Auto-ID based tracking system developed as a result of a National Institute of Health STTRGrant 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 BloodCenters, the tracking system developed by the RFID Consortium has been cleared for marketing. The RFID andbarcode based Blood Product Tracking system enables improved compliance with FDA tracking requirementsfor blood products, enables cross hospital inventory optimization to reduce waste from outdated products andimproves patient safety by preventing the release of unsuitable blood products. The RFID Consortium includesBloodCenter of Wisconsin, SysLogic, Inc., S3Edge Inc., Carter Bloodcare, Mississippi Blood Services, theUniversity of Iowa Hospitals and Clinics (UIHC), Mississippi Baptist Health System, University of WisconsinMadison – RFID Laboratory, and Mediware Corp.
“This effort represents the culmination of years of hard work by Rodeina Davis (principle investigator for theSTTR grant, and a luminary in the transfusion medicine field), and the consortium members in bringing a muchneeded innovation to the market in a collaborative manner. The FDA 510(k) clearance and commercializationwill 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 showedmarked improvements in efficiency and accuracy in reconciling and tracking blood products from collectionsthrough distribution”.
“We are happy to now initiate the transfer of the 510K clearance to S3Edge to enable further commercializationof iTrace for Blood Centers. Today’s announcement showcases our commitment not just to create compellingtechnology, but to realize the vision of creating a successful product for the transfusion medicine industry” saidTina Chang, CEO of SysLogic, Inc., a Brookfield, Wisconsin-based information systems consulting andservices firm, one of the founding members of the consortium and awardee of the STTR grant.
iTrace for Blood Centers, (Version 1.0.924.0), the first application to use Radio Frequency Identification (RFID) technology in blood establishments to assist in enhancing blood safety by preventing the release of unsuitable blood components, was cleared today by the U.S. Food and Drug Administration.
“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 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.”
RFID is a tool widely used for identification and tracking of various objects. In a typical RFID system, a small memory-storage chip is placed on the item being tracked. RFID readers send and receive radio waves to detect chips and read their data. The iTrace RFID application is designed to augment existing blood bank systems and to work in conjunction with barcode identification and labeling processes currently in place.
iTrace for Blood Centers interfaces through a server with blood establishment computer software to receive and store data used by blood establishments during the manufacturing process, including information related to collection; component processing and labeling, including verifying the product code; expiration date; and blood type (ABO/Rh) information.
The device was cleared for marketing based on the submission of a premarket notification, often referred to as a 510(k). A 510(k) submission made to the FDA demonstrates that the device is at least as safe and effective as, that is, substantially equivalent to, a legally marketed device that is not subject to a premarket application.
iTrace for Blood Centers is manufactured by SysLogic, Inc., based in Brookfield, Wis.
Nov. 20, 2012—The Transfusion Medicine RFID Consortium reports that it has submitted the results of a radio frequency identification pilot to the U.S. Food and Drug Administration (FDA), as part of a request for 510(k) clearance of the blood-tracking solution. The consortium's membership includes RFID technology provider S3Edge Inc., numerous universities and clinics, the BloodCenter of Wisconsin, and other centers that supply blood products. The group had carried out the pilot over the course of several months at some of the BloodCenter of Wisconsin's blood-donation sites and headquarters facility (where blood products are manufactured), as well as at the University of Iowa Hospitals and Clinics (UIHC), where blood was administered to patients. Information systems consultant SysLogic Inc. provided project management for the deployment.
The consortium found that the use of RFID during the pilot resulted in a 33 percent reduction in reconciliation issues or misplaced products at the blood-donation points, as well as an 87 percent decrease in reconciliation issues or misplaced products when blood arrived at BloodCenter of Wisconsin's headquarters. In addition, efficiency during final inventory check-in at the BloodCenter of Wisconsin increased by 63 percent. At the hospital, product visibility was improved and the correct blood product was delivered to patient bedsides without a single error, for a total of 144 transfusions. Carter BloodCare and Mississippi Blood Services provided input regarding the system's design, thereby ensuring that a solution would be created to meet the needs of all blood centers, not just the BloodCenter of Wisconsin. Similarly, Baptist Health Systems, located in Mississippi, and UIHC provided input regarding a hospital's requirements.Read more...
Auto-ID based tracking system developed as a result of the National Institute of Health STTR Grant, enters commercialization phase
Portland, OR., October 5, 2012 /PRNewswire/ -- The Transfusion Medicine RFID Consortium announced today that S3Edge Inc., the software partner for the consortium has been selected to exclusively commercialize the RFID and barcode based Blood Product Tracking suite of applications designed and built under a private, academic, and public initiative funded by the NIH. The system, consisting of mobile, desktop, and server software applications provides greater visibility to the physical movement of blood products, while improving the efficiency of Blood Center operations. The RFID consortium includes BloodCenter of Wisconsin, SysLogic, Inc., S3Edge Inc., Carter Bloodcare, Mississippi Blood Services, the University of Iowa Hospitals and Clinics, Mississippi Baptist Health System, University of Wisconsin Madison – RFID Laboratory, and Mediware Corp.
