Member Login | About | Contact
American Association of Oral and Maxillofacial Surgeons

Practice Management & Allied Staff News & Materials

FDA Updates Safety Alert for Steris Processor

February 4th, 2010

The U.S. Food and Drug Administration (FDA) previously issued a safety alert in December for users of the Steris System 1 (SS1), which is a system for disinfecting and sterilizing instruments in healthcare facilities. The SS1 system is commonly used for surgical and endoscopy device disinfection and sterilization. After further consideration, the Food and Drug Administration (FDA) has extended the deadline from a three-six month transition period to 18 months for healthcare facilities to transition away from using the Steris System 1 (SS1) processor. The "FDA now understands that a three-to-six-month transition period may present significant difficulties for some healthcare facilities, which could, in turn, adversely affect patient care," the agency said. Using the FDA's original December 2009 announcement of the six-month period, this week's extension would bring the deadline to August 2011. Steris has been critical of the FDA's stance, saying there has been no documented case of infection caused by the SS1 when the equipment is used properly. For additional information, including information on FDA cleared or approved medical devices, see the "Questions and Answers" document and list of FDA-cleared alternatives to the STERIS System 1 (SS1) device processing system on the FDA Web site.