The Minneapolis Star Tribune reported on the off-label uses of medical devices, which it says is commonplace in some specialties and allows doctors to solve problems that have no existing solution but that also “comes with risks for patients.” It points out that physicians “have complete discretion to use medical devices in any way they think helps their patients,” in part because the FDA’s regulatory authority “extends only to device makers, not doctors.” Christy Foreman of the FDA’s Center for Devices and Radiological Health said, “It is not our place to say, ‘Here is how you should treat that patient.’” The Star Tribune reports on some of the alternate uses for devices, including turning “a prostate product into a promising brain probe” and treating “young stroke victims with a device designed for congenital heart defects.”
From the American Association for Justice news release.
