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Apr 9, 2009
Twenty-five high-risk medical devices that hit the market more than 33 years ago – and are still in use today – were never subjected to scientific scrutiny by the U.S. Food and Drug Administration (FDA). But that's about to change, The New York Times reports.
For the first time, devices as diverse as pacemaker parts and female condoms will be assessed using the contemporary analysis standards, including reports on safety and effectiveness from any company that manufactures them.
Since 1976, when Congress passed the Medical Device Amendments to the Food, Drug and Cosmetic Act, the FDA has been in charge of ensuring that all new medical devices get the job done and do so safely. The agency made plans to re-evaluate devices that were already on the market, but many have been de facto grandfathered in (so to speak) – even though they fall in the highest risk category ("those that support or sustain human life" per the FDA's Web site).
Jan 20, 2009 | 20
Millions of people in the U.S. and around the world watched the historic inauguration of Barack Obama as he vowed to rebuild and reunite a fractured nation facing war, economic turmoil and other major challenges. Among the hurdles, our new President pledged, "We will restore science to its rightful place, and wield technology's wonders to raise health care's quality and lower its cost."
One needn't look far to see how technology has improved medical care – from anesthesia to ultrasounds. And some – Obama seemingly among them – believe that such technology can make health care more efficient. That could mean shorter hospital stays, more complete medical databases or ordering fewer tests because those we have are better.
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