I am getting back into Blood Banking after being out of it for a number of years. As I am waiting for a new Technical Manual and Standards....

I see that CAP (TRM.42470) states we have to do cooler validation, what does AABB state?

Thanks Chris

Pretty much the same thing. Coolers must be validated to maintain temperature within the specified ranges for defined periods of time. For portable ice chest style coolers that falls into the 1-10 degrees C for transport and 1-6 degrees for storage. A truly misleading and confusing regulation pulled from the FDA. I think you are safer to look at 1-6 degrees and have a mechanism to record (document) temperature q4 hours.

Is anyone using a datalogger device in their coolers? I am wondering if this would qualify as 'continuous monitoring'. Would it matter that the device measures the ambient temperature inside the cooler and is not submerged in liquid that simulates the viscosity of blood? I would appreciate any thoughts....especially if anyone is using or has considered using one of these devices.

Thanks, Amelia

Is anyone using a datalogger device in their coolers? I am wondering if this would qualify as 'continuous monitoring'. Would it matter that the device measures the ambient temperature inside the cooler and is not submerged in liquid that simulates the viscosity of blood? I would appreciate any thoughts....especially if anyone is using or has considered using one of these devices.

Thanks, Amelia

Is continuous monitoring of cooler temps required?   You may want to check that.  We have used a datalogger during validation only.

If you are only monitoring the ambient temp you are going to see a wide range of temps and probably some outside the acceptable limits. I would not recommend that.

We use a datalogger in our coolers.  We place the datalogger in a small ziplock bag which will prevents temperature fluctuations.  Since we continuously monitor storage, we do not need to perform cooler validations.

Here's a topic that's bugging me. We have OR doctors that order 2 units of FFP thawed and want them in the OR room in a cooler, STAT. We thaw them and place them in a cooler thinking they would use the FFP right away. The FFP comes back in the cooler but of course the temps taken while the cooler was in the OR range from 10C to 14C. It's way past the 30 minute limit. Any suggestions on how to validate a cooler for thawed FFP?

Excuse my cynicism Minerva, but it sounds like your OR doctors need validating too!!!!!!!!!!!!!!

Just wanted to throw out my two cents on the subject. Data loggers are fine for certain movement of blood. The concern that we have seen in the OR/ER environment is the gray area when the blood is removed from the cooler and then put back in 30-60 minutes later. Nobody has a clue what happened in that window. May blood banks use one time use chemical indicators. Some of these indicators have a 510K so can be used for blood products and then returned back to storage for reuse. No need to throw out the indicator just leave it on the unit for the next use or shipment. They can last up to 42 days....

Minerva,

 

I'm not sure I will be able to explain my logic here, but I'll try......Here we go...

 

You thaw the FFP and put in in a cooler with adequate ice (or some type of appropriate cool-pack) in a validated cooler.  If they return the unused FFP within a reasonable time (say an hour or 2), isn't it reasonable that the cooler temp may be out of the proper range just because the 37C FFP is on its way to cooling down?  If that's the case, the FFP is just as safe to use as the 37C FFP that you thawed and placed in your blood refrigerator until it expires in 24 hours (or 5 days, depending on your policy.)

 

However, if the FFP in the cooler is warmer than the acceptable temperature range because there was not adequate ice (or coolant) to get and keep the FFP within the proper temperature range, then I would consider it unacceptable to return the FFP to the Blood Bank/Transfusion Service for reissue and I would destroy the unit.  (Example:  If the FFP is returned 6 hours later and it is 13C, I would destroy it.)

 

Exactly how long does it take the thawed 37C FFP to come down to 6C?  You will find out when you thaw some FFP and do your cooler validation.

 

Donna