FDA approves RFID-based blood tracking

'Blood is a highly-regulated substance and needs to be accounted for throughout the entire distribution process.'
By Mike Miliard
10:45 AM

The Food and Drug Administration has given clearance to radio frequency identification technology to track the safety and efficiency of the nation's blood supply.

Researchers at the University of Wisconsin-Madison RFID Lab, who have been working on the the project for six years, say the tool is the first of its kind to get FDA approval.

The lab was one of three lead Wisconsin partners in the project, along with the BloodCenter of Wisconsin and SysLogic Inc., a Milwaukee-based information systems firm. Together, they researched, designed, developed and tested a new RFID-enabled solution called iTrace for Blood Centers, which will automatically identify, reconcile and track blood products.

RFID technology is often used for tracking the movement and status of products, but this is the first FDA-approved application involving blood products in healthcare, researchers say. iTrace software is now available for use in the nation's blood centers, and it's hoped that with further FDA approval it will be rolled out in hospitals nationwide.

The UW-Madison team conducted tests to validate the safety of RFID technology with the blood supply, demonstrating no adverse impacts, such as temperature or biochemical changes.

"For RFID to be adopted across the industry, the safety of its use on blood was a fundamental question to be answered," said Raj Veeramani, professor of industrial and systems engineering and executive director of the UW E-Business Institute, in a press statement.

Researchers, led by UW-Madison RFID Lab Director Alfonso Gutierrez, also investigated the reliability and efficiency of the technology; in a process that today requires manual identification and troubleshooting, RFID will enable the health care industry to re-engineer the blood supply chain processes with greater automated controls.

"The big advantage will be elevating the visibility of the blood product, where you can very clearly track where it came from, and where it's going," said Gutierrez in a statement. "Blood is a highly-regulated substance and needs to be accounted for throughout the entire distribution process."

Since the integrity of the blood supply is so critical to quality healthcare, the expectation is that RFID tracking will help reduce common safety errors.

"The system developed by the Transfusion Medicine RFID Consortium is the very first end-to-end solution to the entire supply chain of transfusion medicine, from collection through blood centers to hospitals," said Veeramani in a statement. "We came up with a blueprint of what an RFID-enabled process would look like at every stage in the supply chain."

Another key for UW-Madison RFID Lab was validating the business case for RFID adoption, researchers say. The lab reviewed the financial return-on-investment in terms of expected cost savings, reduced waste and productivity improvement, and developed a model to assess ROI in terms of improved patient safety, with fewer errors and adverse outcomes.

Gutierrez says the university-industry team also helped the International Society of Blood Transfusion RFID Working Party establish global standards for the use of RFID in the blood supply chain. The iTrace solution is the first to adopt these standards in its design.

Support for the project includes $1.5 million from the National Institutes of Health Small Business Technology Transfer program, as well as grants from the America's Blood Centers Foundation and industry partners.

Additional partners in the Transfusion Medicine RFID Consortium that conducted this project included S3Edge, Carter BloodCare, Mississippi Blood Services, the University of Iowa/DeGowin Blood Center and Mississippi Baptist Hospitals.

[See also: RFID consortium to bring blood product tracking technology to market]


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