Expiration Dates

[Barb Thompson]

We have started receiving pre-pooled cryo (10 units in the pool) from our supplier, and I cannot find a reference for when the unit expires after thawing. I checked with several other facilities, as well as the supplier, and have received responses of 4, 6, 8, 12 and 24 hours. Currently, we assign an expiration time of 4 hours post-thaw. What are others doing, and does anyone have a reference for this?

Thanks, Barbara

[Malcolm Needs ☆]

I would have thought that, for this information, your supplier would be the first port of call?

Surely, if they are supplying the stuff, they must be licenced so to do, and would have to supply this kind of information on storage?

Only a thought.

[David Saikin]

Since you store it at room temp, 4 hours post-thaw should be the acceptable time frame.

[tbostock]

4 hours for pooled cryo. AABB Technical Manual, 16th ed, p 214.

[Brenda K Hutson]

Well, it is true that the expiration for "pooled" Cryo is 4 hours, but I am thinking that means Cryo. that is thawed, then Pooled. When a single unit is thawed, it is 6 hours. So the question then becomes, if the pooling occurred "prior" to thawing, when the intact, closed system Cryo. is thawed, could it not be a 6 hour expriation?

The Technical Manual states that: All pooled CRYO, whether prepared in an open or closed system, must be transfused within 6 hours of thawing, or 4 hours of pooling, whichever comes first. Since you are receiving it "pre-pooled," I would think 6 hours. However, I do not yet receive that product from my supplier so those are just my thoughts.

Brenda Hutson, CLS(ASCP)SBB

[tbostock]

Totally agree with you, Brenda. You can't find a reference anywhere for "pre-pooled" cryo, so we went with the blood supplier's instructions, which said to use the "pooled" cryo regs of 4 hours. Hopefully the regs will be better clarified in the future.

[L106]

Thanks for bringing up this topic.....Now it's got me thinking. I'll be looking forward to what everybody has to say about this.

[David Saikin]

As I stated above, it is 4 hrs because once thawed cryo is stored at room temp.

[Barb Thompson]

Thanks for all your replies. My supplier is the one who said 4 hrs,and that is what I go by, but I work per diem at another hospital and their policy is 24 hours. I just didn't think that was right. Thanks again! I'm sticking with 4 hrs until my supplier says otherwise.

Barbara

[SMW]

See AABB Standard, 5.1.8A--Requirements for Storage, Transportation, and Expiration. Item #25. For Thawed Cryoprecipitated AHF, the expiration period listed is 4 hours if in an open system or pooled. Note that there is not a differentiation if the pooling is performed in an open or closed system or when the pooling was performed but that it was pooled; therefore 4 hours would apply. It also specifies storage as 20-24C.

[Hopefully the facility that is assigning a 24-hour expiration date is not using the product for or expecting an increase in Factor VIII once transfused...............]

[Colleen A]

The standards has listed on page 67 (25th edition) that single cryo is good for 6 hours but if it is in a pool it is only good for 4 hours. It is also listed as having 4 hour expiration for pools in the most recent version of the Technical Manual as well (page 214). Hope this helps.

[PaulSunV]

Well, it is true that the expiration for "pooled" Cryo is 4 hours, but I am thinking that means Cryo. that is thawed, then Pooled. When a single unit is thawed, it is 6 hours. So the question then becomes, if the pooling occurred "prior" to thawing, when the intact, closed system Cryo. is thawed, could it not be a 6 hour expriation?

The Technical Manual states that: All pooled CRYO, whether prepared in an open or closed system, must be transfused within 6 hours of thawing, or 4 hours of pooling, whichever comes first. Since you are receiving it "pre-pooled," I would think 6 hours. However, I do not yet receive that product from my supplier so those are just my thoughts.

Brenda Hutson, CLS(ASCP)SBB

I thought the question was if the units were prepooled in a closed system then there isn't really any reason that a pre-pooled unit of cryo shouldn't be good for the six (6) hours the same as a regular unit of cryo receives upon thawing. I presented that question to my supplier and their answer was four (4) hours.

[Brenda K Hutson]

As I stated above, it is 4 hrs because once thawed cryo is stored at room temp.

David,

I am still thinking differently. Even if a single bag of Cryo. is thawed, it can sit out at Room Temp. for 6 hours. So I don't think the fact that the product is at Room Temp., defines the expiration. However, the Technical Manual States: All pooled CRYO, whether prepared in an open or closed system, must be transfused within 6 hours after thawing, or 4 hours after pooling, whichever comes first. So if you thaw multiple units and then pool them, it is a 4 hour expiration. However, It "sounds" to me like this is saying that if thawing (but not pooling; already pre-pooled), that the expiration is 6 hours. Does anyone else interpret it like this?

Also, this just in: I spoke to a large local Medical Center where I previously worked, because I knew they were receiving a minimal amount of pre-pooled Cryo. from their Blood Center; they said it has a 6 hour expiration after thawed.

Brenda Hutson, CLS(ASCP)SBB

[AMcCord]

See AABB Standard, 5.1.8A--Requirements for Storage, Transportation, and Expiration. Item #25. For Thawed Cryoprecipitated AHF, the expiration period listed is 4 hours if in an open system or pooled. Note that there is not a differentiation if the pooling is performed in an open or closed system or when the pooling was performed but that it was pooled; therefore 4 hours would apply. It also specifies storage as 20-24C.

I was also told 4 hours by my supplier based on the std quoted.

24 hrs :eek:!!! That's scary....

