FDA is issuing a notice to healthcare facility administrators and infection control practitioners that conveys agency concerns about the Steris System 1 Processor (SS1). FDA has not approved or cleared the currently-marketed SS1 and the agency has not determined whether it is safe or effective for its labeled claims, including claims that it sterilizes medical devices.
FDA is also issuing a letter to STERIS Corporation (STERIS) notifying the firm that FDA may take regulatory action against it regarding the SS1 and its components and accessories.
On July 31, 2008, STERIS provided a written response to FDA disagreeing with the agency’s assessment that a new 510(k) was required under the agency’s regulations. Subsequently, STERIS and FDA met to discuss the warning letter. Although the parties continue to disagree about the statements in the warning letter, STERIS agreed to submit a new premarket notification for an updated STERIS System 1, which includes the changes referenced above and other technology updates. STERIS submitted this new 510(k) to FDA on January 5, 2009.
FDA has stated that if you have an acceptable alternative to the SYSTEM 1 processor to meet your sterilization needs, you should transition to that alternative.
Steris System 1E
"MENTOR, Ohio (April 6, 2010) -- STERIS Corporation (NYSE: STE) today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the STERIS SYSTEM 1E® Liquid Chemical Sterilant Processing System."
A teleconference will be held Thursday, December 10, 2009 at 1:00 p.m. ET. The call-in number (United States) is 800-593-7185 and the international call-in number is 1-312-470-7294. The participant passcode for all callers is "FDA." Where feasible, please plan to have colleagues from your facility listening to the call from a single telephone line to accommodate the many requests we have had from interested healthcare professionals on the Steris 1 System processor.
If you are unable to attend the call, an instant replay of this teleconference will be available shortly after the call until January 6, 2010. The call-in numbers for the replay are 866-421-5878 (United States) and 203-369-0811 (international). FDA will also provide a transcript of the call within approximately 10 days.
Passcode does work for the replay.12/11/09
FDA warning letter to Steris 5/15/08
FDA Notice 12/03/09
FDA Questions and Answers About the Steris System 1 Processor For Healthcare Facilities
FDA Transcript: December 10, 2009 Steris Conference Call
FDA Alternatives to STERIS System 1 12/17/2009
FDA Steris System 1 Processor: Extension of Recommended Time Period for Healthcare Facilities To Transition to Legally-Marketed Alternatives
STERIS System 1E (SS1E) Liquid Chemical Sterilant - 4/5/10
Steris Important Notice 1/20/09
Steris Important Notice 12/04/09
Steris Transcript of FDA December 4, 2009 Key Stakeholder Conference Call
Update: Dec. 6, 2009 - STERIS Letter to Customers
Transcript of FDA December 10, 2009 Key Stakeholder Conference Call
Steris December 10, 2009 - Customer Letter
Health Leaders Media FDA, Manufacturer at Odds Over Common Sterilizer
Forbes US FDA warns Steris against unapproved sterilizer
DotMed STERIS Responds to FDA Warning
THE MEDICAL NEWS Hospitals to find acceptable alternatives to STERIS System 1 sterile processing system
STERIS Corporation Announces FDA 510(k) Clearance for STERIS SYSTEM 1E® 4/6/10