West’s Vial2Bag DC device receives US FDA 510(k) clearance and CE Mark
Universal needle-free reconstitution and transfer system now available for use in hospitals
West Pharmaceutical Services has received 510(k) clearance of the Vial2Bag DC device from the US Food and Drug Administration, and also the CE Mark for the European Union.
The Vial2Bag DC device is produced by West’s subsidiary, Medimop Medical Projects, and is a universal admixture device designed to enable safe, convenient, needle-free reconstitution and transfer of drug products between a vial and a standard IV bag or bottle.
The device connects to the IV bag set port using a standard IV spike and can be used with all standard manufacturers’ bags. Following transfer of liquid from the bag, the reconstituted drug is then transferred from the vial back into the bag.
‘Intravenous infusions are one of the most universally used methods of administration in healthcare settings. Our new Vial2Bag DC device simplifies the IV admixture process and eliminates the risk of needlestick injuries and minimises potential drug exposure, making this procedure safer and more efficient for healthcare staff,’ said John Paproski, President, Pharmaceutical Delivery Systems, West Pharmaceutical Services.
This 510(k) clearance and CE Mark extends West’s portfolio of needle-free reconstitution and transfer devices and complements the Vial2Bag and Vial Adapter devices, which are already available.
The device is available for 13mm and 20mm diameter vials, fits all standard IV bags and is suitable for point-of-care reconstitution and admixture and can assist in compliance with the immediate use provision of USP <797>.
Progressive Medical Inc (PMI) will distribute the Vial2Bag DC device to hospitals in the US.