Urgent Cooler Question

[Brenda K Hutson]

I have used various coolers to send blood to the OR, in the different Institutions I have worked in. However, in trying to look for the website on 2 different types, I cannot find anything. Do these coolers still exist?

One is ThermoSafe and the other is Cell-Safe. This new Hospital opens July 12th so time if of the essence for me to place orders. If any of you have contact information for either/both of these (or any other company that uses the "freeze" bottles), please let me know.

Also, I have always used the Safe-T-Vue 10 temp. monitors. After reading a recent discussion, am wondering if the coolers for OR are supposed to store blood only at 1-6C instead of the 1-10C that probably many of us have, or still do, use. Does anyone use the Safe-T-Vue 6 Monitors? If yes, do you have any trouble with them turning red frequently?

Thanks very much!

Brenda Hutson, CLS(ASCP)SBB

[L106]

Brenda,

There have been several threads addressing blood coolers and debates about whether they are "transfer" devices (1-10 C) or "temporary storage" devices (1-6 C.) So you may want to search BBTalk for some of those discussions (& info about the Temp Dots.)

We recently wrestled with this and decided to cover ourselves for the conservative "1-6 C" requirements. So we purchased several "Credo Thermal Packaging Solution" blood coolers from a company called Minnesota Thermal Science. Their web site is www.credothermal.com . The model we purchased is called "Series 4-OR" and it uses a built-in "freeze" liner. I thought they were rather expensive, but they do work well (and were easy to validate.)

Hopefully you will get some info from other BBTalk Users about the Temp Dots and other coolers that are available on the market.

Edited June 16, 2009 by L106
Typo

[RR1]

Brenda,

There have been several threads addressing blood coolers and debates about whether they are "transfer" devices (1-10 C) or "temporary storage" devices (1-6 C.)

Why are storage temps in the US always 1-6C or transfer 1-10C, when WHO guidelines, and the UK use 2-6C (core) or 2-10C for transfers? I know this is quoted somewhere in your guidelines...but that 1'C can make a lot of difference ( especially if I would potentially have to get rid of stock if my fridge falls below 2'C)

[tbostock]

In NY state, the Dept of Health has defined coolers as "storage" not transport, so we are changing our Safe-T-Vue from 10 to 6.

[Brenda K Hutson]

Brenda,

There have been several threads addressing blood coolers and debates about whether they are "transfer" devices (1-10 C) or "temporary storage" devices (1-6 C.) So you may want to search BBTalk for some of those discussions (& info about the Temp Dots.)

We recently wrestled with this and decided to cover ourselves for the conservative "1-6 C" requirements. So we purchased several "Credo Thermal Packaging Solution" blood coolers from a company called Minnesota Thermal Science. Their web site is www.credothermal.com . The model we purchased is called "Series 4-OR" and it uses a built-in "freeze" liner. I thought they were rather expensive, but they do work well (and were easy to validate.)

Hopefully you will get some info from other BBTalk Users about the Temp Dots and other coolers that are available on the market.

I am told by someone else that uses those coolers (Credo Thermal), that the ice pack (or whatever it is called), has to be out at room temp. for a certain period of time before you can put the blood in the container or you will hemolyze the blood. How do you deal with that if you don't know exactly when OR is going to send for the blood?

Thanks

Brenda

[L106]

Brenda,

Yes, you have been told correctly. Here are the instructions (in a nutshell):

1. Freeze the liner (I'll call it the "unit" from here on out, OK?) for at least 8 hours.

2. Remove the unit from freezer and let stand at room temp for 25 minutes

3. Then put the liner in your blood refrigerator. Now it can be pulled out & used for up to 48 hours (then it must go back into the freezer for at least 8 hours.)

So, we put all the units in our freezer. First thing in the morning the day shift tech pulls out one (or 2 or 3) units and lets them stand at room temp for 25 min, then puts them in the blood refriger and we're ready to roll for today and tomorrow. (ie: We have several coolers and "leap frog" them so some are always in the freezer & some are always ready to go.)

[Brenda K Hutson]

I called the company for information, but I really appreciate your "instructions in a nutshell!"

Brenda

[martha]

I have used various coolers to send blood to the OR, in the different Institutions I have worked in. However, in trying to look for the website on 2 different types, I cannot find anything. Do these coolers still exist?

One is ThermoSafe and the other is Cell-Safe. This new Hospital opens July 12th so time if of the essence for me to place orders. If any of you have contact information for either/both of these (or any other company that uses the "freeze" bottles), please let me know.

Also, I have always used the Safe-T-Vue 10 temp. monitors. After reading a recent discussion, am wondering if the coolers for OR are supposed to store blood only at 1-6C instead of the 1-10C that probably many of us have, or still do, use. Does anyone use the Safe-T-Vue 6 Monitors? If yes, do you have any trouble with them turning red frequently?

Thanks very much!

