New Study Shows ICU Medical's MicroClave and Neutron Needlefree IV Connectors Have "Significantly Lower Bacterial Transfer Rate" Than All Other Connectors Tested

BERLIN, June 18, 2014 /PRNewswire/ -- ICU Medical, Inc. (NASDAQ: ICUI) today announced that results of a clinically simulated in-vitro study presented at the 3^rd World Congress of Vascular Access in Berlin Germany June 18-20, 2014 showed that the ICU Medical MicroClave^® neutral displacement needlefree I.V. connector and Neutron^® catheter patency device outperformed all other connectors tested in their ability to provide an effective barrier to bacterial transfer and colonization.¹ The ability of MicroClave and Neutron to provide clinicians with an enhanced level of protection from bacteria being transferred from external surfaces into the patient's bloodstream can be an important benefit in their fight to eliminate catheter-related bloodstream infections (CRBSI).

In the study titled "Comparison of Bacterial Transfer and Biofilm Formation on Intraluminal Catheter Surfaces Among Fourteen Connectors in a Clinically Simulated in vitro Model," a team of researchers from the Montana State University Center for Biofilm Engineering led by Marcia Ryder PhD, MS, RN, from Ryder Science, compared 14 needlefree connectors in terms of bacterial transfer and colonization over a 96 hour period. The 14 connectors tested were the ICU Medical MicroClave and Neutron, RyMed^® InVision^®, CareFusion^® Smart Site^® and MaxPlus^®, Baxter^® ClearLink^® and OneLink^®, BD^® Q-Syte^®, BBraun^® Caresite^® and Ultrasite^®, Covidien^® Kendall^®, Nexus Medical^® TKO^®-6, Vygon^® Bionector^®, and Lilly Medical^® Biosite^®.

Researchers measured the difference between connectors in the passage rate of bacteria from the connector surface through the catheter and into the bloodstream over time; the amount of biofilm formation within the connector, catheter hub and catheter lumen; and the amount of biofilm bacteria within the connector at 72 compared to 96 hours. In all three phases of testing—bacteria transfer, biofilm formation, and biofilm bacteria formation—the ICU Medical MicroClave and Neutron significantly outperformed all connectors.

"The risk of transfer of bacteria from a contaminated connector surface through the hub and catheter lumen and into the bloodstream is dependent on the type of connector used," the researchers reported. "The MicroClave and Neutron had a significantly lower bacterial transfer rate than all other connectors."

The researchers concluded that biofilm formation in the catheter hub and internal lumen can result from bacteria transferred through a needlefree connector and that biofilm formation within the connector is the best predictor of the number of bacteria flushed into the bloodstream. They also concluded that the frequency of connector exchange may be dependent on the bacterial transfer potential of each device design, "which brings into question the 72 hour CDC exchange recommendation."

And finally, they stated that "the common classification of split septum and mechanical valve is an over-simplification and an unreliable approach for device selection."

¹ Comparison of Bacterial Transfer and Biofilm Formation on Intraluminal Catheter Surfaces Among Fourteen Connectors in a Clinically Simulated in vitro Model Ryder M1, deLancey Pulcini E2, Parker A2, James G2 (1) Ryder Science, Inc., Escondido, CA (2) Center for Biofilm Engineering Montana State University-Bozeman

Contact: Tom McCall
Vice President, Chief Marketing Officer
949-366-4368
[email protected]

About ICU Medical, Inc.: ICU Medical, Inc. develops, manufactures and sells innovative medical devices used in vascular therapy, oncology and critical care applications. ICU Medical's products improve patient outcomes by helping prevent bloodstream infections and protecting healthcare workers from exposure to infectious diseases or hazardous drugs. The company's complete product line includes custom IV systems, closed delivery systems for hazardous drugs, needlefree IV connectors, catheters and cardiac monitoring systems. ICU Medical is headquartered in San Clemente, California. More information about ICU Medical, Inc. can be found at www.icumed.com.

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SOURCE ICU Medical, Inc.