Friday, March 02, 2012

House bill would rightly close loophole on unsafe medical devices |

More than 5,000 lawsuits have been initiated related to faulty hip replacements in the United States, but the frightening thing is that the flawed device came to market because of a regulatory loophole.

The Food and Drug Administration allows devices to come to market without testing on patients if the manufacturer can show there’s a "predicate," a similar device that was approved earlier.

But what if that predicate was pulled from the market when its maker realized it had flaws? Doesn’t matter.

A voluntary recall, not a recall by the FDA, allows the design to be picked up by other manufacturers and survive as a repeat offender. That means the new device maker can sail onto the market — with the wind of a bad product at its back.

Now, House Democrats have proposed a bill to deal with the loophole that allows these faulty designs a second life. It gives the FDA the power to reject devices that are based on flawed designs recalled by manufacturers. It’s a sensible response that places consumer safety first.

In addition to endangering consumers, the loophole undermines the FDA’s credibility. The agency’s safety designation should be above reproach.

Already, medical representatives say the bill is overkill, another regulation to burden manufacturers. But an FDA official who oversees medical devices says the change could make approvals easier, shortening the negotiations about questionable designs. And makers of the new device would have the opportunity to show how earlier errors had been corrected, or no longer relevant.

That’s fair for both seller and buyer. Consumers shouldn’t have to endure the pain and cost of replacing devices that have the same DNA as Brand X.

Posted via email from Jack's posterous

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