Study calls for proactive surveillance of device AEs

Regulatory NewsRegulatory News
| 29 September 2020 | By Mary Ellen Schneider 

The US Food and Drug Administration (FDA) relies mainly on direct reports and regulator-initiated surveillance to flag safety concerns around medical devices, a system that may delay detection of adverse events (AEs), according to a new analysis published in JAMA Internal Medicine.

“These data highlight the importance of proactive identification of postmarketing device-related safety issues to provide health care professionals with more complete data regarding potential AEs and improve patient safety,” wrote Noam Tau, MD, and Daniel Shepshelovich, MD, both of Tel Aviv University in Israel.

For the cross-sectional study, the researchers examined all FDA Medical Device Safety Communications (MDSCs) published 2011-2019. The researchers excluded any MDSCs that were updates of previously posted safety notices, leaving them with a final cohort of 93 safety communications over the 9-year period.

The most commonly mentioned devices operating room equipment (15 reports), imaging devices (13 reports), cardiac defibrillators (9 reports), and other implantable devices such as heart valves and breast implants (10 reports).

Among the 93 safety communications, 21 were for class III devices that required premarket approval. Of those, two were approved using expedited review. Another 31 devices were cleared through the 510(k) program, 38 devices were never authorized by the FDA, and 3 devices were approved through other regulatory pathways.

The median time from initial device approval or clearance to the publication of a safety communication was 10 years for class II and class III devices. The number of safety communications published each year has remained stable, the researchers noted.

The safety issues most often reported included patient injury (25 reports), potential wrong diagnoses (19 reports), death (18 reports), possible contagious disease transfer (13 reports), and cybersecurity vulnerabilities (9 reports).

In about half of reports (47), the FDA action following a safety communication “was a recommendation for increased vigilance or a suggestion to apply caution when using the related medical device.” Among the cohort analyzed, the FDA requested recalls for 32 devices.

The most common source of data triggering a safety communication – in 44 of 93 communications -- was some form of direct reporting to the Medical Device Reporting (MDR) program, either from a patient, health care professional or the product manufacturer. Regulator-initiated assessments accounted for 32 of the 93 MDSCs. The regulator-initiated actions were the result of routine inspections or awareness of unauthorized marketing practices. In other cases, they were triggered by regulator-affiliated organizations or FDA-mandated postmarketing studies.

The researchers found a statistically significant association between direct reports of adverse events to the FDA and risk of death, compared with other data sources (P = .007). That link was driven mainly by higher prevalence of direct reporting to the FDA for cardiac defibrillators and operating room equipment, they wrote.

The researchers pointed out the limitations of both direct reporting and regulator-initiated surveillance and instead called for automatic collection and continuous real-time analysis from multiple electronic sources. They pointed to the agency’s Sentinel Initiative, a national electronic system that uses administrative and insurance data to flag emerging safety issues related to prescription drugs, as a potential model.

“The medical device equivalent might be the National Evaluation System for Health Technology system, which aims to link and synthesize real-world evidence from different sources across the medical device landscape, including clinical registries, electronic health records, and medical billing claims,” they wrote.

That type of surveillance would be easier with the Unique Device Identification (UDI) number that the FDA has required on the labels of all class II and class III devices, but integrating the UDI into electronic health records has been challenging, the researchers noted.

Additionally, FDA’s enforcement of the use of UDIs has been slow. Under guidance issued earlier this year, the FDA stated it would not enforce UDI labeling for class I and unclassified devices until 24 September 2022. The same guidance said that direct mark UDI requirements for Class II, III, and life-supporting-/sustaining devices would not be enforced by the agency if the device’s UDI “can be derived from other information directly marked on the device.” (RELATED Guidance: FDA holds off on enforcing certain UDI requirements, Regulatory Focus 30 June 2020).

In an accompanying commentary, a former FDA public health analyst, Madris Tomes of Device Events in York, PA, called on the FDA to immediately require – and enforce – the listing of the UDI on every adverse event report and discontinue the practice of redacting the identifier. She also urged agency officials to require physicians to submit reports on faulty devices directly to the FDA instead of sending them first to the manufacturer.

“Direct reporting with the UDI would greatly speed the time to identify signals and improve the chances that all the relevant details of the event are submitted,” Tomes wrote. “A copy of the report could be sent to the manufacturer simultaneously.”

Tau and Shepshelovich reported having no financial disclosures. Tomes is the owner of Device Events, a commercial software tool that identifies patterns of problems with medical devices using publicly available sources.

JAMA Internal Medicine study, invited commentary (abstracts open access)


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