LAKE ZURICH,
Ill.–(BUSINESS WIRE)–Fenwal Inc., a global
medical technology company focused on improving blood separation, collection,
safety and availability, announced today it has received clearances from the
U.S. Food and Drug Administration to market the Fenwal Amicus® separator and
Fenwal DXTTM Relay productivity software for paperless documentation and remote
procedure set-up. Together, the blood-separation system and new software are
designed to help blood collectors improve efficiency and meet regulatory
compliance.
The Amicus® separator is an advanced medical device used to
collect platelets, red cells, and plasma, as well as mononuclear cells for
therapeutic applications. These new regulatory clearances allow blood centers
and hospitals using the Amicus® separator with the Fenwal DXTTM Relay software
to implement a paperless system that reduces manual documentation and helps
assure data accuracy.
“The Amicus® separator with DXTTM Relay software provides
our customers with a flexible and affordable solution that supports paperless
documentation and strengthens data-driven decision making,” said William H.
Cork, chief technology officer for Fenwal. “This is the newest product
introduction in a series of innovations designed to help blood centers improve
productivity, while making it easier to maintain regulatory compliance and
manage blood inventories according to patient needs and donor qualifications.”
For customers who use a donor management system from
Healthcare-ID, a leading provider of collection-site software, Fenwal and
Healthcare-ID have jointly developed a system for blood centers to generate
collection labels and procedure records for the Amicus® separator with DXT
Relay software. This integrated system can meet requirements for 21 CFR Part 11
compliance. Later this year the two companies will introduce remote procedure
set up for the Amicus separator, which will allow for automated programming of
the Amicus® separator based on donor registration information. These features
are also compatible with other donor management systems.
First introduced in early 2011, the Fenwal DXTTM Relay
software provides blood center professionals with easy-to-read, on-demand
reports that aggregate donor and procedure data from Fenwal apheresis systems
at multiple locations. The reports track specific performance indicators to
help identify opportunities for improvement and training. The data reside
securely within the blood center network and can be easily accessed at any time
by authorized blood center personnel.
To simplify implementation and reduce costs for blood
centers, the Fenwal DXT™ Relay software uses an open-architecture approach to
integrate seamlessly with existing blood center management systems. The Amicus®
separator is the first Fenwal apheresis device to receive clearance to
communicate with Fenwal DXT™ Relay software to provide paperless documentation
and remote procedure setup. Similar programs are under development for other
Fenwal apheresis systems.
About Fenwal
Fenwal, Inc. is a global medical technology company focused on improving
transfusion medicine through unique expertise in blood separation, collection,
filtration, storage and transfusion. The company offers a broad range of
products and services for the automated and manual collection of blood and
blood components. Fenwal products and advanced collection and separation
technologies are used to help treat patients on six continents. Fenwal, Inc. is
based in Lake Zurich, Illinois. For more information about Fenwal,
please visit www.fenwalinc.com.
Posted by Sean Fenske, Editor-in-Chief, MDT
