August 1, 2010

Don’t overlook reprocessing instructions

By: Martha Young, MS, CSPDT

Like facilities around the country, you are probably considering alternatives to the Steris System 1 (SS1) for reprocessing your medical devices. The Food and Drug Administration (FDA) issued a notice in December 2009 stating that the SS1 as currently marketed had not been approved or cleared for its label claims, including claims that it sterilizes medical devices. The FDA advised users to transition away from SS1 "as soon as possible." The FDA has since said it expects the transition to be complete within 18 months, or by August 2011.

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