The Atlantic: The Loophole That Keeps Precarious Medical Devices in Use

Publication: The Atlantic

Author: Josh Rising

02/27/2013 - "The U.S. Food and Drug Administration announced last month that it will classify metal-on-metal hip implants as high-risk devices. That comes after the artificial joints were found to have failed at high rates, causing disability and meaning additional surgery for thousands of people.

But hundreds of other potentially high-risk medical devices remain in use without what many consider to be adequate testing.

The FDA's standards for review all high-risk medical devices before allowing them on the market are rooted in the Medical Device Amendments of 1976, which aimed to bring the agency's oversight of devices more closely in line with its regulation of prescription drugs. But it left holes."


"This interim solution was not supposed to last 37 years. Yet nearly four decades since Congress passed the Medical Device Amendments, the FDA still has not classified some of the temporarily "grandfathered" devices. As a result, potentially high-risk devices are continuing to reach the market without ever being tested in people."


"Other grandfathered devices include balloons inserted into the aorta and external pumps that circulate a patient's blood during bypass surgery. Companies can create new versions of these products and obtain clearance to market them with similar safety evidence that is required for medium-risk devices like electric stethoscopes, motorized wheelchairs and blood pressure cuffs.

Not all grandfathered devices -- and their substantial equivalents -- are unsafe or even high-risk. But that does not mean they should be regulated as medium-risk by default. Many patients rely on AEDs and other grandfathered medical devices, and stand to benefit greatly if the FDA would correctly classify these products without delay."

Read the full article at The Atlantic.

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