FDAnews
www.fdanews.com/articles/122622-fda-issues-medwatch-for-device-sterilizer

FDA Issues MedWatch for Device Sterilizer

December 4, 2009
Reports of healthcare providers being burned following exposure to a sterilant solution have led to an FDA MedWatch on Steris’ System 1 (SS1) processor used to sterilize devices. The agency attributes the adverse events to recent modifications to the SS1 processor that were not cleared by the FDA. It advises healthcare providers to find alternatives to the SS1 as soon as possible.