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Flexible gastrointestinal endoscope processing challenges, current issues and future perspectives
N Omidbakhsh1, S Manohar1, R Vu1
1Research & Development Department, Advanced Sterilization Products, Irvine, CA, USA.
Background:
At present, the most frequent method for processing flexible gastrointestinal (GI) endoscopes is cleaning followed by high-level disinfection as terminal sterilization is often not practicable. Post-processing monitoring studies consistently show high levels of positive cultures remaining on endoscopes, which can lead to patient infection and even fatality. The processing deficiency is attributed to the complex design of endoscopes, incomplete cleaning, formation of biofilms and lack of margin of safety with high-level disinfection.
Objective:
To demonstrate that flexible GI endoscopes can be practicably terminally sterilized.
Methods:
An endoscope sterilization cycle was developed in a vaporized hydrogen peroxide sterilization system. The cycle was used to study the sterilization of flexible GI endoscopes which included colonoscopes and duodenoscope and material compatibility for both original flexible GI endoscopes and those experimentally modified endoscopes using compatible materials.
Results:
Testing demonstrated that the vaporized hydrogen peroxide can sterilize flexible GI endoscopes (colonoscopes, duodenoscope) with a sterility assurance level of 10-6. Additionally, no recoverable survivors were detected when devices were artificially soiled with hard water and serum. Material compatibility test results demonstrated that replacing molybdenum disulphide lubricant with a graphite-based inert lubricant can make them compatible with vaporized hydrogen peroxide sterilizers.
Conclusion:
Flexible GI endoscopes can be practicably terminally sterilized using vaporized hydrogen peroxide sterilization technologies if their materials are revised to become compatible.
Insights
Terminal sterilization of flexible gastrointestinal endoscopes is achievable using vaporized hydrogen peroxide. Material compatibility modifications ensure effective sterilization, enhancing patient safety and preventing infections.
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.
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