Replacing your STERIS System 1® (SS1)?

Important Updates on FDA Guidance for Liquid Chemical Sterilant Processing and the STERIS® System 1ETM (SSIE)


When considering SS1 alternatives, it is important to know that many of the commonly used critical devices you processed in the SS1 cannot go into the STERIS® System 1ETM (SS1E). Examples include cameras; rigid telescopes such as arthroscopes or laparoscopes; single-channel flexible endoscopes such as choledocoscopes and ureteroscopes; critical stainless steel instruments; orthopedic drills and saws; and batteries.

The SS1E was cleared by the U.S. Food and Drug Administration (FDA) as a liquid chemical sterilant processing system, not a sterilizer. According to the FDA, liquid chemical sterilant processing systems should be used only to reprocess critical devices that are heat-sensitive and incompatible with other sterilization modalities, such as steam or gas/vapor/plasma low temperature sterilization.

The STERRAD® NX® System Terminally Sterilizes Critical Devices using hydrogen peroxide gas plasma technology.

FDA-cleared as a sterilizer, the STERRAD® NX® System is your clear choice for processing the critical devices you depend on while maintaining sterility assurance in your OR.

Upgrade to the STERRAD® NX® System Today

  • Sterility Assurance Level (SAL) of 10-6 as required for the clearance of sterilizers
  • The STERRAD® CYCLESURE® 24 Biological Indicator (BI) provides evidence of proper sterilization
  • Offers the ability to sterilize a wide range of heat-sensitive and heat-stable critical devices
  • Dry, packaged terminally sterilized devices can be used immediately or stored to use later

Links/Resources for Facilities Transitioning from the SS1:

The deadline to stop using your STERIS System 1® (SS1) is February 2, 2012. At ASP, our goal is to ensure your facility upgrades without a disruption in processing critical devices. We have helped thousands of facilities transition to STERRAD® Systems, and we are here to help you with budgeting, training, installation planning, and any other needs your may have.

STERIS System 1 and STERIS System 1E are trademarks of STERIS Corporation

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