Coolers and Temp. Monitors

[Brenda K Hutson]

I previously posted a Thread asking about the different types of coolers everyone uses, as well as frequency of validation. I appreciate your feedback and wanted to share some of the information I gathered when trying and validating various products.

I have previously used the Cell Safe Coolers (and liked them, but am hearing rumors that they will not be around much longer??; need to take time to look into that more) but had just been using Igloo coolers with bags of wet ice at my current Hospital (only here for 2 years). I prefer a system where there is not a variable with the coolant (i.e. different people putting different amounts of ice in the bags vs. freeze bottles, etc.). Then there was the concern of short-term storage as defined by the FDA.

So, I purchased some of the Credo Coolers others mentioned, as well as some Safe-T-Vue 6 monitors (currently using Safe-T-Vue 10). We use coolers in a number of ways: In-house (OR, ER, L&D); send to Outpatient locations for transfusion, and transfer to the new Hospital we acquired if there is an urgent need. So, the way I see it, we are dealing with a number of scenarios: Short-Term Storage (in-house; so per FDA, 1-6C), and shipping (Outpatient locations and other Hospital) if I understand the criteria as it is now being discussed.

1. Credo Coolers: The "cons" as I see it are that though they are supposed to hold 4 units, I was never able to "squeeze" 4 units in there, and have the lid to the TIC be on tightly; and the preconditioning of the TICs (though if you keep enough in stock and take the time to get a system in place such that you can store some preconditioned TICs in the refrigerator while others are in the freezer, it can work). The Pros are that it is more standardized (vs. bags of ice) and seemed to hold the temp. really well. I am thinking we will start using these for our short-term storage needs (though I will be glad when they come out with the larger model one of you said is in the works).

2. Safe-T-Vue 6 Monitors. I was really afraid to use these because it seems that at times, the

Safe-T-Vue 10 Monitors can be so sensitive (i.e. depending on room temp., and how many units you are taking time to Issue in the computer, which are then warming up; we have addressed this with refrigerated coolant packs on which we sit the units which will go in a cooler, while Issuing them). While I can honestly say that I was pleasantly surprised that NONE of the Safe-T-Vue Monitors changed colors (even in the igloo coolers with ice, monitored for 6 hours), the biggest disadvantage is that they have to be placed on the units in the refrigerator, ahead of time, prior to being activated (opened up and snapped closed). I am drawing a blank now (writing this from home) but it is either for 45 minutes or an hour that the monitors must be on the units, in the refrigerator, before you can use them. This certainly is NOT user-friendly for urgent situations! I am not sure how we are going to deal with that issue. I have used the other temp.monitors out there but I don't like any of them as well as Safe-T-Vue.

Sorry for the long e-mail; just wanted to share.....

Brenda Hutson, CLS(ASCP)SBB

[Antrita]

We use the Red Shield coolers with a validator. It takes temps every 2 minutes. They are from International Wizards. We have small satellite hospital where we do outpatient transfusions. These coolers are heavy (on wheels though), but work really good. Sometimes I don't get them back for 48 hours and the temperature is still good.

Antrita

[swede]

Brenda, we just received some safety vu-6 to try out. We are also scratching our heads with this business of having to put them on the blood an hour before activation. We are trying to figure out a way around this because we rarely know an hour ahead of the time that blood will be going in the coolers. We also send blood to a monitored refrigerator in the OR, but we have to use the monitors on units there because OR cannot always be trusted to leave the units in the frig.

We willl be using the cold packs while we issue. One of my techs is going to call Williams lab and see what they have for suggestions and maybe reasons why these monitors are treated so differently than the 10's

Good luck! Judy

[L106]

Brenda & Swede -

I appreciate this information that you are sharing with everyone. Please continue to let us know how your efforts progress and any helpful new info you discover.

[Antrita]

I did forget to mention with the red shield coolers the cooling element needs to sit out on a counter for about 20 minutes. This is not a problem for our outpatient transfusions. We did decide not to use them for OR trauma packs as this 20 minute wait was not acceptable.

