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Have a question? Call us: 
+1 (801) 290-7500
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Learning From HAIs: Understanding Reprocessing Regulations, Validation & Human Factors


May 6, 2015 to Dec 17, 2018



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This lecture provides an overview of Hospital Acquired Infections, human factors issues encountered in device design and in the health care facility, and how to perform a validation for a reusable medical device for use in the health care facility. Information on test procedures as well as US and EU regulatory requirements, including new guidance from FDA, will be provided.

  • Review of current events
  • Discuss human factors issues
  • Overview of US and EU regulatory requirements
  • Practical example of developing a validation testing strategy including implementation rationales and test choices