FDA approves alternative to STERIS System 1

By: April 7th, 2010 Email This Post Print This Post

Remember those warnings concerning modifications to the STERIS System 1 reprocessor (SS1) that forced the FDA to advise consumers to change disinfection and sterilization methods?

In February the FDA extended the recommended time period for replacement to 18 months, giving facilities until August 2, 2011 to find a legally marketed alternative device. Just over a month later, the FDA has now approved an alternative to the SS1, the STERIS System 1E (SS1E).

STERIS expects to announce a transition plan in the near future, and delivery of the units are expected by the second quarter of fiscal year 2011, according to a press release.

“The SYSTEM 1E is indicated for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat sensitive medical devices in healthcare facilities,” the press release says.

The FDA also lists a number of things that users should be aware of should they choose to switch to the SS1E:

  • SS1E should be used only for processing heat-sensitive devices that are compatible with the S40 sterilant and the processing system
  • Devices that are not validated for processing in the SS1E should not be processed in the SS1E
  • The final processed devices are not sterile
  • Following processing, the devices should be used immediately
  • The S40 sterilant used in the SS1E has not been validated for use with the SS1 and should not be used in the SS1


By P. Wouters, RN, CNOR on April 13th, 2010 at 10:04 am

Even though it says “The System 1E is indicated for liquid chemical sterilization…”, the final rinse renders the item UNSTERILE. Be mindful of this when considering switching to this unit.


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