[sphtmed]

Depends on what the use of cryo is for. If it is for factor 8 or vwf, we go by 4 hours. For fibrinogen, we pool thawed cryo and keep in the fridge for 24 hours. Our usage is usually within four hours for post-op open heart bleed.

[PaulSunV]

Sphtemd. So if you think the patient is going to need a boost in their fibrinogen level do you pool cryo and then refrigerate immediately or do you give it a 4 hour outdate and store at room temp for 4 hours and then change it to a 20 hour outdate and place in the refrigerator. What product do you call it under either example when you store it for 24 hours in the refrigerator?

[Brenda K Hutson]

In looking at that Standard, you are correct in stating that it only discusses a single unit of Cryo. and Pooled Cryo. However, I guess that I am wondering (in light of the reference I made from the Technical Manual), if the issue of "pre-pooled" Cryo. being thawed, just was not differentiated in the Standards??

I don't know what to so; it just seems to me that the way the Technical Manual reads, it does differentiate between Cryo. that was pooled prior to thawing, and that which was pooled after thawing.

I think I will look into that some more; espeically given that this Hospital I used to work at, does receive pre-pooled cryo. and does give it a 6 hour expiration.

But, let's find out the truth! I will call the AABB for clarification.

Brenda Hutson, CLS(ASCP)SBB

[AMcCord]

I was also intrigued by this conversation, so I contacted my supplier (ARC) and asked the director of manufacturing and hospital services what the straight scoop was on pooled cryo. My ARC region does not manufacture cryo, so she contacted the region who supplies us. Their reply was that the outdate for thawed prepooled cryo was 6 hours, though they would recommend transfusing as quickly as possible. Their (ARC's) pooling system is a closed system.

This is a question to the folks who refrigerate cryo up to 24 hrs for fibrinogen.......once you get the cryo down to 6C, doesn't all the good stuff turn to goobers again? Are there problems clogging infusion sets when it's given?

[SMW]

You may want to go back to your source and request a copy of the ARC's Pooled Cryo pamphlet. The copy I've seen states the expiration date is 4 hours after thawing. Similiar to pooled Platelets, regardless if the pooling is peformed in an open or closed (sterile-connected) system, the expiration period is 4 hours after pooling. (This does not apply to the Platelets that are pooled using an FDA-licensed pooling set and are then bacterially tested by culture). I also believe the ARC product is NOT an entirely closed system process but that's less relevant since, at least according to current standards, it's the fact that it's pooled that makes the expiration period 4 hours.

[Brenda K Hutson]

As I mentioned in one of my previous responses, I contaced the AABB Regulatory Division directly; here is their response (so still uncertain of answer).

Brenda Hutson, CLS(ASCP)SBB

Dear Ms. Hutson,

You have sent the question to the correct department.

The FDA is the final arbiter of this question: 21CFR606.122(n)(5) Instructions to store at room temperature after thawing and to begin administration as soon as possible but no more than 4 hours after entering the container or after pooling and within 6 hours after thawing.

The Standard is intended to reflect the CFR, and indeed there are FDA liaisons to the standards program unit. However, I do not know if this CFR reference takes into account that some cryo may be pooled prior to freezing.

I will ask for an interpretation from the FDA and let you know what I find out.

The Technical Manual possibly needs a correction. If that turns out to be correct I will forward that to the correct person.

Regards,

Allene

M. Allene Carr-Greer, MT(ASCP)SBB

Director, Regulatory Affairs

AABB

[eric1980]

So no answers yet for now... Will monitor this topic. ; )

[AMcCord]

At the urging of SMW, I went back to my supplier (ARC) about the question of outdate on thawed, prepooled Cryo. She went back to the ARC region which supplies the prepools we receive and requested a clarification. The reply she got is as follows:

"Our CRYO POOLS were licensed as closed system pools. The reason they must transfuse within 4 hours is because of the thaw to pool and refreeze requirement. All blood centers are required to use the 4 hour transfusion rule."

So, 4 hours it is for me. It will be interesting to see what comes from AABB/FDA (thanks, Brenda).

[Brenda K Hutson]

As per previous e-mails I sent in response to this issue, the AABB Regulatory division consulted with the FDA. Here is the official response (which is, that pre-pooled Cryo, if prepared in closed system using SCD, once thawed, is good for 6 hours; this follows the wording then in the Technical Manual).

Brenda Hutson, CLS(ASCP)SBB

Brenda,

After hearing from FDA I can say that it is their interpretation that the Standards are consistent with the FDA regulation 21CFR606.122(n)(5) although the wording may not be clear. The regulation was written before the days of pre-storage pooled cryo approval. I have reprinted from FDA:

· 6 hours - if pooled before frozen storage (this must be done using a SCD)

• It was determined this met the standard for thawing a single unit that has a 6 hour expiration date because the pre-pooled units were frozen, thawed and administered as a single unit
  

· 6 hours - if thawing and administering a single cryo unit (no spiking or pooling before transfusion)

· 4 hours - if spiked for pooling just before transfusion (the 4 hours can be counted from the first spike or after the completion of the pooling; pooling should be done using a SCD)

I do not think the Technical Manual needs correction, but perhaps elaboration in the next edition would be helpful, as well as the Standard.

Regards,

Allene

M. Allene Carr-Greer, MT(ASCP)SBB

Director, Regulatory Affairs

AABB

[eric1980]

Now I am curious how my blood supplier pool their cryos. Our current expiration time is 4 hours, and if possible, it's best to extend to 6 hours where applicable.

What is SMW and SCD? =S

[L106]

SMW is the name of another person who posted on this site. I believe SCD is "Sterile Connecting Device."