AABB and FDA clearly define the storage (1-6 C) and transport (1-10 C) temperatures for blood products. We have many (30+) coolers that we have validated can hold a temperature between 1-10 C. Most of them will not reach a temperature below 6, and those that do usually only hold it for a couple of hours.

Previously we had considered these products to be in transport; however, I will agree it is more appropriate to consider them often being used for storage, especially in the OR when they may remain there for many hours.

Does anyone have a cooler they have been able to validate that maintains a temperature of 1-6 C?

We did a cooler validation last year. When I go back to work tomorrow I'll look for it.

Problem is the time at which the units stay at or below 6 C. We could get 4 hrs at or below 10 C, but only 1 hr below 6 C.

Bummer ....

Problem is the time at which the units stay at or below 6 C. We could get 4 hrs at or below 10 C, but only 1 hr below 6 C.

Bummer ....

We have the same problem, we can get them (Igloo) to validate under 10 for at least 8 hours, but under 6 is about 1-2 hours, and some won't do even that good.

We still have a few "old" blood coolers in the lab, unfortunately we don't have the ice blocks for them. They are large with an orange lid and hold at least 6 units. They have an insulated cover that is sealed when closed.

We are looking for a similar type cooler, one with an insulated cover that actually holds the temp. Does anyone know of a vendor for these?

ThermoSafe has some models. They were developed mainly for vaccine transport. We got several large ones a few years ago - we validated them for 1-10 for 72 hours. However, they are large and cumbersome. ThermoSafe does have a smaller model I'm looking at to replace.

The last AABB inspection we had, we went round and round with this same issue. My view is they are transport boxes - to me there is no difference in putting units in a cardboard box to ship 2 days across the country and putting units in a cooler to ship to the OR. To say there is a difference based on whether the box sits in the OR or the belly of a plane is illogical.

AABB did not cite us.

Kate,

I agree with you, that's why we've been doing it this way for all these years; however, the January 2006 AABB Assessor Newsletter contradicts us.

In the "Ask the FDA" session that was featured at the 2005 Annual Meeting in Seattle, the FDA representatives clarified issues of interests. One interesting topic was the FDAs stance on temporary storage temperatures vs. transport temperatures. The 21 CFR 600.15(a) refers to shipment and states that blood being transported (e.g. hospital to hospital) should be maintained between 1˚C - 10˚C. However, blood being stored in a temporary location or in a temporary vehicle (i.e. cooler) for the intent, or the potential intent of storage should be stored at 1˚C - 6˚C (e.g. use of a cooler to take blood to the operating room because there is no refrigerator is considered temporary storage).

We send out igloo coolers, with a maximum of 8 units of RBCs or 10 units of thawed plasma. We wrap the products in bubble wrap, put them into the plastic basket that comes with the cooler, put in 2 freezer packs - one on either side of the basket. We place one refrigerator pack in front of the basket.

This packing configuration has been validated and can maintain a temperature not to exceed 6 degrees for up to seven hours. We put a maximum time out at 6 hours, where the highest temperature reached is about 5.5 degrees.

I have to say our QC person worked very hard to find what worked here. We actually had some trouble initially with the temperature going too low, until we perfected the right balance of freezer and refrigerator packs.

This is a major problem for every blood banker I've talked to !!

I wonder if we can get that "clarification" in writing from the FDA ...

We use the Cell-Safe igloos (ISC) packed as per manufacturer's instructions:

3 plastic Freezer Bottles stored in a freezer between -10 and -20 C for a minimum of 24 hours - one at both ends of the igloo and one along the wall. We place up to 6 units of blood inside of the plastic tray/tub along with a thermometer. Then we put a large Polar Gel Pack (from the 1-6 C refrigerator) over the top of the blood units in the tub. We have validated each igloo to maintain a temp of 1-6 C packed like this for up to 6 hours (they actually are OK longer than that, but we set the 6 hour limit so that surgery, the ED or PICU have to return the igloo for re-packing with new freezer bottles if they want to keep the igloo out longer.)

The Cell-Safe igloo system comes with the freezer bottles and the plastic tray/tub. They also come with the manufacturer's validation report, but then of course, you need to do your own validations as well. For the packing method we use, you cannot keep the freezer bottles in your plasma freezer... it freezes them too cold and takes the temp too low in the igloos, so we purchased just a regular inexpensive upright home-type GE freezer for the bottles. We've numbered each igloo and it's 3 corresponding feezer bottles, so that we know to check the igloo issue log and not to re-use that same igloo with the same freezer bottles for at least 24 hours from the last time it was returned. We keep several sets of frozen "back-up" freezer bottles in case we cannot wait the full 24 hours before re-issue of that igloo.

Note: we also attach HemoTemp II indicators to the units so that we can verify that the units were not removed from the igloo and warmed to 10 C.

We use some cheap, small coolers, some are Igloo, some are Coleman for RBC storage in ER & OR. We have been able to "validate" them as holding 1-6 for 24 hours. (I guess we got lucky!) This was in the BB and not typical for the OR or ER settings.

So, we only let OR keep them for 6 hours without re-icing (they rarely have a case go longer anyway.)

We re-validate every 6 months.

If you pack the cooler with ice below and above the blood/FFP - the temperature remains between 1-6oC. We validated this for a 12 hour period. Be sure to have barriers between the ice bags and the component - we use bubble wrap. We were never able to maintain a temperature range of 1-6oC with only one layer of ice.

