In a surprise move, one of the country’s top scientific groups has recommended that the government scrap the system for approving medical devices such as artificial hips, external heart defibrlilators and hospital pumps. The Institute of Medicine, a branch of the National Academy of Sciences, said the process does not reliably screen products for safety and effectiveness before they go on the market.
The Food and Drug Administration had asked the institute to review whether the process for a wide range of moderate-risk products protects patients “optimally” and promotes innovation. Several devices that went on the market after undergoing little, if any, testing — including metal-on-metal artificial hips that crippled some patients — recently have been recalled by manufacturers.
The institute was expected to recommend toughening the current approval process, called 501(k), which requires manufacturers to show only that a device is “substantially equivalent,” or similar, to one already on the market. But in its report, the institute went further, concluding that the current approach is not fixable.
“It’s not clear that the 510(k) process is serving the needs of either industry or patients, and simply modifying it again will not help,” the chair of the institute’s review committee, Dr. David Challoner, said in a news release.
According to The New York Times, patient advocates have welcomed the report “as an affirmation that current rules allow dangerous or ineffective devices onto the market with scant review.”
But industry groups had lobbied to discredit the report even before it was released, arguing that it would be biased. The Advanced Medical Technology Association, or AdvaMed, quickly dismissed the report, saying in a news release that its “conclusions do not deserve serious consideration from the Congress or the Administration.”
In place of the 510(k) system, the institute recommended that the FDA develop a new framework that is “based on sound science” and is “clear, predictable, straightforward, and fair.” Such a system, Challoner said, could be established “within a reasonable time frame.” But AdvaMed criticized the institute for proposing “an untried, unproven and unspecified new legal structure.”
For its part, the FDA isn’t backing away from the 501(k) process, and it’s unclear what impact the institute’s report will have. The FDA believes that the process “should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs,” Dr. Jeffrey Shuren, an agency official, said in a news release.
The institute report did not examine the FDA’s far more rigorous process for evaluating high-risk devices such as implantable heart defibrillators.
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