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Consortium Pilot Finds RFID Improves Efficiency of Blood Supply Chain
The Transfusion Medicine RFID Consortium is seeking 510(k) clearance from the FDA for the blood-tracking solutions it developed, which technology provider S3Edge intends to market to blood banks, clinics and hospitals.
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.
The group applied adhesive paper labels with embedded Avery Dennison AD-730x and Smartrac MiniTrack RFID tags to more than 75,000 blood bags. The RFID technology was tested in parallel with the existing bar-code-based tracking method.
The RFID Consortium plans to commercialize the technology once it receives 510(k) clearance from the FDA. According to the FDA's Web site, "a 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). 510(k) (premarket notification) to FDA is required at least 90 days before marketing unless the device is exempt from 510(k) requirements."
The consortium was formed in 2007 to study the integration of RFID into the blood product supply chain (see BloodCenter of Wisconsin to Study RFID's Effect on Blood). After completing studies into RFID's impact on blood products in 2008 and 2010, the group received FDA approval to proceed to a live pilot in November 2011, and to apply and encode HF tags on packets of red cells, platelets and plasma. The National Institutes of Health (NIH) provided a grant to conduct a study under SysLogic's management.
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