Safety

The FDA posts alternatives to Steris SS1 equipment

Hospital Safety Insider, December 23, 2009

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As we reported two weeks ago, the FDA has warned hospitals to seek alternatives to Steris System 1 (SS1) processors.
 
Since the initial notice, the FDA has released an extensive list of approved alternatives to the SS1, including approaches under the following broad categories:
  • Endoscope washer disinfectors and automated endoscope reprocessors
  • Liquid chemical sterilants and high-level disinfectants
  • Low-temperature sterilizers using hydrogen peroxide or ozone
  • Ethylene oxide sterilizers
  • Steam sterilizers
The FDA said Steris Corp. of Mentor, OH, modified the SS1 processor and that the agency hasn’t approved the modifications yet.
 
Steris has been critical of the FDA’s alert, saying there has been no documented case of infection caused by the SS1 when the equipment is used properly.



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