Political Quotes

“another key aspect of the Safe Medical Device Act, which this bill undermines, is the mandatory surveillance program for high-risk medical devices. These surveillance programs are extremely important for early detection. In some cases, the initial breakage of a device may not cause instantaneous harm. For example, in the case of the Telectronics Heart Pacemaker ``J'' Leads which are found to be defective in 12 percent of the patients with them, breakage didn't result in any harm until the next bout of heart arythmia. Surveillance of these leads identified problems in some patients. And this led to the notification of patients with these leads of the need to have them checked. Likewise, in the case of the Bjork-Shiley heart valves, 300 Americans died when this tiny heart valve no bigger than a pen turned out to have a structural defect. This is a blowup of a photograph of a heart valve. And it shows a crack in one of these struts on this heart valve. This crack alone wouldn't be lethal. But when the strut next to it cracks, it is too late. You are going to die unless you have immediate surgical relief. We believe that once you know that the heart valve is in danger, you should know the people who have received it so that you can notify them so that they can go to a doctor and have the necessary test to see if they are in danger. Early detection and correction could have prevented many of the 300 deaths that occurred when this Bjork-Shiley valve failed.”