Fenwal, a Fresenius Kabi company, announced it has received 60601- 1 3rd edition certification for the Aurora plasmapheresis system designed for collection of plasma. According to a release, 60601-1 3rd edition is the latest international consensus standard representing the current "state of the art" for medical device design and allows Fenwal to market the Aurora system in
"The Aurora system represents a significant advancement for plasma collection professionals," said
The Aurora system continues to use the company's proprietary filtration separation method which enables the collection of virtually cell-free plasma and meets European requirements without further filtration.
The Aurora system offers new features that aid work flow and help ensure a successful collection. Intuitive on-screen instructions simplify training for operators and provide troubleshooting assistance. An LCD display allows donors themselves to see how their donation is progressing.
The Aurora system can support remote procedure set up and paperless documentation when used with the Fenwal DXT Relay software and a plasma center's donor management system. With remote procedure set up, the Aurora system can be programmed automatically based on donor registration information. These features help assure data accuracy, documentation compliance, and a more streamlined procedure.
The Fenwal DXT Relay software also provides plasma center professionals with easy-to-read, on-demand reports that consolidate donor and procedure data from multiple Aurora systems at different locations. The reports track specific performance indicators and can be used to identify opportunities for operational improvement and training. The Fenwal DXT Relay software was built with open architecture so that it can seamlessly integrate with existing plasma center systems without requiring expensive, proprietary add- ons.
Plasma is the liquid portion of blood that contains valuable proteins used to treat burn victims, bleeding disorders, human immune deficiencies, and other chronic or genetic disorders. Unlike other blood components, which are stored at room temperature or refrigerated, plasma is frozen and thawed prior to fractionation or transfusion.
Plasmapheresis is an automated process in which plasma is taken from donated blood and the remaining components - primarily red cells and platelets - are returned to the donor. Source plasma is used by pharmaceutical companies that produce therapies from plasma- derived proteins.
Fenwal is focused on improving transfusion medicine through expertise in blood separation, collection, filtration, storage and transfusion.
Fresenius Kabi is a global health care company that focuses on pharmaceuticals and medical devices used to care for critically and chronically ill patients inside and outside the hospital.
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Fenwal, a Fresenius Kabi company, announced it has received 60601- 1 3rd edition certification for the Aurora plasmapheresis system designed for collection of plasma.
According to a release, 60601-1 3rd edition is the latest international consensus standard representing the current "state of the art" for medical device design and allows Fenwal to market the Aurora system in