Facilities that use the Steris System 1 tabletop liquid chemical sterilizer now have an additional 6 months to make the federally mandated transition to an alternative reprocessing method, the company announced Monday.
Steris will continue to support its SS1 customers through Feb. 2, 2012, the new timeframe the U.S. Food and Drug Administration has set for healthcare providers to switch out the sterilizers.
"The Company recently requested the extension in light of the FDA's ongoing review of the SYSTEM 1E biological indicator 510(k) submission," the Mentor, Ohio-based device manufacturer reported in a shareholders' report filed with the government, "and to allow healthcare providers additional time to assess their alternatives, make any necessary changes to internal protocols, install replacement devices and conduct appropriate operator training."
The System 1E, an FDA-cleared liquid chemical sterilizer marketed as a successor to the SS1, has been the subject of scrutiny by the agency over the efficiency of its biological indicators."A biological indicator is not required by FDA for the proper use of SYSTEM 1E," says Steris's report. "No assurance can be made as to if or when the FDA may clear this indicator."
The FDA issued a safety alert for the SS1 in December 2009 and recommended that all users voluntarily replace the device. Modifications made since the device's original FDA approval could lead to malfunctions and patient injuries, the agency warned. Steris replied that the SS1 is safe and effective when used as directed.
David Bernard
