Transitioning from the STERIS System 1® (SS1)?

The STERIS® SYSTEM 1E™ (SS1E) was FDA-cleared as a liquid chemical processing system, not as a sterilizer, and it cannot meet your critical device processing needs. The STERRAD® NX® System is the clear choice for processing the critical devices you depend on while maintaining sterility assurance in your OR.

Updated FDA Guidance for Liquid Chemical Sterilant Processing: What You Need to Know

The U.S. Food and Drug Administration (FDA) updated the “General Hospital Devices and Supplies” Web site with new guidance and recommendations for liquid chemical sterilant processing to include the following:

  • "FDA believes that sterilization with liquid chemical sterilants does not convey the same sterility assurance as sterilization using thermal or gas/vapor/plasma low temperature sterilization methods.”
  • “FDA recommends that the use of liquid chemical sterilants be limited to reprocessing only critical devices that are heat-sensitive and incompatible with sterilization methods such as steam and gas/vapor/plasma low temperature processes.”
  • “Biological Indicators are not appropriate or required for monitoring liquid chemical sterilization process. They are generally used for monitoring traditional sterilization processes where an SAL 10-6 is achieved. FDA has not cleared any biological indicators for monitoring liquid chemical sterilization process.”

View the full FDA guidance.

Upgrade to Sterility Assurance: Hydrogen Peroxide Gas Plasma Sterilization

The ASP STERRAD® NX® System is a hydrogen peroxide gas plasma sterilization process that provides the sterility assurance level you need to provide your patients the highest standard of care. Assuring sterility is paramount to preventing healthcare-associated infections, and with STERRAD® CYCLESURE® 24 Biological Indicator (BI), you can be assured that proper sterilization conditions were achieved.

Don’t Wait. Begin Your Upgrade Today!

The deadline to stop using your STERIS System 1® is fast approaching, and our goal is to ensure your facility upgrades in a timely manner without disruption to the processing of critical devices. We have successfully helped thousands of facilities transition to STERRAD® Systems. ASP is here to provide world-class service and clinical education to help you make a smooth transition.

Learn more about our Financing Programs and Replacement Options.

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