Antrita

[PHYLLIS]

Hi Brenda,

I just recently validated the ThermoSafe coolers and the HemoTemp 11 temperature indicators. They both worked great. The HemoTemp 11 indicators have to be heat activated for 60 seconds. I use the MTS gel incubator. Then remove it from the incubator and let stand at RT for 60 seconds until the indicator turns blue and put it on the refrigerated blood bag. That's it!

Phyllis MT(ASCP) BB Sup.

[mawomack]

We opted to use the blood suppliers blood boxes. We validated shipping/receiving. This process should be re-validated annually. this is a good question for AABB "ask the experts"

[lwalton]

Am I the only person out there who has trouble reading the Safe-T-Vue monitors? No, actually I know I'm not the only one, because my entire staff had trouble with them! The brochures show a very clear white and a very vibrant red, but all we could see were shades of pink! We thought they would be the perfect indicator...available in 6C or 10C, non-reversible, etc., but we weren't happy with them so are now looking at HemoTemp II and temperature data loggers.

[adiescast]

Am I the only person out there who has trouble reading the Safe-T-Vue monitors? No, actually I know I'm not the only one, because my entire staff had trouble with them! The brochures show a very clear white and a very vibrant red, but all we could see were shades of pink! We thought they would be the perfect indicator...available in 6C or 10C, non-reversible, etc., but we weren't happy with them so are now looking at HemoTemp II and temperature data loggers.

We found the Hemotemp II indicators to be difficult to read. Their color change is a little too subtle. We saw alot of muddy brown.

Essentially with the Safe-T-Vue monitor, anything that is not red did not exceed the 10 C limit. We discovered this when we did validation. We also discovered that they stay white better if you are careful not to press on the middle of the indicator while applying it and you apply it quickly after removing both the blood and the indicator from the refrigerator (we do not even lay the indicator on the counter at all; if we have to set it down, it rests on the unit.)

The data loggers are probably going to be easier to interpret since they give you actual temperature readings. The expense will have to be considered against the ease of use. I have considered using those in coolers that go to OR. The problem there is the logger measures the temperature of the cooler and not the individual unit. You still would not know if a unit leaves the cooler, sits out for awhile, and then returns to the cooler.

[Brenda K Hutson]

Hi Brenda,

I just recently validated the ThermoSafe coolers and the HemoTemp 11 temperature indicators. They both worked great. The HemoTemp 11 indicators have to be heat activated for 60 seconds. I use the MTS gel incubator. Then remove it from the incubator and let stand at RT for 60 seconds until the indicator turns blue and put it on the refrigerated blood bag. That's it!

Phyllis MT(ASCP) BB Sup.

Are the HemoTemp Monitors the ones with flowers? If yes, I did use them in another place but did not like them as well as Safe-T-Vue.

If there are any other types out there, I would love to know about them.

I also have a couple of new ThermoSafe Coolers to validate (I have used them before and like them; I tried Credo because of the new 1-6C required for short term storage, and long spine surgeries; these coolers are supposed to be good in both of those areas).

Thanks for the info.!

Brenda Hutson

[lwalton]

Has anyone tried using the Traceable infrared thermometer for taking temps on red cell units returned in the coolers?

[Brenda K Hutson]

Am I the only person out there who has trouble reading the Safe-T-Vue monitors? No, actually I know I'm not the only one, because my entire staff had trouble with them! The brochures show a very clear white and a very vibrant red, but all we could see were shades of pink! We thought they would be the perfect indicator...available in 6C or 10C, non-reversible, etc., but we weren't happy with them so are now looking at HemoTemp II and temperature data loggers.

Well, there are some things you can do to better ensure success (discovered during different episodes of problems myself over the years):

1. Best to put monitor on while unit is in the refrigerator. So after Issue, return unit to refrigerator first.

2. Just apply to unit initially; then wait a couple of minutes or so to activate them (close them)

3. When you have the Units our of refrig. to Issue, place the units on refrigerated coolant packs; the units must be

< 4.5 (I think) when the monitor is applied.

