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Cardinal Health DuraBlue™ Sterilization Wrap Gets New Clearances From Food and Drug Administration
03/21/2013
Clearances Make Wrap Only Dual-layer Wrap in U.S. Market Approved for Current ASP STERRAD® System Modalities

DUBLIN, Ohio, March 21, 2013 —Cardinal Health today announced that DuraBlue™ Sterilization Wrap received Food and Drug Administration (FDA) clearance for STERRAD® NX® and STERRAD® 100NX® Systems from Advanced Sterilization Products (ASP). The wrap also received FDA clearance for 180-day extended sterility maintenance indications for each 510(k)-cleared sterilization modality.

The clearances separate the Cardinal Health DuraBlue™ Sterilization Wrap from alternative wraps. DuraBlue™ Sterilization Wrap is now the only dual-layered sterilization wrap in the U.S. market cleared by the FDA for current ASP STERRAD® Systems modalities. It is also the only dual-layer wrap in the U.S. market where the entire product line has longer-than-30-day sterility maintenance indications for all highly utilized sterilization modalities.

“In further support of clinical efficacy and efficiency, we’ve taken steps to ensure that our product is cleared for use in the most commonly utilized sterilization modalities,” said Lisa Ashby, president, Medical Devices and Diagnostics at Cardinal Health. “Regulatory clearances are of the utmost importance to both Cardinal Health and clinicians, and we pursued both these clearances out of our dedication to the product quality and performance clinicians need and expect.”

Sterilization wrap is critical for the productive use of reusable surgical instruments, because it enables the effective sterilization of enclosed medical devices and maintains their sterility during storage and transport. As part of the recent 510(k) submissions, maintenance of package sterility was validated for all models of DuraBlue™ Sterilization Wrap with testing for 180 days for each indicated modality. The testing time period does not prevent healthcare facilities from using established protocols to monitor sterility maintenance of packages wrapped with the DuraBlue™ Sterilization Wraps. 

DuraBlue™ Sterilization Wrap now has FDA clearances for use with the following sterilization modalities:

  • Pre-Vacuum Steam
  • 100 percent Ethylene Oxide
  • ASP STERRAD® 100S System
  • ASP STERRAD® NX® System, Standard and Advanced cycles
  • ASP STERRAD® 100NX® System, STANDARD, FLEX, EXPRESS and DUO Cycles
  • All cycles (Lumen, Non-Lumen and Flexible Cycles) of the STERIS Amsco® V-PRO® 1, STERIS Amsco® V-PRO® 1 Plus, and STERIS Amsco® V-PRO® maX Low Temperature Sterilization Systems

To learn more about Cardinal Health DuraBlue Sterilization Wrap and its FDA clearances, e-mail GMB-DURABLUE@cardinalhealth.com.

About Cardinal Health

 Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a $108 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 #21 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.

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