The device-surveillance system maintained by the FDA doesn’t recall flawed medical devices quickly enough, reports the Minnesota Star Tribune.
Many device problems are never logged in the FDA’s public system for adverse-event reporting known as MAUDE. And a study published last month by University of Minnesota researchers found that even when device companies do have the relevant information at hand, they are often biased in favor of waiting too long to issue product recalls.
“The reality is, if you look at the results, clearly there is under-reaction” to events that spur device recalls, said Kingshuk “KK” Sinha, a department chair with the U’s Carlson School of Management.
