Alert:Expiration Date of Pre-Pooled Cryo

[Brenda K Hutson]

I just wanted to direct interested parties back to the Thread on the expiration of thawed, pre-pooled Cryo. The AABB and FDA have given their official response. The short of it is: For Cryo. that is pre-pooled using a closed system (SCD), the expiration after thawing is 6 hours. This coicides to what the Technical Manual says. The previous FDA guidelines were written prior to pre-pooled cryo.

Brenda Hutson, CLS(ASCP)SBB

[Ellen Zeigler]

A consideration if your cryo is made in a closed or open system... the individual units of cryoprecipitated AHF may be connected to the pooling system by a sterile connection devise, however, typically the saline used to rinse the individual bags is not. Most bags of saline are made for infusion and do not have tubing to connect. You may want to contact your supplier and ask the question or request a copy of the procedure that they use.

[estiner]

I just checked with the AABB accreditation department and was referred to Std. 5.1.8A #25 which states that the expiration for thawed pooled cryoprecipitate is 4hrs. I even questioned the answer in reference to ambiguous statements on pages 202, 287 and a conflicting statement on page 294 of the 16th edition of Technical Manual. I was told that since the Technical Manual is guidance, the Standards rule.

[Brenda K Hutson]

I just checked with the AABB accreditation department and was referred to Std. 5.1.8A #25 which states that the expiration for thawed pooled cryoprecipitate is 4hrs. I even questioned the answer in reference to ambiguous statements on pages 202, 287 and a conflicting statement on page 294 of the 16th edition of Technical Manual. I was told that since the Technical Manual is guidance, the Standards rule.

Perhaps they thought you mean thawed then pooled?

The response I copied and pasted above, came from the AABB Regulatory Dept. as well as the FDA. They clearly stated that if pre-pooled in a closed system, it would have a 6 hour expiration after thawing. I don't know what else to say. Perhaps contact one of the regulatory people in the 2 cut and paste e-mails I sent??

Brenda Hutson, CLS(ASCP)SBB

[eric1980]

My interpretation of this is that if the cryo are pre-pooled, the expiration time of this thawed cryo will be 6 hours.

Other than that, the expiration time will be 4 hours...

[Brenda K Hutson]

My interpretation of this is that if the cryo are pre-pooled, the expiration time of this thawed cryo will be 6 hours.

Other than that, the expiration time will be 4 hours...

I just received another e-mail from the AABB Regulatory person who initially clarified this with the FDA. She stated she was looking at these comments with interest. She still states, per the FDA, Cryoprecipitate that is pre-pooled in a closed system, will have a 6 hour expiration upon thawing (but wants to make sure everyone knows that once spiked, it will change to 4; I referred her to my previous Thread and subsequent responses regarding "When does the Clock Start.."

Also, just a note for those of you who receive blood products from the Red Cross: Having been a Reference Supervisor at the Red Cross about 5 years ago, they will always err on the side of caution due to their FDA Consent Decree. Given that the FDA states that their regulation related to Pooled Cryo. did not address Pre-Pooled Cryo (since that is relatively new), I would not be surprised if the Red Cross will NOT change their stance on that until they see it IN WRITING from the FDA (and I can't blame them for that).

Brenda Hutson, CLS(ASCPSBB