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Human Factors

June 1, 2026

Human Factors Engineering for Medical Devices From Concept Through Reprocessing and Post-market Surveillance

Human factors engineering (HFE), also referred to as usability engineering, is a structured, risk-based process intended to reduce use errors and ensure medical devices are safe and effective for their intended users, uses, and environments. As regulatory expectations continue to...

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April 2, 2015

Important Considerations for Reusable Medical Endoscope Processing and Reprocessing

Every year Nelson Laboratories tests and validates thousands of medical devices. One particular family of reusable medical devices, endoscopes, can present unique challenges for manufacturers and  healthcare reprocessing facilities. Responding to recent attention on reusable endoscopes, particularly the reusable duodenoscopes...

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March 20, 2015

Comments on “Reprocessing Guidance for Industry and FDA Staff,” issued March 17, 2015

The FDA’s new guidance document, Reprocessing Guidance for Industry and FDA Staff issued March 17, 2015, outlines a summary of changes to the FDA’s May 11, 2011 reprocessing draft guidance.  Based on the content and addition of Appendix E, this...

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May 14, 2014

AAMI Sterilization Standards Meeting Update on Processing of Reusable Medical Devices

On April 14-16, 2014, I attended the Association for the Advancement of Medical Instrumentation (AAMI) semi-annual Sterilization Standards Meeting. These Association meetings, and the standards discussed during them, have a major impact on medical device manufacturers, testing facilities, HCF managers,...

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February 6, 2014

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

Agenda: 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...

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