2018-01-26 / On Second Thought


Are medical devices like hip replacements subjected to the same scrutiny by the Federal Drug Administration as new drugs?
Compiled by Warren Hughes

Contrary to what one may think, many medical devices are not subjected to the same scrutiny as a prescribed medicine, says Jeanne Lenzer, author of The Danger within Us: America’s

Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It. According to Lenzer, some 32 million Americans have at least one medical device implanted, ranging from artificial joints and cardiac stents to pacemakers, surgical mesh, and nerve stimulators.

Summarizing her findings recently for the New York Times, she noted, “Many people assume the Food and Drug Administration requires rigorous testing of medical devices before they are approved, the same as the lengthy approval process it requires for new drugs. In fact, most high- risk devices on the market, including implants, have undergone no clinical testing at all.”

Whereas a new drug usually is required to have at least two randomized, controlled clinical trials, there may be no such standard for many medical devices. That’s because medical devices weren’t regulated by the FDA until 1976.

At that time, the agency “grandfathered” all devices that were already on the market. That allows manufacturers to sell most new devices without any clinical testing as long as the product is considered “substantially equivalent” to an existing device.

In addition, she says, medical device companies can avoid clinical testing for the new high- risk devices by stipulating only a minor change has been made to a previously approved device. The National Academy of Medicine has called for the FDA to impose more stringent requirements because of the risks involved.

A recent study by Johns Hopkins University suggests medical errors are now the third leading cause of death in the United States, a statistic that includes fatalities involving medical devices.

Lenzer’s article appeared in the January 13, 2018 issue of the The New York Times.

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