April 09, 2010 | | Comments 2
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Steris SS1 fans have new alternative to consider that is FDA-cleared

Those of you who have been fans of the maligned Steris System 1 (SS1) processor may be interested in knowing that the FDA has approved an alternative to that product from Steris.

The new item is called the Steris System 1E (SS1E), which is chemical sterilant system that is used to process reusable heat-sensitive devices (e.g., endoscopes and their accessories) that cannot be processed using steam.

The FDA has warned hospitals against using the SS1, saying Steris allegedly changed the system without agency approval and in doing so, may have increased infection control risks. Steris denies any infection control hazards, but the FDA has nonetheless recommended facilities switch to alternative systems by August 2011.

You can read full information from Steris here.

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Filed Under: CDC/infection control


Scott Wallask About the Author: Scott Wallask is senior managing editor for HCPro's Hospital Safety Center (www.hospitalsafetycenter.com) and the award-winning newsletters, Briefings on Hospital Safety and Healthcare Life Safety Compliance. He has written about healthcare for HCPro since 1998, with a focus on occupational and building safety, emergency management, fire protection, and infection control. Prior to joining HCPro, he worked as a reporter for several newspapers in eastern Massachusetts. He holds a BA in print journalism, magna cum laude, from Northeastern University in Boston. Contact Scott at swallask@hcpro.com.

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  1. Scott.

    There appears to be some controversy about FDA’s approval of this system. Apparently it does not use sterile water for rinse and therefor may not meet standards for sterilization.

    Why is this called “liquid chemical sterilant processing system” and not a sterilizing device like the SS1 was?

  2. Information I’ve read regarding the “new” steris unit was ambiguos but seemed touted more as a high level disenfectant rather than sterilization.

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