More than 8 months after the FDA cleared the Steris System 1E for processing "heat-sensitive semi-critical and critical devices," questions about the system, designed to replace the Steris System 1, and how it's to be used in practice still persist.
Have biological indicators for the SS1E been approved? No, says Rosemary Niewolak, Steris's director of low temperature sterilization, but that doesn't mean you can't use the SS1E. Steris is "still in discussion with the FDA on the clearance of" its biological indicator for the SS1E and "cannot provide any assurances to our customers that the FDA will clear the biological indicator," says Ms. Niewolak.
However, the FDA cleared the SS1E for usage without a biological indicator back in April 2010, and in fact biological indicators are not included in the FDA guidance on liquid chemical sterilants. The FDA requires several other steps to validate the efficacy of such systems, including chemical indicators, but not biological indicators. (The FDA has cleared Steris's chemical indicators for the SS1E.)
"Since a biological indicator is not required for our customers to be able to utilize the processor," says Ms. Niewolak, and because there are less than 7 months left for SS1 users to transition to an alternative system, Steris is recommending that customers "move forward with the transition" rather than wait for the FDA to approve the biological indicator.
For a more detailed review of process monitoring and validation for the System 1E, check out Steris' live webcasts scheduled for 2 p.m. ET Monday, Jan. 31, and 10 a.m. ET Tuesday, Feb. 1.
Is the SS1E a sterilizer? In April 2010, the FDA cleared the Steris System 1E as a "liquid chemical sterilization system" intended for "liquid chemical sterilization of cleaned, immersible and reusable critical and semi-critical heat-sensitive medical devices."
This language suggests the SS1E is, in fact, a sterilizer — right? However, the FDA's clearance letter also notes that devices processed in the SS1E are rinsed with potable water that, despite going through a 3-step treatment process that involves filtration and exposure to ultraviolet rays, is not sterile. Therefore, "devices processed using liquid chemical sterilization cannot be assured to be sterile" and should be used immediately.
"There's a very fine line here, and it's caused a lot of confusion in the healthcare community," says Nancy Chobin, RN, AAS, ASCP, CSPDM, executive director of the Certification Board for Sterile Processing and Distribution. "The process is cleared as a sterilant, not as a sterilizer." She recommends that you go back to the FDA clearance letter, read the language carefully and don't just assume that whatever devices you used to process in the SS1 are OK to process via the SS1E. "Devices should not be processed in the 1E unless the device manufacturer has validated their product for use in the 1E."
Irene Tsikitas
