DUBLIN, Ohio, March 27, 2011 —Cardinal Health today announced the Food and Drug Administration clearance of Cardinal Health DuraBlue™ Sterilization Wrap, 510(k) Premarket Notification K112918, including specific Indications For Use with the Lumen, Non Lumen and Flexible Cycles of STERIS’s Amsco V-PRO®1, Amsco V-PRO®1 Plus, and Amsco V-PRO® maX Low-Temperature Sterilization Systems. This clearance makes DuraBlue™ Sterilization Wrap the only sterilization wrap in the market that is cleared for use with the Flexible Cycle in the Amsco V-PRO® maX Sterilization System.
DuraBlue™ Sterilization Wrap, a double-layer Spunbond/Meltblown/Spunbond wrap made with non-woven, polypropylene technology for strength, durability and microbial protection, was validated for sterilization and aeration during all pre-programmed V-PRO® Sterilization System cycles. As a result, DuraBlue™ Instructions For Use have been amended to include all V-PRO® Systems as an intended modality for items wrapped in DuraBlue™ Sterilization Wrap.
Sterilization wrap is critical for the productive use of reusable surgical instruments, because it enables the effective sterilization of medical devices contained in instrument trays and maintains their sterility.Cardinal Health DuraBlue™ Sterilization Wrap can help bring efficiencies to the sterilization process while maintaining a high standard of aseptic technique. Its double-layer construction enables users to save time by using the simultaneous wrapping technique, eliminating the need for sequential wrapping with single-layer wrap.
“We’re pleased that our wrap now has clearance for the STERIS Amsco V-PRO® Low-Temperature Sterilization System in addition to the pre-vacuum steam and STERRAD® Systems for which it already was approved,” said Greg Groenke, general manager of Environmental Technologies at Cardinal Health. “We’re committed to regulatory compliance, and we’re pleased to assure our customers using DuraBlue™ Sterilization Wrap that that they can reprocess their wrapped items in any V-PRO® System with confidence; because, the process has been thoroughly tested and is fully compliant with Food and Drug Administration regulations.”
V-PRO® Sterilization Systems offer versatility, productivity and efficiency for low-temperature reprocessing of a variety of heat-sensitive lumened and non-lumened devices. The newest system, the V-PRO® maX Sterilizer, offers a new 35-minute Flexible Cycle for single and dual-channel surgical flexible endoscopes, along with the 28-minute Non Lumen Cycle and 55-minute Lumen cycle.
DuraBlue™ Sterilization Wrap is available in six color-coded basis weight models, providing durable protection for everything from lightweight linen packs to heavy instrument trays weighing up to 25 pounds. The wrap also is available in 14 sizes ranging from 12 inches by 12 inches to 54 inches by 90 inches.
About Cardinal Health
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a $103 billion health care services company that improves the cost-effectiveness of health care. As the business behind health care, Cardinal Health helps pharmacies, hospitals, ambulatory surgery centers and physician offices focus on patient care while reducing costs, enhancing efficiency and improving quality. Cardinal Health is an essential link in the health care supply chain, providing pharmaceuticals and medical products to more than 60,000 locations each day. The company is also a leading manufacturer of medical and surgical products, including gloves, surgical apparel and fluid management products. In addition, the company supports the growing diagnostic industry by supplying medical products to clinical laboratories and operating the nation's largest network of radiopharmacies that dispense products to aid in the early diagnosis and treatment of disease. Ranked #19 on the Fortune 500, Cardinal Health employs more than 30,000 people worldwide. More information about the company may be found at cardinalhealth.com and @CardinalHealth on Twitter.