Catheter Connections Receives 510(k) Clearance From FDA For DualCap Vascular Access Disinfecting Cap
7/12/2010 7:21:52 AM
SALT LAKE CITY--(BUSINESS WIRE)--Catheter Connections, Inc., a manufacturer of innovative vascular access and infection control products, today announced that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its DualCap™ product. DualCap is the only device that nests two disinfecting caps together – for both IV access points, the needleless injection site (NIS) and the male luer at the end of the IV tubing. Previously overlooked as a route of microbial colonization, Catheter Connections has developed the first disinfecting cap for the male luer.
“We believe that the ability to safely disinfect and protect exposed IV connectors is significant for the medical community,” says Vicki Farrar, chief executive officer of Catheter Connections. “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.”
Patients contract CRBSIs when microbes enter the bloodstream in one of two ways. The less prevalent route is from the skin at the catheter insertion site. The most common route is called intraluminal contamination when the two primary IV access points, the NIS and the male luer, become contaminated. In order to combat intraluminal contamination, nurses are instructed to swab the NIS with isopropyl alcohol. However, nothing is done to decontaminate the male luer.
“CRBSIs are a serious healthcare concern,” says Vicki Farrar, chief executive officer. “DualCap was invented by infusion nurses who understood exactly what was needed to protect patients from these deadly and expensive infections.”
There are nearly 500,000 cases every year with a 12-25% mortality rate in the U.S. Because most of these infections are preventable, Medicare and many other insurance companies are not reimbursing for the treatment of healthcare-acquired CRBSIs. Consequently, tremendous effort goes into preventing CRBSIs. Using in vitro data, DualCap has been proven to significantly reduce the bacterial contamination associated with CRBSIs.
DualCap will be commercially available in the fall of 2010, with a series of additional products to follow.
About Catheter Connections
Headquartered in Salt Lake City, Utah, Catheter Connections, Inc., a University of Utah start-up, develops and commercializes innovative vascular access products designed to protect patients from acquiring infections during periods of intravenous infusion therapy. For more information visit www.catheterconnections.com.
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