SAN CLEMENTE, Calif., June 13, 2012- ICU Medical, Inc. (NASDAQ: ICUI) announced today that a clinical case study prepared by clinicians from Women & Infants Hospital in Providence, R.I. showed that a collaboratively-developed custom IV system featuring the MicroClave® needlefree neutral displacement connector helped reduce NICU infection rates and medication errors, while also addressing recent FDA concerns regarding the safety of positive displacement needlefree connectors. The study, titledDeveloping a Closed, Intravenous Medication System for a Neonatal Intensive Care Unit, is featured in the current issue ofNeonatal Intensive Caremagazine.
Following a spike in central line infection rates and an increase in reported NICU medication errors, a multidisciplinary task force at Women & Infants took a series of proactive steps to reverse those trends. One of the first things they did was to replace the positive displacement needlefree device previously in use with the MicroClave neutral displacement connector. The author notes several reasons the task force selected the MicroClave, including the connector's split-septum design-which has been noted by the Centers for Disease Control as a preferred design feature for connectors-along with other design features including a straight fluid path and minimal deadspace for effective flushing at low volumes, a smooth swabable surface that facilitates more effective hub disinfection, as well as the MicroClave's proven ability to provide a safe and effective barrier against bacterial transfer and contamination.
In addition to selecting the MicroClave, the task force worked collaboratively with ICU Medical to develop a custom IV set to meet the specific needs of the NICU, including a feature that would effectively close the IV system and limit the administration technique to a single delivery method with the fewest connections possible. Working from an initial design developed by a member of the task force, the ICU Medical custom set development team created multiple prototypes for clinical evaluation, followed by delivery of sterile sets for use in a patient trial. Results of that four-week trial led to further modifications to the system based on clinician feedback. Clinician data gathered during initial testing of the system and the first two years of full clinical implementation showed the number of reported medication errors and infection rates decreased from 5.0 infections per 1,000 line days in 2008, prior to implementation, to 2.0 infections per 1,000 line days in 2011-a 60% reduction in three years.
As the result of collaboration between the task force at Women & Infants Hospital and ICU Medical, the study concludes that the customized closed IV system met the unique needs of the NICU environment, allowing a standardization of the medication administration process that "fosters a high degree of nursing compliance." In addition, the study concluded that the active engagement and involvement of the nursing staff in designing and training on the use of the system has resulted in "documented reductions in NICU infection rates and medication errors." The on-line issue of Neonatal Intensive Care magazine can be found here.
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.