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Three Studies Presented at the 2011 SHEA Annual Scientific Meeting Show That the ICU Medical MicroCLAVE® Contributes to a Significant Decrease in Bacterial Transfer and Reduction in Bloodstream Infections
Date:4/4/2011

SAN CLEMENTE, Calif., April 4, 2011 /PRNewswire/ -- ICU Medical, Inc. (NASDAQ: ICUI) today announced that three different clinical studies presented at the Annual Scientific Meeting of the Society for Healthcare Epidemiology of America (SHEA) April 1-4 in Dallas showed that the MicroCLAVE neutral displacement needleless connector helps significantly reduce the risk of bacterial contamination and limit the incidence of hospital-acquired bloodstream infection when used in connection with an IHI bundle. ICU Medical initiated the full market release of the MicroCLAVE Clear at this year's SHEA meeting, highlighting the connector's clear housing that allows for visualization of the internal fluid path upon flushing and its ability to allow clinicians to effectively clear blood and blood residual with flush volumes as low as 2.0 mL.(1)

In a poster titled Three Years Experience of Central Line Associated Bloodstream Infections in the Intensive Care Units and Blood and Marrow Transplant Unit at an Academic Medical Center, researchers Concepcion N. Moore, RN, MBA, CIC , et al from the University Medical Center in Tucson, AZ showed that the rate of catheter-related bloodstream infections declined by 43% following the hospital-wide implementation of an IHI central line bundle that included the use of ICU Medical CLAVE® and MicroCLAVE connectors. Infection rates at the facility dropped from 5.09% in 2007 to 2.06% in 2010(1). The University Medical Center also uses both the MicroCLAVE Clear and Antimicrobial MicroCLAVE.(2)

Marcia Ryder, PhD, MS, RN, presented a poster titled Differences in Bacterial Transfer and Fluid Path Colonization through Needlefree Connector-Catheter Systems In-Vitro that evaluated differences in transfer of bacteria through the connector-catheter system and biofilm formation using an in-vitro model designed to simulate clinical use. In testing the Clearlink™, SmartSite®, InVision-Plus®, MaxPlus®, Q-Syte® and MicroCLAVE® connectors, Dr. Ryder reported that "there are significant differences among connectors were observed for bacterial transfer and colonization of the catheter hub and internal lumen of the catheter. The Q-Syte connector tested performed poorly compared to the other connectors while the MicroCLAVE performed better than the other connectors. The MicroCLAVE demonstrated a significantly smaller log density of bacteria than the other connectors." She further concluded that "overall, the results suggest that connector selection may impact both bacterial transfer to the bloodstream and bacterial colonization of catheter hub and internal lumen."(3)

A third poster titled A Multi-Faceted Approach to Reduction of Blood Culture Contaminants at an Academic Medical Center presented by Rebecca L. Landreth, RN et al from the University Medical Center in Tucson, AZ sought to explore whether implementing a hospital-wide program to educate clinicians on blood culture drawing protocol that included the use of a MicroCLAVE neutral displacement connector would reduce contaminated blood cultures from central lines. In 2009, UMC began a study drawing central line blood cultures through the MicroCLAVE, and in the first year of the study they saw a 48% reduction in BCC with a 62% reduction in blood culture contamination (BCC) from central line draws. The last six months of the house wide study showed a further reduction of BCC from central line drawn specimens of 34%, with a BCC rate in 2010 was down to 1.42%.(4)

ICU Medical offers a complete line of MicroCLAVE neutral displacement connectors that includes the original MicroCLAVE, the antimicrobial MicroCLAVE, and the MicroCLAVE Clear. Each connector in the line shares the design features that have been clinically proven to provide a safe and effective microbial barrier. The neutral displacement straight fluid path design, split-septum and minimal deadspace of the MicroCLAVE work together to help minimize blood reflux into the tip of the catheter upon connection or disconnection of the luer. Not only does the MicroCLAVE provide enhanced patient safety through innovative technology but it has also been proven to provide an effective microbial barrier against bacteria transfer and contamination.(5-7) In addition, The MicroCLAVE's neutral displacement design may help hospitals address recent concerns raised by the FDA regarding the safety of positive displacement connectors.(8)

Media Contact: Tom McCall
Vice President, Marketing
949-366-4368
tmccall@icumed.com

(1) Sylvia, C. DVM, MS, Breznock E. DVM, PhD, Diplomate ACVS. The in vivo evaluation of the flushing efficiency of different designs of clear needlefree connectors, data on file at ICU Medical, February 2011. (2) Moore C. RN, MBA, CIC, et al. Three Years Experience of Central Line Associated Bloodstream Infections in the Intensive Care Units and Blood and Marrow Transplant Unit at an Academic Medical Center. Poster presented at the Annual Society for Healthcare Epidemiology of America (SHEA) conference 2011.  (3) Marcia Ryder, PhD, MS, RN , et al.  Differences in Bacterial Transfer and Fluid Path Colonization through Needlefree Connector-Catheter Systems In-Vitro. Poster presented at the Annual Society for Healthcare Epidemiology of America (SHEA) conference 2011. (4) Rebecca L. Landreth, RN, et al. A Multi-Faceted Approach to Reduction of Blood Culture Contaminants at an Academic Medical Center.  Poster presented at the Annual Society for Healthcare Epidemiology of America (SHEA) conference 2011.  (5) ECRI Institute, Health Devices. Evaluation of Needleless Connectors. September 2008, Volume 37, Number 9: 259-286. (6) Ryder M, RN, PhD. Bacterial transfer through needlefree connectors: Comparison of nine different devices. Poster presented at the Annual Society for Healthcare Epidemiology of America (SHEA) conference 2007, Abstract 412. (7) Moore C, RN, MBA, CIC. Maintained Low Rate of Catheter-Related Bloodstream Infections (CR-BSIs) After Discontinuation of a Luer Access Device (LAD) At an Academic Medical Center. Poster presented at the annual Association for Professionals in Infection Control and Epidemiology (APIC) Conference 2010, Abstract 4-028. (8) FDA Medical Device Safety Alert, July 28, 2010: Letter to Infection Control Practitioners Regarding Positive Displacement Needleless Connectors (http://www.fda.gov/Medical Devices/Safety/AlertsandNotices/ucm220459.htm).


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