The temperature is rising. The FDA has been completely blindsided by the release of the National Academy of Sciences’ (NAS) report – and the outrage it’s fanned – saying that the current program for testing medical devices should be scrapped, according to a story by Barry Meier in a follow-up story at nytimes.com Saturday.
On Friday the NAS, part of the Institute of Medicine (IoM), said that thousands of medical devices are allowed to go on the market without proper safety testing, due to a quirk in the current evaluation process that lets medical devices go unscreened if they are replacing a product that has already been approved.
The shocking part? The FDA commissioned the study!
According to Meier’s follow-up story Saturday, “The report’s unequivocal recommendation to scrap the current system was unexpected, and it unleashed reactions ranging from outright rejection by industry officials, an embrace by patient groups and seeming disbelief from federal regulators, who had commissioned the review.”
The report comes after several recalls of medical devices in recent years, including “metal-on-metal” hip replacements that fail in 1 out of every 8 patients, which Meier reported at nytimes.com on Friday. “In its report,” Meier writes, “the panel found that existing rules used to approve many devices were never intended to play the critical role of screening out dangerous or ineffective products.”
In fact, the “quirk” in the current approval process actually only applies to low-to-moderate-risk devices, but some of the replacement products should be considered high-risk, Meier writes.
The FDA had commissioned the IoM in September 2009 to go over its medical device approval process, according to medicalnewstoday.com. The story added that the FDA medical device unit “is said to suffer from high turnover, funding problems, and major recalls.”
The controversy actually got its start in April, when The Los Angeles Times reported that “analysts and industry watchers alike have come together to criticize the way in which the FDA approves medical devices. Over the past few years, the FDA has been mired in controversy following its approval of high-risk devices that were later deemed defective and required large-scale recalls,” according to a story at strategicsourceror.com, which referred to the LA Times story in its own story.
Industry isn’t standing still. Even before the report came out, companies like Medtronics, Boston Scientific and Johnson & Johnson, tried to discredit it and now, according to Meier’s story, they’re taking legal steps to prevent the FDA from changing anything.
Deborah DiSesa Hirsch is an award-winning health and technology writer who has worked for newspapers, magazines and IBM in her 20-year career. To read more of her articles, please visit her columnist page.Edited by
Rich Steeves
