Cardinal Health announces that DuraBlue™ Sterilization Wrap has been granted Food and Drug Administration (FDA) clearance (K120658) for extended sterility maintenance indications. This latest clearance makes DuraBlue™ Sterilization Wrap the only dual-layered sterilization wrap in the U.S. market where the entire product line has longer-than 30-day sterility maintenance test data cleared by the FDA.
Data from an event-related shelf life study of 180 days, or six months, was reviewed by the FDA as part of this clearance. The updated sterility maintenance indications are based on validation of wrap sterilized via the Johnson & Johnson STERRAD® 100S and STERIS Amsco® V-PRO® Systems.
"We understand how important extended sterility maintenance testing is to our customers, and we pursued this testing out of our dedication to product quality and performance," saya Lisa Ashby, president of category management at Cardinal Health.
Cardinal Health is currently finalizing extended shelf life testing for Pre-Vacuum Steam and Ethylene Oxide sterilization systems. The company expects to submit results of that testing to the FDA for acceptance in the very near future.
DuraBlue™ Sterilization Wrap is also cleared by the FDA for use in the most sterilization modalities of any dual-layered sterilization wrap in the market today. DuraBlue™ Sterilization Wrap is currently the only sterilization wrap on the market with FDA clearance for use with any of the Johnson & Johnson STERRAD® Sterilization Systems. The following is a comprehensive list of all sterilization systems for which DuraBlue™ Sterilization Wrap has FDA clearance:
• Pre-Vacuum Steam
• Ethylene Oxide
• Johnson & Johnson STERRAD® 100S
• All cycles (Lumen, Non-Lumen and Flexible Cycles) of the STERIS Amsco® V-PRO® 1, 1 Plus, and maX Sterilization Systems