The suite of applications has been deployed in a production pilot at the BloodCenter of Wisconsin and the University of Iowa Hospitals and Clinics (UIHC) with promising results. "Thanks to the outstanding work of the entire consortium team, we have successfully piloted the new system to track blood products as they move from fixed and mobile donation sites, through the blood center and to distribution. After 24 weeks of running the system in a pilot mode here at the BloodCenter of Wisconsin, we have seen process efficiency and traceability gains, as well as marked improvements in reconciliation", said Lynne Briggs, Vice President and Chief Information Officer for BloodCenter of Wisconsin in Milwaukee.Read more...
July 19, 2012 - Production pilots were completed in June for the RFID solution at both the blood center and the hospital. BloodCenter of Wisconsin (Milwaukee) conducted an eight-week pilot from blood donation through packing and shipping to hospital customers, including both whole blood and apheresis collections and mobile collections. At the University of Iowa Hospital and Clinics, RFID tags were applied to blood products in the blood bank and were tracked through transfusion in a single nursing unit for a period of four weeks.Read more...
BloodCenter of Wisconsin (BCW) has begun a 12-week pilot of the RFID solution for blood centers in production. The pilot schedule, begun on March 5, calls for a gradual phase-in of system functions over the first 8 weeks. BCW staff has taken very little time to accept the new technology and initial observations are that efficiency gains seem to exceed expectations. The pilot follows a two-week process qualification (PQ) of the solution by users at BCW. Only minor changes and some needed enhancements were noted during PQ, prompting the RFID team to move ahead with the pilot.
Excerpt form UW System News: July 8, 2011
MADISON, Wis. — The University of Wisconsin System Board of Regents will honor this year’s recipients of the Academic Staff Awards for Excellence July 15 in Madison. This is the UW System’s highest recognition bestowed on members of its academic staff.
The 2011 recipients, including two individuals and one program, are:
Alfonso Gutierrez, Director of the UW Radio Frequency Identification (RFID) Lab and Director of Research and Education for the UW E-Business Consortium, UW-Madison. Over the past nine years, Gutierrez’ leadership and critical research support for several innovative multidisciplinary university-industry partnerships have placed the College of Engineering and the campus in the international spotlight and garnered recognition for UW-Madison as a preeminent center for thought leadership in the radio frequency identification field. Gutierrez helped establish the UW RFID lab, a state-of-the-art facility for research, development, and technology transfer of radio frequency identification. Putting the Wisconsin Idea into practice, the lab’s projects have impacted areas as diverse as blood transfusion to parking ramp access. As Director for Research and Education of the UW E-Business Consortium, which includes about 70 leading Wisconsin companies, Gutierrez helped to develop and implement offerings such as industry peer groups to foster collaborative learning among members and the sharing of best practices. He is also known for his dedicated mentoring of students.
The RFID solutions we’re developing for blood centers and hospital transfusion services are a customization of Spotlight, an S3Edge asset-tracking application. Spotlight is based on BizTalk Server RFID 2010, BizTalk RFID Mobile, Microsoft SQL Server 2008 data management software, the Windows Server 2008 operating system, and the Microsoft Silverlight browser plug-in. Microsoft has showcased our development effort in a case study which can be viewed by clicking here.
Clive Hohberger, PhD, made a presentation about our RFID project to the Hospital Blood Bank Supervisors Symposium on March 26, 2011. Click here to view his presentation.
13th October 2010.
Rodeina Davis, Principal Investigator and Program Director for this project, was honored with the AABB President's Award at the annual convention that was held in Baltimore this year. The award recognizes Rodeina "For her long-term, global leadership in the field of information technology in transfusion medicine. She has led the development of RFID technology from donor to patient bedside in the United States".
The award was presented by Jacquelyn Fredrick, President of the AABB.
Auto-ID based tracking system developed as a result of a National Institute of Health STTRGrant 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 BloodCenters, the trac...
Nov. 20, 2012—The Transfusion Medicine RFID Consortium reports that it has submitted the results of a radio frequency identification pilot to the U.S. Food and Drug Administration (FDA), as part of a request for 510(k) clearance of the blood-tracking solution. The consortium's membership includes...
Auto-ID based tracking system developed as a result of the National Institute of Health STTR Grant, enters commercialization phase ...
July 19, 2012 - Production pilots were completed in June for the RFID solution at both the blood center and the hospital. BloodCenter of Wisconsin (Milwaukee) conducted an eight-week pilot from blood donation through packing and shipping to hospital customers, including both whole blood and...