My supplier plans to use ”E3588 POOLED CRYOPRECIPITATE|None/XX/<=-18C|Open” for frozen pre-pooled cryoprecipitate. This leads me to think I should use "E3592 Thawed POOLED CRYOPRECIPITATE|None/XX/rt|Open” for the thawed version.

This leaves me wondering what code to use for pooled cryo that we pool ourselves (from individual units) after thawing? E3592 does seem appropriate, but I can’t use the same E code for 2 different products. Is "E5284 Thawed POOLED CRYOPRECIPITATE|NS/XX/rt|Open” acceptable (NS anticoagulant vs. None)??

You can contact ICCBA and ask. They are very helpful. Or Pat Distler may come on here and answer your question as she often does.

Who is your supplier? We have ARC and they will use the E3587 for the pre-pooled cryo, frozen. I didn't even realize that there was an "open" pooled component that could then be frozen. We will use E3591 for the thawed version of the pre-pooled product "Thawed POOLED CRYOPRECIPITATE/NONE/XX/rt".

Our supplier is ARC, South Carolina region. I'm checking with them now to verify that they will be using an open system manufacturing process.

Aha! We asked our ARC region to clarify whether they will truly be manufacturing the pre-pooled cyro using an open system. They informed us that they will now be using a closed system. Problem solved!

Sometimes it's good to press an issue....:o:o

We submitted pooled cryo license supplement to change number of units in the pool. We submitted our labels also and when the reviewer saw E3588 "open" system we were told the FDA does not allow the process of spiking or opening the unit when you are manufacturing it. Check the Ask the FDA and CLIA 2011 transcript.

The FDA stated that all steps in the manufacturing of pre-storage pooled cryo should be either closed or what they consider functionally closed which is Sterile Connecting.

The ISBT 128 product description codes for Thawed Pooled Cryo products do not differentiate whether the Cryo was pooled prior to freezing or after thawing individual units.  The same Thawed Pooled Cryo code applies to both.

 

Both core conditions of "None/XX/refg" and "NS/XX/refg" are acceptable to use.  Some people prefer to use NS (not specified) for their pooled cryo products because they feel that the trace amounts of anticoagulant in each individual unit can sum up to an amount that could potentially affect the patient.  "None" is also acceptable to use because (theoretically) pooling multiple units of "None" should still result in "None".

 

If your system doesn't allow you to assign the same ISBT 128 product description code to your Thawed Pooled Cryo, you can use "None/XX/refg" for one and "NS/XX/refg" for the other.

 

 

Erwin Cabana

Lead Information Standards Specialist

ICCBBA