Kimberly-Clark has become the first and only manufacturer to receive 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use of the Kimguard One-Step Sterilization Wrap portfolio with all advanced sterilization products (ASP) Sterrad Systems, including the new Duo Cycle for the Sterrad 100NX System.
Instruments wrapped with Kimguard One-Step Sterilization Wrap, which includes Kimguard One-Step Quick Check, will maintain sterility of the enclosed medical instruments until used. The One-Step Sterilization Wrap is cleared for use with all major sterilization modalities including Sterrad Sterilization Systems, Pre-vacuum Steam, Ethylene Oxide (EO) and Amsco V-Pro.
"Surgical sterilization technology is rapidly evolving and, as an innovator in the market, we have worked closely with ASP and FDA to obtain clearance of the Kimguard One-Step Sterilization Wrap now qualified for use with all Sterrad Systems," says Steve Camp, vice president, regulatory and clinical affairs, Kimberly-Clark Health Care. "Thorough testing and evaluation of the Kimguard family of Sterilization Wrap products with all available sterilization processing modalities are paramount to sterility assurance. Kimberly-Clark is pleased to provide clinicians with this added assurance of sterility of their instruments supporting their mission of delivering excellent patient care."
Kimguard Sterilization Wrap meets the most rigorous industry standards for safety and performance, including resistance to fire, abrasion, and microbial contamination, to maintain the sterility of instruments. The Kimguard One-Step family of sterilization wrap is the most validated sterilization wrap on the U.S. market with comprehensive FDA clearance for use with the following sterilization modalities:
Sterrad Sterilization Systems; Sterrad100 NX System; Standard Cycle; Flex Cycle; Express Cycle; Duo Cycle; SterradNX System; Standard Cycle; Advanced Cycle; Sterrad 100S System; Sterrad200 System; Sterrad 50 System; Pre-vacuum Steam; Ethylene Oxide (EO); Amsco V-PRO; maX (V-PRO Lumen, Non Lumen, and Flexible Cycles); 1 Plus (V-PRO Lumen and Non Lumen Cycles); and 1 (V-PRO Lumen Cycle).
"Advanced Sterilization Products' Sterrad Systems represents the largest installed base of hydrogen peroxide sterilization systems throughout the world," says Anthony Bishop, vice president, global marketing, ASP. "With the growing importance of having the manufacturers' instructions for use (IFUs) support the sterilization system, this new update will help ensure the safest possible environment for patients and their families, healthcare workers, providers and communities."