Food and Drug Administration officials rely on outdated computer systems featuring error-ridden databases to manage their inspections of domestic and foreign medical devices, according to a Government Accountability Office report.
The findings, revealed during a recent congressional hearing, were part of a GAO assessment of the FDA's ability to ensure the safety of both imported and domestic medical devices. The report concluded that, among other challenges, a lack of current information technology has made it virtually impossible for the agency to meet its product-safety mission.
The "two databases that provide FDA with information about foreign medical-device establishments and the products they manufacture for the U.S. market contain inaccuracies that create disparate estimates of establishments subject to FDA inspection," observed GAO officials. At issue is the FDA's Device Registration & Listing System, or DRLS, which the FDA uses to identify foreign and domestic devicemakers doing business in the U.S., and U.S. Custom's Operational and Administrative System for Import Support, or OASIS, which generates data on foreign companies shipping FDA-regulated products to the U.S.
The GAO found that:
- The FDA's DRLS system cannot communicate with Customs, making it difficult for the agency to keep track of which foreign devicemakers are frequently shipping products to the U.S. and which are simply registered with the agency in anticipation of future activity.
- FDA inspectors often miss significant foreign-product arrivals because their computer system cannot distinguish between such items as table salt and road salt.
- Data-entry duplications and inaccuracies have created disparate estimates of how many foreign device manufacturers are actually subject to FDA inspections. The DRLS system estimates some 5,000 foreign manufacturers are shipping medical devices to the U.S., while OASIS estimates roughly 22,000 devicemakers are sending products.
The revelations have prompted at least two lawmakers to call for greater FDA funding. In a Jan. 29 letter to U.S. Comptroller General David Walker of the GAO, Sen. Edward Kennedy (D-Mass.) and Rep. Henry Waxman (D-Calif.) requested an official examination of what IT improvements and other resources the agency will need to carryout oversight of its duties.
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