Cardinal Health's sterilisation wrap gets new clearances from Food and Drug Administration

摘要

Cardinal Health's DuraBlue Sterilization Wrap has received US Food and Drug Administration (US FDA) clearance for Sterrad NX and Sterrad 100NX Systems from Advanced Sterilization Products. The wrap also received FDA clearance for 180-day extended sterility maintenance indications for each 510(k)-cleared sterilisation modality. The clearances distinguish the Cardinal Health sterilisation wrap from alternative wraps, as it is now the only dual-layered sterilisation wrap in the US market cleared by the FDA for current ASP Sterrad Systems modalities. It is also the only dual-layer wrap in the US market where the entire product line has longer than 30-day sterility maintenance indications for all highly utilised sterilisation modalities.