FDA recommends using acceptable alternative to STERIS System 1 processor
Dec. 16—As health care professionals and facilities continue to have questions regarding the FDA's Dec. 3 notice on concerns about the STERIS System 1 Processor (SS1), the FDA is directing those with questions to an online resource page, Questions and Answers About the Steris System 1 Processor For Healthcare Facilities . The resource page includes answers to frequently asked questions, including guidance on alternative products.
Questions can also be directed to Candace McManus, DrPH, at the Office of Compliance, CDRH, 10903 New Hampshire Avenue, WO66, Silver Spring, Maryland, 20993, by email at candace.mcmanus@fda.hhs.gov, or by telephone message at 1-877-260-3731.
STERIS has created an online source for their latest news and information on the System 1 processor , including a Twitter feed, opt-in email address, downloadable letters, and a hotline for customers to call with questions at 1-800-548-4873.
Stay tuned to AORN news as further updates become available.
Dec. 7—The FDA issued a notice on Dec. 3 to health care facility administrators and infection control practitioners conveying 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.
According to the notice, if health care facilities have an acceptable alternative to the SS1 to meet sterilization and disinfection needs, they should transition to this alternative as soon as possible to ensure continued patient safety. If facilities do not have an acceptable alternative to the SS1, they should promptly assess their patient-care needs and sterilization and disinfection requirements and take steps to obtain legally-marketed substitutes for the SS1.
FDA-cleared liquid sterilants and high-level disinfectants can be found here.
AORN reported in March 2009 that the FDA had issued a Warning Letter to STERIS on May 15, 2008, identifying significant changes that STERIS made to the SS1 that could significantly affect the safety or effectiveness of the device. The AORN news report also discussed a STERIS notice to customers sent Jan. 20, 2009, informing them of the FDA Warning Letter and the actions the firm was taking in response to the letter to stop marketing its device and to transition its customers to replacement products.
According the FDA's Questions and Answers on the STERIS System 1 processor, also released on Dec. 3, , STERIS did not recall the SS1, but voluntarily told the FDA that it would discontinue U.S. sales of the SS1, apart from one-for-one product replacement and support of existing SS1 units with accessories, service, and parts, and that it would work with customers on a timetable to replace SS1 units in their facilities.
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