FDA well on its way to full Sentinel system for device safety monitoring

The U.S. Food and Drug Administration's Mini-Sentinel program, used for medical product safety monitoring, is ready to move to the full-scale system, according to Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

The program started in 2009 as a five-year pilot to monitor the safety of FDA-regulated medical products by using claims and electronic health record data from 18 healthcare organizations.

"The Mini-Sentinel pilot program has established secure access to the electronic healthcare data of more than 178 million patients across the country, enabling researchers to evaluate a great deal of valuable safety information," Woodcock writes in a recent blog post.

She adds that the FDA is well on its way to transitioning to the full Sentinel System. Going forward, she says, the agency will continue to develop ways to evaluate the data gained through the program. With help from other groups, the agency will create a national data infrastructure that will allow users to access the Sentinel program for multiple reasons, Woodcock writes.

Some of the healthcare organizations participating in the program include Kaiser Permanente, Aetna, the University of Pennsylvania and Weill Cornell's School of Public Health.

The security of medical devices increasingly has been on the FDA's radar, with the agency this past fall outlining measures it believes medical device manufacturers must take to ensure the safety and security of their tools in the face of growing cyberthreats.

In addition, the FDA also is joining with the National Health Information Sharing and Analysis Center on cybersecurity of medical device information.

To learn more:
- read the blog post