Syslogic Gains FDA Clearance for Blood Products Tracking System

Brookfield, Wis.-based Syslogic Inc. has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its radio frequency identification (RFID) enabled blood products tracking system, iTrace. iTrace for blood centers is the first FDA-cleared RFID-enabled tracking and process automation system designed specifically to improve quality and efficiency in the transfusion medicine supply chain.

SysLogic is an information systems consulting firm, and its previous work in the healthcare industry consists of electronic health records and other IT solutions.

“We are thrilled to have achieved FDA clearance for the first RFID-enabled medical device in the transfusion medicine industry,” said Tina Chang, CEO of SysLogic. “As an information systems services company, we always seek out challenging engagements that allow us to truly partner with our clients on innovative and important work. iTrace for blood centers is the perfect example of such an initiative; we collaborated with blood industry experts and RFID experts from Wisconsin and beyond to create a product that can truly enhance the safety of our nation’s blood supply.”

The Institute of Medicine and other leading organizations have highlighted the incidence of medical errors that cause 44,000-98,000 American deaths each year; subsets of these incidents are due to the wrong blood being given to the wrong patient. Reducing medical errors and enhancing the safety and quality of healthcare delivery widely is recognized as a national priority, and reducing errors in the delivery of blood products is a key component of enhancing overall healthcare safety.

iTrace was developed to leverage high-frequency RFID tags and technology to provide greater visibility to blood products and their location, movement and status. By using RFID technology with with barcodes, 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 is touted to increase workflow efficiency and provide increased visibility to inventory as well as reduce the cost of compliance in blood product tracking and reconciliation.

According to Lynne Briggs, vice president and chief information officer of BloodCenter of Wisconsin in Milwaukee, “Our three month pilot use of iTrace for blood centers showed significant efficiency and accuracy gains in the movement and reconciliation of blood products from collection through distribution. We are just now digging into the additional compliance gains the solution provides with its granular and up to date visibility capabilities.”

The development of iTrace for Blood Centers partially was funded by two National Institutes of Health (NIH) grants, along with an early grant from the 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, hospitals, RFID systems experts, and research institutions.

Chang noted, “Our state has such a wealth of industry and technical expertise. It was a privilege to work with our many partners including the BloodCenter of Wisconsin and the University of Wisconsin-Madison RFID Lab to create iTrace for Blood Centers.”

Collaborators on the new technology make up the Transfusion Medicine RFID Consortium. The group consists of partners from the for-profit and non-profit segments as well as academia. The Transfusion Medicine RFID Consortium members included BloodCenter of Wisconsin, the University of Wisconsin-Madison RFID Lab, Carter BloodCare, Mississippi Blood Services, the University of Iowa/DeGowan Blood Center, Mississippi Baptist Hospitals and SysLogic, Inc. The consortium’s key software development partner, S3Edge, is based in Beaverton, Oregon.