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Storage vs. Shipping/ Validation


Brenda K Hutson

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The recommended intervals for validating coolers used for Shipping is twice yearly (per the Technical Manual). Now that many/most of our cooler use in a Transfusion Service is going to be considered Storage (per FDA), how frequently are you all validating your coolers?

I did throw out a general question last year regarding validation of coolers (and saw some responses such as "only need to validate 1 cooler of a type," and "once validated; always ok; responses that I would disagree with).

So, for those of you who validate your "storage" coolers on an ongoing basis, how frequently are you doing it? :confused:

Thanks as usual for your input! :)

Brenda Hutson, CLS(ASCP)SBB

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Hi Brenda,

Are the coolers you use for storage just insulated boxes or are there electrical components in them?

No electrical components (and various cooler types; some igloos with bags of ice, which I want to slowly eliminate, and Credo Coolers with a cold box that must be pre-conditioned in the freezer, then placed at RT or refrigerator for specific time-frame before use). As it was explained to me, the insulation could be faulty or break down on any of these (thus the need to validate all of them, not just one). And I have to say that we do seem to have 1 Credo cooler that just does not maintain the temperature as long as the others.

Brenda

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Hello Brenda,

Since they have to be cleaned regularly, this could be the right time to do a visual inspection.

A validated cold box, can be invalid in a day if damaged.

As long as the lid/seal, outer shell and inner shell are intact, we can assume, the insulation layer,

usually foam, is intact as well.

If the inner or outer shell are punctured, liquid can enter, and will affect the insulation and

it will decay after a while. If in doubt, compare the weight of a new and old box, to see if there is

water between the layers.

Also dents will compress the insulation layer, and change the characteristics.

Since the insulation, when intact, does not really change its insulating properties, I think, it is "overkill",

to Validate them more then once a year.

Marc

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Hello Brenda,

Since they have to be cleaned regularly, this could be the right time to do a visual inspection.

A validated cold box, can be invalid in a day if damaged.

As long as the lid/seal, outer shell and inner shell are intact, we can assume, the insulation layer,

usually foam, is intact as well.

If the inner or outer shell are punctured, liquid can enter, and will affect the insulation and

it will decay after a while. If in doubt, compare the weight of a new and old box, to see if there is

water between the layers.

Also dents will compress the insulation layer, and change the characteristics.

Since the insulation, when intact, does not really change its insulating properties, I think, it is "overkill",

to Validate them more then once a year.

Marc

Well, if you are using your coolers for shipping purposes, per the 16th edition of the Technical Manual, you should be validating them twice a year.

Brenda

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We are still doing it twice a year. I would think that if you frequently have coolers that "fail" validation, you might need to do it more frequently than that. We have not yet had one fail (now that I've said that, it will happen!). The point of the validation (or really verification in this instance) is to ensure that the product continues to function as you need it to function for the intended use. So the biggest change may not be how often, but what criteria you use.

As Marc mentions, it may be a good idea to document more regular inspections for damage, since damage would change the characteristics of the cooler. We are not currently doing that, so I will be thinking about how to accomplish that without adding to the workload!

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Well, if you are using your coolers for shipping purposes, per the 16th edition of the Technical Manual, you should be validating them twice a year.

Brenda

The Technical Manual is for use as a guide only. I don't see any value in re-validating coolers, even on an annual basis, unless there is some change in form or function made by the manufacturer. What value can you get -- you are surely not going to test every cooler. If you pick 10 new coolers for validation, then you are likely to get good results. What happens if you pick a damaged cooler? Would you stop issuing blood in the coolers, find a new vendor, then validate new coolers? When your 10 new coolers are validated, what if the next day one gets dropped down a stairwell and the lid becomes damaged...you wouldn't notice it until 6 months later?

Initial validation should show if the coolers are acceptable for use, and under what packaging conditions. Prior to each use thereafter, inspect them for signs of wear and damage. If they show any signs of impaired integrity, then throw them out and get a new cooler. Define in your procedure what is acceptable and what is not acceptable. Set up a Cooler Maintenance procedure that addresses cleaning and inspection.

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  • 3 weeks later...

