FDA Approves RFID Blood Tracking Device

The iTrace for Blood Centers device is the first to use Radio Frequency Identification technology, according to the agency.

FDA announced it has cleared iTrace for Blood Centers (Version 1.0.924.0) for marketing based on a premarket notification. Manufactured by SysLogic Inc. of Brookfied, Wis., it is the first application to use Radio Frequency Identification (RFID) technology to help prevent the release of unsuitable blood components, according to the agency.

"The iTrace for Blood Centers device has the ability to enhance blood safety by helping to ensure that unsuitable units are not released," said Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research. "iTrace for Blood Centers will be used in blood establishments by trained personnel as a tool in streamlining blood collection and processing and aiding in product tracking and reconciliation."

iTrace will augment existing blood bank systems and to work in conjunction with their existing barcode identification and labeling processes. The information it will store includes collection data; component processing and labeling, including verifying the product code; expiration date; and blood type.

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