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We get this question from blood banks a lot when helping them select and validate indicators. Our answer? No, there is not one irreversible indicator that works for two temperatures. Yet at the 2017 AABB Annual Meeting, we heard from a number of blood banks who said they are using ONE.
There are two problems with a “one size fits both” indicator: (1) the indicator is reversible up until it reaches endpoint and (2) the inability to validate the indicator.
When blood is in the blood bank, under your control, you have a reasonable assurance that it is being maintained below the AABB guideline temperatures of 6°C for storage and 10°C for transport. But when blood is out of your control, and then returned to the blood bank, an indicator is critical for confirming that it never exceeded the temperature endpoint. If the blood product reaches endpoint, an IRREVERSIBLE indicator gives you a visual cue – even if it has cooled down to an acceptable temperature by the time it arrives back in the blood bank.
As noted, some blood banks are currently using a single product for both 6°C and 10°C requirements. Let’s call it “Indicator A.” While it is true that this indicator gives you a real-time visual of the blood product temperature between 1°C to 9°C, indication is only irreversible at 10°C.
So, in the case of 10°C applications, if the endpoint “flower” hasn’t changed color when Indicator A arrives back to the blood bank, the blood is considered safe and can be returned to inventory.
This isn’t the case for 6°C applications, however, because the indicator does not provide irreversible indication until the blood reaches 10°C. That means if the temperature of the blood rose above 6°C for a period of time, but still stayed below 10°C and then fell below 6°C before returning to the blood bank – there would be NO visual indication that exposure over 6°C had occurred.
The assumption that Indicator A is irreversible for BOTH 6°C and 10°C indication is false. It is not.
Validating a temperature indicator is an iterative process that involves measuring blood product temperature with a calibrated thermometer, and then recording the temperature at which the indicator reaches its irreversible visual indication state.
Indicator A can be accurately validated for 10°C applications, similar to our Safe-T-Vue 10. Both will provide irreversible indication when the 10°C endpoint is reached – with Indicator A’s flower changing colors and Safe-T-Vue’s dot turning red.
If the intent is to use Indicator A for 6°C applications, however, it is impossible to validate it. Indicator A provides no irreversible visual indication if the blood exceeded 6°C at any point during the time it was out of control of the blood bank.
Let’s Get Back to the Meat of It
Think about cooking a turkey. You set your oven to 450 degrees for 5 hours and wait for the plastic thermometer to pop to let you know the bird is done. You don’t care if the oven dipped to 350 when you opened the door to check it, you just care that your turkey is thoroughly cooked. The pop-up thermometer gives you an irreversible visual indication, but with no record of the actual temperature as it’s cooking.
The same applies to blood indicators:
This is why Zebra recommends using Safe-T-Vue 6 for 6°C applications and Safe-T-Vue 10 for 10°C applications. Both are irreversible and can be validated for the indication temperature.
If you have questions about the difference between reversible and irreversible temperature indicators, and the importance of irreversible indicators, please contact us. You can also read the validation procedures below to get a better understanding of how a reversible indicator cannot be validated. Or, request Safe-T-Vue samples and see for yourself.
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