Thursday, August 4, 2011

Astonishing statistics!

(1) Diana Zuckerman, president of the National Research Center for Women and Families, found that in 2010 more than 437 million devices were recalled out of fear that they might kill or permanently harm patients.

(2)Right now, the U.S. Food and Drug Administration uses a streamlined review, called 510(k), to approve products that are similar to those it has already approved and are on the market. The streamlined review, used for about 90 percent of medical device applications, including those for knee and hip replacement, takes about 10 months as opposed to the years a more complex review would take.

(3) The Institute of Medicine said in a report released today that the FDA should instead require each device maker to prove the moderate-risk (or Class II) products are safe and effective, and possibly test the devices on actual patients. Last week, the Government Accountability office said that a staggering 83 percent of 700 devices recalled every year are Class II.

(4)Artificial hips and knees are now a nearly $7 billion market, with 1 million people getting either knee or hip surgery every year, according to several reports.

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