Utility of temperature‐sensitive indicators for temperature monitoring of red‐blood‐cell units

Abstract

Background and Objectives The 30‐min rule has been used to maintain a core temperature (CT) of red‐blood‐cell (RBC) units below 10°C during transportation. We evaluated the utility of temperature‐sensitive indicators (TIs) to monitor the surface temperature (ST) of RBC units and to explore whether TIs can help with compliance with the 30‐min rule by extrapolating or correlating temperature change with time. Materials and Methods Two US FDA‐approved TIs, Safe‐T‐Vue 10 (STV10; Temptime Corporation, Morris Plains, NJ, USA) and Timestrip Blood Temp 10 (BT10; Timestrip UK Ltd, Cambridge, UK), were attached to 50 RBC units. After issue, their colour change indicating 10°C was monitored, and temperature excursions were measured by standard reading. In additional 18 RBC units, both ST and CT were monitored simultaneously. Results In 50 RBC units, 94% of STV10 and 100% of BT10 showed colour change indicating 10°C within 30 min; 4% of STV10 and 18% of BT10 showed it during transportation. The time for colour change indicating 10°C differed significantly between STV10 and BT10 (19·0 vs. 5·6 min, P < 0·001). In additional 18 RBC units, 83·3% of STV10, 100% of BT10 and 88·9% of CT reached 10°C within 30 min, and the time for colour change indicating 10°C was 24·4 min in STV10, 14·6 min in BT 10 and 24·2 min in CT (P < 0·001). Conclusion In two TIs, the time for colour change indicating 10°C varied considerably. To enhance the utility of TIs, further improvement and standardization would be needed.

Time–temperature indicators versus temperature indicators for transfusion practice: Application in the real hospital setting

“…Of the 91 RBC units, eight units were stored in blood refrigerators (hereafter, refrigerators) immediately on the arrival in the ward or in the injection room until transfusion, and the data were analysed separately according to storage site. On issue, moisture was removed from the blood bags, and FZTTI, STV10 and BT10 were simultaneously attached to the lower part of each bag according to the manufacturer's instructions [23, 25, 26]. The material was transported on ice following conventional transfusion practices.…”

“…These units were stored separately in the refrigerator, and the time from donation to experimental (transfusion) simulation was 17 and 20 days. The ST and CT of these two units were monitored using a data logger (CR23X Micrologger, Campbell Scientific Inc., Logan, UT) and a type K thermocouple probe (OMEGA Engineering Inc., Stanford, CA) [23, 28]. The probe was attached to the outside and centre of each unit in a cold room at 3.1°C [23].…”

“…We previously evaluated the performance of two US Food and Drug Administration (FDA)‐approved TIs: Safe‐T‐Vue 10 (STV10; Temptime Corporation, Morris Plains, NJ) and Blood Temp 10 (BT10; Timestrip UK Ltd, Cambridge, UK) [23]. In most cases, these TIs showed colour changes (CCs) – indicating that the temperature of RBC units exceeded 10°C – within 30 min; however, the CC assessments were vulnerable to variation or heterogeneity [23]. Therefore, it was difficult to determine the clinical utility of these TIs.…”

“…Thus, this study aimed to compare the CC of FZTTI with that of two TIs (STV10 and BT10) approved by US FDA for monitoring RBC units based on the 30‐min rule. We hypothesized that FZTTI would outperform the TIs [23].…”

Mean kinetic temperature evaluations through simulated temperature excursions and risk assessment with oral dosage usage for health programs

“…Devices are available to accompany shipments in order to monitor for temperature excursions (period of exposure to temperatures exceeding the designated range for the product [ 9 ]) during transport and storage [ 10 , 11 ]. Although the data from these monitors indicate whether an excursion has occurred, the severity of the excursion and the risk to the product are likely to be less understood and may need to be assessed.…”