Late Reporting of Medical Device Deaths and Injuries to the FDA: A Major Gap in Postmarket Surveillance

Is vital medical device safety information reaching the FDA on time? A recent cross-sectional study analyzing the US Food and Drug Administration's (FDA) Manufacturer And User Facility Device Experience (MAUDE) database has revealed a concerning trend; nearly a third of adverse event reports submitted by manufacturers were not filed within the regulatory 30-day deadline. This significant delay in reporting, with a large proportion occurring more than six months after the manufacturer was notified of the event, raises serious questions about the timeliness and completeness of data crucial for identifying potential patient safety concerns.

How Late Reporting of Medical Device Adverse Events to the FDA Puts Patients at Risk

The safety of medical devices is paramount to public health. Unlike pharmaceuticals, many medical devices in the US and globally receive regulatory authorization based on non-clinical data or clinical trials with inherent limitations. This reality underscores the critical importance of robust post-market device safety surveillance. As the US Food and Drug Administration (FDA) increasingly relies on post-market data during premarket reviews, the integrity and timeliness of this data become even more crucial.

A cornerstone of this post-market surveillance system is the FDA's Manufacturer And User Facility Device Experience (MAUDE) database. This central repository collects reports of device-related adverse events and product problems from manufacturers and other stakeholders. MAUDE reports are the most common source of information used by the FDA to issue medical device safety communications, their primary mechanism for informing the public about potential safety issues.

However, the MAUDE system is not without its flaws. It relies on external reporting, which can be inaccurate and incomplete, sometimes lacking key clinical details or miscategorizing serious events. In a recent cross-sectional study published in the BMJ, a anlysis of data from the MAUDE database between September 2019 and December 2022, sheds light on the extent of this late reporting, its distribution among manufacturers and devices, and its potential implications for patient safety.

A Third of Reports Missed the Deadline

The study examined over 4.4 million initial adverse event reports submitted by more than 3,000 unique medical device manufacturers. The findings paint a concerning picture: nearly a third (29%) of these reports were not submitted within the FDA's mandated 30-day window following the manufacturer's awareness of the event. The majority of these late reports, a staggering 9.1% of the total, were submitted more than six months (180 days) after the manufacturer was notified.

This delay was not uniform across all event types. While the majority of reports, including those of 13,587 deaths, 1,552,268 injuries, and 2,866,693 malfunctions, were submitted on time (within 30 days), a significant proportion experienced delays. Specifically, 7.4% of death reports, 12.7% of injury reports, and 14.0% of malfunction reports were submitted late. Furthermore, the study observed a concerning trend: on-time reporting significantly declined over the study period for overall reports, as well as specifically for deaths and injuries.

The consequences of such delays can be severe. Late adverse event reporting may prevent the early detection of critical patient safety concerns. When manufacturers fail to promptly report issues, regulators, clinicians, and patients may remain unaware of emerging risks, potentially leading to avoidable patient harm.

A Few Bad Actors

The study also uncovered a significant concentration of late reporting. Three manufacturers (a mere 0.1% of the total) were responsible for a striking 54.8% of all late reports. When expanded to the top 200 manufacturers with the most late reports, this group accounted for over 99% of all late submissions. Similarly, late reports were concentrated among a small number of devices. Just 13 devices (less than 0.1% of the total) accounted for 50.4% of late reports.

The top 10 manufacturers with the highest number of late reports included prominent names such as Becton Dickinson, Medtronic, Dentsply, Abbott, and Boston Scientific. Similarly, the top 10 devices with the most late reports included critical medical technologies like Becton Dickinson's infusion pumps, Abbott's glucose monitors, and Medtronic's insulin pumps. The fact that devices crucial for patient care are among those with high rates of late reporting is particularly worrisome.

Interestingly, the timing of late reports also revealed a pattern. Late reports were more likely to be released in short bursts and large batches rather than consistently over time. This "bunching" phenomenon was evident when examining specific devices with high numbers of late reports. For example, nearly all late reports for one of Abbott's glucose monitors were released in March 2021, the same month the manufacturer issued a recall for the device. This pattern aligns with media reports suggesting that manufacturers may only report significant safety information after a recall initiation or other high-profile events. Such delayed and clustered reporting could hinder timely responses from clinicians and patients, potentially exacerbating harm.

Insights for Policy

The study found that higher-risk devices (Class III) had a significantly higher percentage of late reports compared to lower-risk (Class I) devices. This is concerning given the greater potential for harm associated with these devices.

The relationship between late reporting and other device characteristics was more nuanced:

• Lifesaving and implantable devices had higher percentages of late injury reports but lower percentages of late death and malfunction reports.
• Breakthrough devices, which receive expedited FDA review due to their potential for significant patient benefit, surprisingly had less overall late reporting compared to non-breakthrough devices. However, a higher percentage of death reports for breakthrough devices were late. This finding is concerning because these novel devices may have less robust premarket safety data, making timely post-market surveillance even more critical.

