Flexible gastrointestinal endoscope processing challenges, current issues and future perspectives

Area of Science:

• Medical device reprocessing
• Infection control
• Sterilization technologies

Background:

• Current flexible gastrointestinal (GI) endoscope processing relies on cleaning and high-level disinfection, often failing to achieve terminal sterilization.
• Inadequate reprocessing leads to persistent microbial contamination, posing risks of patient infection and fatality.
• Complex endoscope design, biofilm formation, and limitations of high-level disinfection contribute to processing deficiencies.

Purpose of the Study:

• To establish the feasibility of terminal sterilization for flexible GI endoscopes.
• To evaluate vaporized hydrogen peroxide as a sterilization method for endoscopes.

Main Methods:

• Development of a specific sterilization cycle for vaporized hydrogen peroxide (VHP) systems.
• Testing VHP sterilization efficacy on colonoscopes and duodenoscopes.
• Assessment of material compatibility for both standard and modified endoscopes.

Main Results:

• VHP successfully sterilized flexible GI endoscopes (colonoscopes, duodenoscopes) to a sterility assurance level of 10^-6.
• No viable microorganisms were recovered from endoscopes artificially contaminated with hard water and serum.
• Replacing molybdenum disulfide lubricants with graphite-based alternatives improved material compatibility with VHP sterilizers.

Conclusions:

• Flexible GI endoscopes can be effectively terminally sterilized using VHP technology.
• Material modifications are crucial for successful VHP sterilization of endoscopes.
• This approach offers a safer alternative to high-level disinfection, reducing infection risks.