Novel and effective disposable device that provides 2-way protection to the duodenoscope from microbial contamination

Background and Aims: Duodenoscope contamination is associated with notable patient morbidity and mortality and can occur despite high-level disinfection protocols, requiring a solution that protects against contamination of the endoscope in the first place. Methods: We assessed a newly cleared, single-use device to seal the distal end of duodenoscopes while preserving optics and other endoscope functionality and tested its ability to protect against contamination using dye immersion tests and microbial inoculation. Results: Dye immersion tests revealed a complete seal with no leakage. Rigorous microbial challenge tests showed the device can both protect against contamination of the endoscope by external microbes (“outside-in” protection) and shield instruments from contact with pre-existing microbial biofilm on or around the elevator that may have survived reprocessing (“inside-out” protection). Optical and mechanical performance of the endoscope was not compromised by the addition of the device. Conclusions: The results show that this disposable device provides 2-way protection to the duodenoscope from microbial contamination, without the potential for disrupting current equipment, technique, and workflow.