Spurred on largely by recent problems with implantable cardioverter debrillators (ICDs) and pacemakers, the FDA held a rare "media briefing" to discuss the problems the agency faces in tracking the safety of medical devices after they've been approved for use.
The Star Tribune reports the FDA acknowledged it is "challenged by the size and growth of the device industry, the complexity of devices, increased home use of devices and the tension between safety and cutting-edge technology that could improve people's lives."
You could cut and paste those words into a description of the challenges faced in drug monitoring.
The newspaper reports that last week the FDA sent "an unusually harsh and broad warning letter" to the Boston Scientific corporation. "The FDA cited serious quality-control problems -- and inadequate responses to earlier warnings -- at numerous factories operated by Boston Scientific, whose products include the best-selling Taxus stent."
Posted by schwitz at February 3, 2006 08:25 AM | TrackBack