Surprising as it may seem, the way the present system works is that thousands of devices are routinely cleared for market without any of the clinical testing for safety or effectiveness that is required for prescription drugs.
"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.
When the FDA was given responsibility for medical devices in 1976, Congress specified that those already on the market could continue to be sold without testing. At the same time, Congress created the so-called 510(k) process under which new devices could be cleared for market if they were "substantially equivalent" to existing products.
As a result, thousands of medical devices have received FDA clearance based on older devices, neither of which were subjected to the kinds of rigorous pre-market testing required for pharmaceuticals.
Further, a study of high-risk recalls from 2005 to 2009 found that more than two-thirds of medical devices recalled for potentially serious risks went through the expedited-approval process.
More than 90,000 artificial hip joints were recalled last summer after studies showed that about 1 in 8 recipients needed to have them replaced. The implants, manufactured by a subsidiary of Johnson & Johnson, were found to release small metallic particles into patients' bloodstreams over time.
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