STERIS says upon receiving the December 3 notice from the FDA, it began discussions with the agency on a number of important issues regarding the SS1. In a letter distributed to customers and press, the company says: "We greatly respect the FDA, its mission and its important responsibilities, and we are continuing to work with the Agency to clarify these issues and develop an effective transition plan. As part of that plan, we are seeking to address any confusion these events may have caused you."

STERIS adds that when considering acceptable alternatives a facility should review the FDA's Q&A on the topic, including the section "What factors should I consider in selecting an alternative product?" STERIS says a facility may also want to consider alternative reprocessing methods including, among others:
--Ethylene oxide

--Manual soak
--Hydrogen peroxide
--Steam sterilization
--High level disinfection

Read the details:

FDA Notice: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192842.htm

FDA Q&A on the STERIS situation: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm192685.htm

STERIS Notice: http://www.steris.com/media/pdf/news/product/2009/SS1%20Customer%20Letter%2012-04-09%20FINAL.pdf

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