Guidance to Surveyors Regarding the STERIS SYSTEM 1 Sterile Processing System (SS1)

On December 3, 2009 the FDA issued a Notice and Recommendations regarding the SS1. In this notice, the FDA reported that modifications by the manufacturer to the SS1 system have not been approved or cleared. For that reason, the FDA has not determined whether the SS1 is safe or effective for its labeled claims. The FDA has urged health care facilities to find acceptable alternatives to the SS1 to meet their sterilization and disinfection needs.