FDA Clears Device to Help Reduce Catheter-Associated Bloodstream Infections

?July 16, 2010 — The US Food and Drug Administration (FDA) has granted 510(k) clearance for a novel infection-control device containing 2 disinfecting caps (DualCap; Catheter Connections, Inc) designed to fit securely on both the needleless injection site and the end of the intravenous tubing (male luer).
The caps disinfect the connectors within 5 minutes of application and provide a physical barrier to contamination for up to 96 hours if left in place.
As the first single-use vascular access device to feature a disinfecting cap for the male luer, the product addresses an overlooked source of intraluminal contamination — the most common cause of catheter-related bloodstream infections.
"[Catheter-related bloodstream infections] are a serious healthcare concern," noted Vicki Farrar, chief executive officer of Catheter Connections, in a company news release. "Now there is a cost effective and easy to use technology that gives healthcare facilities a powerful tool in the fight against these life-threatening infections."
The device is expected to be available in the fall of 2010, marketed alone and as an accessory in procedure kits.
FDA Clears Device to Help Reduce Catheter-Associated Bloodstream InfectionsOriginally from: http://www.nursinglink.monster.com/news/articles/15045-fda-clears-device-to-help-reduce-catheter-associated-bloodstream-infections

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