Recall that FDA’s Device Center was recently shown to make political decisions re medical device approvals, and to grandfather in devices on the basis of earlier approvals of very different devices. GAO wrote several damning reports including this one from June 2009: Shortcomings in FDA’s Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments. GAO pointed out in January 2009 that only cursory reviews were taking place for most devices. Thus the Center’s Director was let go.
Yesterday’s NYT reports on devices that fail, and how the health care system has to eat the very expensive results of such failures. But in the US, medical devices come with no warranty:
When a car breaks, a computer fails or a toaster flames out, the manufacturer is often liable under the product warranty. But that is not how the multibillion-dollar orthopedics industry tends to work, according to doctors, industry experts and three of the biggest device makers.
The article points out that the new healthcare bill should have addressed this issue, but did not.