My facility needs to validate coolers to use in the transport of red cells to the OR and other critcal areas. If I have 10 cooler (all are the same manufacturer) do they all have to be validated or could I just chose 1 of each size? Also, I'll appreciate any other suggestions that anyone might have in writting a validation procedure. Thanks

I do not have a validation procedure for cooler validation; however, I have validated a lot of coolers, mostly Igloo coolers.

For the most part they all respond similarly, but every now and then we get a bad one that won't keep temp no matter how hard we try.

I'd propose to validate each cooler individually.

We validate new coolers on receipt.

If they respond just like the others, then we enter them into the rotation and do half each quarter, so each cooler gets checked twice a year. Some coolers seem to hold temp a bit better than others, but we strive for a minimum hold time, instead of "calibrating" each cooler.

If one doesn't behave, we would have to decide what to do with it.

Not sure what I'd do if I worked at a large site with a room full of 'em ...

Not sure what I'd do if I worked at a large site with a room full of 'em ...

We have many, let's say about 30 in use. A concern I have is revalidating them. We only validate them before initial use. How many do you have?

Well, at the moment we only have 10 but will be purchasing more in order to cover all of our OR's as well as ER. We should have about 30 or so. I also have another question to all, What is actually better to use gel packs or regular wet ice? My experience has only been with wet ice but I am considering using the refrigerated gel packs.

Does anyone know if the coolers have been pre validated by the manufacturer for the transport and storage of red cells would I still have to validate in house or does yearly QC suffice.

Does anyone know if the coolers have been pre validated by the manufacturer for the transport and storage of red cells would I still have to validate in house or does yearly QC suffice.

Yes, the coolers had been validated by the manufacturers, but you have to do your own validation. In our hospital we set it up for twice a year validation.

Yes, the coolers had been validated by the manufacturers, but you have to do your own validation. In our hospital we set it up for twice a year validation.

Carefully read the documentation that comes with pre-validated coolers.

I suspect the "process" has been validated, and not each individual cooler.

We only have five coolers but will probably be purchasing more. We validate the coolers every 6 months. We use a Onset HOBO with Boxcar Pro software to monitor temperature in the cooler every 1 minute for 24 hours. Once the HOBO is downloaded you can use it to produce and graph to illustrate the slow rise in temperature.

Our coolers can be packed with 4 units of blood and we pack according to the manufacturers recommendations. (3 square ice boxes with at least 2 refrigerated gel packs) They will usually hold their 1 to 10 C temperature for a whole 24 hours althought we require their return within 8 hours to avoid the search for the missing cooler. At this point, the coolers are used for traumas and surgery only. The staff are very good at calling for the return of the cooler at the 8 hours mark. The surgery staff are good about bringing it back for repacking if they want to keep it longer.

In addition to the thermometer in the cooler each bag has a Hemotemp attached. We used the Safe t Vue dots for awhile but they fall of the units very easily.

I hope this input helps.

We only have five coolers but will probably be purchasing more. We validate the coolers every 6 months. We use a Onset HOBO with Boxcar Pro software to monitor temperature in the cooler every 1 minute for 24 hours. Once the HOBO is downloaded you can use it to produce and graph to illustrate the slow rise in temperature.

Our coolers can be packed with 4 units of blood and we pack according to the manufacturers recommendations. (3 square ice boxes with at least 2 refrigerated gel packs) They will usually hold their 1 to 10 C temperature for a whole 24 hours althought we require their return within 8 hours to avoid the search for the missing cooler. At this point, the coolers are used for traumas and surgery only. The staff are very good at calling for the return of the cooler at the 8 hours mark. The surgery staff are good about bringing it back for repacking if they want to keep it longer.

In addition to the thermometer in the cooler each bag has a Hemotemp attached. We used the Safe t Vue dots for awhile but they fall of the units very easily.

I hope this input helps.

Mirage,

Which Onset HOBO model do you use for your coolers? I like the idea of checking coolers with continuous monitoring and recording, but looked at coolers that came with their own temperature recorders at a cost of $1000 per! Not what I want to pay for coolers that get beat up during traumas and transport! I'd like to investigate HOBO as an alternative. With the differences between transport and storage temps, I'd like to know timeframes for both activities by cooler.

