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This is Scientific American 60-Second Science. I'm Cynthia Graber. This'll just take a minute.

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We like to think that medical equipment implanted in our bodies undergoes rigorous testing before it's put inside a person.

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That's not always the case, at least for cardiovascular devices.

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That's according to an article in the Journal of the American Medical Association.

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Researchers evaluated the FDA premarket approval process for 78 high-risk devices,

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such as pacemakers, stents and implanted defibrillators.

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They had assumed that these types of devices should and would be subject to random double-blinded studies with controls over an appropriate time-frame to investigate safety and efficacy.

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But for 51 of the devices--65 percent--approval was based on a single study.

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Only 27 percent of studies were randomized, and only 14 percent were blinded.

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Only half of the devices were compared with controls.

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The authors recognize the tension between sufficient testing and the need to get new drugs and devices to the public.

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But, they say, "The bar for evidence of benefit should be higher for devices because they are implanted and cannot simply be discontinued, as drugs can.

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In addition, although devices can be lifesaving, they also have great potential for risk and adverse events."

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Thanks for the minute, for Scientific American 60-Second Science. I'm Cynthia Graber.

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