What You’ll Learn at the MD&M West Nelson Laboratories Classroom on Validation Considerations for Managing Human Factors in Reprocessing of Reusable Devices

Emily Mitzel, Laboratory ManagerSterilization-of-reusable-tray


Emily Mitzel will present on reusable medical device cleaning, disinfection and sterilization validations at the 2014 MD&M West Conference. Emily is a Laboratory Manager at Nelson Laboratories in Salt Lake City, Utah. Her presentation will include:

  • Standards that govern medical device reprocessing, which include cleaning, disinfection and sterilization validations
    – Specifically, the new standards associated with human factors
    – Updates from the AAMI/FDA Round Table Discussion
  • Challenges inherent in device design for human factors
  • Considerations for cleaning and sterilization validations relevant to the practices of healthcare facilities
  • New recommendations for manufacturers, Instructions for Use (IFU) documents, etc.
  • Review of the manufacturer’s responsibilities and considerations

Take Away:

• Attendees will gain a better understanding of the central processing personnel who reprocess medical devices and how the ability to clean and sterilize the devices is a factor in the successful reuse of those devices
• Attendees will learn how to answer the question, “How clean is clean?”
– Three specific residual amounts have been agreed upon by the FDA/AAMI/industry and will be presented


Emily will present for approximately one hour at the Nelson Labs classroom in 208AB on February 12, 2014 at 4:00 PM. She will also present an innovation brief titled “Healthcare Reprocessing of Medical Devices and Human Factors Debrief” on February 11, 2014 from 1:40 PM until 2:10 PM. The innovation brief will be at booth 635 in the Tech Theater.

Register at www.canontradeshows.com/expo/west14/conference-nelson-rsvp.html

Nelson Laboratories website: www.nelsonlabs.com

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