Though it has a handle on measuring the safety and effectiveness of medical devices, the FDA isn’t sure there’s enough publically-accessible information for patients and clinicians to make fully-informed decisions about medical products.
The road to a firm medical device surveillance policy began in 2012, when the Center for Devices and Radiologic Health (CDRH) at the FDA created an action plan. Last year, the CDRH and the Engelberg Center for Healthcare Reform at Brookings Institution assembled a planning board to develop a national postmarket surveillance strategy for medical devices.
The planning board was then funded by the FDA to write a report on what it would take to create a long-term medical device surveillance program that would “generate meaningful and reliable information about medical devices.” The chief objective of the national surveillance program would be to offer more evidence on the benefits and risks of medical devices and inform better regulation of such devices. The program would be separated into two stages. In the first two years, a pilot or “incubator” project would develop a five-year plan installing the surveillance system. The implementation and adjustments to the system would occur in years three through seven.
An FDA blog post — co-authored by the CDRH Director Jeffrey Shuren, M.D., and Thomas P. Gross, M.D., director of the Office of Surveillance and Biometrics in the CDRH — offered insight into the postmarket plan. The authors submit that no amount of premarket evaluation can predict how well a medical device will work for patients and providers once it’s put into action. Due to this fact, Shuren and Gross stressed that building an effective postmarket surveillance system will be a cooperative endeavor. They emphasized this writing, “Achieving our vision for a national system requires thoughtful input and active participation from many key national and international stakeholders.”
In the Strategic Priorities document, covering the FDA’s goals for 2014 through 2018, the agency stated it plans to move from a passive to an active medical device surveillance system. The priorities report left no doubt about the agency’s intentions: “postmarket surveillance of FDA’s regulated products is a major part of our mission to protect public health.”