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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."

The full FDA guidance can also be viewed here:

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.

In addition, ASP offers a variety of replacement programs and financing options designed to help you upgrade to terminal sterilization. Contact your local representative to begin upgrading an ASP solution today.

For more information, call 888.783.7723, visit or contact your local ASP representative.

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