FDA Speaks Out on the Steris System 1 and on CT Dose Risks—ECRI Institute Responds
January 1, 2010 | Evaluations & Guidance
On December 3, 2009, the U.S. Food and Drug Administration (FDA), citing ongoing questions regarding safety, recommended that healthcare facilities in the United States discontinue use of the Steris System 1 (SS1) Sterile Processing System. The SS1 is used to reprocess a variety of medical instruments. Steris estimates that approximately 20,000 units are currently in service in the United States.
According to FDA, Steris has in recent years made changes to the design of the SS1 that may affect the safety or effectiveness of the system, without first submitting premarket notification (i.e., 510(k)). FDA states that it has not approved or cleared this modified product, nor has it determined whether...