FDA Medical Device Pilot Safety Program Transitioning to Full-Scale System

The Food and Drug Administration (FDA) recently announced that a medical product safety monitoring pilot program launched in 2009 is set to become a full-time system.

According to a blog post written by Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation, the Mini-Sentinel program, which uses a scientific technique called “active surveillance,” is well underway to becoming a full-scale system called the Sentinel System. Active surveillance, says Dr. Woodcock, will complement the agency’s ongoing use of “passive surveillance” through the FDA Adverse Event Reporting System (FAERS).

“Over many years, FDA’s program that we now call FAERS has been our main tool for assessing the safety of medical products,” explains Woodcock on FDA Voice, the FDA’s official blog. “This system relies on patient, medical professionals, and product manufacturers to report to us potential safety issues of the products FDA regulates.”

While not seeking to replace FAERS, the FDA hopes to greatly improve its safety monitoring capacity with the Sentinel System, which, Woodcock says, “enables us to go out and get” safety information.

Under the Mini-sentinel pilot program, the FDA has had access to the electronic healthcare data of more than 178 million patients nationwide through collaborating institutions that also provide the FDA with scientific and organizational expertise.

“While protecting the identity of individual patients we can get valuable information from Mini-Sentinel that helps us better understand potential safety issues, and share with you information on how to use medicines safely,” says Woodcock, who adds that Mini-Sentinel has helped the agency to explore safety issues, enhance its drug surveillance capabilities, and given it valuable input in drug and vaccine decision-making.

The new Sentinel System will be a “nationwide rapid-response electronic active surveillance system” that builds on the successes of the Mini-Sentinel pilot program and further refines its methods. In collaboration with other scientific groups, Sentinel may one day evolve into a national infrastructure that allows other users, such as governmental agencies and academics, to perform medical product research and undertake quality improvement initiatives.

FDA’s Premarket Medical Device Surveillance Criticized
The Sentinel System is an important development in terms of postmarket medical product surveillance, but it does little to quiet concerns over the way the FDA conducts premarket surveillance, particularly of medical devices.

Andrus Wagstaff reported in October on two JAMA Internal Medicine studies critical of the FDA’s 510(K) medical device clearance process, which allows fast-track approval of devices that are “substantially equivalent” to a so-called “predicate device” that is already on the market. The studies were critical of what they perceived as a lack of evidence verifying the safety and effectiveness of 510(K)-cleared devices.

Two of the most injurious medical devices in recent years—DePuy metal hip implants and transvaginal mesh—were approved through the 510(K) process.

Injured by a Medical Product? You Need a Lawyer.
The FDA may have good intentions, but with an annual budget of less than $5 billion, it simply does not have the resources to oversee hugely profitable medical product companies.
Johnson & Johnson, the most profitable U.S. pharmaceutical company in 2014, made $71.3 billion and has an annual advertising budget that is nearly half of the FDA’s entire budget. Procter & Gamble has an advertising budget ($4.9 billion) that exceeds the FDA budget.

You can’t take the money out of the medical product business, but you may be eligible to receive financial compensation if a dangerous drug or defective medical device caused you or a loved one harm.

To learn how you can hold manufacturers responsible for personal injuries their products cause, contact the national law firm Andrus Wagstaff, PC, for a free case review.