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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 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