In an editorial published in The Journal of the American Medical Association, top officials of the Food and Drug Administration call for a better system to detect and understand medical device issues when they come about.
Commissioner Robert Califf, MD, and Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health (CDRH), write, “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 U.S. 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].”
Key dilemmas for device regulation, according to Califf and Shuren, are underreporting and spontaneous reporting. As reporting of adverse events and device malfunctions currently depends on clinicians identifying a possible association, underreporting is likely, while spontaneous reporting does not have the ability to capture numerators and denominators that enable reliable risk estimation. Because of this, safety issues are not identified until they were exposed to risks, leading to potential for avoidable harm, greater liability and loss of consumer confidence.
As said by Califf and Shuren, “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.”