Does anyone have a cooler validation protocol to share? If the coolers are used for storage vs. transport, do you require temps of 1-6C or stick with the 1-10C range? Also do you validate each cooler or just one of each size cooler?

We validate one of each size/brand. Our coolers are just for transport so we use 1-10C. We also make sure the ice packs have a standardized weight. We check the coolers over a 12 hour period (hourly) using expired units to test the coolers. We buy the thermometers in the bottles as we were getting too much breakage with thermometers in plastic bags. We also have room temperature coolers (20-24C) for platelets, usually for the storage in the O.R.

We perform QC on each of our coolers twice each year - once in winter and once in summer. We use a commerically available temperature device to tag each unit we place it teh coolers. We use them for transport/storage to the OR and to the ED -- we have had really good results with this process.

We use coolers for Transport (requiring temperatures between 1C-10C) for our outreach centers Transport boxes are calibrated for 4-8 hrs at the required temperatures or Storage (requiring temperatures between 1C to 6C) for our ER, OR, ICU designated areas. Our boxes for Storage are calibrated to ensure 8 hrs at the required temperatures.

Our calibrations are performed quarterly on all boxes for transport/storage.

We use the thermometers in a bottle containing 10% glycerol in water for in-hospital boxes and use Hemotemp Stickers on units when sent in boxes to our outreach areas. We fill out a log form and place it in the box form holder each time a box is ready to issue, noting the patient, MR#, etc.

We had completed a in depth validation study on coolers including boundary testing. If you would like I could see if our customer would be willing to share that information assuming that you are using the same cooler and loading technique.John Dozier

www.stiservice.com

We validate each cooler once a year. Each cooler is numbered.

We monitor the temperature for 6 hours using 10 units of blood and a volume of wet ice equal to 10 units.

We use coolers for transport and storage.

We put temperature indicators on units sent that will be stored.

We use a thermometer with a probe- probe inside between two units and temperature unit outside of cooler for temperature monitoring during re-validation

I validated each cooler but then we do quality monitor periodic check of coolers twice a year so that all coolers get checked annually.

You must pack our coolers per manufacturer instructions. There are specific instructions for "conditioning" of coolants. The instruction say to freeze at certain temperature for the frozen pack(s) and to refrigerate other packs. If you e-mail me I will send you the validation.

I also am validating a small temperature data logger that records temperature and downloads this to a PC for chart output. That way we can verify the storage of products not in our control. The problem has been that it is sensitive and we need to educate nursing not to take the logger out of the box or cooler when they remove the products. We see spikes on the charts where with regular thermometers they take ~10 minute ti change so you don't see the spike when they open the box/cooler.

I validated each cooler but then we do quality monitor periodic check of coolers twice a year so that all coolers get checked annually.

You must pack our coolers per manufacturer instructions. There are specific instructions for "conditioning" of coolants. The instruction say to freeze at certain temperature for the frozen pack(s) and to refrigerate other packs. If you e-mail me I will send you the validation.

I also am validating a small temperature data logger that records temperature and downloads this to a PC for chart output. That way we can verify the storage of products not in our control. The problem has been that it is sensitive and we need to educate nursing not to take the logger out of the box or cooler when they remove the products. We see spikes on the charts where with regular thermometers they take ~10 minute ti change so you don't see the spike when they open the box/cooler.

We need to revalidate our coolers, as now we understand that they are considered to be storage, not transport. Our coolers won't keep the blood cooler then 6 degrees when packed according to our protocol. We use 10 units and wet ice in our validations. Any suggestions?

We are considering using the Insul-ice instead of wet ice. Have you heard anything about the success of this coolant?

When validating your coolers several things should be considered when testing. The coolers should always be loaded with the same amount of mass. For example if you load the cooler short by 2 units of blood something like a gel pack needs to take up the volume. Secondly you should be testing your coolers in the worst case upper and lower temperatures. Different loading methods should also be observed. Stacking the units differently has a impact on the results. Once you have completed your test then whatever type and brand gel packs are used during the test should be used in the field since some are more dense, etc.

Does anyone have a cooler validation protocol to share? If the coolers are used for storage vs. transport, do you require temps of 1-6C or stick with the 1-10C range? Also do you validate each cooler or just one of each size cooler?

I use the HemoTemp device that is attached to each unit of blood before it is placed in a cooler with ice. Each unit is monitored, continuously, between 1 - 6 degrees. If the unit exceeds these ranges they are discarded. Each lot number of Hemotemps is validated when recieved.

Although expensive, you are monitoring units for the duration they are stored on ice and out of your control. You cannot monitor a thermometer 100% of the time. If you choose this method, I don't think you need to validate coolers on a scheduled basis. I would validate them when placed in service.

Hope this helps and welcome any replies.

MWL

The HemoTemp II that we use become irreversible at >10oC but between 6 & 10 there is no permanent change. Which HemoTemps are you using?

The HemoTemp II that we use become irreversible at >10oC but between 6 & 10 there is no permanent change. Which HemoTemps are you using?

We also use the HemoTemp II with a range of 1-9oC that is activated above 9o, howvever, it is not monitored if the unit is cooled below 1oC. Are you aware of any devices that monitor units (not electronic or digital recording) below 1oC? Also, since you use the HemoTemp II, do you validate your coolers on a scheduled basis?

Quite frankly, with the safety issues we are facing today I am considering removing them from practice. Remember the day refrigerators were in the O.R.? Not a common practice today that I am aware of. What are your thoughts on coolers in the O.R. and safety?

Thanks, Mark

We also use the HemoTemp II with a range of 1-9oC that is activated above 9o, If it is stored below 1.C no temperature will be highlighted indicating it went below 1oC. In either case we would discard the unit(s). Also, since you use the HemoTemp II, do you validate your coolers on a scheduled basis?

Quite frankly, with the safety issues we are facing today I am considering removing coolers from practice. Remember the day refrigerators were in the O.R.? Not a common practice today that I am aware of. What are your thoughts on coolers in the O.R. and safety?

Thanks, Mark

Updated

See update

Safe-Vue will soon have available a temp monitor with a range of 1-6C. They currently have one that monitors 1-10C.

Where can I find the procedure for the validation of a cooler? We have never validated our coolers before and from what I'm reading it's a pain. I understand that they have to be validated 1-6 C if sent to OR for storage and that's our primary use. Thanks for your time and help. Tony R

If you are evaluating the HemoTemps or other indicators when the products come back to you, just use the previously mentioned data loggers. If the temp went above 10 or below 1, it is plain as day on the graph.

Course, if the end users are doing the evaluation this isn't of much use...