We use ACR Smart Button data loggers. They are about the size of nickel but thicker. I got them online from the Data logger store. Here is the link:

http://www.microdaq.com/acr/smartbutton/smartbutton.php

We use Igloo coolers and validate each cooler upon receipt.

We also use Hemotemp stickers on RBCs, when packed on ice.

Each cooler issue is recorded on a dry erase board with the cooler#, date, time, destination and patient ID.

Can you tell me which one of the Igloos you use. I found the picnic ones on line.

Thanks

Liz

We use the ThermoSafe BC15 Blood Transport Coolers. The SmartButton Temperature Logger System looks pretty pricey! We only have 4 coolers currently. How do you justify the cost?

We use the collers from Chek-Lab.

Do you have a website address for Chek Lab? On Google I just get a bunch of links with information about them, but no direct URL.

Chek-Lab company info: cheklab@xnet.com; 630-896-0574 in Aurora, Il.

Do you have to validate coolers when dry ice is used? We are dispensing bone and tissue and have no control if products are removed from the cooler. How can I make sure that the product is used approriately!

We have 5 coolers and we validate each one separately. We have an aliquot bag filled with saline and then refrigerated that we use. That is if we can't get our hands on an expired autologous unit. We like those better, they are more indicative of what we put in there.

Thanks Lara for that. Then how do you check the temp of the saline or blood unit? Do you use the stickers? or thermometer in the igloo? or other means.

Thank you

Liz

We have a regular thermometer that comes out of a glycerine bottle that we put in it and seal it.

We use the Igloo-made coolers from Market Lab and validate yearly with 3 chests, one minimally packed, one maximally packed and unopened; and one maximally packed and one unit removed every 2 hours. I wonder what all of you consider the correct limits. If this is defined as transport, 1-10C is acceptable; if this is storage, only 1-6C is acceptable. We don't see a difference among the chests but rotate them for use and for checks anyway.

Someone asked me for our validation protocol for coolers. I'm attaching our validation results, forms for documenting quarterly QC, and Quarterly QC SOP. The validation was basically done the same as the Quarterly QC. We have 15 coolers and perform QC on 4 each quarter, therefore in addition to the initial validation, each cooler is QC'd once a year. We use FDA temperature criteria for "extension of storage" (1-6C) rather than the temp criteria for transport (1-10 C)as defined in the reference listed after the SOP. Flaked wet ice has the best temperature exchange properties and is better than cubed ice or gel packs. This is due to the increased available surface area on the flakes for heat exchange. I'm also attaching a powerpoint used for training of blood center, OR nursing, and anesthesia personnel. Hope it helps! I've removed headers and footers which contain our facility identity. If you use any of these documents be sure to add your facility ID, adoption/revision date etc.

Related to all the discussion on infrared vs other thermometers, I'll add that our SOP is not very clear on the type of thermometer used. We used a digital thermometer, NIST traceable and sent out each year for calibration. The unit has 2 wire probes on it and can take temperatures in 2 locations at once. The wire probes were placed between the units of blood and the lid closed over the wires. The lid is not opened during the 24 hours of QC testing. During validation however, we simulated OR staff opening and closing the cooler to remove and replace blood.

In the pictures you'll note that there are note cards with various instructions on them.

OK, I can't upload the power point with the pictures and training. So if you want it, e-mail me and I'll send it. <removed by admin>

Validation of the Smart Shippers 100.doc

Blue Cooler QC.xls

Cooler QC.DOC

Edited August 20, 200816 yr by Cliff
deleted email address to reduce users spam

At an ARC technical advisory meeting, someone brought up that the FDA considers coolers for the OR "storage" containers and their temp range has to be 1-6 not 1-10. They also mentioned that the temp has to be taken every 4 hours if not monitored by a chart recording device.

We have 12 Playmate Igloo coolers that are re-validated every 1-2 years or when units start to come back warm. A max of 4 units with 2 large blue ice packs that are stored in the -30 freezer are put in the cooler. Each cooler has a cardboard box for the units so they do not come in contact with the ice. I have found that the units will stay less than 10C for 7-8 hours. So the coolers are issued for 6 hours and then they must be returned to be checked and new ice if the CVOR wants to have longer. I am getting ready to test with more ice to see if we can maintain less than 6C since I have been reading that I should consider the cooler as "storage" not "transporting".