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Brett Emison
Brett Emison
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FDA Reviews Medical Device Regulation; Report Shows Lack Of Testing

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According to an Associated Press report last week, “most medical devices recalled in recent years because of deaths or life-threatening problems were cleared for approval under less stringent regulations that don’t require human testing.” The piece draws attention to a study led by Diana Zuckerman, president of the National Research Center for Women & Families, a Washington-area research-based think tank.

This latest news is timely since the FDA is currently looking at proposals for stricter safety measures for medical devices. This includes heart defibrillators, and should include knee replacements. Under the agency’s proposal posted online this month, makers of external defibrillators would need to submit more data and undergo manufacturing inspections before launching a new product.

Some of the research’s highlights:

1. Thousands of deaths or serious medical problems occurred in patients with the recall devices, which include external heart defibrillators, brain shunts and implanted pumps that deliver cancer drugs.

2. "Because so many medical devices are not being held to a higher safety standards, people are dying who wouldn’t otherwise die and you don’t have to die, and people are being harmed don’t have to be harmed." – Diana Zuckerman

3. Of the 113 highest-risk recalled devices, reportedly 71%, or 80 devices, had been approved through the less stringent regulation. Only 19%, or 21 devices, were approved under a stricter process for brand-new products that involves inspections and human testing.

The researchers looked at the FDA’s list of high-risk devices that were recalled from 2005 through 2009 for this study.

Under the FDA’s 510(k) process, new devices can be approved without human testing if they are similar to devices already on the market. A stricter category, the pre-market approval process, requires scientific evidence, typically extensive testing that is similar to what is required of new medicines.

This “back-door” approach to getting a device approved is the same approach that we can thank for the DePuy ASR hip implant and its troubles, which are now the subject of many lawsuits. And when large pharmaceutical and medical device companies can fast-track a product, it will resort to deceitful marketing of that product through whatever means it can. Without, sadly, going through rigorous testing of that device, testing that would have made sure the product was a safe one.

(c) Copyright 2011 Brett A. Emison