Clearing Up Confusion about the Steris System 1E: ECRI Institute's Perspective on Its Appropriate Use

December 1, 2010 | Evaluations & Guidance


The Steris System 1E (SS1E) Liquid Chemical Sterilant Processing System, which is marketed for reprocessing heat-sensitive medical devices, including many endoscopes used in operating rooms (ORs), received clearance from the U.S. Food and Drug Administration (FDA) in April 2010. Since then, confusion has developed based on a statement on the FDA website that seems to be in conflict with the agency’s clearance of the SS1E. Resolving this confusion is important, since the SS1E is seen as one possible replacement for the Steris System 1, which FDA has recommended that facilities stop using (see Background).

While the SS1E was cleared for liquid chemical sterilization (LCS) of heat-sensitive critical devices, the FDA website states that the SS1E should be used for this purpose only if other, “traditional” sterilization methods are unable to be used. Because of this statement, hospitals want to know whether use of the SS1E may create patient safety or liability concerns. (Note that there is no controversy over the use of the SS1E for semicritical devices such as flexible endoscopes outside the surgical setting. Semicritical devices require a high-level disinfection process, while critical devices, which are often used in the OR, require sterilization.)

We have not seen any evidence from FDA that there is unreasonable risk in using the SS1E to reprocess devices intended for critical use (provided that it is used with the device models that have been validated by the manufacturer for processing in the SS1E, and that it is used in compliance with the use instructions). Furthermore, in our discussions with FDA, the agency has pointed out that it is up to the hospital to decide whether the SS1E is appropriate for that use. We therefore believe that the SS1E can be considered for that application,...

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