Skip to main content

Why it took years for the FDA to warn about infections tied to medical scopes

By Los Angeles Times  
   February 08, 2016

Congress passed a law in 2007 requiring that each device get a unique number, like a bar code, that would correspond to the specific brand and model. The number would be recorded in patient records and medical claims. But the law included no deadlines. And it took the FDA until 2012 to finalize rules requiring manufacturers to stamp the "unique device identifiers" on their products. 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.

Full story

Tagged Under:


Get the latest on healthcare leadership in your inbox.