Brenda Hutson, CLS(ASCP)SBB

Brenda,

You can purchase the Thermosafe coolers from Market Lab 1800-237-3604 and the Safe-T-vue 6 from

Williams Laboratories1-860-749-1350. I just purchased both items.

Martha

[Blupo]

We did an extensive search for approved coolers to meet the AABB requirement that the cooler is a storage device. Thermosafe was the only mfg. that has a FDA clearance on their cooler.

[carolyn swickard]

We use the Credo Thermo coolers too. I have 10 liners (units) for 5 coolers - you will need the extras to keep up with the rotation. We freeze the units for at least 8 hours in a -30C freezer to recharge them. I keep 4 units in the refrigerator at all times. After you remove them from the freezer, they will take 2-3 hours in the refrigerator to come to the proper temp (this can be determined to be when there is no frost left on the outside of the unit), but since I am rotating 4 of them at all times in the frig, we always have one ready to go. (In moist climates, they sweat a lot - place them on towels to soak up the water.) If they have been in the frig over 24-48 hours, you can always rotate some back to the freezer and replace them with ones from the freezer (this happens after the weekend when they don't rotate out as fast). Hope this helps - they are small coolers and will take only 2-4 units, but the RNs love them. The Thermo-Safe coolers are much heavier and require 3 ice blocks to keep them at temp - the RNs hated carrying them. Make sure you label the Credo lids - "Don't lose this Lid" and label the back of the lid with "Return to Blood Bank" it will help you keep up with the lids - if they are lost, the unit has to be replaced - expensive.

[dferia]

Terri,

Do you happen to know where that is in a regulation from NYSDOH or was it something verbally provided by an inspector from NY?

In NY state, the Dept of Health has defined coolers as "storage" not transport, so we are changing our Safe-T-Vue from 10 to 6.

[tbostock]

It came from a NYSDOH letter mailed 5/22/2009 that came with new guidelines: Guidelines for Remote Blood Storage. There is a section in it that is quite thorough about coolers, and very specific that they are storage and not transport containers, also information about validation of coolers.

In my experience, these are "guidelines" and not regulations, but Blood Banks are strongly encouraged to follow their guidelines.

[dferia]

Reading the applicable sections of the guidelines I found online (the 2008 first edition, which I'm hoping is the most current, and which sadly did not come with a copy of the letter you mentioned from 5/22/2009), it seems directed specifically towards hospital blood banks/transfusion services relating to remote storage of product for issuance from the coolers (or portable fridges), such as ERs I'm assuming. Does the letter identify something more specific regarding coolers as "remote storage" for the purposes of blood collection prior to transport to the manufacturing/processing facilty? If it wasn't obvious, I'm more involved in the blood collection process and am trying to see if this is applicable to that side of the operation.

Regards,

David

[tbostock]

The letter states: This is to clarify interpretation of certain requirements concerning blood banking and to provide you with guidelines recently approved by the NYS Council on Human Blood and Transfusion Services.

The first page of the guidelines states: The document is intended to assist hospital transfusion service directors and hospital staff in developing and maintaining programs for blood storage outside the blood bank.

So...looks like these guidelines are strictly for transfusion services/hospitals, not for blood centers. I would have to assume that what you do still falls under "transport". Hope this helps.

[dferia]

It was that very sentence you quoted that I was hanging onto with hope.

Regards,

David

[BBK710]

I have used various coolers to send blood to the OR, in the different Institutions I have worked in. However, in trying to look for the website on 2 different types, I cannot find anything. Do these coolers still exist?

One is ThermoSafe and the other is Cell-Safe. This new Hospital opens July 12th so time if of the essence for me to place orders. If any of you have contact information for either/both of these (or any other company that uses the "freeze" bottles), please let me know.

Also, I have always used the Safe-T-Vue 10 temp. monitors. After reading a recent discussion, am wondering if the coolers for OR are supposed to store blood only at 1-6C instead of the 1-10C that probably many of us have, or still do, use. Does anyone use the Safe-T-Vue 6 Monitors? If yes, do you have any trouble with them turning red frequently?

Thanks very much!

Brenda Hutson, CLS(ASCP)SBB

Brenda, Were you able to get these coolers? I tried to order the Cell Safe through Fisher Healthcare and was told that they were discontinued. They suggested the ThermoSafe but it is larger (holds up to 8 units) and 3 times as expensive.

[Brenda K Hutson]

I was never able to find a reference for Cell Safe any longer, I had already purchased a Thermo Safe cooler earlier this year; very similar operation.

But, I am going to try the Credo Thermo Cooler out for 2 reasons:

1. It appears to have the longest "potential" storage time (12 hours according to

Manufacturer)

2. We have recently had problems with our Safe-T-Vue 10 turning red shortly after we issue

the units. I am switching to Safe-T-Vue 6 (as I hear that is what the FDA states) so I need

something which will hopefully hold temp. better than the Thermo Safe.

We will see...

