Database System to Boost FDA’s Postmarket Surveillance Capability

NEWS TRENDS

It can take a long time for FDA to piece together medical device reports (MDRs) and other data to determine that there is a public health problem with a medical device. The agency hopes that a new database system will allow it to spot negative trends—and have device companies correct the problem or pull their products off the market—much more quickly.

The Sentinel System, unveiled in May, is envisioned as a series of databases that will allow the agency to query a broad array of information to identify possible postmarket adverse events related to devices, drugs, and biologics. Rather than waiting for adverse-event reports to trickle in, the agency will now be able to actively search databases and look for problematic patterns of side effects and adverse events. If the system works as envisioned, the agency could identify problems and alert doctors and patients much more quickly than it can now. This could prevent problems and save costs.

“The initiative will tremendously increase FDA's capacity to monitor the use of medical products on the market,” said HHS secretary Michael Leavitt at a press conference. “We are moving from reactive dependence on voluntary reporting of safety concerns to proactive surveillance of medical products on the market. This will result in much-improved safety for the American people.”

As much as it tries to, the agency can't anticipate every potential problem with a medical product by parsing through clinical trial data, nor can it mandate longer and larger trials for every product, officials said. Instead, it can combat postmarket problems—and inevitably, there will be some—by detecting them earlier.

The effort begins with a pilot program using CMS's Medicare Part D database. Eventually, FDA envisions being able to search other CMS data­bases, as well as databases from other government entities such as the Department of Veterans Affairs and the Department of Defense. It is also negotiating to be able to use resources from the private sector, such as electronic medical records in hospital systems and insurance-company databases. Using outside resources gives FDA access to information about incidents for which no MDR was filed, and allows it to spot trends in ways unavailable now.

“We will have the ability to monitor a product's performance in millions of patients in real time,” said FDA commissioner Andrew von Eschenbach. “The Sentinel System will give us an unprecedented ability to detect problems as they first begin to surface.”

No patient-specific data will be returned in the searches, so privacy issues should not be a concern.

The initiative does not require the creation of a new information technology system, officials said. Rather, it will link and search databases that already exist in a new way.

The agency published a white paper on the system. It can be found at www.fda.gov/oc/initiatives/advance/reports/report0508.html.

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