Dr. Robert Hauser of Abbott Northwestern Hospital has been fighting for years to push the U.S. Food and Drug Administration to take a more painstaking approach to approving high risk medical devices, such as implantable heart defibrillators (ICDs) and the leads, or wires, that run from the device to the heart. He also has fought for a more aggressive system of monitoring device performance and notifying patients of any safety concerns or device recalls.
His advocacy for tougher standards began in early 2005, when a young patient in whom Hauser implanted an ICD died of a heart attack after the device failed to deliver a life-saving shock.
On Sunday, Hauser, a cardiologist at Abbott’s Minneapolis Heart Institute, was featured in a report by CBS Sunday Morning that raises questions about the adequacy of the FDA approval process. You can watch the video here: