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Substantially Unsafe

Medical Devices Pose Great Threat to Patients; Safeguards Must be Strengthened, Not Weakened

Feb. 15, 2012 — Regulation of medical devices­—a $350 billion industry that includes such products as heart and brain stents, artificial hips and implantable defibrillators—is at a crossroads. With a major reauthorization bill up for debate, members of Congress already have introduced 14 bills (as of Feb. 14, 2012) that aim to accelerate devices’ path to the market, often by weakening measures intended to ensure patient safety.

Relaxing review standards for medical devices, as proposed by recently introduced bills, would be exactly the wrong course of action, further weakening an inadequate system. Recalls are rising. The average number of high-risk recalls in 2011 was more than double than in recent years. Congress should reject the medical device industry’s lobbying requests and devise an approval process for medical devices that prioritizes patients’ lives and health over companies’ profits.

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