Train the Trainer Case Study: Reprocessing Reusable Endoscopes

The Challenge

The FDA mandated the validation of reprocessing Instructions for Use (rIFU) of reusable endoscopes after increased incidents of post-use related infections due to cross contaminations.

At the time, there was a wide variety of known use problems during reprocessing due to the complexity of both the cleaning process and the design of the scopes themselves, resulting in scopes remaining contaminated even after cleaning and disinfection.

Previous training programs were not standardized and did not have a step for the trainer to indicate if the trainees were deemed to have been ‘trained’ in the specified materials.

Designed, standardized, and validated a training program
Provided training to hospital trainers, who in turn trained reprocessing technicians
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 200 participants (GI nurses & Reprocessing Techs) over the course of the program
Successfully refined and tested the effectiveness of the training as part of the overall Human Factors program

Development of a standardized training curriculum based on iterative testing with various scopes and trainers became a new industry standard
Reduced complexity of rIFU to drive user’s ability to identify required steps, important information, and required materials for successful reprocessing
Produced a Human Factors Summative Validation Report and a Human Factors Engineering Summary Report

Aided client with successful navigation of FDA-mandated 522 Postmarket Surveillance Studies Program

The Challenge

What We Did

Results Delivered

Key Outcomes

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