Typical per PDA/ISTA/ASTM would be to do an initial qualification that entails worst case hot and cold ambient profiles with max and min loads and thermocouple probes in simulated product throughout the box showing the box [and that particular packing configuration] can maintain temperatures under typical extreme conditions. This is typically done by an outside vendor as the thermal chambers are computer programmable to vary the ambient conditions. When we do one, it usually runs about $30k for a 48 hour test.

Then a process performance qualification whch would utilize temperature devices, typically between two products in the box. [AABB NOW requires a process validation of the shipping PROCESS, which is a lot more than just the boxes].

In years past people would take temperature upon receipt but that is almost worthless data as a box can exceed limits on the tarmac at an airport etc. so the newer approach [much more recent than the old remnants of FDA regulations from the 70s before people were even thinking about validation, or before requiring 'periodic monitoring' is to use RFID data collection devices and download the data for a statistically significant sampling of boxes.

IMO, igloo coolers are worthless for more than a few hours based on several years of experience looking at their performance data. Perhaps for transport inside a building or a short jump across town is ok, but that is pretty much it.

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IMO, igloo coolers are worthless for more than a few hours based on several years of experience looking at their performance data. Perhaps for transport inside a building or a short jump across town is ok, but that is pretty much it.

We only use coolers for transport short distances and no more than 6 hours time. The Igloo, Coleman, and similar brand coolers work just fine for these applications.

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Yes Tadpole,

Here we see again.

A -80 Freezer can work perfect in Canada, but can fail in Bahrain.

A particular Box can fail with you, but works fine within specs in Norway.

Work out the variables, and write your own PQ according regulations.

Marc

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I had an extensive talk with AABB last week on this topic.

Each cooler should be validated upon receipt to verify that it can perform as expected.

Each cooler should be QC'd at regular intervals, as defined by the facility, to ensure that they are still in working condition. And the impression I got was this should be done as they are in use (ie ED or OR, not on counter top in TS).

We haven't defined QC yet, I am having a meeting in a few days with representatives from all my hospitals and this is on my agenda. I don't see doing QC more than quarterly but still haven't figured out exactly how I am going to do this. We do visual inspections quarterly now so that is why I am considering temp QC quarterly also. This will be a pain in the rear with 20 coolers but must be done.

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We validate our Igloo Playmate coolers twice a year and we do it in the Blood Bank.

On another note, I have recently heard that FDA considers coolers going to OR as storage and as such they have to be monitored every four hours. Has anyone else heard that? does that mean that coolers can only be out up to 4 hours unless they have some way of being monitored continuously? would we have to check on the blood every 4 hours if not? Since it is storage, does the blood also have to be maintained at 1-6C?

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The Technical Manual is for use as a guide only. I don't see any value in re-validating coolers, even on an annual basis, unless there is some change in form or function made by the manufacturer. What value can you get -- you are surely not going to test every cooler. If you pick 10 new coolers for validation, then you are likely to get good results. What happens if you pick a damaged cooler? Would you stop issuing blood in the coolers, find a new vendor, then validate new coolers? When your 10 new coolers are validated, what if the next day one gets dropped down a stairwell and the lid becomes damaged...you wouldn't notice it until 6 months later?

Initial validation should show if the coolers are acceptable for use, and under what packaging conditions. Prior to each use thereafter, inspect them for signs of wear and damage. If they show any signs of impaired integrity, then throw them out and get a new cooler. Define in your procedure what is acceptable and what is not acceptable. Set up a Cooler Maintenance procedure that addresses cleaning and inspection.

Yes, I am going to validate all coolers. We also just found that at least one of our older ones no longer held temp.

(1-10C) so we have put it out of service.

Brenda Hutson

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We validate our Igloo Playmate coolers twice a year and we do it in the Blood Bank.

On another note, I have recently heard that FDA considers coolers going to OR as storage and as such they have to be monitored every four hours. Has anyone else heard that? does that mean that coolers can only be out up to 4 hours unless they have some way of being monitored continuously? would we have to check on the blood every 4 hours if not? Since it is storage, does the blood also have to be maintained at 1-6C?

The issue of storage vs. shipment has been addressed in other Threads by me (and others). I am thinking that we do not have to take the temp. every 4 hours as long as we do not use the coolers past the validated time frame, and we use some kind of temperature monitors (we are in the process of validating our coolers with Safe-T-Vue 6 monitors).

