San Clemente, Calif. October 9, 2018 – ICU Medical, Inc., a worldwide leader in the development, manufacture and sale of innovative medical devices used in infusion therapy and critical care applications, today announced that the Diana ChemoLock Transfer Set for use with the Diana Compounding Workflow System has received United States Food and Drug Administration (FDA) 510K clearance. The Diana ChemoLock Transfer Set is a sterile, single-use closed system transfer device (CSTD) used to transfer drugs from a drug vial to an IV bag for intravenous drug administration. As a CSTD with FDA ONB classification, the Diana ChemoLock Transfer Set can be used for hazardous drug preparation to prohibit the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system. It is an integral part of the Diana compounding workflow system.
The Diana system was first launched in late 2016 and is the first and only system to combine automated compounding and IV workflow technologies with wireless pharmacist verification. Use of the Diana ChemoLock Transfer Set with the Diana system helps minimize hazardous drug exposure and maintain drug sterility as shown in microbial ingress testing. The needlefree access site of the set mechanically prohibits the transfer of environmental contaminants into the system after access, and assures no escape of drug from the closed system.
The Diana ChemoLock Transfer Set uses non-DEHP PVC tubing. Di(2-ethlhexyl) phthalate (DEHP) has been linked to adverse health effects.
“The 510K clearance of the Diana ChemoLock Transfer Set for use with the Diana compounding workflow system is another step in helping ICU Medical continue to provide innovative products and services that help maximize drug compounding efficiency and safety,” said Jay Hachey, director marketing oncology systems and consumables.
Demonstrations of the Diana compounding workflow system with the Diana ChemoLock Transfer Set can be seen at booth #1811 at the American Society of Health-System Pharmacists (ASHP) midyear clinical meeting in Anaheim, Ca., USA on Dec. 2-6, 2018.