The FDA changes a deadline, says hospitals have 18 months to replace SS1
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February 3, 2010
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.
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.
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.