Absence of acute adverse in vitro effects on aged AS-1 red blood cells and thawed plasma after prolonged exposure to 13.56-MHz radio energy.

BACKGROUND: There is growing interest in radio frequency identification (RFID) technology for tracking blood products to improve productivity and safety in the transfusion medicine supply chain. We conducted a limited study to assess the temperature and biologic effects after extreme exposure to 13.56-MHz RF radiation on aged red blood cells (aRBCs) nearing their 42-day life and three types of thawed plasma (TP). STUDY DESIGN AND METHODS: Using a Food and Drug Administration-approved limit test protocol, test units of both aRBCs and three types of TP were subjected to high levels of RF energy for an extended duration to assess worst-case effects compared to minimally exposed control units. Three replications were performed for each product type. RESULTS: Hemolysis after 23 to 25 hours of RF energy exposure was less than 0.3% for all test and control aRBC units and well within the 1% or less acceptance criterion. Both biologic test and temperature increase results were within acceptance criteria and consistent with earlier tests on 6- to 9-day RBCs, with no detectable acceleration in cellular degradation of aRBCs. Nine different plasma coagulation factors were evaluated and, with one explainable exception, all showed less than 20% change in their measured test versus control values, meeting the acceptance criteria. The relative temperature increase between test and control units never exceeded the 1.5°C acceptance criterion for RBCs and 4°C for plasma. CONCLUSION: Use of 13.56-MHz RFID technology is unlikely to have any significant temperature or biologic effects on aRBC and plasma units under normal operating conditions.

Applying radio-frequency identification (RFID) technology in transfusion medicine.

ISO/IEC 18000-3 mode 1 standard 13.56 MHz RFID tags have been accepted by the International Society for Blood Transfusion (ISBT) and the United States Food and Drug Administration (FDA) as data carriers to integrate with and augment ISBT 128 barcode data carried on blood products. The use of 13.56 MHz RFID carrying ISBT 128 data structures allows the global deployment and use of RFID, supporting both international transfer of blood and international disaster relief. The deployment in process at the BloodCenter of Wisconsin and testing at the University of Iowa Health Center is the first FDA-permitted implementation of RFID throughout in all phases of blood banking, donation through transfusion. RFID technology and equipment selection will be discussed along with FDA-required RF safety testing; integration with the blood enterprise computing system and required RFID tag performance. Tag design and survivability is an issue due to blood bag centrifugation and irradiation. Deployment issues will be discussed. Use of RFID results in significant return on investment over the use of barcodes in the blood center operations through labor savings and error reduction.

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.

BACKGROUND: There is growing interest in radio frequency identification (RFID) technology application for tracking blood products to achieve higher productivity and safety in the transfusion medicine supply chain. We have conducted a limited study to assess the temperature and biological effects of 13.56 MHz RF radiation on RBCs and whole blood-derived platelets (WBDP) under extreme exposure conditions. STUDY DESIGN AND METHODS: Using an FDA-approved protocol, test units of both RBC and WBDP were subjected to approximately 100 watts of RF energy for an extended duration (23-25 h) to assess worst-case effects. Three replications of the test were performed. RESULTS: Hemolysis after 23-25 hours of RF energy exposure was 0.09% and 0.05%, respectively, for TEST and CONTROL RBC units and well within the ≤1% limit in the FDA-approved acceptance criteria. For WBDP units, the mean pH of TEST and CONTROL units were 7.27 and 7.19, respectively, following 23-25 hours of RF energy exposure, and well above the ≥6.2 acceptance limit. Further, there was no detectable acceleration in cellular degradation of RBC and WBDP products. While there was minimal temperature rise, the relative temperature increase between TEST and CONTROL units never exceeded the 1.5°C acceptance criterion. CONCLUSIONS: 13.56 MHz-based RFID technology is unlikely to have any significant temperature or biological effects on RBC and WBDP units under the normal operating conditions (a maximum of 4 watts RF power exposure for about 20 nonconsecutive minutes for RFID tracking during the life of the blood product).

RFID in the blood supply chain--increasing productivity, quality and patient safety.

As part of an overall design of a new, standardized RFID-enabled blood transfusion medicine supply chain, an assessment was conducted for two hospitals: the University of Iowa Hospital and Clinics (UIHC) and Mississippi Baptist Health System (MBHS). The main objectives of the study were to assess RFID technological and economic feasibility, along with possible impacts to productivity, quality and patient safety. A step-by-step process analysis focused on the factors contributing to process "pain points" (errors, inefficiency, product losses). A process re-engineering exercise produced blueprints of RFID-enabled processes to alleviate or eliminate those pain-points. In addition, an innovative model quantifying the potential reduction in adverse patient effects as a result of RFID implementation was created, allowing improvement initiatives to focus on process areas with the greatest potential impact to patient safety. The study concluded that it is feasible to implement RFID-enabled processes, with tangible improvements to productivity and safety expected. Based on a comprehensive cost/benefit model, it is estimated for a large hospital (UIHC) to recover investment from implementation within two to three years, while smaller hospitals may need longer to realize ROI. More importantly, the study estimated that RFID technology could reduce morbidity and mortality effects substantially among patients receiving transfusions.

Tracking blood products in blood centres using radio frequency identification: a comprehensive assessment.

BACKGROUND AND OBJECTIVES: Radio frequency identification (RFID) can be a key enabler for enhancing productivity and safety of the blood product supply chain. This article describes a systematic approach developed by the RFID Blood Consortium for a comprehensive feasibility and impact assessment of RFID application in blood centre operations. MATERIALS AND METHODS: Our comprehensive assessment approach incorporates process-orientated and technological perspectives as well as impact analysis. Assessment of RFID-enabled process redesign is based on generic core processes derived from the three participating blood centres. The technological assessment includes RFID tag readability and performance evaluation, testing of temperature and biological effects of RF energy on blood products, and RFID system architecture design and standards. The scope of this article is limited to blood centre processes (from donation to manufacturing/distribution) for selected mainstream blood products (red blood cells and platelets). RESULTS: Radio frequency identification can help overcome a number of common challenges and process inefficiencies associated with identification and tracking of blood products. High frequency-based RFID technology performs adequately and safely for red blood cell and platelet products. Productivity and quality improvements in RFID-enabled blood centre processes can recoup investment cost in a 4-year payback period. CONCLUSION: Radio frequency identification application has significant process-orientated and technological implications. It is feasible and economically justifiable to incorporate RFID into blood centre processes.