Effectiveness of the SYSTEM 1E Liquid Chemical Sterilant Processing System for reprocessing duodenoscopes

Area of Science:

• Infection Control
• Medical Device Sterilization
• Microbiology

Background:

• Reusable duodenoscopes are linked to health care-associated infection outbreaks.
• Highly resistant pathogens and serious patient outcomes have been reported.
• The FDA requested efficacy verification for the SYSTEM 1E® Liquid Chemical Sterilant Processing System.

Purpose of the Study:

• To verify the liquid chemical sterilization efficacy of the SYSTEM 1E® system.
• To test performance with varied duodenoscope designs under arduous conditions.
• To evaluate the system's effectiveness in worst-case processing scenarios.

Main Methods:

• A fractional cycle was used to challenge system performance.
• Recoverable test spores (Geobacillus stearothermophilus) were evaluated.
• Heavily contaminated endoscopes, including all channels and distal tips, were tested.

Main Results:

• All tested duodenoscopes were successfully liquid chemically sterilized.
• A greater than 6 log10 reduction of Geobacillus stearothermophilus spores was achieved at all inoculation sites.
• Sterilization occurred in less than half the standard cycle exposure time.

Conclusions:

• The SYSTEM 1E® is an effective low-temperature liquid chemical sterilization method for duodenoscopes.
• It provides a fast, safe, and convenient processing alternative.
• The system is tested and cleared for specific validated duodenoscope models.