturer reports describing device-related adverse events during a recent 3-and-a-half-year period – or over 1.2 million reports – were submitted to FDA either late or with missing or invalid date information, a March study has found, raising questions about patient safety and the potential for undetected device risks.
Late submission of adverse event reports to FDA can interfere with the agency’s detection of, and prompt response to, device-related safety issues, increasing the risk of patient harms.
A total of 4.4 million initial manufacturer reports were included in the analysis. A significant number of them – or approximately 600,000 reports – were submitted to FDA late, the March study by Everhart et al. (2025) found.
Published in the British Medical Journal (BMJ), the study considered a manufacturer report “late” if FDA received it after the regulatory deadline.
This article I wrote proposes a change for the FDA’s consideration to reduce confusion and mitigate a potential clinical dilemma that may arise once the agency cites a device for violating a federal regulation, including the FDA’s 30 day reporting deadline. — Lawrence F. Muscarella, Ph.D.
Everhart et al. (2025) similarly found that almost 700,000 of the study’s other included reports, or approximately 15%, “had missing or invalid receipt dates” and, therefore, may have been submitted late to FDA.
Federal regulations require that manufacturers submit adverse event reports to the FDA’s “MAUDE” database within 30 days of being notified that a medical device may have caused or contributed to a death or serious injury.
Approximately 1.3 million reports – or nearly a third of the analyzed reports – “were not demonstrably submitted to the FDA” within this 30-day regulatory deadline, this BMJ study determined.
While the late reporting of device-related adverse events (among other regulatory violations) can increase the risk of patient harms, particularly a manufacturer’s failure to report on-time device-related patient deaths, published guidance and safety communications that notify the public about a device’s regulatory lapses along with instructions to reduce the risk of patient harm are generally lacking.
Infection Case Reviews, Forensic Analyses, Expert Guidance: LFM-Healthcare Solutions, LLC provides medical expertise for legal representatives, device manufacturers, and medical facilities specializing in healthcare-associated infections linked to contaminated reusable medical equipment.
More study details
The authors of this BMJ study reviewed approximately 4.5 million initial device reports manufacturers had submitted to FDA between September 1, 2019, and December 31, 2022. Only a small fraction (2%) of these reports was excluded from the study for not satisfying certain criteria.
This BMJ analysis also found that over two thirds of the late reports were submitted to FDA more than six months after the device’s manufacturer first learned about the reportable adverse event.
Insufficient enforcement may give manufacturers the impression that late reporting will be tolerated and result in ultimately harming patients by delaying access to important safety information. — Everhart et al. (2025)
More than half of the late reports “were attributable to three manufacturers” the study found, with 13 devices representing approximately 50.4% of the late reports. “Many of the devices with large numbers of late reports were crucial to patient care,” including infusion pumps and continuous glucose monitors.
Only “initial” FDA reports were included in the analysis, defined in the study as those reports the manufacturer submitted to FDA after being notified of the adverse event. Certain other reports that did not satisfy the study’s requirements (e.g., follow-up reports that described a previous event) were excluded.
FDA reports describe device-related patient injuries and deaths along with device malfunctions. All FDA reports submitted by manufacturers (and other stakeholders, such as medical facilities and patients) are housed in the agency’s public MAUDE database.
The BMJ study found that, despite the many submitted late, the majority of the adverse event reports analyzed, or almost 3,000,000, were submitted to FDA within 30 days (i.e., on time).
Other recent posts by Dr. Muscarella include:
- “Endoscopy Patients at Vanderbilt Potentially Exposed to HIV and Hepatitis, County Officials Have Confirmed” (2024)
- “17 U.S. Patients Were Exposed in December to a Colonoscope Contaminated with Salmonella Bacteria” (2024)
- “Esophageal Tissue Tears and Other Adverse Events Reported When Using Duodenoscopes with a Single-Use Endcap (2023)
Not a newly publicized safety concern
Late reporting of adverse event reports is not a new safety issue for patients.
A news article in 2023 reported that since 2010, “the FDA has cited companies more than 5,000 times for not handling, reviewing, or investigating complaints properly, or for not reporting adverse events on time.”
Five years earlier, federal officials reached a settlement with a device manufacturer in part for “failing to file required adverse event reports” describing device-related patient harms.
