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New Legislation Would Weaken Testing and Regulation of Medical Devices

Jul 22, 2015

The 21st Century Cures Act, currently under consideration by Congress, would make it possible for high-risk medical devices to reach the market using case-study evidence rather than clinical trial results to demonstrate the device’s safety and efficacy.

The Food and Drug Administration (FDA) has regulated medical devices since 1976, but many high-risk medical devices are approved on the basis of just one clinical trial, unlike new drugs, which usually require two trials. And only a small minority of clinical studies of medical devices are randomized, controlled, and blinded, which is the gold standard in trials, Drs. Rita Redberg and Sanket S. Dhruva explain in an op-ed piece in the New York Times.

As a result, Redberg and Dhruva say, there have been numerous warnings, recalls, and withdrawals of medical devices found to be dangerous only after they were on the market. The Sprint Fidelis defibrillator, for example, implanted in hundreds of thousands of heart patients, was recalled in 2009 because it frequently malfunctioned, harming many patients and leading to a number of deaths.

If passed and signed into law, the 21st Century Cures Act would also create a faster approval process for "breakthrough technologies" that are believed to offer significant advantages over existing devices. This would allow a device to be approved based on even lower standards of evidence than are currently used, on the theory that the need outweighs the risk. The legislation contains a loose definition of what constitutes a "breakthrough," and Redberg and Dhruva warn that manufacturers are likely to use the term both to speed device approval and as a marketing gimmick.

The law seems likely to shift the burden of evidence to clinical studies that are conducted only after a device has come to the market, though studies are often delayed months or even years after a device is approved. Many studies are not completed, the authors warn, and findings from completed studies are often not publicly available, according to the Times. The legislation refers to "timely postmarket data collection," but this needs to be clearly defined — and enforced. According to a 2014 article in JAMA Internal Medicine, for which Redberg was a co-author, the FDA has never issued a warning letter or penalty for a postmarket study delay.

Redberg and Dhruva say that even if a postmarket clinical study finds a medical device dangerous, it can still be difficult to remove the device from the marketplace. A clinical trial completed in 2011 of the Wingspan intracranial stent (the device had been approved in 2005), found that patients with the device were more likely to have another stroke and to die than patients under medical management. Despite this finding, the FDA did not withdraw the device, though the agency did narrow the recommended uses. The Wingspan continues to be marketed and implanted, "putting patients at unnecessary risk," Redberg and Dhruva write.

The act would establish a third-party program of nongovernmental authorities to assess whether changes could be made to already approved devices. The manufacturer itself could select, and pay, the third party from an approved list, creating "flagrant conflict of interest" that would make it impossible for physicians or patients to have trust in the safety or effectiveness of updated medical devices, according to the Times op-ed.

Redberg and Dhruva call instead for stricter evidence standards and increased federal funding of the FDA to ensure that innovative medical devices lead to better health.

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