As the $110 billion-a-year U.S. medical device industry continues to expand, the Food and Drug Administration is exploring how to better monitor the market.
The Brookings Institution, under an arrangement with FDA, released a proposed $250 million framework this week for a postmarket medical device tracking system. Under the plan, the National Medical Device Postmarket Surveillance System would use the “experiences of patients to inform decisions about medical device safety, effectiveness, and quality in order to promote the public health.”
According to the report, the system would tap into current public and private sector programs, and use data to better track devices. Authors wrote they don’t envision an entirely new program, and they cite the potential to build on existing schemes like the FDA’s Sentinel Initiative, a national electronic system that tracks products like pharmaceuticals.
The FDA currently has the ability to issue mandatory device recalls. However, the report notes, the agency is limited by its poor access to postmarket data.
“Despite rigorous premarket evaluation, what really counts is how well a medical device works when it’s used day-to-day by patients, caregivers and clinicians,” wrote Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, and Dr. Thomas Gross, director of the Office of Surveillance and Biometrics within CDRH, in a blog post announcing the release of the report.
In the first two years, the report recommends starting an incubator to develop a five-year plan for the system and then spending the next five years establishing a program.
FDA’s Center for Devices and Radiologic Health put forth a plan to establish such a surveillance system for medical devices in 2012. It called for a multi-stakeholder planning board to find what was needed to develop a national system. This is the planning board’s report.
At the same time, authors of the report noted barriers to seeing the proposed plan through.
“The Planning Board recognizes that it is a challenging time for public funding of a national initiative on device surveillance, and that FDA does not currently have specific appropriations dedicated to support such an effort,” the report authors wrote.
They called on Congress to support infrastructure needed to track medical devices.