Steris System 1 Processor (SS1):
Transitioning to Legally-Marketed Alternatives
According to the FDA notice on February 2, 2010, healthcare facilities that use the Steris Corporation’s modified System 1 (SS1) have 18 months to comply with FDA’s recommendation to transition to a legally-marketed alternative reprocessing method.
Steris System 1 is NOT a FDA legally-marketed device. The FDA has not determined whether it is safe and effective for its stated label claims (including sterilization). The associated risks for using an unapproved or uncleared medical device increases risk to the patients. Improper disinfection or sterilization of instruments may transmit pathogens to patients and users, or expose them to hazardous chemicals. It may also affect the quality and functionality of reprocessed instruments. The FDA issued “Questions and Answers about the Steris System 1 Processor for Healthcare Facilities,” where they stated, “There are FDA-cleared products available to sterilize or disinfect medical devices between patient uses. These include chemical sterilant (LCS)/high-level disinfectant (HLD) products that may be used alone or with an automated endoscope reprocessor (AER), or sterilizer for processing (sterilizing or disinfecting) medical devices, including those that employ low process temperatures. More than one alternative method may be needed in your facility to reprocess all of the devices that you currently process in SS1.”
Metrex is here to help you and your customers with a solution that will assist in addressing healthcare workers’ high-level disinfection needs. Below is a cross reference of FDA cleared HLD and enzymatic products to assist you during your transition to a legally-marketed alternative:
Enzymatic Detergents
High-Level Disinfectants
Before switching to any alternative reprocessing method, the FDA recommends the user should consult the endoscope or reusable device manufacturer’s written instructions for use or contact the reusable device manufacturer for appropriate, alterative and validated reprocessing procedures.
Additional information on this issue may be found on the FDA website and questions can be directed to Candace McManus, DrPH, at the Office of Compliance, CDRH, 10903 New Hampshire Avenue, WO 66, Silver Spring, Maryland 20993, by email or by telephone message at 1-877-260-3731.