Brenda Hutson

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We initally validate each cooler to maintain temperatures for 6 hours. For ongoing QC of each cooler issued, we apply a HemoTemp indicator to each RBC and Thawed Plasma unit issued in a cooler and verify & document the HemoTemp is OK if the unit is returned (to ensure it was not removed, warmed up, then placed back into the cooler). We will soon also add that if units are returned in the cooler, in addition to verifying the acceptability of the HemoTemp, we will also take the temperature of one of the units in the cooler with an infrared thermometer gun and record it on our cooler Issue/Return log. By adding this process, we will be essentially QC'ing every cooler's ability to maintain its temperature each time it is sent out and brought back. (We issue all of our blood to surgery in Cell-Safe coolers, so we get a lot of practice with cooler issues & returns!)

I would suggest the investment in a high-quality infrared thermometer since eliminating the 30 minute rule for returning an issued unit is the next big change coming. You will only be able to accept an issued unit back into inventory if you have verified (by either documented pre-validation or documented measurement) that its temperature has not exceeded 10 degrees. Since I think it would be impossible to validate the issue/return temp of different sizes of units at 30 minutes post-issue during each season of the year to every single area of the hospital & outpatient clinics on campus, I think taking the temp each time a unit is returned is the best and easiest way to go for us. I foresee discarding many more units, since in reality, my experience has been that units warm up to 10 degrees faster than 30 minutes. We are currently validating our new infrared thermometers, training staff to use them, and updating our procedures to do away with the 30 minute return policy.

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We initally validate each cooler to maintain temperatures for 6 hours. For ongoing QC of each cooler issued, we apply a HemoTemp indicator to each RBC and Thawed Plasma unit issued in a cooler and verify & document the HemoTemp is OK if the unit is returned (to ensure it was not removed, warmed up, then placed back into the cooler). We will soon also add that if units are returned in the cooler, in addition to verifying the acceptability of the HemoTemp, we will also take the temperature of one of the units in the cooler with an infrared thermometer gun and record it on our cooler Issue/Return log. By adding this process, we will be essentially QC'ing every cooler's ability to maintain its temperature each time it is sent out and brought back. (We issue all of our blood to surgery in Cell-Safe coolers, so we get a lot of practice with cooler issues & returns!)

I would suggest the investment in a high-quality infrared thermometer since eliminating the 30 minute rule for returning an issued unit is the next big change coming. You will only be able to accept an issued unit back into inventory if you have verified (by either documented pre-validation or documented measurement) that its temperature has not exceeded 10 degrees. Since I think it would be impossible to validate the issue/return temp of different sizes of units at 30 minutes post-issue during each season of the year to every single area of the hospital & outpatient clinics on campus, I think taking the temp each time a unit is returned is the best and easiest way to go for us. I foresee discarding many more units, since in reality, my experience has been that units warm up to 10 degrees faster than 30 minutes. We are currently validating our new infrared thermometers, training staff to use them, and updating our procedures to do away with the 30 minute return policy.

I am not sure I see the purpose in taking the temperature of the units returned in coolers if they have irreversible temperature monitors on them. Wouldn't the acceptability of the monitor show that the cooler never exceeded that temperature?

With regard to the "change" coming for the 30 minute rule; is that a regulatory change? If yes, can I get the reference? I had not heard this (and we do use the 30 minute limit).

With regard to the infrared thermometer, what company did you purchase that from?

Thanks

Brenda Hutson, CLS(ASCP)SBB

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We purchased two "Fluke 561" IR Thermometers from Global Sensors for $175.

We are happy with them so far. They have a +/- 1 degree variability compared to many that advertise +/- 2 degree variations.

At the AABB meeting in Oct., it was brought up both in the assessor training day and also during one of the sessions I attended about the 30 minute "rule" having no real foundational basis, and that there isn't (and has never been) any "rule" or regulation about this. There are however, temperature limits that are clearly defined and should be regulated. The 30 minute deal has been more of a widespread common practice over the ages that no one has challenged. They stated that if you want to use a 30 minute limit (or any limit based on time), then you have to show studies and evidence that proves your units are still within allowed temperatures at that predefined time at room temp (or outside temp, or where ever that unit traveled) after issue.

