Human Factors Validation of the CathBuddy Cleaning and Sterilizer Operation Procedures.

This SBIR project validates the operability of the CathBuddy Reusable Urinary Catheter System by end users as a safer, more cost-effective alternative to the currently available single-use intermittent urinary catheters. Currently, intermittent catheterization is practiced by millions of individuals in the U.S. to manage conditions such as neurogenic bladder and lower urinary tract symptoms. While this practice enables individuals to reliably empty their bladders, it is associated with a high incidence of urinary tract infections (UTIs) even when single-use catheters are used. Safer closed catheter systems or no-touch catheters help reduce incidence of UTIs; however, they are cost-prohibitive and rarely covered by insurance. The CathBuddy system is an affordable alternative comprised of a reusable intermittent catheter, a removable catheter insertion aid, and an at-home sterilizer. This project conducts formative functional design testing with 20 CathBuddy system end users, where the users are tasked with cleaning and sterilizing CathBuddy catheters and insertion aids using a laboratory-verified protocol. Researchers evaluate end users’ ability to understand and implement the protocol instructions as well as remotely observe end users to assess the completeness of the protocol steps, the number of failed steps, and the objective cleanliness of the catheters following protocol completion. Project outcomes include a modified CathBuddy system that reduces UTI incidence relative to the existing standard of care, reduces plastic waste generated annually by catherization, and provides end users with a consistent and safer catherization system for day to day use that lowers UTI incidence resulting in improved user health and fewer secondary complications for individuals who use catherization systems