After six years of research, the FDA this week approved an RFID solution for tracking the U.S. blood supply chain, a development that will boost safety and efficiency for the nation’s vital blood supply.
Researchers at the University of Wisconsin-Madison RFID Lab say that the iTrace tool is the first of its kind to receive FDA approval.
The lab was one of three Wisconsin partners in the project, along with the BloodCenter of Wisconsin and SysLogic Inc., a Milwaukee-based information systems firm. The three groups researched, designed, developed and tested a new RFID-enabled solution called iTrace for Blood Centers, which will automatically identify, reconcile and track blood products.
“The iTrace for Blood Centers device has the ability to enhance blood safety by helping to ensure that unsuitable units are not released,” says Karen Midthun, M.D., director of the 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.”
The iTrace solution is available for use in U.S. blood centers. It will be deployed in hospitals once the FDA grants approval for iTrace for hospitals.
iTrace automates blood bag check-in at donor sites, eliminates line-of-sight requirements for checking in blood products to the manufacturing process, and streamlines the process of preparing blood products for shipment to hospitals or transfusion centers. iTrace for Blood Centers can increase workflow efficiency, provide increased visibility to inventory, as well as reduce the cost of compliance in blood product tracking and reconciliation.
Lynne Briggs, vice president & CIO at the BloodCenter of Wisconsin says that a three month pilot of iTrace for Blood Centers showed significant efficiency and accuracy gains in the movement and reconciliation of blood products from collection through distribution. More than 75,000 blood products were tagged.
“We are just now digging into the additional compliance gains the solution provides with its granular and up to date visibility capabilities,” she says.
The BloodCenter of Wisconsin says that it reduced errors or misplaced products at the point of collection by one-third and recorded an 87 percent reduction in errors or misplaced products at material check-in. In addition, the facility saw a 63 percent efficiency increase during check-in to inventory.
In addition to demonstrating the safety of RFID with blood products, the UW-Madison team investigated the reliability and efficiency of the technology. In a process that currently requires labor intensive manual identification and trouble-shooting, RFID will enable the healthcare industry to re-engineer the blood supply chain processes by applying 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,” says University of Wisconsin RFID Lab Director Alfonso Gutierrez. “Blood is a highly regulated substance and needs to be accounted for throughout the entire distribution process. We’ve made that more transparent with iTrace.”
Raj Veeramani, professor of industrial and systems engineering and executive director of the UW E-Business Institute, says that safety concerns about the use of RFID with blood was a concern that needed to be addressed to ensure broad adoption.
“Blood is a life-giving product,” he says. “This advance in managing the blood supply chain will create huge value since you’re dealing with something that is a matter of health security and is so important to every society. ”