ICU Medical Reports Two Clinical Studies Demonstrated Chemoclave Reduced Hazardous Drug Exposure

ICU Medical, Inc.(NASDAQ: ICUI) today announced that two new studies presented this week at the37^th Annual Association of Pediatric Hematology/Oncology Nurses (APHON)Annual Conference in Louisville, KY showed that the company's ChemoClave^®closed system and closed system transfer device (CSTD) improves patient andclinician safety by reducing hazardous drug exposure and eliminatingaccidental needlesticks.The studies were performed by clinicians at two major children's hospitals—TheCenter for Cancer and Blood Disorders at Children's National Medical Center inWashington DC, and Cook Children's Medical Center (CCMC) in Fort Worth, TX—whowill be available to discuss their findings at the ICU Medical booth (#205) atthe APHON conference.In the study titled Reducing Hazardous Drug Exposure: Are All Closed SystemsCreated Equal? a research team from Children's National Medical Centerreported on an initiative to reduce hazardous drug spills, blood exposure, andthe risks associated with an open central venous catheter caused when a CSTDdisconnects from a patient's IV tubing. The initiative was begun following "adramatic rise in exposure to antineoplastic agents due to spills as a directresult of disconnections of the infusion tubing to the CSTD." (PhaSeal^TM,Beccton, Dickenson, and Company).The safety improvement process was implemented in two phases. The first phaseinvolved assembling an interdisciplinary team to identify the root cause ofhazardous drug spills during patient administration. This team evaluatedincident report data and consulted with PhaSeal CSTD manufacturerrepresentative. Subsequent practice changes were instituted, and both nursingand pharmacy teams were reeducated. The outcomes of these changes wererecorded and analyzed.During the second phase, the interdisciplinary team researched alternativeCSTD systems, including the ICU Medical ChemoClave needlefree CSTD, featuringthe Spinning Spiros^® closed male luer. The team conducted a trial of thesystem in June 2012, and implemented the product in November 2012.In spite of efforts to reduce disconnects with the existing PhaSeal product,there continued to be disconnects on a regular basis, the researchersreported. After research and a product trial were completed, the team atChildren's National Medical Center introduced and implemented the ChemoClaveneedlefree CSTD featuring the Spinning Spiros in November 2012. To date, therehave been no exposures to hazardous drugs from disconnects following theconversion to the ChemoClave system."The Spiros closed male luer proved to be an effective solution for reducingdisconnects and the potential for dangerous exposure to hazardous drugs andblood, and complications related to an open line," the researchers concluded,adding that the Spiros' "small size is ideal for our pediatric patients,increasing patient/family satisfaction."In the study titled Improving Chemotherapy Safety via Use of ChemoClave^®System (Spiros^®), Priming Technique, DoseEdge™, and Volutrols, researchersfrom Cook Children's Medical Center took a multi-faceted approach to safetyimprovement aimed at reducing exposure to hazardous drugs during both pharmacypreparation and patient administration. In order to decrease the potential foraerosolization and leaks of dangerous chemotherapy drugs, CCMC implemented theChemoClave CSTD, which included the Spiros closed male luer, needlefree vialaccess devices and bag spikes, and administration devices.To facilitate the effective implementation of ChemoClave, ICU Medical providedin-servicing for both pharmacy and nursing staff and worked to create a customadministration set with a pre-bonded Spiros. ChemoClave made it possible forCCMC staff to prime tubing under the compounding hood, helping to minimize therisk of chemotherapy aerosolization and surface contamination in themedication room, while also decreasing the risk of microbial contamination ofthe patient line. In addition to the ChemoClave system, CCMC initiated avariety of practice changes including priming with chemotherapy drugs,utilizing the DoseEdge™ pharmacy system, and using volutrols for time-limitedinfusions.As a result of these efforts, CCMC has not experienced any events related tochemotherapy leaks since February 2012. Following additional process changesin chemotherapy drug preparation and administration, overall central lineassociated bloodstream infection rates for the Hematology/Oncology and StemCell Transplant units decreased from 5.8 per 1,000 catheter days in 2009 to1.6 per 1,000 catheter days in 2012.