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.