iTrace for Blood Centers Receives FDA 510(k) Clearance

Share Article

Auto-ID based tracking system developed as a result of a National Institute of Health STTR Grant secures FDA 510(k) pre-market clearance, SysLogic initiates transfer to S3Edge.

S3Edge, Inc. welcomes the announcement by the Food & Drug Administration (FDA) that iTrace for Blood Centers, the tracking system developed by the RFID Consortium has been cleared for marketing. The RFID and barcode based Blood Product Tracking system enables improved compliance with FDA tracking requirements for blood products, enables cross hospital inventory optimization to reduce waste from outdated products and improves patient safety by preventing the release of unsuitable blood products. The RFID Consortium includes BloodCenter of Wisconsin, SysLogic, Inc., S3Edge Inc., Carter Bloodcare, Mississippi Blood Services, the University of Iowa Hospitals and Clinics (UIHC), Mississippi Baptist Health System, University of Wisconsin Madison – RFID Laboratory, and Mediware Corp.

“This effort represents the culmination of years of hard work by Rodeina Davis (principle investigator for the STTR grant, and a luminary in the transfusion medicine field), and the consortium members in bringing a much needed innovation to the market in a collaborative manner. The FDA 510(k) clearance and commercialization will ensure that the cumulative efforts of the consortium benefit the transfusion medicine industry as a whole”, said Lynne Briggs VP and CIO at BloodCenter of Wisconsin. “Our pilot of iTrace for Blood Centers showed marked improvements in efficiency and accuracy in reconciling and tracking blood products from collections through distribution”.

“We are happy to now initiate the transfer of the 510K clearance to S3Edge to enable further commercialization of iTrace for Blood Centers. Today’s announcement showcases our commitment not just to create compelling technology, but to realize the vision of creating a successful product for the transfusion medicine industry” said Tina Chang, CEO of SysLogic, Inc., a Brookfield, Wisconsin-based information systems consulting and services firm, one of the founding members of the consortium and awardee of the STTR grant.

The suite of mobile, desktop and server software applications was deployed in production pilots at the BloodCenter of Wisconsin and the DeGowin Blood Center at UIHC where it was run in parallel with IPR, an internally developed barcode-based tracking system. “The RFID system provided equivalent capabilities to those of IPR in terms of detecting and resolving process errors. It additionally provided the blood bank staff real-time visibility for blood products in transit to the point-of-care and in remote storage in our emergency department. We are excited by the potential of this technology to further improve transfusion safety in operating rooms because of its hands-free non-invasive nature” said Dr. Thomas J. Raife, MD, Clinical Professor & Medical Director, UIHC DeGowin Blood Center.

“As the exclusive commercialization partner selected by the RFID Consortium, this is an exciting development that enables us to broadly market and deploy iTrace for Blood Centers. We look forward to completing the requirements for the transfer of the 510K from SysLogic and bringing this solution to the market. This significant milestone could not have happened without the efforts, guidance and leadership of the consortium. We look forward to working in tandem with this team of health care stakeholders and distinguished researchers to ensure Blood Centers around the world can take full advantage of this new system”, said Mark Anastas, President of S3Edge Inc.

About BloodCenter of Wisconsin

As a pioneering leader in science and medicine, BloodCenter of Wisconsin contributes to the discovery, diagnosis, treatment and cures for patients like no other single organization can by virtue of the expertise, diversity and innovation that reside within each of its service areas. BloodCenter of Wisconsin collects and distributes life-saving blood and marrow for Wisconsin families and tissue and organs for southeastern Wisconsin families. A private, not-for-profit organization, BloodCenter of Wisconsin also specializes in diagnostic testing, medical services, and leading-edge basic and clinical research. For more information, visit http://www.bcw.edu.

About University of Iowa Hospitals and Clinics

University of Iowa Hospitals and Clinics is Iowa's only comprehensive academic medical center and a regional referral center. UI Hospitals and Clinics and UI Children's Hospital together deliver quality care in collaboration with University of Iowa Physicians, the state's largest multi-specialty medical and surgical group practice composed of faculty physicians of the UI Roy J. and Lucille A. Carver College of Medicine. Together, these partners work together as University of Iowa Health Care to provide patient care, conduct biomedical research, and train the next generation of health professionals. Learn more at uihealthcare.org.

About SysLogic, Inc.

SysLogic, Inc. is a Brookfield, Wisconsin-based information systems consulting and services firm dedicated to helping clients conduct business more effectively by delivering proven and emerging process and technology solutions. Learn more at http://www.syslogicinc.com

About S3Edge, Inc.

S3Edge is a software product company that provides packaged, Auto-ID-based tracking solutions for automation and error proofing of supply chain operations. Spotlight, S3Edge's software product enables enterprises to configure and view assets, zones, alerts, and reports and to track and obtain trends on asset movement within their organizations. For more information, visit http://www.s3edge.com.

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Mark Anastas
Visit website