Health Equipment RECALLED

Please read the following. It's scary.

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Consumer Reports taps ire over bad medical devices
Tue Mar 13, 2012 3:16pm GMT

By Debra Sherman

CHICAGO (Reuters) - Consumer Reports, the 76-year-old publication best known for its reviews of automobiles and refrigerators, is trying to galvanize the American public into protesting the way medical devices are approved by the U.S. Food and Drug Administration.

The past couple of years have seen a steady drumbeat of concerns by some lawmakers that health regulators are doing too little to protect consumers from hastily approved devices that can cause injury or even death.

It's a nightmare scenario," Consumer Reports President Jim Guest wrote in an email blast to 1 million Americans earlier this year. “The implant that fixed your knee or your heart may actually be a ticking time bomb that could disable or kill you.

This isn't science fiction. Millions of medical devices including artificial hips, contact lens solution, heart stents, and pacemakers are being recalled -- 700 different products a year. And the vast majority of recalled products were never safety tested in humans, because the manufacturers claimed they were 'similar' to products already on the market," he wrote.

For decades, certain devices have been cleared by the FDA without the manufacturers ever having to test them in human beings in clinical trials, which take time and money.

The fast-track approval process is known in the industry as Pre-market Notification, or 510(k), named for the numbered section of the Food, Drug and Cosmetic Act.

Intended for low- and moderate-risk medical devices, such as blood pressure cuffs and hypodermic needles, too many high-risk devices, such as hip implants and heart valves, were cleared through the 510(k) process and later found to cause life-threatening incidents, according to Guest.

Consumer Reports, an independent nonprofit, publishes a monthly magazine, as well as newsletters focusing on health, money, travel, home and garden, weddings and other topics.

It has a total of 8 million subscribers to all of its publications and 800,000 for its On Health monthly newsletter, which was established in 1989. On Health maintains its own medical experts, but sometimes taps outside physicians.

Consumer Reports' advocacy arm, Consumers Union, would not disclose how much money it is spending on efforts to change the medical device approval process, but says its campaign is a top priority. The campaign was launched late last year at its annual Patient Safety Summit.

The Institute of Medicine, a nongovernmental, nonprofit organization that provides medical advice to policy makers and the public, characterized the 510(k) approval process as “fatally flawed" and said it should be scrapped.