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Regulatory News | 11 July 2016 | By Zachary Brennan
The US needs a better system to quickly detect and understand medical device issues when they arise, US Food and Drug Administration (FDA) Commissioner Robert Califf and Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), wrote in a viewpoint published Monday in JAMA.
The call for better postmarket tracking of devices comes as professional societies have developed registries with details on clinical circumstances, procedures and outcomes.
“When linked with projects leveraging EHRs [electronic health records] and complementary sources, such as claims databases, device registries can provide rich data on long-term outcomes. In addition, the FDA’s Sentinel Initiative collects detailed claims data on the clinical outcomes of more than 100 million individuals in the US system. If the Sentinel Initiative would incorporate UDIs [unique device identifiers], it could provide a strong component of NEST [National Evaluation System for Health Technology],” the FDA officials write.
The call for an updated NEST, which first sparked interest in 2012, comes as FDA is looking to better identify problematic devices, accurately and transparently characterize and release data on device performance in clinical practice, and efficiently generate data to support premarket clearance or approval of new devices and new uses of currently marketed devices.
The viewpoint comes as some have railed against FDA for what they allege to be the agency’s allowance of devices linked to many adverse events to remain on the market. Similarly, the Government Accountability Office recently said that almost 90% of the postmarket device surveillance studies FDA ordered companies to perform over the past seven years were categorized as inactive, though FDA later finalized guidance on postmarket device surveillance.
“Essentially, NEST should be of, by, and for the medical device ecosystem and configured to provide maximal value to stakeholders, including the critical data needed by the FDA to make decisions that currently must be made with less comprehensive information,” Califf and Shuren write.
Both officials also lament the fact that the reporting of adverse events and device malfunctions currently depends on clinicians identifying and reporting a possible association, which means underreporting is likely common.
“Safety issues are therefore often not identified until many patients have been exposed to risks, leading to greater potential for avoidable harm as well as greater liability and loss of consumer confidence in the manufacturer,” they write. “Spontaneous reporting is not systematic and can be biased by extraneous factors such as news reports. Other safety issues also depend on companies appropriately assimilating and reporting data.”
Califf and Shuren call for an approach that links to and uses clinically based data sources, such as registries, electronic health records (EHRs), and claims data, which could potentially reduce the burdens of obtaining such device data.
“By leveraging clinical data and applying advanced analytics and flexible regulatory approaches tailored to the unique data needs and innovation cycles of specific device types, a more comprehensive and accurate framework could be created for assessing the risks and benefits of devices,” they write.
Tags: Sentinel, device safety, NEST, GAO, Robert Califf