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How Safe and Effective Are Medical Devices?

With little information about safety and effectiveness of medical devices, doctors and patients can only guess whether or not a given device is suitable.

A new study has identified important weaknesses in the FDA’s approval of medical devices. The agency can speed devices such as implants, stents or artificial joints through the approval process more quickly if they are substantially equivalent to equipment already on the market.

The law requires that information about the new device be publicly available, but the new study examining 50 recently approved devices found adequate public information on only 16 percent of them. Until safety and effectiveness data about stents, implants and other devices is made available, patients and health professionals are handicapped in making decisions about the best options for treatment.

[JAMA Internal Medicine, online, Sept. 29, 2014]


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About the Author
Terry Graedon, PhD, is a medical anthropologist and co-host of The People’s Pharmacy radio show, co-author of The People’s Pharmacy syndicated newspaper columns and numerous books, and co-founder of The People’s Pharmacy website. Terry taught in the Duke University School of Nursing and was an adjunct assistant professor in the Department of Anthropology. She is a Fellow of the Society of Applied Anthropology. Terry is one of the country's leading authorities on the science behind folk remedies. .
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