FENWAL RECEIVES NEW REGULATORY CLEARANCES FOR AMICUS SEPARATOR AND DXT RELAY SOFTWARE New paperless documentation and remote procedure set-up for blood center efficiency and regulatory compliance
LAKE ZURICH, Ill., January 25, 2012 – 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, Inc., 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 DXT TM 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.
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.
Incorporated in January 1995, Healthcare-ID develops and markets products to meet the Blood Center's need for automating the entry of accurate information at both fixed and mobile collection sites to eliminate disposal of collected blood units based on donor eligibility and suitability and significantly reduce the cost of blood collection. Healthcare-ID, with its Donor-ID WebÔ product offers modules including Registration, Health History Screening, CASI, CASI over the Internet, Physical Exam, Daily QC, Donor Adverse Reaction, Phlebotomy, Donor Adverse Reaction (as developed with the AABB biovigilence committee), Shipping, and Survey. Donor-ID WebÔ interfaces to most major blood center data management systems.
Donor-ID WebÔ is used to collect over 7,000,000 units of blood annually at eleven blood centers across the United States: Gulf Coast Regional Blood Center in Houston, TX; Memorial Blood Center in St Paul, MN; Mississippi Blood Services in Jackson, MS; Oklahoma Blood Institute in Oklahoma City, OK; Coffee Memorial Blood Center in Amarillo, TX; Blood Bank of Delmarva in Newark, DE; Stanford Blood Center in Palo Alto, CA, LifeStream in San Bernardino, CA, ITxM in Illinois (LifeSource Blood Center) and Pennsylvania (Central Blood Bank); Dak-Minn Blood Bank in Grand Forks, ND; and The American Red Cross, nationwide.