System enables new uses, but critics say this flexibility comes with risks.
The Mayo Clinic's Dr. Richard Marsh helps control brain seizures in epileptic patients with a fiber-optic laser first introduced to treat prostate tumors.
At the University of Minnesota, Dr. Ganesh Raveendran has figured out how to treat young stroke victims with a device designed for congenital heart defects.
It doesn’t matter whether the medical devices’ inventors, or the regulators who approved the products, ever considered such methods.
“It is common practice in the cardiology world,” said Raveendran, director of the U’s cardiac catheterization laboratory. “We expand the scope.”
Doctors have complete discretion to use medical devices in any way they think helps their patients — including “off-label” uses that were never envisioned. These adaptations are expanding the use of medical devices among U.S. patients of all ages.
But the flexibility this system enables comes with risks for patients.
The same kind of experimentation that transformed a prostate product into a promising brain probe led to the flawed use of surgical mesh as a treatment for women’s incontinence, injuring thousands.
“Frankly, the oversight is really quite relaxed and not accountable to the public,” said Lisa McGiffert, director of the Consumers Union Safe Patient Project.
The Food and Drug Administration reviews the safety and effectiveness of devices and how they can be sold. In recent years, criticism of the FDA has intensified, as device companies accuse the agency of stifling business and innovation through unnecessary review protocols. Consumer advocates argue the opposite, claiming the FDA fails to demand adequate product testing.
But the FDA’s oversight extends only to device makers, not doctors.
IT IS NOT OUR PLACE TO say, ‘Here is how you should treat that patient,’ ” said Christy Foreman, who directs evaluations at the FDA’s Center for Devices and Radiological Health.
The only way the FDA gets involved with the off-label use of a device is when a medical technology company seeks the agency’s approval for a popular adaptation to increase its sales. However, the typical process requires only that companies demonstrate that a new device is similar to an existing product, which means little human testing.
Often, device adaptations occur when doctors simply have no other options, or they are searching for a less-invasive treatment. The decision to adapt is never “cavalier,” said Marsh, a neurosurgeon.
At Nascent Surgical in Eden Prairie, Dr. Leonard Schultz is helping turn a surgical smoke control device into a product that can be used to reduce postoperative infections.
Schultz says he understands the concerns as devices are used in new ways, but there’s no such thing as risk-free medicine.
“Progress will never be done without risk,” Schultz said. “Every time technology changes, there is a chance that someone is going to get hurt.”
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