Safety

The FDA changes a deadline, says hospitals have 18 months to replace SS1

Hospital Safety Insider, February 3, 2010

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After further consideration, the Food and Drug Administration (FDA) has extended the deadline to 18 months for hospitals to transition away from using the Steris System 1 (SS1) processor.
 
Previously, FDA officials said the transition could be made within three to six months. But after hearing from hospitals and others in the industry, the “FDA now understands that a three-to-six-month transition period may present significant difficulties for some healthcare facilities, which could, in turn, adversely affect patient care,” the agency said.
 
Using the FDA’s original December 2009 announcement of the six-month time frame, this week’s extension would bring the deadline to August 2011.
 
The SS1 is a popular sterilizing device used by thousands of hospitals and clinics in the United States. The FDA said Steris Corp. of Mentor, OH, modified the SS1 processor 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 does not expect to enforce the 18-month timeline for hospitals that don’t stop using the SS1. “But these facilities should be aware that the current SS1 is a misbranded and adulterated medical device because it has not been cleared by FDA as safe and effective for its labeled claims,” the agency said.



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