Evaluating medical device evaluators: Conflicts of interest?
Health News DigestPosted: November 17th, 2008 by Steve Trinward
Author: Michael D. Shaw
“The US Food and Drug Administration’s Center for Devices and Radiological Health has in place means for awarding approval to new medical devices. The FDA’s mission in this regard is ‘Ensuring that medical devices are reasonably safe and effective.’ The agency acknowledges that no system is perfect, especially since safety and effectiveness testing cannot be conducted indefinitely. … Still, once the products do get to the market — even though they are all approved — those within a particular class are not necessarily equivalent. As such, healthcare practitioners want to know which devices are best, and actively seek recommendations from supposedly impartial organizations. Since the matter of infection control affects virtually all medical devices, let’s examine how one aspect of this has been handled.” (11/16/08)