Brenda Hutson, CLS(ASCP)SBB

[Franklyn]

I know I sound like a broken record, but for about $2500 you can purchase a portable refrigerator from Helmer. The lifespan of the device is easily 10 years or more, so reducing surgical waste due to improper storage by two units per year pays for the device over that span. They come with temp charts and audible alarms and eliminate the chatter and regulator noise of cooler validation and provide a better level of service (an open cooler on the OR floor results in lost product - and open door on the refrigerator results in a piercing alarm the 'usually' results in somebody closing the door).

[clmergen]

But I would need about 15 of those portable refrigerators, storage would be a nightmare.

[Randal Miller]

Have been working with this issue for many years as a it impacts heavily with changing regulations, work place reality, and costs. Being a trained medical laboatory technologist I believe all FDA controlled products need to be under constant monitoring regardless if in the Blood Bank or during tranport. Supportive real time temperature documentation (logging or recording) is confirmation. Anything else is subjective to a myriad of variables. Consider trying this solution. Phoenix blood and organ transport container from World Life Transport - check out the website http://worldlifetransport.com and the blog which is sharing its development with users for input and perfection. This product is engineered for accountability for donor blood, tissues, bone marrow and organs. Designed from input of blood bankers and organ transport providers.

UP to 10 units of PRBC can be stored in a transport unit under constant temperature monitoriing that is captured, graphed and downloaded then filed on CD. Unlimited, free software capture application seats for all users

.

Payload will hold 2 to 6 C for up to 24 hours. Cost is below capital expense limits

Meets and exceeds all FDA, AABB, and CAP requirements.

Randal Miller MT(ASCP)

Washington DC

randalhmiller@gmail.com

[adiescast]

FDA has been very clear that coolers used in ORs are considered "storage" (1-6) and not "transport" (1-10). We have changed our policies to reflect this. We use regular coolers (mostly Coleman and Igloo) and do temperature monitoring on them twice annually to ensure that they maintain the expected temperatures for at least 8 hours, which is far longer than we actually allow them to be used for storage. We use the Safe-T-Vue 10s, mainly to show major temperature excursions since we are not constantly monitoring. We provide a thermometer in fluid just like the ones we use in our refrigerators, and we require 4 hour readings if the cooler is out that long (although they almost never are). We read the thermometer when the cooler returns if there is still blood in it.

This process has worked well for years and has been through several inspections/assessments.

[Brenda K Hutson]

FDA has been very clear that coolers used in ORs are considered "storage" (1-6) and not "transport" (1-10). We have changed our policies to reflect this. We use regular coolers (mostly Coleman and Igloo) and do temperature monitoring on them twice annually to ensure that they maintain the expected temperatures for at least 8 hours, which is far longer than we actually allow them to be used for storage. We use the Safe-T-Vue 10s, mainly to show major temperature excursions since we are not constantly monitoring. We provide a thermometer in fluid just like the ones we use in our refrigerators, and we require 4 hour readings if the cooler is out that long (although they almost never are). We read the thermometer when the cooler returns if there is still blood in it.

This process has worked well for years and has been through several inspections/assessments.

I know this is an old thread so you may not get this message, but I am just wondering why you are using

Safe-T-Vue 10 Temp. monitors instead of Safe-T-Vue 6, in light of the fact that you stated the FDA clearly states that OR coolers are for storage?

Brenda Hutson, CLS(ASCP)SBB

[clmergen]

New question to add to this topic. If a cooler is a "storage device" how do we meet the revised AABB standard 3.7 that states "Storage devices for blood, components, tissue, and derivitives shall have alarms" (abbreviated version)?

FDA defines a cooler as a storage device. AABB did NOT define a cooler as a storage device and effectively made it impossible to define it as a storage device. Does this mean I can keep using my coooler as a transport device (AABB) and risk the FDA? The only time AABB mentions coolers in the 26th edition is under std 5.1.8.2.1 which is transportation.

My head hurts.

[Brenda K Hutson]

New question to add to this topic. If a cooler is a "storage device" how do we meet the revised AABB standard 3.7 that states "Storage devices for blood, components, tissue, and derivitives shall have alarms" (abbreviated version)?

FDA defines a cooler as a storage device. AABB did NOT define a cooler as a storage device and effectively made it impossible to define it as a storage device. Does this mean I can keep using my coooler as a transport device (AABB) and risk the FDA? The only time AABB mentions coolers in the 26th edition is under std 5.1.8.2.1 which is transportation.

My head hurts.

I do not have the Standards in front of me, but I can only hope that the AABB was not considering the issue of the FDA now considering a cooler as a storage device?? Let's hope. After I read it, I may contact the AABB if I too see this as a conflict.

Brenda Hutson, CLS(ASCP)SBB

[lehooke]

I just purchased two of the Credo coolers as well. Would you be willing to share your validation procedure with me? I may have asked this in another post, I'm not sure. Thank you in advance!

Lisa

lisa.hooke@alvaradohospital.com