Dive Brief:

• Direct reports to the FDA through the Medical Device Reporting program are the most common source of initial safety signals that trigger Medical Device Safety Communications (MDSCs), according to an analysis published in JAMA Internal Medicine this week.

• FDA can spot safety signals in Medical Device Reports (MDRs) submitted to its Manufacturer and User Facility Device Experience (MAUDE) database, medical literature or investigator-initiated postmarketing assessments. The newly published paper found MDRs accounted for almost half the MDSCs sent by FDA to communicate important emerging safety information from 2011 to 2019.

• The authors framed the finding as evidence of the need to proactively identify safety issues that emerge after a device comes to market, for example through a medtech equivalent of the FDA’s Sentinel Initiative, an electronic safety monitoring system that technically includes medical devices under its FDA-regulated medical products but focuses also on drugs, biologics and vaccines.

Dive Insight:

FDA has taken some steps in recent years to improve postmarket device surveillance and real-world evidence generation, such as in helping to set up the National Evaluation System for health Technology (NEST), but has not made wholesale changes to the MAUDE database meant to collect and display adverse event reports.

"As anyone who has tried to use it will attest, the database provides a difficult-to-use interface to search these reports," wrote Madris Tomes, a former FDA analyst who now runs a safety-focused company that uses special software to better analyze medical device report data.

To better analyze the initial safety signals that prompt an FDA response, researchers at Tel Aviv University examined the triggers for 93 MDSCs issued by FDA from 2011 to 2019 to assess the current state of postmarket monitoring and identify opportunities to improve detection of safety signals. 

Over the analyzed period, 47% of MDSCs were triggered by direct reports gathered through FDA’s MDR program. Another one-third of MDSCs stemmed from regulator-initiated assessments.

The importance of direct reports was emphasized by an analysis of the sources of information about the subset of adverse events that pose a risk of death. One-third of the direct reports detailed a risk of death, compared to 8% of other data sources. The findings show MDRs are the most common cause of MDSCs and account for a disproportionate number of adverse events that can kill.

In light of the importance of direct reporting to postmarket safety, the authors of the paper looked at the effectiveness of MAUDE as a tool for identifying safety signals. They argue the database is hindered by underreporting, a reliance on manufacturers for reports, and a lack of certainty about whether a medical device is responsible for an adverse event.

Given the potential for the delayed identification of safety signals to cause harm, the authors see a need for FDA to implement a better system for tracking and identifying adverse events of concern. The system would be underpinned by mandatory reporting.

“An efficient modern surveillance system would require automatic collection and continuous analysis of real-time, real-world data from multiple electronic sources (such as anonymized electronic patient records) allowing rapid identification of emerging safety issues and swift implementation of corrective actions by proactive regulators,” the authors wrote.

Tomes recommended requiring that physicians report directly to the agency and permitting the collection of reports via the third-party Medwatcher mobile app.

She also detailed systemic problems resulting from lack of widespread adoption of unique device identifiers. "The FDA should require immediately (and enforce) the listing of the UDI on every adverse event report and discontinue all redactions of the identifier to decrease chances that patients are not unknowingly receiving harmful devices."

Tomes and the authors of the original paper identify the National Evaluation System for health Technology (NEST) as a potential improvement over the current system. NEST will analyze real-world data to track the performance of devices across the lifecycle and, in doing so, may support better, more timely regulatory actions. Still, Tomes believes FDA should try to improve MAUDE rather than wait for the components of NEST to come online.