if you buy a car in America the manufacturer keeps a record of your name and address, or if there is a defect they can recall the car. This bill removes the requirement for medical device manufacturers to keep a record of those people who receive pacemakers and heart valves. Why is that important? Because, if there is a defect in that lifesaving medical device, they can't find the patients. What results? Just a few years ago 300 Americans died. They had the Bjork-Shiley heart valve that was defective and they couldn't be found. Does it make sense for us to remove this responsibility of medical device manufacturers? Take a look on your desk at a letter from 27 different organizations representing patients across America who say it is only sensible to make certain that we track and keep track of those who are receiving these medical devices. I urge my colleagues to vote for this amendment. It is not too great a burden on a medical device manufacturer to keep a record of those receiving pacemakers and heart valves.
Editor's note · Context
Discussing the importance of tracking patients who receive medical devices during Senate floor debate.
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