The staff at the Food and Drug Administration losing a report was one of many missteps that cause the FDA to take years to warn about scope-related infections, according to an article on the L.A. Times website.
The missing paperwork, revealed in a recent Senate inquiry, underscores the serious shortcomings in the antiquated national database used to monitor the safety of medical devices, which even the FDA has long admitted is flawed, the article said.
The speedy implementation of a new system has hit a roadblock put up by opponents who say an essential part of the upgrade will cost too much.
A 2007 requiring that each device get a unique number had no deadlines. A trade group of the nation's hospitals and Medicare directors say adding a line to the standard insurance claim form so that the device numbers can be recorded is too expensive.
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