Breaking Studies: ICU Medical Inc.'s ChemoClave™ System Shown to Protect Nurses from Exposure to Hazardous Drugs While Increasing Nurse Satisfaction Studies Presented at the 2012 Annual Congress of the Oncology Nursing Society Show Significant Clinical Benefits of Company's Closed System Transfer Device (CSTD)

NEW ORLEANS, May 3, 2012 /PRNewswire-FirstCall/ -- ICU Medical, Inc. (NASDAQ: ICUI) today announced that two studies presented this week at the 37th Annual Congress of the Oncology Nursing Society (ONS) in New Orleans show that the company's ChemoClave™ needlefree closed system transfer device (CSTD) protects nurses from accidental exposure to hazardous chemotherapy drugs while increasing nurse satisfaction and perceptions of safety.

The ChemoClave system is the world's first and only needlefree CSTD, designed to keep healthcare workers and patients safe from exposure to hazardous drugs during the entire safe handling continuum, from preparation through to transportation, administration and disposal. Exposure to hazardous drugs used in chemotherapy has been proven to cause hair loss, skin rashes, infertility, miscarriage, birth defects, and even leukemia and other cancers in healthcare workers.(1,2) The use of the ChemoClave system has been shown to effectively limit exposure to, and mitigate the potential health hazards of, these toxic chemicals.

In a study entitled "Dirty Little Secrets: Hazardous Drug Contamination at the Chairside" conducted at Wake Forest Baptist Health by Lisa Hodges, RN, BSN, OCN®, ChemoClave was shown to be effective in eliminating accidental exposure to hazardous drugs and decreasing levels of surface contamination at the point of administration in an outpatient infusion center. For the study, ChemoGLO wipe samples were collected from the infusion chair arm, side tables and utility cart before implementing ChemoClave, and then again six, 15 and 24 months after implementation. Samples were subsequently analyzed by liquid chromatography coupled with tandem mass spectronomy. The pre-study wipe test showed that the side table was contaminated with docetaxel and paclitaxel levels at 847.4 ng/ft2 and 1530.9 ng/ft2 respectively, while the wipe tests conducted six months after implementation of ChemoClave showed an elimination of docetaxel contamination and a 99.5% reduction in paclitaxel contamination from 1530.9 ng/ft2 to 7.4 ng/ft2. Follow-up wipe studies at 15 and 24 months post-implementation showed no contamination at chairside for either docetaxel or paclitaxel. In addition, no incidence of clinician or patient exposure was reported due to inadvertent line disconnects, free flow or improper connections.

Another study, entitled "Creating a Culture of Closure: Implementation of ICU Medical, Inc.'s Closed System for Antineoplastic Agent Administration," was conducted by a team of nurses at the Abramson Cancer Center of the Hospital of the University of Pennsylvania, a National Cancer Institute-designated comprehensive cancer center with more than 55,000 doses of chemotherapy delivered per year. The purpose of the study was to reduce the environmental and human exposure to hazardous drugs used during chemotherapy, and to standardize the chemotherapy preparation and administration practices to improve safety and reduce costs by implementing the ChemoClave system.

For the study, more than 160 clinical registered nurses in both the inpatient and outpatient antineoplastic administration areas were trained on the proper use of the ChemoClave system, with multidisciplinary meetings between pharmacy and nursing being held throughout the trial to track progress. Written guidelines were established and communicated to reduce variation in practice and ensure staff safety. Quantitative reports post-implementation showed that nurse satisfaction and perceptions of safety increased while preparing and handling antineoplastic agents with the ChemoClave system. Furthermore, administration of antineoplastic agents became standardized and preliminary results of wipe tests reveal a reduction in surface contamination levels.

"Despite numerous studies showing the danger of exposure at the point of administration, nurses have not received the same attention as pharmacists when it comes to hazardous drug protection," said Robert J Houde RPh, Director of ICU Medical's Oncology Division. "We are committed to keeping everyone safe across the hazardous drug continuum and we designed ChemoClave to enhance nurses' protection by making it intuitive and easy to use, following familiar IV therapy protocols, while completely eliminating the risk of needlesticks."

In addition to providing significant protection from exposure to hazardous drugs, the ChemoClave system costs less to implement than any other commercially available CSTD.(3) In a recent study comparing all commercially available CSTDs ChemoClave was found to not only provide significant cost savings to hospitals but also scored highest in terms of ease of use, practicality, and perceived safety by a cross-functional evaluation team of pharmacists, nurses, and value analysis professionals.(4)

(1)Valanis B, Vollmer WM, Steele P. Occupational exposure to antineoplastic agents: self-reported miscarriages and stillbirths among nurses and pharmacists. Journal of Occupational and Environmental Medicine: 41(8) August 1999; 632-638.

(2)Skov T, Maarrup B, Olsen J et al. Leukemia and reproductive outcome among nurses handling antineoplastic drugs. British J of Industrial Medicine 1992; 49:855-861.

(3)Barnachea L, Lee T, Gitler J, Saria M. Presented at the California Society of Health System Pharmacists (CSHP), November 4, 2011.

(4)Saria M et al. The Cost of Safety: Closed System Transfer Devices, Abstract Accepted at the International Forum on Quality & Safety in Healthcare, April 2011, Amsterdam NL.

Media Contact: Tom McCall
Vice President, Marketing
949-291-8959
tmccall@icumed.com

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 I.V. systems, closed delivery systems for hazardous drugs, needle-free I.V. connectors, catheters and cardiac monitoring systems. ICU Medical is headquartered in San Clemente, California.

SOURCE ICU Medical, Inc.



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