What OEMs Should Learn From The Recent Endoscope Reprocessing Incidents (And Their Fallout)
Unless you’ve been living under a rock for the past several months, you probably heard about the superbug outbreaks at the UCLA Medical Center and Cedars-Sinai, both of which were caused by ineffectively (not necessarily improperly) reprocessed endoscopes. You may also know that in the immediate aftermath these episodes, the FDA (coincidentally?) published final guidance on reprocessing medical devices in healthcare settings, and the White House unveiled an anti-superbug strategy. But say the medical device you’re developing isn’t an endoscope — does any of this even apply to you? In this podcast, Michael Drues, Ph.D., author of the popular Guerilla Regulatory Strategy guest column series, joins Jim Pomager, executive editor of Med Device Online, to explore these recent events and what all medical device makers should be taking away from them.