By Lamont Williams
Blood industry leaders gathered at the Annual Meeting to review the implementation of radiofrequency identification, or RFID, solutions in blood centers and hospitals. Moderated by Lynne Briggs, BS, MBA, of the BloodCenter of Wisconsin, the session (9305-LMT-IT) discussed the journey of a group of blood center and hospital facilities and their academic and technology partners — altogether called the Transfusion Medicine RFID Consortium — as it defined, developed and began testing RFID technology and an RFID-based application.
Rodeina Davis, vice president and chief information officer of the BloodCenter of Wisconsin, began the session by giving background on the development of the system, which is now in the prototype phase. She noted that "the use of RFID technology in blood banking and transfusion medicine has the potential to advance both patient safety and operational efficiency and effectiveness."
She explained, however, that to realize the benefits of RFID, the industry must establish definitions and adopt consistent standards for the technology's use throughout the blood supply chain. She further explained that RFID must also be integrated with existing and planned bar-coding and labeling standards as well as blood and transfusion systems already in use.
Davis described how the consortium's system complies with ISBT 128 labeling, data and messaging standards; uses passive high-frequency tags (13.56 MHz); and includes unit identification, product code, expiration dates and ABO/Rh on the RFID tag, in accordance with the ISBT RFID Working Party guidelines.
Alfonso Guttierez, BS, MS, of the University of Wisconsin – Madison, followed Davis' presentation by reviewing the testing of RFID technology. The testing studies were designed to answer questions such as the following:
- Is high-frequency RFID, or HF RFID, safe?
- Can RFID tags survive (e.g., centrifugation, blast freezing, gamma radiation)?
- How well will RFID perform?
Relative to safety, Guttierez explained that the Food and Drug Administration's Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health advised the consortium as it developed its testing protocols for red cells, platelets and plasma. The basic concept of the protocols was to expose a small group of blood components to reader radiofrequency power levels and times higher than what would be seen in practice. Blood product samples were assayed at zero, seven and 24 hours for morphological and biochemical changes and compared with an unexposed control sample. These tests indicated that HF RFID had no measurable impact on blood products, and the FDA provided the go-ahead to the RFID consortium for activities using HF RFID with blood products.
Guttierez noted that HF RFID tag performance and survivability test scenarios passed the thresholds that were set based on actual pretest data and practicality considerations for real-world application. Currently, the consortium, with UW-Madison, is designing and conducting tests around the electromagnetic interference, or EMI, typical in blood centers and hospitals to reduce the potential for RFID systems to be the cause, or in some cases, the "victim" of EMI.
Mark Anastas, BS, MS, and Ram Venkatesh, both of S3Edge, showed portions of RFID-based applications that will be piloted first at the BloodCenter of Wisconsin beginning in the first quarter of 2012. The consortium also plans to complete and pilot a solution for transfusion services in 2012. A 510(k) submission will be completed during or after the blood center pilot.
During the session, the International Council for Commonality in Blood Banking Automation, or ICCBBA, presented its One World Award to Clive Hohberger, PhD, recognizing his significant contribution to the understanding and application of international information standards in transfusion and transplantation medicine.