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Greg Webb
Greg Webb
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FDA Giving Defective Defibrillators and Hip Replacements A Pass?

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The Food and Drug Administration’s (FDA’s) fast-track review process has been allowing items such as hip replacements and defibrillators and other high-risk devices to slip through the cracks of its scrutiny, or so the U.S. GAO now says in a report released last week, The Los Angeles Times reports.

One might draw the conclusion, as The LA Times reporter Amina Khan has, that this may portend "potentially unsafe devices are being used by, and even implanted in, unsuspecting patients…" , a person can check this. For instance, the website for hip replacements which have been through the pre-market approval process in the past few years is: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pmasimplesearch.cfm

The former U.S. Government Accounting Office, now renamed the U.S. Government Accountability Office (GAO) appears to take these things seriously and issued a report April 14, 2011 on FDA’s pre-market review processes, noting that there have been 3,510 voluntary medical device recalls between 2005 and 2009 — or about 700 recalls per year—at least 67 of those were high-risk devices in the fast-track process. If manufacturers can prove that their product is "roughly equivalent to" a device currently on the market, then their product can go through the fast-track approval process known as, "510(k)". The fast-track approval does not require testing on humans.

If I’d had a hip replaced or a pacemaker inserted, I’d want to know whether the replacement or other device was cleared by the fast-track or more closely scrutinized approval process. By going to the FDA’s PreMarket Approval webpage

One might conclude that a quick review or pass on products similar to those already on the market might miss a defect or two and leave the consumer holding the bag… in this case, perhaps a faulty hip replacement.