FDA mandated human factors testing and improvement of the reprocessing procedure due to industry-wide patient incidents in 2014 & 2015.
What We Did
- Updated risk analysis
- Redesigned training program
- Redesigned Instructions for Use (IFU)
- Formative and summative human factors testing with 80 participants (GI nurses & reprocessing techs)
- Standardized training that addresses numerous significant risks identified in earlier rounds of testing
- Significantly redesigned IFU that addresses risks which contributed to significant risk of harm.
- Helping client successfully navigate 522 process