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 wasmore 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’ livesand health over companies’ profits.

  • Read the Report (PDF)
  • Read the Press Release
  • Read our Statement to the Subcommittee on Health of the House Energy and Commerce Committee (PDF)
  • Take Action: Tell Congress to Strengthen the FDA’s Medical Device Approval Process