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ICU Medical to Launch MicroCLAVE® Clear Needlefree Connector at the Annual Scientific Meeting of the Society for Healthcare Epidemiology of America (SHEA) April 1-4 in Dallas
Date:3/31/2011

SAN CLEMENTE, Calif., March 31, 2011 /PRNewswire-FirstCall/ -- ICU Medical, Inc. (Nasdaq: ICUI) today announced that it will initiate the full market release of the MicroCLAVE Clear Neutral Displacement Needlefree Connector at the Annual Scientific Meeting of the Society for Healthcare Epidemiology of America (SHEA) April 1-4 in Dallas. MicroCLAVE Clear allows clinicians to visualize the fluid path, verifying effective flushing of the patient catheter after use with blood and medications that could leave residual or fluid precipitates after aspiration or infusion. The connector's clinically proven MicroCLAVE design effectively clears blood and blood residual with flush volumes as low as 2.0 mL, while the connector's clear housing allows for visualization of the internal fluid path upon flushing the connector.

In a recent study comparing the flushing efficiency of different designs of clear needlefree connectors, the neutral displacement MicroCLAVE Clear was shown to be superior to either the positive displacement CareFusion® MaxPlus® or the negative displacement Baxter® ClearLink® as determined by the total flush volume needed to clear the connector of blood elements. The study showed that the MicroCLAVE Clear was free of blood residual after an average of 2.5mL saline flush, with 60% of the connectors flushing clear with only a 2 mL flush. By contrast, 100% of the MaxPlus connectors tested showed residual blood after a 10mL saline flush, as did 40% of the ClearLink connectors.(1)

Previous studies have demonstrated that the more proteinaceous material—including small blood clots—that resides in the connector hub, the greater the chance infection.(2) Infection is a major concern in the hospital environment and especially so given the issues of antibiotic resistance and hospital acquired infection.

Part of a full line of MicroCLAVE connectors that includes the original MicroCLAVE and the antimicrobial MicroCLAVE, MicroCLAVE Clear 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.(3-5) 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.(6)

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) Jarvis WR, et al Increased bloodstream infection rates in surgical patients associated with variation from recommended use and care following implementation of a needleless device. Infect Control Hosp Epidemiol. 1998 Jan; 19(1):23-7 (3) ECRI Institute, Health Devices. Evaluation of Needleless Connectors. September 2008, Volume 37, Number 9: 259-286. (4) 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. (5) 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. (6) FDA Medical Device Safety Alert, July 28, 2010: Letter to Infection Control Practitioners Regarding Positive Displacement Needleless Connectors (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm220459.htm).


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