This week the Institutes of Medicine (IOM) called for the FDA to completely scrap its controversial 510(k) clearance for medical devices and replace it with a more comprehensive system. A report in the Chicago Times shows just how strongly the IOM feels about the process’ weaknesses:
‘”What we are recommending is that the 510(k) is fatally flawed in terms of it not evaluating safety and effectiveness of a device,” said Dr. David Challoner, chairman of the IOM’s committee.’
Currently companies can introduce and sell new medical devices without going through any sort of simple testing phase. The device only has to be “substantially equivalent” to a previously approved one. That’s the loophole used over and over by medical device makers like DePuy Orthopaedics, Inc. to get their newest products on the market quickly. The ASR hip implant recall fiasco is a glaring example of how less testing and more marketing hurts patients. More than 90,000 of these “substantially equivalent” hip replacements have been recalled. Clearly, these devices are nowhere near “equivalent” in quality and effectiveness to anything else that the FDA may have green-lighted earlier in DePuy’s approval chain. The 510(k) process may be misleading patients into believing that “approval” means these products have gone through clinical trials, as one patient explained in a recent L.A. Times column by Christine Mai-Duc:
“I thought that any medical device that was actually being put into people’s bodies had been extensively tested before it was released to the public,” said Ayers. Not exactly. “
Ironically, the FDA asked the Institutes of Medicine to review the 510(k) process and give their recommendations. What good is asking for advice, if you’re not going to take it?