Now is the time to evolve to a higher standard of care
in endoscope reprocessing.

To assist healthcare facilities affected by the FDA Recall on November 13, 2015, we suggest cleared STERIS alternatives to Custom Ultrasonics products. The FDA's recall order applies to all Custom Ultrasonics AERs, including the System 83 Plus, System 83 Plus 2 and System 83 Plus 9.

Offer a higher standard of reprocessing: Liquid Chemical Sterilization

When compared to high level disinfection (HLD), liquid chemical sterilization (LCS) provides a higher level of reprocessing assurance for heat-sensitive critical and
semi-critical medical devices.

Example after
high level disinfection

May not fully inactivate
large numbers of bacterial spores.

Example after
liquid chemical sterilization

Kills all microbial life
including bacterial spores.

SYSTEM 1E® Liquid Chemical Sterilant Processing System

The only automated solution that offers liquid chemical sterilization of heat sensitive, complex flexible endoscopes.

SYSTEM 1E Liquid Chemical Sterilant Processing System
  • For reprocessing of cleaned, reusable heat-sensitive critical and
    semi-critical devices
  • Kills all microbial life, including bacterial spores during the exposure phase of the standard 23 minute cycle

“To date, only liquid chemical sterilants have been cleared by FDA specifically for sterilization of complex endoscopes, such asduodenoscopes.”*

*FDA Executive Summary: Effective Reprocessing of Endoscopes used in Endoscopic Retrograde Cholangiopancreatography Procedures, pg. 40

Resources/Downloads to Assist in Transition

STERIS Low Temperature Reprocessing Device Compatibility Matrix

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

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

*American Journal of Infection Control (2016).



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STERIS Corporation
5960 Heisley Road | Mentor, OH 44060 | USA