temp regulation blood bank

[sakeenah]

Is there any FDA/ allowed temperature range for blood bank refrigerator once the door of blood bank is opened for a certain period of time, say 30 seconds or 01 min etc and at waht environmental condition.Say if the room temp in hot season is arround 36-37C what is the allowableble temperature variation when door of blood bank is opened. And how long the blood bank refrigerator should take to return to the required temperature range of 2-6C.

Running transfusion services in hot climate -----problematic.

[David Saikin]

Your alarm should go off it the temp rises to near the allowable limit . . . which is 6C for storage. How or why the alarm is triggered is a moot point (door open, ref malfunction). Actually, in most BB refs, an alarm will sound if the door is open/ajar for more than 5 minutes.

[sakeenah]

Hi David

Thanks for ur reply.

Infact we 've got anew blood bank with capacity of 336 blood bags of 500ml. the room tem is arround 30-35 C in summers. whwn the dsoor is opened for 2min the temp display shows >8C and at 3min of door opened thetemp display shows >10C . alarm sounds at temp >8*C. Due to the higher room temp the temp of the Blood bank cabinet is expected to rise. but the core temp of the blood bags would probably not be affected.

what are the recommendations, the temp display should show the temp of the cabinet or simulated blood bag core temperature. When shold the alrm sound when te core temp goes beyond limit or whenthe cabinet temp goes beyond limit. what are the recommendations for room temp for blood bank refrigerator.

[dferia]

I am goign to recommend you refer to the following thread: http://www.bloodbanktalk.com/forum/showthread.php?t=3438

There was extensive discussion rgearding temperature monitoring or products and samples, what to monitoring, how to monitor it and even some discussion rgearding alarms that myself and others have provided alot of information on that I believe will be of assistance.

Hope that helps!

David

[heathervaught]

If your room temp is that high, then how long does it actually take for a unit of blood that sits on the counter to rise above 10C? I know that there is a lot of talk about the "30-minute rule" for accepting blood for reissue, but that should still be validated within your institution (we validated it here, and our room temperature is kept at 20-24 C). I would be concerned that blood, once removed from your refrigerator, does not take very long to become unsuitable to be placed back into general inventory and should either be (1) issued for transfusion or (2) discarded. If one of our customer hospitals handled blood products in an environment identical to your description, then we would not allow them to return units to us for inventory.

[David Saikin]

Your temperature probe should be in a volume of solution equivalent to the products being stored (and with like viscosity too - 10% glycerol comes to mind). I'd hate to have to explain spikes beyond the limit to an FDA inspector - they have been known to make you discard all products that were not isolated to the proper storage temp. Or at least cite you for "being bad".

[Mary**]

Wise words, David!

[Franklyn]

Another approach is to use a machined aluminum block drilled for your probe. With a little experimentation you can duplicate the thermal characteristics of the venerable bottle of glycerol, yet avoid the spills and re-fills that plague this old-tech approach. Some monitoring system vendors (CIMTechniques, Veriteq) manufacture them for their products and they are fairly cheap.