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Don Tumminelli: The Unknown World of Medical Device Validation

Don Tumminelli: The Unknown World of Medical Device Validation

FromBeyond Clean Podcast


Don Tumminelli: The Unknown World of Medical Device Validation

FromBeyond Clean Podcast

ratings:
Length:
26 minutes
Released:
Mar 2, 2020
Format:
Podcast episode

Description

There are many questions and often a critical level of misunderstanding about medical device validation so on this re-released throwback episode from Season 2, we went right to the source and interviewed validation expert Don Tumminelli, Senior Technical Manager, Client Services at HIGHPOWER Validation Testing and Lab Services. When a manufacturer designs a medical device, specifically a Class II device that requires 510K clearance by the FDA, they need an IFU that outlines how the device is to be safely cleaned and sterilized. Listen to Don talk about biocompatibility testing (compatible with the human body), sterilization validation and cleaning validation of the devices that sterile processing professionals work with and prepare every day for safe surgery. Do testing facilities such as this mimic the hospital setting? Listen now to find out! CE Credit -> https://www.beyondclean.net/ce-credit-hub #BeyondClean #WeFightDirty #MedicalDeviceValidation #HIGHPOWER #Biocompatibility #SterilizationValidation #CleaningValidation #Season2ThrowBack #SterileProcessing #Podcast #MDR #CSSD #SPD #Surgery
Released:
Mar 2, 2020
Format:
Podcast episode

Titles in the series (100)

Even though their tools and equipment touch nearly every surgical patient in the world, how much do you really know about the people, processes, and products used in the Sterile Processing industry? Beyond Clean offers a creative look into the inner workings of a healthcare industry surrounded by challenges, disrupted by change, and committed to getting it right -- every instrument, every time. The team at Beyond Clean will bring on some of the biggest names in surgical instrument reprocessing and provide commentary on the biggest issues facing Sterile Processing professionals, facilities, administrators, manufacturers, and vendors. Join us every week as we explore the hidden world of one of the most important aspect of safe surgical care.