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We purchased two "Fluke 561" IR Thermometers from Global Sensors for $175.

We are happy with them so far. They have a +/- 1 degree variability compared to many that advertise +/- 2 degree variations.

At the AABB meeting in Oct., it was brought up both in the assessor training day and also during one of the sessions I attended about the 30 minute "rule" having no real foundational basis, and that there isn't (and has never been) any "rule" or regulation about this. There are however, temperature limits that are clearly defined and should be regulated. The 30 minute deal has been more of a widespread common practice over the ages that no one has challenged. They stated that if you want to use a 30 minute limit (or any limit based on time), then you have to show studies and evidence that proves your units are still within allowed temperatures at that predefined time at room temp (or outside temp, or where ever that unit traveled) after issue.

You are correct that the 30 minutes was not a rule (aka regulation). It was a timeframe mentioned in various Editions of the Technical Manual. Given their rationale (which I agree with), I don't think I would want to just test "some" units, to then come up with a generalization about "all" units. I don't think you can say that "all units are treated equal" once they leave the Transfusion Service. So, best to take the temperature upon return.

Oh boy, more SOPs to revise!! Ha Ha

Brenda Hutson, CLS(ASCP)SBB

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Exactly! This is especially true at our pediatric hospital where issued units come in widely variable sizes. That's why we are opting to just take the temp of each one that comes back before assuming its OK and re-entering it into inventory. I agree that verifying the HemoTemp AND taking the temperature with the IR thermometer is probably overkill (we could skip taking the IR temp if the indicator is OK), but talking with my techs, they would prefer to build a uniform method into the process and use it for everything that comes back. I don't want to give up using the HemoTemps because I don't trust that they won't take a unit out for awhile, warm it up, and then try to sneak it back into the cooler to send back to us.

Added note: Based on our most recent FDA inspection, we also are now verifying the acceptability of the packing/transport methods used by our donor center by taking the temperature of units at the time of delivery using the IR thermometer. Our inspector said we didn't need to do it for every delivery, but should probably hit each type of product (RBC, PLT, FFP, CRYO) periodically, so currently, we are doing each one at least once per month.

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I went on this quest to find something in writing that now considers transport coolers "temporary storage" but haven't found any treasures yet. I am trying to go with the current industry flow and comply by modifying our practice here but I also hate being a lemming. Can anybody point me in the right direction to that FDA guidance/instruction/new rule? We will be inspected sometime this Fall and I heard nothing about this from the last inspection. Thank you.

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Exactly! This is especially true at our pediatric hospital where issued units come in widely variable sizes. That's why we are opting to just take the temp of each one that comes back before assuming its OK and re-entering it into inventory. I agree that verifying the HemoTemp AND taking the temperature with the IR thermometer is probably overkill (we could skip taking the IR temp if the indicator is OK), but talking with my techs, they would prefer to build a uniform method into the process and use it for everything that comes back. I don't want to give up using the HemoTemps because I don't trust that they won't take a unit out for awhile, warm it up, and then try to sneak it back into the cooler to send back to us.

Added note: Based on our most recent FDA inspection, we also are now verifying the acceptability of the packing/transport methods used by our donor center by taking the temperature of units at the time of delivery using the IR thermometer. Our inspector said we didn't need to do it for every delivery, but should probably hit each type of product (RBC, PLT, FFP, CRYO) periodically, so currently, we are doing each one at least once per month.

First, I can atest to the fact that you "shouldn't" blindly trust that units are NOT removed and then placed back in the cooler! I know for a fact that it happens (and that they will deny it); not a generalization for everyone at every Hospital; but enough to know better (and worse things than that happen in the OR room at times).

As far as verifying the acceptability of packing from your Donor Facility; our Donor Facility does that periodic testing throughout the year when they bring coolers (and they ask us to look at their temp. to concur; then they document the information). It is interesting that the FDA is requiring that of you as I don't think it is a regulatory requirement for a Transfusion Service (?? anyone know??). It makes me wonder where your Hospital is located given my previous experience in a location in a state where it was said to be "the thing" for that particular FDA Inspector. None of the Blood Bank management in that area were all too happy that we had to comply with things that were not in the regulations, and not required of others (and on top of that, the only way we were finding out was when cited at an FDA Inspection for not doing it; I had already heard of another local hosptial being cited so I started doing it; then when I had my Inspection, they askef for the records).