4. Do not touch center of monitor when closing.

5. Read Instructions carefully and follow any recommendations they give you for success!

Brenda Hutson, CLS(ASCP)SBB

[Brenda K Hutson]

Has anyone tried using the Traceable infrared thermometer for taking temps on red cell units returned in the coolers?

Question: Does that mean it is in the cooler at all times and that you can "trace" the temp. for all of that period of time (sorry, may sound like a silly question, but I am not familiar with them at all). I only ask because just taking a temperature on units when they are returned, does not account for the temperature ranges that may have taken place when they were out of your control. That is why the use of irreversible monitors.

Brenda Hutson, CLS(ASCP)SBB

[jfboyer]

I have been working what feels like around the clock to get a new cooler system established. I have a system that will allow 2-6 units to stay 1-6 degrees C for 8-12 hours depending on how many units are in the cooler, (which they should never be away for that long.) We have always used the safe-t-vue 10's but are switching to the 6's. Does anyone else have any concerns about using the safe-t-vue 6's? We are a level 1 trauma center and have trauma frequently. I am a little concerned that we might have to waste some units because of any defects with the safe-t-vue 6's, which would be expensive. I like the idea of using gel packs at 2-4 degrees C, but has anyone noticed any problems on the OR/ER side of using your cooler systems? Thanks for all the info!

[R1R2]

Hi everyone,

If your coolers are validated to keep temp at 1-6 C why put a Safe-T-Vue 6 on them? I think a wiser choice would to put a Safe-T-Vue 10 on the units. A color change of Safe-T-Vue 10s will occur if units are removed from the validated storage cooler by the patient care area and then replaced some time later. The use of Safe-T-Vue 10s on units stored in validated 1-6 C coolers will alert the blood banker to units that are unacceptable for reissue when returned.

Regards,

R1R2

Edited November 24, 2009 by R1R2

[Brenda K Hutson]

I have been working what feels like around the clock to get a new cooler system established. I have a system that will allow 2-6 units to stay 1-6 degrees C for 8-12 hours depending on how many units are in the cooler, (which they should never be away for that long.) We have always used the safe-t-vue 10's but are switching to the 6's. Does anyone else have any concerns about using the safe-t-vue 6's? We are a level 1 trauma center and have trauma frequently. I am a little concerned that we might have to waste some units because of any defects with the safe-t-vue 6's, which would be expensive. I like the idea of using gel packs at 2-4 degrees C, but has anyone noticed any problems on the OR/ER side of using your cooler systems? Thanks for all the info!

For the Safe-T-Vue 6, I found that my concerns with them turning red easily, were unfounded when I was performing validation. That being said, I followed the more conservative instruction of applying the monitor in the refrigerator and activating it for 1 hour before placing it in the cooler. Pre-Activation however is not a luxury that we have MOST of the time. It can also be activated immediately (and I still need to validate that process); don't know if that will create more problems with monitors turning red. Insert says the units should be < 4.5C before applying the monitor (and we apply it in the refrigerator).

In the comment by R1R2 that is asking why you need temp. monitors if the coolers are validated, here is my response:

1. We are now required to ensure the units are 1-6C when in Storage (which a cooler waiting for transfusion is now considered).

2. Temp. monitors are placed on units to "ensure" that temperature is maintained given the fact that the units (and cooler) are out of our site and the OR can (and DO) remove the units for an inappropriate amount of time, causing them to go outside of the acceptable range. If you are trusting your OR to not do that, and/or to always be honest with you if it comes back with a RED monitor and they say they didn't do it, you have been more fortunate than I have in 6 different Institutions; I have seen and heard it all!! So if we are saying it has to be 1-6C, we must confirm that this is what it stayed. The cooler validation just gives us the knowledge of how "long" we can expect them to stay at that temp. Putting a Safe-T-Vue 10 monitor on units which you are trying to confirm stayed between 1-6C, does not make sense to me. It leaves an "unknown" area from 6-10C.

