How do most people label a unit for exchange transfusion which have red cells that are O neg and plasma that is AB? What abo do you use and what product ID do you use?

Thanks-

VCH

If you are using ISBT128, there are codes for recombined units. Open up the ICCBBA website and the Access database and put your cursor in the Prodescrip0 field. Do a find for "plasma added" and select the correct combination of red cell additive and modifiers.

We use O for the ABO label.

Besides the hassle of re-labeling, aren't you required to register with the FDA? I remember working at a place where we gave requested amount of red cells and plasma adding some volume for the lines and released both units.

That is the reason we stopped adding plasma to Red cell and we give them separately. We do not want to get FDA registered for the procedure we do once every three to four year.

I don't believe that recombining blood and plasma requires registration any more than pooling cryoprecipitate or platelets does. You have to register if you are modifying a product, such as by blood irradiation or pre-storage leukoreduction. The regs, of course, are not completely clear on this issue as they do not list pooling as an exemption for registration, so maybe my theory is not correct...

If you add plasma to RBCs you must be FDA registered.

Question 14: At previous Ask the FDA sessions, the FDA has explained that combining Plasma and Red Blood Cells to create a "reconstituted" Whole Blood for neonatal exchange transfusion is considered manufacturing and requires FDA registration. Is there a threshhold frequency before registration is required (for this or other infrequent occurrences), e.g., if a procedure is only performed 1-4 times per year, is the facility required to register with the FDA for these infrequent activities?

MS. CIARALDI: FDA does require registration for this procedure because the reconstitution of red cells and plasma to make a third product, the Whole Blood, meets the general definition of manufacture in 21 CFR 607.3(d). There is no threshold frequency that is described in any of our guidance documents or regulations, but we feel, if you have established procedures for performing this process, you must register regardless of the frequency.

I would like to add a comment on top of that because it just came in right before I came to the meeting and it came in from a field investigator. There was a concern expressed and I do want to share that with you. If you are having staff members perform a procedure as infrequently as described in the example on the slide, how will you ensure their competency, consistent with our requirements in 21 CFR 606.20(? For procedures performed infrequently, there may be a GMP issue with making sure that staff are competent and experienced and knowledgeable about doing these procedures. It is just something to think about.

Edited March 22, 201015 yr by tricore
spelling

thanks tricore...i don't think I could have explained it any better. Unfortunately, this is an on-going discussion, to register or not register. And every so often somebody would clarify this registration issue. When it comes to pooling (please correct me if I am wrong), you still end up with the same product......platelet or cryo. I don't know if requirements have changed, I have not done both for years because of readily available plateletpheresis and pre-pooled cryo.

thank you for this reply. this is an issue our facility is struggling with again. we dropped our FDA registration a few years back with the intent of issuing the 2 items separately, but our neonatalogist seems to have forgotten the process. so here we go again.