When we performed our validations, we did them with empty coolers. If we place two dummy bags filled with 10% glycerol, then they validate just fine!

When we issue the coolers they always have a dummy bag with a temp indicator, and at least one unit of blood. So this is our process.

Apparently the blood acts as a temperature buffer.

We use ISC BC-15 coolers for our OR "storage". Theses coolers will maintain 6 units of red cells at 6 C. for 12 hours. We have ~25 coolers and our only challenge is the storage and rotation of the coolant bottles.

We did a cooler validation last year. When I go back to work tomorrow I'll look for it.

Did you locate your cooler validation? Would you be willing to share how you went about validating your coolers?

YES and I have just finished validating them. They are "ISC Custom Cell Safe BC-15 Blood Transporter for hospital transport and operating room storage of units of red blood cells." The maximum load is 1500ml (6 x 250ml). Manufacture instructions must be followed but they hold 24 hours @ 1-10 C and 6 hours @ 1-6C.

My validation showed 1-6C for 8 hours which is plenty of time for surgery or c-section, I would hope. We have a monitored refrigerator in our ER and OR, the coolers are used for labor & delivery.

What about recording the temp every 4 hours since the cooler is used for storage?

Do you use temp indicators?

What do you do to revalidate every 6 months?

Do you do a trial on each cooler in use or summarize data from the 6 month period?

Sorry to be responding so late to this thread. After over a year of investigating and validating, we found a cooler that will hold the temperature of red cells, up to 10 per cooler between 1-6 C for 24 hours. We actually have data for up to 72 hours but implemented 24 hours. Part of the solution is the use of "wet ice", flaked ice from an ice machine. The frozen "blue ice" containers we formerly used in the rubbermaid coolers just doesn't have the same heat exchange properties as does melting ice at 0 C.

The coolers are a cube about 14 inches per side. They are called Smart shippers and run for over $300 each. We also needed to purchase an ice flaker for the OR satellite blood bank dispense station. But with the wastage of red cells in the OR that we were experiencing, these coolers will pay for themselves in less than a year. The use of blood in coolers for the OR is mainly for major heart cases as well as liver transplants. If anyone is interested in more information on the coolers, I can refer to the manufacturer, I can send pictures of how we use them, etc. In fact I have a whole power point that I used to inservice the OR staff.

We consistently validate our transport coolers to house up to 6 units of packed red cells for a period of 6 hours. It is our current policy to have there products returned to the Transfusion Service no more than 4 hours after their release.

For Ann Viernes:

I would love to have more info about the cooler set-up you use. Would you be willing to share the PowerPoint as well? What a great idea for staff training. Has it been a successful tool for training purposes?

For the moderators...Perhaps a new forum area with Powerpoint presentations that people would be willing to share would be a great idea for this forum...

Ann, here is my fax (813) 634-0127 and email sandra.rothenberger@hcahealthcare.com

As for my own views I too find it ridiculous that you can ship blood for 24 hours (or more)across the country at 1-10C but I can't keep it in our surgery for a couple of hours at the same temp range. I have not yet "officially" changed my temp range on my procedure but am contemplating it. I validate the two igloo coolers (rarely used) every 6 months and did come up with a configeration that seemed to work at 1-6C. I use frozen gel coolants with a plastic barrier between the blood and the ice packs. I think regular ice above and below would work better, but it would have to be obtained from the hospital cafeteria and would not be as convenient. I imagine I will change my procedure this year to comply...

Question:

If blood is considered stored in the cooler in O.R. do you have to provide continuous monitoring of the temperaure? I was told yes by one AABB assessor.

I have tried the Temp-Tail and could not maintain a constant reading. Just was too sensitive.

Now, I place a thermometer in the cooler, in glycerol, and require them to take and document the temperature every hour. In addition, I use the Hemotemp. The temperature is maintained between 1 and 6 degrees when taken with the thermometer. What are your thoughts on this satisfying this standard?

Thanks, MWL

I am searching for following information. It will be helpful if anyone could tell me their experience

1) Who manufactures plasma blast freezer?

2) Could you please suggest me one which you think is the best?

Thank you very much for your time

Rao

We use igloo coolers, validate them every 6 months using expired autologous units we hold onto for just that purpose, and attach temp indicators to each unit we pack. We typically only send 2 units at a time. It seems to works well, but our new OR director and my own director are not comfortable with it, so we'll probably have to stop.

I have never had an inspector ask me specifically about them, but if they do, I will, with a straight face, refer to them as a transport device.

E-Z Carry Alls from Cheklab,Inc. 630-896-0574 with their U-Tek Refrigerant Gel Packs.

We do not use coolers. We eliminated them in favor of portable, wheeled, refrigerators. Whatever you use for this storage/transport, however, will require some method to record the temperature q4 hours. This question has started comming up with the AABB and the FDA and the requirement to track temperature a 4 hour intervals is NOT dependent on what it is stored in or the transit/storage issue. Blood centers typically use data loggers for this task, but there are other mechanisms available.

A single, portable refrigerator is a several thousand dollar investment but we now are up to eight units in our blood bank. They have eliminated so many other issues connected to using igloo coolers and wastage/tracking that they have been more cost effective in the long run. Certainly more money at inception, but less time and monkey business on an ongoing basis translates as a substantial savings. Jewette and GEM both offer models that will work quite well.