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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

Steris Discontinued Products

Replacement Options from Metrex

Product Name
Size              
Part #
Product Name Size Part #
Klenzyme® Enzymatic Presoak & Cleaner
4 x 1 Gallon
1673-08
EmPower/Metrizyme
4 x 1 Gallon
10-4100/10-4000
Klenzyme® Enzymatic Presoak & Cleaner 5 Gallon 1673-05 EmPower/Metrizyme
5 Gallon 10-4150/10-4050
Klenzyme® Enzymatic Presoak & Cleaner 15 Gallon 1673-P3 EmPower/Metrizyme
15 Gallon 10-4115/10-4015
Klenzyme® Enzymatic Presoak & Cleaner 30 Gallon 1673-02 EmPower/Metrizyme 30 Gallon 10-4130/10-4030
EnyCare® 2 Enzymatic Presoak & Cleaner
4 x 1 Gallon
1041-08
EmPower/Metrizyme
4 x 1 Gallon
10-4100/10-4000
EnyCare® 2 Enzymatic Presoak & Cleaner 5 Gallon
1041-05
EmPower/Metrizyme
5 Gallon
10-4150/10-4050
EnyCare® 2 Enzymatic Presoak & Cleaner 15 Gallon 1041-P3 EmPower/Metrizyme
15 Gallon 10-4115/10-4015
Adi-Zyme®
4 x 1 Gallon
1035-08
EmPower/Metrizyme
4 x 1 Gallon
10-4100/10-4000

High-Level Disinfectants

Steris Discontinued Products

Replacement Options from Metrex

Product Name Size Part # Product Name Size Part #
Steris 20 Sterilant Concentrate Case of 20 S2000 MetriCide OPA Plus Solution*
*To be used with MetriCide OPA Plus Test Strips
4 x 1 Gallon
*100 count
2 bottle /case
10-6000
*10-602

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.