Safety

New Steris System 1 alternative approved by the FDA

Hospital Safety Connection, April 7, 2010

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The FDA has approved a new alternative system to the Steris System 1 (SS1) processor, which came under federal fire because of alleged infection control risks with the device. 

The Steris System 1E (SS1E) is a liquid chemical sterilant processing system that is used to process reusable heat-sensitive devices (e.g., endoscopes and their accessories) that cannot be processed using steam. The FDA cleared the SS1E on March 16 and publicly posted an announcement on April 5. 

“This is good news for our [SS1] customers and we look forward to working with them as they continue their transition to acceptable alternative technologies,” said Walt Rosebrough, president and CEO of Steris Corp. in Mentor, OH.
 
The original SS1 is a popular sterilizing device used by thousands of hospitals and clinics in the United States. The FDA said Steris modified the SS1 and the agency hasn’t approved the modifications yet.
 
Steris has been critical of the FDA’s stance, saying there has been no documented case of infection caused by the SS1 when the equipment is used properly.
 
The FDA has asked hospitals to transition away from the SS1 to alternative reprocessing systems by August 2011.
 
“The SS1E may be considered as an alternative to the SS1 for processing compatible heat-sensitive devices, as healthcare facilities transition away from the SS1,” the FDA said.
 
Items reprocessed in the new SS1E are not considered sterile and should be used immediately, the agency said.
 
Steris is hopeful the SS1E will fill the gap created by the SS1 controversy. “Steris continues dialogue with the agency to close out the remaining System 1 issues and expects to announce a transition plan in the near future,” Steris said.



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