July 30, 2011 – The Los Angeles Times
Reporting from Washington — Katherine Ayers was 36 when she decided the pain in her hip had become too much to bear. A surgically implanted metal-on-metal hip joint soon made her pain-free.
But a few years later, she was startled to receive a letter saying the artificial joint was being recalled.
“In my mind, recalls were for dishwasher and cars, not body parts,” she told a congressional hearing earlier this year. Ultimately, Ayers had to have a new implant.
It was experiences such as Ayers’ — and scores of others with even more serious consequences — that has led the Institute of Medicine, an arm of the National Academy of Sciences, to call on the government to design a new system for evaluating and approving many high-risk medical devices before they reach the market.
“It’s not clear that the … process is serving the needs of either industry or patients, and simply modifying it again will not help,” David Challoner, chairman of the committee that wrote the recommendation, said in a statement.
Medical devices range from simple adhesive strip bandages used for minor cuts to contact lenses and pacemakers. When complex devices fail, they can generate health problems and healthcare costs, even imperil lives.
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.