The study also examined the association between recall status and reporting timeliness for Class II and III devices. While recalled devices had a lower overall late reporting rate, they had higher late reporting rates for deaths and injuries compared to devices with no recalls. This suggests that recalls may be triggered by the delayed reporting of serious adverse events that should have been submitted to the FDA earlier.

Why the Delays?

The study acknowledges that the reasons behind late reporting were not directly investigated. However, it posits two potential contributing factors:

1. Intentional withholding of safety information: Previous reports and media investigations have suggested that some manufacturers may knowingly delay reporting important safety issues.
2. Time required for verification and information gathering: Manufacturers may take time to verify adverse events and collect additional details before submitting a report to the FDA.

Regardless of the underlying cause, the study emphasizes that late reporting is a violation of existing FDA regulations. The consequences of withholding safety information can be significant, undermining the MAUDE database's role in identifying emerging safety issues and potentially leading to avoidable patient harm.

Strengthening Post-market Surveillance

The findings of this study carry significant implications for various stakeholders:

• Patients and Clinicians: Late reporting can deprive patients and their healthcare providers of crucial information needed to make informed treatment decisions and recognize potential device-related risks.
• Regulators (FDA): Delayed data hinders the FDA's ability to promptly identify and address medical device safety problems, potentially delaying necessary safety communications, recalls, and other regulatory actions.
• Future Device Development: The MAUDE database is increasingly being considered in premarket authorization reviews. If adverse event reports are missing due to late reporting, manufacturers might incorrectly conclude that their devices are safe, hindering a comprehensive understanding of the device's benefit-risk profile.

The study authors propose several potential policy actions to address the issue of late reporting:

• Stronger Enforcement: While most reports are submitted on time, the concentration of late reporting among a few manufacturers suggests that more consistent enforcement of existing reporting requirements through warning letters, penalties, and other sanctions might be necessary. The FDA currently often relies on manufacturer cooperation rather than fully utilizing its enforcement powers.
• Improved Data Quality: Requiring manufacturers to include the manufacturer notification date on electronic submissions could significantly improve the accuracy and completeness of report timing data. The study found that many reports with invalid date information simply lacked this crucial date.
• Increased Transparency: Regularly publishing a list of manufacturers or devices associated with large numbers of late reports could inform patient and clinician decision-making and incentivize manufacturers to improve their reporting practices.
• Active Post-market Surveillance: The study highlights the inherent limitations of a passive surveillance system like MAUDE, which relies on voluntary and mandatory reporting. The authors advocate for the development of more active post-market surveillance mechanisms that routinely collect standardized data on device usage and outcomes. Integrating unique device identifiers (UDIs) into administrative claims and electronic health records is suggested as a key step in this direction. While this would require resources from regulators and healthcare providers, it could provide a more comprehensive and timely understanding of real-world device safety.

Limitations to Consider

The authors acknowledge several limitations to their study:

• Reliance on Manufacturer-Reported Dates: The accuracy of report times depends on the dates provided by manufacturers, which may be subject to misreporting.
• Inability to Differentiate Reporting Requirements: MAUDE does not distinguish between reports subject to a five-day urgent reporting requirement versus the standard 30-day requirement. The study conservatively classified all reports exceeding 30 days as late, potentially underestimating the extent of truly delayed urgent reports. However, older FDA analyses suggest that urgent reports are a very small fraction of the total.
• Inability to Identify Unreported Events: The study could only analyze reported events and could not account for adverse events that were never reported to MAUDE.
• Difficulty in Directly Linking Late Reporting to Harm: Establishing a direct causal link between late reporting and patient harm is challenging within the MAUDE framework due to the nature of passive surveillance.
• Exploratory Nature of Device Characteristic Associations: The analyses examining the relationship between device characteristics and report times were exploratory and did not establish causality. The study could not determine the underlying reasons for late reporting.

Despite these limitations, the study provides compelling evidence of a significant problem within the US medical device post-market surveillance system.

Time for Change in Medical Device Safety Reporting

This comprehensive analysis of the MAUDE database reveals a concerning reality: a substantial proportion of medical device adverse event reports are submitted late by manufacturers, often by many months. This delay, concentrated among a few key players and affecting critical medical devices, has the potential to undermine the timely identification of patient safety issues and contribute to avoidable harm.

While the majority of reports are submitted on time, the significant number of late submissions and the declining trend in on-time reporting, particularly for serious events like deaths and injuries, warrant serious attention. The study's findings underscore the limitations of the current passive post-market surveillance system and highlight the need for stronger enforcement of existing regulations, improved data quality, increased transparency, and a potential shift towards more active surveillance mechanisms.

Ensuring the timely and accurate reporting of medical device adverse events is not merely a regulatory requirement; it is a fundamental aspect of protecting patient safety. By addressing the issue of late reporting, the FDA and the medical device industry can work together to create a more robust and reliable post-market surveillance system, ultimately safeguarding the health and well-being of patients who rely on these life-altering technologies. The time for hidden delays in medical device safety reporting must come to an end.