Hi - We use coolers for blood storage (1-6C) in the O.R. and some select locations in the hospital.  Validation is performed when new, once/year, and as needed, using LogTag temp recorders with probes inserted in expired RBCs.  Two trials per cooler, min (1 RBC) and max (6 RBCs) are performed.  When 6 RBCs are validated, one LogTag on either end unit and one in the middle.  I was wondering, for those sites using similar type validations, when you test your max capacity, do you open the lid intermittently during the trial or do anything else to try to mimic actual use?  Thank you.

 

 

I do not open the lid intermittently, not a bad idea though

We do not, but we also put temp indicators on our units to verify the cooler wasn't left open or the units dumped on the counter for a while before returning to the cooler.

Purely anecdotal: years ago my hospital didn't have the digital trackers so I tried validating the coolers with checking temps every hour-they went out of range within 4-5 hours. They stayed in temp over 12 hours not opening the coolers.

I use LogTags with probes. For a two unit red cell cooler, I validated with one unit left untouched, lid unopened for 24 hours. Then I put 2 units in, removed one at 2 hours and left the other in the cooler, lid not opened again, for a total of 24 hours. The coolers held temp below 6C for 24 hours for both trials. I did the same thing for our small platelet cooler. The idea was to mimic use for routine transfusion. Our policy when issuing blood products in these coolers is that the cooler must be returned within 8 hours, so temps are well within range...as long as they leave the lid closed unless removing product.

I need to validate a couple of 6 unit coolers for mass transfusions and will follow a similar plan. Stack 6 units, the top and bottom units will have probes. After 20 minutes one unit will be removed from the middle of the stack and every 20 minutes thereafter another unit will be removed from the middle until 4 units are gone. Another 20 minutes and the bottom unit will come out, leaving the top unit in until 24 hours have passed. It will be interesting to see how long the temp will hold, but I'm betting 3-4 hours won't be a problem and that will work just fine for mass transfusion.

 

Well, I'm happy to hear someone else is doing that, taking out a unit periodically when testing multiple units in a cooler.  I wanted to see if someone else was using the same thought process.  That is what I have been doing when testing 6 units over 12 hours; opening the cooler every hour to two and taking out a unit without the probe until one unit is left at 12 hours.  When initially setting up our cooler configuration, I validated a number of different ways, including testing 6 units for the entire duration.  Then, the temps held 1-6C for 16-24 hours.  Opening and closing the cooler, removing a unit periodically, we were able to validate the coolers for 10 hours, using 12 hour trials.  We had our AABB/CAP/FDA inspections in the fall and so far this has been ok with them.  But, talking to someone at another institution recently, they were just opening and closing their coolers during validation, not removing units.  So, it's interesting to see how others approach this.  Thank you.