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High-Risk Medical Devices Backed by Few Studies, Authors Find

Yale team reviews evidence behind device approvals

Many high-risk therapeutic devices win FDA approval with only one study proving their safety and efficacy before going to market. Studies of how the devices work once they are on the market are also few and far between, according to findings published in JAMA and reported by Reuters.

“Medical device regulation in the U.S. is well known to be more rigorous than in other parts of the world,” but there had not been a comprehensive review of the evidence behind high-risk devices, said senior author Dr. Joseph S. Ross of the Yale University School of Medicine.

“The difference is, in many European countries they have much better capacity to follow devices once they are in practice,” Ross told Reuters Health. “They allow devices on the market quicker in the U.K., but follow the devices so they can observe them in practice.”

The U.S. does not have the same kind of robust electronic health records (EHR) system in place to track devices in use and to record when there are problems, he said.

High-risk devices are those that sustain human life or pose a potential risk to it. Of the 28 such devices granted initial marketing approval by the FDA during the study period (2010–2011), 15 were new stents for the heart or elsewhere in the body. Ten were later recalled from the market.

Using, the researchers found that there had been 286 clinical studies of the 28 devices, including 82 before the devices were approved and 204 after they were on the market.

The FDA relied on approximately one study per device to determine market approval, and there were 33 FDA-required postmarket studies for the 28 devices. Only six of those required studies had been completed by October 2014, Ross and his colleagues report in JAMA. Five devices had no postmarket studies, and 13 others had three or fewer postmarket studies. Half of the studies did not compare the new device to an existing one.

The 21st Century Cures Act, passed in the U.S. House of Representatives in July, would make it easier and less expensive for companies to bring drugs and devices to market.

“That’s not going to help, by diminishing the quality of evidence required,” said Dr. Bruce Psaty of the University of Washington in Seattle who serves as vice chair of the FDA Science Board.

The push for lowered evidence standards for approval is part of a move toward “life cycle evaluation,” shifting the burden from before-market approval to continual tracking of safety and efficacy after the device is in use.

Sources: Reuters; August 11, 2015; and JAMA; August 11, 2015.


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