Steris System 1 (SS1) Processor: Second 6 Month Extension for Health Care Facilities to Replace STERIS System 1 with a Legally-Marketed Alternative
MedSun: Newsletter #68, January 2012
FDA Medical Device Safety Alerts
In December, 2009, the FDA announced that Steris had modified the SS1 processor and that the FDA had not approved or cleared the modified SS1 for its labeled claims. STERIS Corporation has chosen not to seek the FDA's clearance of this device so its use should be discontinued.
The FDA’s primary objective is that safe and effective alternative reprocessing devices be identified and placed into use as soon as possible, without compromising either patient care or employee health. During this transition period, the FDA will monitor the availability and supply of legally-marketed replacement products. FDA has extended the transition period to period to August 2, 2012, with some requirements. Please visit the website below for more information.
FDA Medical Device Safety Alerts. Steris System 1 (SS1) Processor: Second 6 Month Extension for Health Care Facilities to Replace STERIS System 1 with a Legally-Marketed Alternative. December 22, 2011.