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.

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).