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Senate OKs weak Safety And Innovation Act for medical devices

Consumer Reports News: April 25, 2012 03:08 PM

The Senate HELP Committee today voted to approve the Food and Drug Administration Safety And Innovation Act, and although the bill included some improvements, it lacked key medical device safety provisions.

The legislation left unaddressed many significant flaws with the FDA's current medical device oversight system, says Consumers Union, the policy and advocacy arm of Consumer Reports.

According to our investigation, many implanted devices, including artificial joints and surgical mesh, are never clinically tested on humans before being put on the market. Tens of millions of Americans live with medical device implants, including artificial joints, heart defibrillators and surgical mesh, among others. As it stands now, manufacturers simply file paperwork and pay the FDA a user fee to start selling a medical device product.

"The FDA's current fast track review process has allowed too many dangerous and defective devices onto the market," said Lisa McGiffert, director of Consumers Union's Safe Patient Project. "To make matters worse, the FDA doesn't have the tools it needs to react quickly when safety problems with medical devices arise."

Americans support stricter safety standards for medical devices, according to a recent Consumer Reports poll. More than eight of 10 people in the survey said it was more important to prevent safety problems in the devices than it was to encourage innovation or avoid delays in getting them to market.

"Unfortunately, this bill doesn't fix some of the most serious flaws in our current system and leaves patients at risk," McGiffert said.

Consumers Union had previously urged the HELP Committee to strengthen the bill by prohibiting the clearance of new medical devices based on recalls of such devices, as well as the following:

  • Improving the system for monitoring devices once they are cleared for sale.
  • Providing the FDA with greater authority to require post-market safety studies.
  • Retaining current strong conflict of interest standards.

Previously:
Consumers Union pushes to improve medical device safety
Medical device maker to pay $16.8 million penalty for bribery

Source:
Consumers Union: Medical Device Bills Missing Critical Protections For Patients [Consumers Union]

Maggie Shader


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