This project represents the first-ever comprehensive investigation to research, develop and introduce innovative application of radio frequency identification (RFID) technology for automatic identification, tracking and status-monitoring of blood and blood products across the entire transfusion medicine supply chain, from the point of collection to the delivery of a product by a healthcare provider to a patient. The goal is to create a failsafe system for automatic identification and data capture that will reduce medical errors and enhance the patient safety, quality, and cost-effectiveness of patient-centered transfusion medicine care.
The specific aims of this STTR Phase 2 proposal are to: 1. Develop a comprehensive RFID-enabled blood product tracking (BPT) solution for the transfusion medicine supply chain including blood centers and hospitals. The BPT application software will be a market-ready product and will be positioned for FDA 510(k) clearance. The BPT system will augment existing blood center and transfusion services functionality and will not replace or interfere with any required barcode or key labeling information. Further, it will comply and work in conjunction with the internationally accepted ISBT 128 labeling and data messaging standard. 2. Conduct a proof-of-concept exercise followed by an integrated operational pilot implementation at one blood center and one hospital. The purpose is to demonstrate, verify and validate the technical feasibility and potential benefits of using RFID in transfusion medicine. 3. Perform technical and clinical tests, following scientifically rigorous protocols developed in collaboration with and approval of the FDA, to conclusively confirm the safety, reliability and performance of using 13.56 MHz RFID technology with blood products. The STTR Phase 2 will provide insight into three fundamental research questions that are central to the industry acceptance of the proposed RFID-enabled BPT solution, and the success of this project. 1. Can the proposed RFID-enabled BPT solution, from donation to transfusion, be applied safely and effectively to the core processes in the transfusion medicine supply chain? 2. What is the extent of improvement on operational productivity, patient safety, quality, supply chain responsiveness and cost-effectiveness that can be achieved in a real-world setting? 3. What is a roadmap for successfully implementing and deploying the RFID-enabled BPT solution within a blood center and a hospital? What are the success factors and potential barriers for introduction, integration, adoption and use of the system within an organization and across the supply chain? These efforts will lead to the commercialization and deployment of the RFID-enabled BPT solution in military and civilian health care organizations where failsafe distribution of blood products is critical to public health.
The nation's blood products supply chain is a critical pillar of our public health infrastructure. Studies conducted by the National Academy of Science's Institute of Medicine and other leading organizations have highlighted the high incidence of medical errors that result in between 44,000 and 98,000 American deaths each year. The proposed project aims at enhancing the safety, quality, productivity and responsiveness of our nation's blood supply through research, development and pilot of an innovative application of radio frequency identification technology for accurate and failsafe identification, tracking, and status monitoring of blood and blood products through the entire transfusion medicine supply chain (including collection, manufacturing, distribution and transfusion). Thus, this project addresses one of the national priorities of the US Department of Health and Human Services and the National Institutes of Health, and will help in minimizing mortalities due to transfusion medical errors, as well as helping increase cost-effectiveness of patient care with enhanced efficiency and productivity in the blood supply chain.
| Davis, Rodeina; Gottschall, Jerome; Gutierrez, Alfonso et al. (2010) Absence of acute adverse in-vitro effects on AS-1 RBCs and whole blood-derived platelets following prolonged exposure to 13.56 MHz radio energy. Transfusion 50:1596-603 |
