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FDA Clears Fenwal Amicus Separator With Wireless Connectivity

Fenwal, a medical technology company, has received FDA 510(k) clearance for its Amicus separator with new wireless data-export capabilities. The Fenwal Amicus separator is an advanced medical device used to collect platelets and other blood components from donors.

Fenwal said that the addition of wireless data management allows blood centers to easily access procedure information to monitor machine and operator performance without the added cost or capital investment of rewiring facilities.

During customer trials, blood centers reported that the Amicus separator with DXT helped them increase platelet yield per donor by enabling better analysis of performance by device, operator and collection site.

Fenwal claimed that the Amicus separators with DXT offer blood-center professionals easy-to-read, on-demand reports concerning donations at multiple locations. The reports help identify opportunities for improvement and training.

The Amicus separator with DXT uses barcode scanners to capture kit lot numbers, operator ID and donation ID for each collection procedure. The information is then sent through a secure wireless connection from the Amicus separator to a server connected through the blood center’s network. Standard reports analyze procedure data by operator and by device, with data typically available within minutes of a completed procedure.

According to Fenwal, the Amicus separator with DXT is one of several recent advancements for the Amicus separator. Fenwal plans to add wireless functionality to its other automated blood collection and separation systems.

Karen Nielsen, group manager of ARUP Blood Services, one of the blood collectors in Utah, said: “With Amicus DXT from Fenwal we increased our platelet split rate 23% points. The technology and data-analysis reports have helped our staff measure and improve our performance and productivity and helped to assure platelets are available for critical therapies. By collecting and splitting a large platelet product from eligible donors, blood centers can obtain two or more therapeutic doses from a single platelet donation.

William Cork, chief technology officer and senior vice president of Fenwal, said: “Fenwal’s data management strategy is designed to deliver what blood centers say they want most a simple, open-ended solution that allows them to securely capture and analyze procedure data from different locations without having to make a big investment in multiple systems and training.

“Blood centers, like many other companies, want to automate data collection to optimize operations, address training needs and improve documentation. We are pleased to introduce this customer-focused innovation for use with our popular Amicus separator.”