Temperature-sensitive indicators for monitoring RBC concentrates out of controlled temperature storage

Abstract

Objectives: The 30-minute rule for RBC concentrates out of controlled temperature storage does not take into account multiple parameters that influence warming of RBC concentrates. This study evaluated two temperature-sensitive indicators (TIs) for monitoring RBC concentrates during transport. Methods: TI labels (Check-Spot [Harald H. Temmel KG, Gleisdorf, Austria] and Thermoindikator V4 [BASF, Basel, Switzerland]) were attached to RBC concentrates prior to delivery. Duration of transport, ambient temperatures, and label results (valid vs expired) were recorded. We evaluated the proportion of labels discrepant to the 30-minute rule overall and among deliveries 30 minutes or less and more than 30 minutes and compared the rates of valid and expired readings between both TIs. Results: In total, 201 RBC concentrate deliveries (86.6%) lasted 30 minutes or less, and 31 (13.4%) were more than 30 minutes. Forty-six (19.8%) Check-Spot and 37 (15.9%) Thermoindikator V4 results were discrepant to the 30-minute rule. Sixteen (51.6%) and 27 (87.1%) RBC concentrate deliveries more than 30 minutes displayed valid label readings with Check-Spot and Thermoindikator V4, respectively. Rates of expired labels among deliveries 30 minutes or less and valid labels among deliveries more than 30 minutes differed significantly between TIs (P > .01). Conclusions: TIs identified a considerable number of RBC concentrates whose temperatures may not be adequately reflected by the 30-minute rule. Variability of readings between TIs stresses the necessity of validation prior to implementation.