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1 .This is Scientific American 60-Second Science. I'm Cynthia Graber. This'll just take a minute.
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2 .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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3 .That's not always the case, at least for cardiovascular devices.
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4 .That's according to an article in the Journal of the American Medical Association.
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5 .Researchers evaluated the FDA premarket approval process for 78 high-risk devices,
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6 .such as pacemakers, stents and implanted defibrillators.
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7 .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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8 .But for 51 of the devices--65 percent--approval was based on a single study.
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9 .Only 27 percent of studies were randomized, and only 14 percent were blinded.
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10 .Only half of the devices were compared with controls.
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11 .The authors recognize the tension between sufficient testing and the need to get new drugs and devices to the public.
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12 .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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13 .In addition, although devices can be lifesaving, they also have great potential for risk and adverse events."
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14 .Thanks for the minute, for Scientific American 60-Second Science. I'm Cynthia Graber.
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