Almost a decade ago, a report by a U.S. Senate committee focusing on endoscopes concluded in 2016 that problems with FDA’s “adverse event device database, as well as slow and incomplete reporting by manufacturers and hospitals, appear to have left FDA staff unable to develop an accurate sense of the frequency and severity of the infection outbreaks.”
FDA warning letters
FDA routinely issues “warning letters” to manufacturers for violating one or more federal regulations that could cause a medical device, currently in use, to pose a safety concern. While public, these letters are not ordinarily written to, nor provide specific guidance for, healthcare facilities or patients, which can cause them confusion.
Some of these warning letters may label a device “misbranded,” consistent with the FDA’s legal authority under the Federal Food, Drug, and Cosmetic Act (“FDCA”), due to the manufacturer’s alledged failure to submit adverse event reports to the FDA within the 30-day regulatory timeframe. Similarly, FDA may state that a device is “adulterated” for certain other regulatory violations.
The FDA wrote a letter to a manufacturer in 2022, for example, claiming that some of the firm’s marketed devices were misbranded under the FDCA primarily because of the manufacturer failing to submit the required adverse event reports to the FDA on time.
Medical device adverse event reporting requirements are designed to protect Americans by providing FDA with a tool to detect potential safety issues. When device manufacturers fail to report adverse events, unsuspecting patients are placed at risk. — FDA Commissioner (2018)
In 2023, the FDA wrote a similar letter to a manufacturer listing a number of regulatory lapses, including claiming the agency had not received a number of adverse event reports involving an endoscope component “within the required 30 calendar day timeframe.”
However, as explained in the FDCA, federal law places certain prohibitions on misbranded and adulterated devices. (Everhart et al. [2025] did not discuss the FDA’s policy of concluding a device is misbranded due to the manufacturer failing to submit one or more adverse event reports to the agency on time.)
Once made public, an FDA’s warning letter censuring a device in response to the manufacturer submitting adverse event reports to the agency late, like certain other regulatory violations, can thus cause confusion and uncertainty, among clinicians, risk managers and patients alike, about the device’s use and patient disclosures due to differing interpretations of applicable laws.
Forensic Case Reviews, Expert Guidance, Infection Investigations: LFM-Healthcare Solutions, LLC provides medical expertise for legal representatives, device manufacturers, and medical facilities specializing in healthcare-associated infections linked to contaminated reusable medical equipment.
A proposal
To reduce this confusion and avoid a potential clinical predicament, this article (by Dr. Muscarella) proposes that the FDA consider using similarly appropriate language, but other than necessarily declaring a device misbranded and/or adulterated, in response to certain regulatory violations, such as a manufacturer submitting adverse event reports late to FDA.
The warning letter might instead state, for example, that FDA has concluded that the manufacturer’s device, currently in use, is “noncompliant” or “non-conforming” for violating a specific regulation (e.g., FDA’s 30-day reporting deadline). The letter might further specify a deadline for the manufacturer to correct the listed deviations and clarify that the regulatory violation could compromise the device’s safety. The violations might also be graded based on the safety risk, realizing that not all regulatory lapses pose the same safety concerns.
Alternatively, this article (by Dr. Muscarella) suggests that FDA warning letters include clear guidance directed to clinicians, risk managers and patients (similar to an FDA safety communication) explaining the significance of the misbranded (or adulterated) device’s regulatory violation(s) along with a safety assessment, a discussion of safe alternative options (if available), and recommendations to prevent patient harm.
Absent policy changes, a key question remains that FDA warning letters and guidance documents generally do not address despite today’s federal efforts to reduce the risk of patient harm and enhance transparency in health care: what the public should know, or patients should be told during the informed consent process, about the safety of a medical device FDA has censured (e.g., in a warning letter or other type of FDA device communication) for violating one or more federal regulations.
Article by: Lawrence F Muscarella, PhD. LFM Healthcare Solutions, LLC. Dr. Muscarella is the president and founder of LFM Healthcare Solutions, LLC, an independent quality improvement company. Click here for a list of his quality improvement healthcare services. E: Larry@LFM-HCS.com. [LFM-ver-2.5]
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Acknowledgment: This article was sponsored, in part, by AMBU, a manufacturer of single-use flexible endoscopes.
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