The FDA announces that a consent decree has been filed against device manufacturer STERIS Corp, which stops the company from distributing its System 1 Processor, or SS1, a tabletop liquid chemical system marketed to disinfect certain devices.
As a result, the company has developed a transition plan and rebate program for its US customers to ease the transitioning to legally marketed alternatives.
The transition plan allows STERIS to continue to support existing customers who are using the SS1, but requires these customers to obtain a Certificate of Medical Necessity to get parts, components, accessories, and service during the transition period ending August 2, 2011.
In May 2008, the FDA advised the company in a Warning Letter that significant changes made to the SS1 caused the device to be adulterated and misbranded. The FDA advised health care facilities in December 2009 that it had not cleared the current version of the SS1.
Under the consent decree, STERIS agreed to destroy used SS1 devices, components, parts, and accessories in the company’s possession within the US by September 30, 2011. For more information, visit the FDA’s Web page on the Steris I system.