Improving How the FDA Reviews Medical Device Safety
April 15th, 2015|
The U.S. Food and Drug Administration is tasked with the job of regulating which medical devices are made available on the market; however, some feel as though better policies and more thorough safety inspections could help reduce defective medical device numbers in the U.S.
Two experts in medical device safety, former FDA deputy commissioner, Scott Gottlieb, and cardiology professor at the University of California at San Francisco, Rita Redberg, recently sat down and discussed what can be done to reduce injuries and fatalities that are caused by faulty medical devices with The Wall Street Journal. They both tend to agree that the current methods being utilized to ensure medical device safety could be improved.
Gottlieb stated he felt the FDA was taking too much of a “uniform” approach to determining the safety of medical devices by trying to create broad safety standards for all devices. Redberg pointed out these broad standards have numerous loopholes that allow dangerous devices to make their way onto the market.
Redberg then goes on to say she feels public device registries where issues and problems can be tracked in real time is one of the best solutions she’s heard of to improve the safety of medical devices in the U.S.
Even with safety improvements, it’s clear that a small percentage of unsafe medical devices will always find their way on to the market and our Terre Haute personal injury lawyers want you to know help is available if you or a loved one have been the victim of such an accident. Feel free to call us anytime at (800) 477-7315 to discuss your case with our legal staff today.