FDA expands medical device surveillance program

After five years, the FDA is transitioning its Mini-Sentinel program to a full-scale Sentinel System.

“We’re on our way to developing a nationwide rapid-response electronic active surveillance system, Sentinel System, for monitoring the safety of FDA-regulated drugs and other products,” wrote Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a recent blog post. To date, the Mini-Sentinel program has established access to the health data of more than 178 million patients for safety research purposes.

The agency launched the Sentinel Initiative in 2008, and one year later commenced the Mini-Sentinel program. This effort complements the FDA Adverse Event Reporting System (FAERS), in which patients, medical professionals and product manufacturers report potential safety issues of FDA-regulated products.

“FAERS is an invaluable asset, and we’re not seeking to replace it. However, the Sentinel System offers us the exciting possibility of not waiting for safety information to come to us in the form of reports, but rather it enables us to go out and get that information, adding greatly to our safety monitoring capability,” wrote Woodcock.

The agency plans to expand the Mini-Sentinel program by continuing its safety assessments while expanding the reach and capabilities of the system. “Mini-Sentinel gave us an important start, but it is essential to continue to develop and refine existing scientific methods to evaluate the data we access through the Sentinel.”

The FDA also plans to work with other scientific groups to build a National Data Infrastructure so industry and academic researchers can study medical product research, quality improvement and more. “Not only will such access directly serve the public health, it will also help sustain these programs because stakeholders will have an incentive to provide support for its maintenance and growth.”