Registering with the FDA

[Robert1015]

Does a transfusion service need to be registered with the FDA in order to set up recostituted whole blood for neonatal exchange transfusions?

How do you go about training your staff and making sure they're competent in performing such a procedure?

Thanks.

[tricore]

From Ask the FDA at the 2009 aaBB annual meeting

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.

[David Saikin]

We always had a form to fill out for each reconstituted whole blood . . . it defined how much plasma was added to how much rbc to achieve the desired hct. You could always use outdated rbc/plasma or therapeutic phlebotomy blood to document competencies for this. You know the desired hct. After the product is made you can perform a hct and see how "competent" your staff (or your procedure) is. The feds do not care about the cost of compliance. If you do it, you have to do it right.