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Kimberly-Clark Health Care announces that it has received 510(k) clearance from the Food and Drug Administration (FDA) to market the KIMGUARD ONE-STEP portfolio with one-year maintenance of package integrity (MPI) for KC300 to KC600 for Pre-vacuum Steam and Ethylene Oxide (EO). Users can now have confidence that their instruments wrapped with KIMGUARD ONE-STEP Sterilization Wrap will maintain sterility on the shelf for at least 365 days.
The KIMGUARD family of sterilization wrap is now the most validated sterilization wrap with the longest shelf-life on the U.S. market.Â These additional clearances will assist facilities in complying with The Joint Commissions sterilization processing guidelines.
We are the only manufacturer with sterilization wraps that has been validated and FDA cleared for at least 365 days post-sterilization processing shelf-life. In fact, KIMGUARD ONE-STEP shelf-life is currently 12 times longer than any other sterilization wraps shelf-life that has been previously cleared and marketed.Â This is especially significant for surgical trays that arent used on a regular basis, says Tom Gonzalez, vice president of quality assuranceÂ and regulatory affairs for Kimberly-Clark Health Care.
The extensive testing conducted to obtain MPI one-year 510(k) clearance illustrates Kimberly-Clarks commitment to providing our customers with sterilization solutions that meet their needs while offeringÂ the optimum balance of properties including lint and flame resistance, and high bacterial filtration efficiency (BFE), to provide our customers with confidence in sterility,Â adds Gonzalez.
With the most recent FDA clearance for Amsco V-PROÂ maX Low Temperature Sterilization System (Flexible Cycle), the KIMGUARD ONE-STEP Sterilization Wrap is now FDA cleared for use with all cycles in the three Amsco V-PROÂ Sterilization Systems.Â With this announcement, KIMGUARD Sterilization Wrap has the most 510(k) clearances than any other sterilization wrap including use with:Â Â
Â Pre-vacuum Steam up to 1 Year MPI
Â Ethylene Oxide (EO) up to 1 Year MPI
Â Amsco V-PRO maX (V-PRO Lumen, Non Lumen and Flexible Cycles)
Â Amsco V-PRO 1 Plus (V-PRO Lumen and Non Lumen Cycles)
Â Amsco V-PRO 1 (V-PRO Lumen Cycle)
These are some of the commonly used sterilization modalities, making One-Step the most widely compatible sterilization wrap on the market.Â
Kimberly-Clark has also completed testing that supports use of KIMGUARD ONE-STEP Sterilization Wrap with additional low temperature sterilization systems. This data has been submitted to the FDA for acceptance.
KIMGUARD ONE-STEP Sterilization Wrap consists of two layers of wrap thermally sealed along the sides to provide protection of double-wrapping in one step. This feature cuts the wrapping and unwrapping time in half compared to sequential wrapping, saving valuable time in Sterile Processing, as well as sterility assurance in the operating room (OR). The most recent addition to the KIMGUARD ONE-STEP Wrap portfolio, QUICK CHECK Sterilization Wrap, securely joins a blue wrap layer with a white layer so users can quickly and easily identify if sterility has been breached - ensuring patient safety. In addition, KIMGUARD Sterilization Wrap, manufactured in the U.S., features PowerGuard Technology to provide superior protection against contamination, making it one of the best microbial barriers available.
Launched earlier this year, Kimberly-Clark Health Care offers a wrap recycling program called Blue ReNew to bring interested hospitals a systematized approach to wrap recycling. The program is designed to help hospitals organize the process of recycling their wrap into five achievable stages and can be customized to meet the specific needs of each facility. The Kimberly-Clark Blue ReNew Team works with hospitals to identify key recycling partners, train OR teams and measure results to achieve a sustainable wrap recycling program.