Investigators Criticizes FDA Device Oversight
Investigators claim that the U.S. Food and Drug Administration is not doing its job of properly monitoring the safety of medical devices, which may have contributed to hundreds of deaths in the case of at least one device.
The online edition of BMJ reported this week that the FDA “is lax in both its initial approval of devices and ongoing monitoring of related problems.” This lack of oversight causes the agency to miss problematic devices, such as the vagus nerve stimulator made by Cybertronics. The device, used to treat seizures in patients who don’t respond to drug treatments, shockingly remains on the market although it has been cited in more than 900 FDA-reported deaths.
The new findings suggest that the FDA is understaffed and underfunded in many areas, Follow-up studies that could be used to examine adverse reactions to a device are either not done, or “conducted so poorly as to be meaningless,” said an FDA spokeswoman.
Experts suggest that the agency reevaluate its standards for approving new devices and revamp its surveillance system to identify patients that received faulty devices before they are seriously harmed.