Medical Devices Need More Scrutiny

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Medical Devices Need More Scrutiny

February 7th, 2008 joshua

A recent article in Journal of General Internal Medicine says medical devices need more rigorous review in the United States, the medical news site DotMed News reports.

The study, conducted by the University of California at San Francisco says the time following Food & Drug Administration (FDA) approval of a medical device is most important. This is the time when an independent organization can identify safe and unsafe devices. “Evidence-based” information is most helpful to doctors receiving patients that are asking for specific devices or courses of treatment.

Thousands of medical device applications are submitted to the FDA annually, but less than a hundred get the type of review a prescription drug is supposed to. So the study says FDA approval is rather easy for a device, making reality-based study of the effects of the device more beneficial than being assured because of an FDA approval.

Most times the only information available to doctors is direct from the manufacturer. Having an independent review system, according to the UCSF researchers, does better in eliminating biased reporting.

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