- Get the Facts
Medical Device Loophole Leaves Patients At RiskAs Congress reauthorizes the statute governing medical devices this year, it has the opportunity to close a dangerous loophole in the law that puts patients at risk of serious harm. Under current law, the FDA does not have the power to require device makers to prove they’ve fixed safety flaws when they want to market a new device based on one that has been recalled by manufacturers.
Link to Consumers Union news release
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You shouldn't be an industry test subject!
You told us you want medical devices such as heart valves and hip replacements tested for safety before they’re put into your bodies. And you told us it’s just plain crazy that products from cars to coffeemakers are tracked in case of a problem, but that a life-saving medical device isn’t.
Now, it’s time you tell your members of Congress. This week they’ll be voting on rules that will determine the safety of a medical device you may need someday – and the current bill is full of gaping loopholes industry lobbyists want.
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The Safe Patient Project is a Consumers Union campaign focused on eliminating medical harm, improving FDA oversight of prescription drugs and promoting disclosure laws that give information to consumers about health care safety and quality.