FDA Approves Blood Tracking Device

The FDA just cleared “iTrace for Blood Centers “(version 1.0.924.0) that will use Radio Frequency Identification (RFID) technology in blood centers and improve blood safety by preventing the release of unsuitable blood components. The device is manufactured by SysLogic Inc., at www.syslogicinc.com based in Brookfield Wisconsin.

“iTrace” uses High Frequency RFID tags and technology to provide greater visibility to blood products and their location, movement, and status. By using RFID technology in concert with barcodes, “iTrace” automates blood bag check-in at donor sites, eliminates line-of-sight requirements for checking blood products in the manufacturing process, and streamlines the process of preparing blood products for shipment to hospitals or transfusion centers.

Information on component processing and labeling, verification of the product code, date of expiration, along with blood type information is provided. The system can increase workflow efficiency, provide increased visibility to inventory, as well as reduce the cost of compliance in blood product tracking and reconciliation.

According to Karen Midthun, M.D., Director for the Center for Biologics Evaluation and Research, “iTrace for Blood Centers” will be used in blood establishments by trained personnel as a tool to streamline blood collection and processing and aid in product tracking and reconciliation.”

The development of iTrace for Blood Centers was partially funded by grants at two institutes at NIH plus an early grant from America’s Blood Centers Foundation. SysLogic secured the NIH Small Business Technology Transfer Phase I and Phase II grants on behalf of the Transfusion Medicine RFID Consortium a group that includes blood centers, hospital, RFID systems experts, and research institutions.

 

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