Breaking Study: ICU Medical, Inc. ChemoClave® System Costs Less to Implement than any Closed System Transfer Device for the Safe Handling of Hazardous Drugs

SAN CLEMENTE, Calif., Nov. 8, 2011 /PRNewswire/ -- ICU Medical, Inc. (NASDAQ: ICUI) today announced that a study presented this past weekend at the 36th annual meeting of the California Society of Health-System Pharmacists (CSHP) in Anaheim, CA has shown that the company's ChemoClave® closed system transfer device (CSTD) designed to keep pharmacists, nurses and patients safe from accidental exposure to hazardous drugs is more affordable for hospitals to implement than any commercially available CSTD.

The cost study, conducted by a team of researchers from Moores Cancer Center at the University of California San Diego Medical Center, reviewed all five commercially available CSTD systems: the ChemoClave™ by ICU Medical, Inc.; EquaShield® by EquaShield Medical, Ltd.; OnGuard™ by B. Braun Medical, Inc.; PhaSeal® by Carmel Pharma, Inc.; and Texium®/SmartSite® by CareFusion Corp. To determine price, researchers included the actual number of components needed for a closed-system secondary infusion based on compounding techniques and intravenous administration set configuration in compliance with their institutional policies and practice guidelines. The cost of each individual component necessary to compound and administer a hazardous drug via a secondary infusion set for each CSTD was based on advertised prices at the time of the study, and individual component costs added together to generate a total cost for a single infusion. For indirect costs, researchers weighed the amount of waste generated by each system. Cost and waste totals for individual infusions were then multiplied by 15,312 infusions (average of 1,276 monthly infusions) to generate an annual acquisition cost and waste per system.

Of the five evaluated CSTDs, the least expensive system was determined to be ChemoClave, which generated an annual cost of $200,281, followed by Texium/Smartsite with $239,020; OnGuard with $393,978; EquaShield with $435,473; and PhaSeal with $507,287. The acquisition cost difference between the most expensive system studied (PhaSeal), and the least expensive system (ChemoCLAVE) was calculated to be $307,005, a difference of 153.3 percent. In addition, the ChemoClave system was shown to generate 1,229 pounds less waste than the PhaSeal system, second only to the Texium/SmartSite system, which generated 214 pounds less waste annually than ChemoClave but cost nearly $40,000 more per year to implement.

"As economic pressures increase, procurement decisions can no longer rely solely on clinical efficacy studies that fail to also assess cost-effectiveness. Limiting waste volume generation to the lowest practical amount is also a major objective for facilities due to its toxicity and adverse implications to the environment," the researchers concluded. "In the absence of current, reliable comparative data on commercially available CSTDs, this evaluation of costs and waste may be used to guide organizations in the implementation of a CSTD."

In a March 2011 editorial in Journal of Oncology Pharmacy Practice, the authors concluded that "If, in fact, the different closed systems currently available are equally effective, then the choice comes down to cost and ease of use." In addition, the editorial urged hospitals to make sure that the CSTD they choose "is capable of containing the hazardous drug throughout all handling steps from reconstitution to administration."(1) To that end, a recent study comparing all commercially available CSTDs found that ChemoCLAVE provided significant cost savings to hospitals while scoring highest in terms of ease of use, practicality, and perceived safety by a cross-functional evaluation team of pharmacists, nurses, and value analysis professionals.(2)

In addition, as the world's only 100% needlefree system, ChemoClave completely and totally eliminates the risk of hazardous needlestick injuries. Estimates indicate that 600,000 to 800,000 such injuries occur annually.(3) Most reported needlestick injuries involve nursing staff who are exposed to bloodborne pathogens, including HBV, HCV, and HIV, which can be potentially life threatening. The emotional impact of a needlestick injury can be severe and long lasting, even when a serious infection is not transmitted. Consequently, NIOSH and other organizations are encouraging efforts to eliminate needle-bearing devices where safe and effective alternatives are available.(4)

(1) Davis J, McLauchlan R, Connor TH. Exposure to hazardous drugs in Healthcare: An issue that will not go away. J Oncol Pharm Pract 2011 17: 9.

(2) 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.

(3) Henry K, Campbell S [1995]. Needlestick/sharps injuries and HIV exposures among health care workers: national estimates based on a survey of U.S. hospitals. Minn Med 78:1765.1768.

(4) National Institute for Occupational Safety and Health. NIOSH Alert: preventing occupational exposures to antineoplastic and other hazardous drugs in the health care setting. Centers for Disease Control and Prevention, National Institute for Occupation Safety and Health, DHHS (NIOSH) Publication No. 2004-165. Washington, DC: U.S. Department of Health and Human Services.

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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, needlefree I.V. connectors, catheters and cardiac monitoring systems. ICU Medical is headquartered in San Clemente, California.

SOURCE ICU Medical, Inc.