Nov 20, 2012The 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 pilot employed 13.56 MHz passive high-frequency (HF) RFID tags, complying with the ISO 15693 standard, on blood bags, as well as on the containers in which those bags were shipped. Mobile and desktop readers were used at the BloodCenter of Wisconsin's blood-donation units in Milwaukee.
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.
The study's hypothesis, says Lynne Briggs, the BloodCenter of Wisconsin's VP and CIO, was that RFID would reduce the incidence of product loss and expiration, and that it would improve efficiency by providing greater product visibility and process automation. The group found that the RFID system did, indeed, achieve these expected benefits, and that it could provide an additional layer of visibility. By following the International Society of Blood Transfusion (ISBT) 128 bar-code-based system currently used worldwide for blood supply chain tracking, and by applying that system to RFID technology, the team ensured that the RFID-enabled solution they developed could be used anywhere.
S3Edge designed the solution to be integrated with Mediware's LifeTrak software employed by the BloodCenter of Wisconsin, explains Anush Kumar, S3Edge's CTO and VP of business development. LifeTrak is a type of blood establishment computer software (BECS) that, according to the FDA, the blood transfusion industry utilizes to prevent disease in humans, "by identifying unsuitable donors and preventing the release of infectious or otherwise harmful blood and blood components for transfusion or for further manufacturing use."
The technology was first piloted at several donor sites, and at the BloodCenter of Wisconsin, for a period of three months, beginning in March of this year. In May, the solution was then tested for one month at the UIHC. "Since then," Briggs reports, "we've done a tremendous amount of assessing the measurements/data collected."
Piloting in a health-care environment, Briggs says, required that the group move slowly and thoroughly at each step of the process. They initially provided extensive end-user training, as well as preliminary research into the operations of those working at the blood-donation sites and at the BloodCenter of Wisconsin, in order to ensure that the system would not affect operations.
The group applied RFID tags to blood bags at three donor sites, and to the containers in which those tagged blood bags were placed and then shipped to the BloodCenter of Wisconsin. In addition, they affixed tags to blood bags at a mobile location that transports the blood-drive services to outlying communities and organizations.
Once the filled containers of blood bags arrived at the BloodCenter of Wisconsin, the boxes were moved through a Tagsys 50x50 HF RFID Tunnel reader, says Kumar, indicating which items had been received. Typically, the blood products are "manufactured," meaning the blood is put through specific processes in order to separate out various components, such as platelets and red blood cells. The resulting products can then be placed inside the bags with RFID tags, or into additional bags with tags married to the originating bag's RFID number.
A clinic or hospital typically places an order for specific blood products, and the BloodCenter of Wisconsin's staff members then locate those items in storage and pack them into a container. At this point, during the pilot, employees used a second Tagsys tunnel reader to interrogate the ID of every bag packed in the container. The S3Edge software then compared the read data with the list of products intended for that specific order, to ensure that the correct items were being packed.
For the portion of the pilot involving the University of Iowa, UIHC's staff had to apply RFID labels to products as they were received. That, Briggs explains, was because the university is not a recipient of blood products from the BloodCenter of Wisconsin, but instead receives its blood products from the DeGowin Blood Center. "Unfortunately," she states, "the timing of the pilot did not allow for BloodCenter of Wisconsin's existing customers to participate." Those customers received tagged products, but did not read those tags.
Once the university hospital tagged the bags it received from the DeGowin Blood Center, its staff utilized a Tagsys PAD antenna mounted on top of a counter-height refrigerator with a table display to read the tagged bags. Workers interrogated the tag on each bag of blood before moving that product, and then selected a prompt either for "check-in" (to store the blood after receiving it from the DeGowin blood center) or "checkout" (indicating it was intended to be administered to a patient).
"One of our goals was academic," Briggs explains. "We wanted to see if RFID technology would work in live transfusion medicine operations, and prove out various hypotheses from our original NIH study phases." Based on the study of the pilot, she says, she found that there were tremendous efficiency gains, primarily at the BloodCenter of Wisconsin's headquarters, where the technology and system allowed for rapid and accurate reconciliation of product counts and locations. Because the BloodCenter's employees saw which specific items were being shipped from the donor sites, Briggs adds, they were better able to prepare for the particular products en route to the facility. The system also helped eliminate errors that could occur at the time of receiving or shipping, when products are sometimes miscounted.
"This is a mission-critical solution," Kumar states. Although Briggs notes that the BECS will always serve as the main system to manage inventory traceability, as well as information and decisions regarding blood products, the RFID technology adds a layer of visibility that can be integrated as part of the operational flow, "while still allowing the main system to do its work." RFID, he says, "augmented those systems to better protect the blood products," by providing greater visibility into the supply chain.
Once the FDA provides 501(k) clearance—which the group expects to take 90 to 180 days to complete—S3Edge will then be able to actively market and sell the blood center's RFID solution. The company anticipates selling two packaged solutions: the Blood Center Solution (for blood centers and donor locations) and the Hospital Transfusion Services Solution (for hospitals). Both systems can operate independently, the firm reports, or data can be shared between supply chain partners using both offerings.
Although the system was initially designed to be integrated with Mediware software, Kumar says, it could operate with other blood center BECS technology as well.