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The Challenge

FDA mandated the validation of reprocessing Instructions for Use (rIFU) of reusable endoscopes after increased incidents of post use related infections. The mandate included a 522 postmarket surveillance study to validate the reprocessing training and rIFU.

Due to the length and complexity of current training practices and rIFUs, end users often did not reference materials intended to aid in the reprocessing steps.

Unique challenges included:

  • Risk of recall for product currently on the market
  • Previous rIFU were lengthy and not referenced by users
  • Materials required for use to properly reprocess (i.e., detergents, wipes, brushes, etc.) were not standardly available to all end users
Doctors utilizing medical devices
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What We Did

  • Combined Human Factors, Device Development and Regulatory Subject Matter Experts (SMEs) to tailor project plan to unique project needs
  • Designed, standardized and validated a training program
  • Effectively raised awareness of reprocessing requirement, reprocessing deficiencies, and device damage
  • Redesigned rIFU tailored to reprocessing technicians and nurses (layout, organization, and balance of graphics to text)
  • Executed and reported on Formative and Summative Validation Testing with 80 participants (Gastroenterology Nurses & Reprocessing Technicians)
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Results Delivered

  • Produced a Human Factors Summative Validation report and a Human Factors Engineering (HFE) Summary Report
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Key Outcomes

  • Reduced the complexity of the rIFU to drive users’ ability to identify required steps, important information, and required materials for successful reprocessing
  • Aided client with successful navigation of FDA-mandated post-market surveillance for Human Factors studies under section 55 of the FD&C Act
  • Standardized training and updated rIFU became a new industry standard