Cardinal Health announces 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 altern ative 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," says Lisa Ashby, president of 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 sur gical 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