I have heard this with regard to FDA Inspections in other areas, with regard to different issues. That the FDA Inspectors seem to be allowed to walk into Institutions and cite them for something that "they" think they should be doing. My feeling is; if a particular Inspector believes Blood Banks should do something, they should address that at an FDA regulatory meeting and decide whether to put it in the CFR; only then should we be held accountable for it (and be subject to citation). Just my opinion...

Brenda Hutson

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I went on this quest to find something in writing that now considers transport coolers "temporary storage" but haven't found any treasures yet. I am trying to go with the current industry flow and comply by modifying our practice here but I also hate being a lemming. Can anybody point me in the right direction to that FDA guidance/instruction/new rule? We will be inspected sometime this Fall and I heard nothing about this from the last inspection. Thank you.

I believe this is not a change in the regulations so much as a change in the way FDA is interpreting the regulations (or it could be that they are reasserting a stance they have always had but had not enforced before now).

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I believe that whoever wrote the 'Store at 1-6, Transport at 1-10' rule was a bit narrow sighted.

Obvious storage is in our refrigerators, but what about the boxes we 'store' the blood in while they are waiting (sometimes for hours!) to be loaded onto a truck? Are they 'in storage' or 'in transport'? When they are IN the truck,we clearly see them as 'in transport'. So, I guess the criteria is based on is really 'is it in a moving state?'. Given that, if the cooler is sitting on the ground, it must remain between 1-6oC. If it is being carried somewhere, it can go up to 10oC. (Ummm, what temp check stickers are we using, 1-6 or 1-10 for these?)

Are we all nuts or what!?

Whatever ... the rule should be rewritten for clarity's sake: e.g. RBC's must be maintained at 1-6oC. However, if allowed to warm up to 10oC for longer than X minutes (hours?), then the outdate must be amended to ____ (24hrs?). If allowed to warm up greater than 10oC, it must be discarded. (Interesting that the current rule states we can't reissue it ... why doesn't it state we must discard it? Do YOU store such units in quarantine until they outdate? We don't either.) This is how it is stated for bones ... it's very clear what to do when.

So, if there is anyone out there who has any control over writing the FDA regulations, can you bring this up at your next meeting please?

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I believe that whoever wrote the 'Store at 1-6, Transport at 1-10' rule was a bit narrow sighted.

Obvious storage is in our refrigerators, but what about the boxes we 'store' the blood in while they are waiting (sometimes for hours!) to be loaded onto a truck? Are they 'in storage' or 'in transport'? When they are IN the truck,we clearly see them as 'in transport'. So, I guess the criteria is based on is really 'is it in a moving state?'. Given that, if the cooler is sitting on the ground, it must remain between 1-6oC. If it is being carried somewhere, it can go up to 10oC. (Ummm, what temp check stickers are we using, 1-6 or 1-10 for these?)

Are we all nuts or what!?

Whatever ... the rule should be rewritten for clarity's sake: e.g. RBC's must be maintained at 1-6oC. However, if allowed to warm up to 10oC for longer than X minutes (hours?), then the outdate must be amended to ____ (24hrs?). If allowed to warm up greater than 10oC, it must be discarded. (Interesting that the current rule states we can't reissue it ... why doesn't it state we must discard it? Do YOU store such units in quarantine until they outdate? We don't either.) This is how it is stated for bones ... it's very clear what to do when.

So, if there is anyone out there who has any control over writing the FDA regulations, can you bring this up at your next meeting please?

I agree. The distinction of Storage and Transport defies common sense because there really isn't any logical reasoning behind why while moving blood is ok at 10degrees but absolutely unacceptable if the same temp while stored. In their defense though, I guess they saw transport as temporary so it was ok to temporarily relax the rules to prevent a large scale wastage of blood. If that's the logic, transport coolers are even more temporary so why this new wave of inspectors calling them storage? Like you said, it should all be 1-6 for the sake of clarity. If inspectors these days are allowed to deploy personal opinions in deciding what's a violation or not, then we may have something else on our hands here.

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