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High-Risk Medical Devices Receive Approval without Sufficient Studies

A new study conducted by the Journal of the American Medical Association (JAMA) that analyzed all the 28 high-risk devices approved in 2010 and 2011 by the FDA Premarket Approval pathway shed light on how many of these devices get FDA approval with only one study proving their safety and efficiency before going to market.

"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 FDA during the study period, 15 were new stents for the heart or elsewhere in the body. Ten were later recalled from the market.

The research also noted how there are only a few studies done to measure how these high-risk devices are working once they are on the market.

The studies conducted by JAMA report that the FDA relied on roughly one study per device to determine market approval, and there were 33 FDA-required post-market studies for the 28 devices. Only six of those required studies had been completed by October 2014. Five devices had no post-market studies, and 13 others had three or fewer postmarket studies.

"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, stated senior author Dr. Joseph S. Ross of the Yale University School of Medicine in New Haven, Connecticut.

This is different from many European countries that spend a great deal of resources to follow devices once they are in practice. Although they approve devices to enter the market faster in the U.K., they spend more time observing them in practice. In comparison, the U.S. does not have as strong of an electronic health records system to track and record errors of devices in use.

"Perhaps we need to consider requiring more, larger and more robust postmarket studies," Dr. Ross said. The experts agree that implementing unique device identifier codes for each device would be a good first initiative toward better postmarket studies.

Read the full article here.

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