Design Intelligence: Insights on “End User Error” and Common Themes from the Front Lines

Should medical device manufacturers employ a reprocessing specialist during the development process?  Should recalls and updates impact the entire family of devices connected to the predicate device?  Does laboratory testing fall short of real-world practicality?  Jason Minutillo joins Justin Poulin and Dr. Larry Muscarella to discuss a number of topics related to medical device design that creates challenges for healthcare providers and reprocessors.  Jason outlines his concerns with vague instructions for use, improving pre-market control to limit recalls, and exploring the responsibility for MAUDE reports that are classified as “End User Error”.  This episode is packed with important details on the topics covered and you don’t want to miss it!

#MAUDE # MDR #MedicalDevices #FDA #AdverseEvents #SurgicalServices #SterileProcessing #TransmissionControl #Podcast #Education #IPT #InfectionPrevention #InfectionControl #Infection #ICP #PublicHealth #Healthcare

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