Regulatory News

Steris Customers Given Extension to Find System 1 Alternative

March 22, 2011

The U.S. Food and Drug Administration (FDA) is giving customers of Steris Corp.'s recalled System 1 six additional months to find a new sterilization device.
According to a filing with the Securities & Exchange Commission, customers now have until Feb. 2, 2012, to change to an alternate processing system, which is a liquid chemical sterilizing systems used to clean endoscopes and other heat-sensitive medical devices. Steris officials said they would continue to support System 1 customers in the United States until that date, according to the filing.
The agency previously gave System 1 users until August to find a substitute for the machine. The FDA revoked its approval for the device in December 2009 because Steris had made several changes to the machine that were not approved by the agency.
The company has been working to transition customers to its new System 1E product, but another FDA-related holdup is creating problems around the replacement device.
Steris petitioned the FDA for the System 1 extension while the agency reviews a 510(k) application for an accessory part to the replacement system. That part, called a biological indicator, isn’t necessary to operate the System 1E, though many customers prefer to use it. The part indicates the presence of biological materials on equipment to be sterilized.

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