Brenda Hutson, CLS(ASCP)SBB

[clmergen]

I am with R1R2 and have changed my procedures to reflect that. I am validating the storage coolers to 1-6C as required. My concern is with units that are removed from the cooler. If they are removed from the cooler then they must be returned to the Transfusion Services before they warm to above 10C. The Saf-T-Vue 10's cover that.

[Brenda K Hutson]

I am with R1R2 and have changed my procedures to reflect that. I am validating the storage coolers to 1-6C as required. My concern is with units that are removed from the cooler. If they are removed from the cooler then they must be returned to the Transfusion Services before they warm to above 10C. The Saf-T-Vue 10's cover that.

So I am confused about the rationale you are both using.

We validate a cooler so we know what it can do, "if" the Units are kept in there. We put temperature monitors on units because we know they are NOT always kept in there; if we just trusted everyone, we would never have needed temp. monitors in the first place.

And if the required temp. is 1-6C, a 1-10C monitor coming back white does not prove the unit(s) was never between 6-10C (which would then be unacceptable).

Anyway, that is just where I am coming from.

Thanks,

Brenda Hutson, CLS(ASCP)SBB

[JOANBALONE]

Hi Brenda,

Do you tell the OR staff to look at the Safe-T-Vue before transfusion? If it is red do not transfuse...

JB

[Brenda K Hutson]

Hi Brenda,

Do you tell the OR staff to look at the Safe-T-Vue before transfusion? If it is red do not transfuse...

JB

Yes, but again, I have been around (26 years in Blood Bank only; 6 Institutions) and I have truly seen and heard it all (including falsification of records in the OR; not my current Facility).

And again, if we trusted everyone to do that, why use temperature monitors in the first place?

Brenda Hutson, CSL(ASCP)SBB

[adiescast]

How's this for the logic of validating coolers to 1-6 and using the Safe-T-Vue 10 - when the blood is in the cooler, it is "being stored" and must be between 1-6; when the blood is taken out of the cooler, it is not being stored and can be 1-10? The whole transport versus storage thing is rather arbitrary and at this point, AABB and FDA do not see eye to eye on the issue as far as I can tell. If you issue a unit of blood to the nursing area without a cooler and it is returned, do you expect it to be between 1-6 or between 1-10 on return?

[clmergen]

Adiescast, that is EXACTLY the reasoning I was using. And as I told my AABB assessor friend, that is my story and I am sticking to it.

[nmpoupard]

The HemoTemp II indicators need to be activated at or above 38 degrees. The MTS gel incubator is lower than that level. Has that been a problem? The heat block sold for use with the HemoTemp II recommends a temp range of 38-42 degrees for activation.

[jfboyer]

i understand both sides of what you all are saying. and thanks a lof for all the input. i have thought about putting both temp monitors on a unit at the same time. here are my concerns:

i would hate to quarantine a unit of blood because it is 7-9 degrees. that being said, this is why i would agree with using both temp monitors. however the idea for the temp monitor is the ensure that or/er are following procedures and properly handling blood products. (its not like we are asking them to much) we require or/er to have the blood in the cooler 100% of the time. the moment if leaves the frig, we do a couple mins of computer work then place them in the cooler. the only reasons they should leave the cooler is to be checked to ensure its the right blood product for the right patient or to be transfused.

so what do you do when a unit come back with the safe-t-vue 6 red and the 10 white? this of course raised concern and the or/er practice with handling blood products, but to me its raises the same concern as if a safe-t-vue 6 turned red. i would still need to investigate, troubleshoot, whatever else, and quarantine the unit. if or/er is setting units out for 30-45 mins and the safe-t-vue 6 is red and the 10 is white, the unit will still need to be quarantined. thats not what we validate. so to me by having both temp monitors on the unit, and one of both turning red you are going to have the same outcome as if having just the safe-t-vue 6 on the unit and it turning red.

this is a good debate though and im still a little up on the wall about the issue so keep it coming!

[PHYLLIS]

We purchased the Thermosafe Coolers and Hemo-Temp II temperature indicators. Everyone in the hospital is very happy with our procedure. It has only been active for a few months now but, so far so good.

Phyllis