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.”
Monday, August 01, 2011
FDA Blind-sided by Anger Over IoM Report
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IoM reports have been routinely ignored on the health IT area as well. The IoM reports I have read on HIT have been well considered, consistent with my first hand observations, and reality based as to what can be done.
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