I can't find anything that gives me the inkling about where AABB will go with storage versus transport. Currenlty we send blood to OR, or ED or the floors for dialysis or to an outpatient transfusion center across our parking lot in coolers. If i go with the 1-6 degree ruling, I am only going to get 2 hours from our current coolers.

So, what is everyone else doing, and what type of containers are you using?

Thanks!

I have Credo coolers and can get at least 18 hours at 1-6 C and longer for 1-10 C.

We use Golden Hour coolers. They keep the blood 1-6 C for up to 8 hours or more (we only validated to 8 hours). They work great.

We use Igloo MaxCold Playmate coolers (kind of greyish blue color) straight off the shelf of the local retailer. The MaxCold variety have additional insulation in the lids so they maintain temperature for much, much longer than the regular red or royal blue models of the same shape and size. We use frozen blue "ice blocks" with refrigerated gel pack on top and bottom of units to keep them from keeping too cold. We have validated our coolers to maintain 1-6C for more than 8 hours.

FYI: the storage vs. transport issue is courtesy of the FDA

We use Igloo MaxCold Playmate coolers (kind of greyish blue color) straight off the shelf of the local retailer. The MaxCold variety have additional insulation in the lids so they maintain temperature for much, much longer than the regular red or royal blue models of the same shape and size. We use frozen blue "ice blocks" with refrigerated gel pack on top and bottom of units to keep them from keeping too cold. We have validated our coolers to maintain 1-6C for more than 8 hours.

FYI: the storage vs. transport issue is courtesy of the FDA

Hi BB479,

Have you trained the patient care area staff how to re pack coolers after they remove a unit? I would be concerned if the frozen pack was placed next to a unit of blood instead of the refrigerated pack.

We use Thermosafe coolers and we palce HEMOTEMP indicators on each units. Cooler were ordered from FISHER and they were validated with Blue packs for over 16 hrs at temp. We allow them to remain out for 8 hrs to OR cases. I would be interested to hear from anyone regarding the documentation that is sent with these cooler.

here is link

http://www.fishersci.com/ecomm/servlet/fsproductdetail?storeId=10652&productId=1094703&catalogId=29104&matchedCatNo=22031878&fromSearch=1&searchKey=coolers||blood||cooler&highlightProductsItemsFlag=Y&endecaSearchQuery=%23store%3DScientific%23nav%3D0%23rpp%3D25%23offSet%3D0%23keyWord%3Dblood%2Bcooler&xrefPartType=From&savings=0.0&xrefEvent=1356116999238_0&searchType=PROD

I found a reference in a shared procedure that says that in the 'Ask the FDA' session at the 2005 AABB meeting in Seattle, the FDA representatives clarified storage vs. transport temperatures for blood products in coolers. The approved temperature range for transport is 1-10C, while the FDA clarified that blood stored in a cooler for use in the OR, etc, is indeed temporary storage and therefore must be maintained at 1-6C.

I think now the big question is how to define when a cooler is being used for transport and when it is being used for storage. I understand that it depends on how you define it in your SOP. For example, if a cooler is sent to the CVOR to hold blood during a case, you may define that as storage and the temp must be maintained between 1-6C. But, if you send units in a cooler to the bedside for the initiation of ECMO or for use in an apheresis procedure you may define that as transport and the allowable temp is 1-10C. It is hard to distinguish between the two.

The FDA has stated that keeping blood in a cooler within the hospital is considered storage, and therefore requires 1-6C.

Last I heard, Transport was blood going somewhere with the intent of being transfused (i.e. Outpatient Transfusion, Dialysis, etc.). Storage was blood sitting somewhere, "just in case." That would represent OR, ER, etc. (unless of course, they requested it to definitely transfuse; but then if that were the case, you wouldn't be getting it back and it wouldn't be an issue, right)? :tongue:

Brenda Hutson

So, just being the devil's advocate here, what if you issue a cooler with a unit to transfuse and due to some complication, the unit is not transfused and returned to the blood bank in 1 hour? That unit should have been maintained at 1 - 10C. But if I send a cooler to the OR for one hour, that unit must maintain 1-6C. I suppose it all comes down to timing. For example "Any blood returned in a cooler after ____ minutes must have maintained 1-6C. Hmmm... will we ever figure out these coolers?

I also use the Credo coolers and validated them for 20 hours at 1-6C.

Yep, it does all seem like an exercise in futility sometimes! At the very least, illogical. And I guess "we" will only figure it out when the regulatory agencies figure it out;then establish (in writing) more precise, uncomplicated and straight-forward guidelines/regulations on the subject.

Brenda

So, just being the devil's advocate here, what if you issue a cooler with a unit to transfuse and due to some complication, the unit is not transfused and returned to the blood bank in 1 hour? That unit should have been maintained at 1 - 10C. But if I send a cooler to the OR for one hour, that unit must maintain 1-6C. I suppose it all comes down to timing. For example "Any blood returned in a cooler after ____ minutes must have maintained 1-6C. Hmmm... will we ever figure out these coolers?

I also use the Credo coolers and validated them for 20 hours at 1-6C.

I'm not sure the regulatory agencies are capable of writing any rule clearly or concisely..

As Meatloaf said, "You took the words right out of my mouth" (and we are about the same weight - or we were about the same weight - he's slimmed down)!!!!!!!!!!!!!!!!

DeeMc, I would adhere to whatever rule applies to whatever cooler you are using. If you are using an OR cooler that is designated 'temporary storage' then units need to be kept at 1-6 even if they are returned within an hour.