From: Ellen Eagan [Ellen.Eagan@clinlab.ucsfmedctr.org]
Sent: Wednesday, February 07, 2001 1:22 AM
To: fdadockets@oc.fda.gov
Subject: Comments on Universal Pre-Storage Leukocyte Reduction of Whole
Bl ood

To Whomever,
 
    I am the Processing supervisor at the UCSF Medical Center, overseeing
the processing, testing and labeling of blood drawn at the UCSF Medical
Center Clinical Laboratories Blood Center. I wish to make some comments on
the Guidance for Industry recently released on Pre-Storage Leukocyte
Reduction of Whole Blood and Blood Components Intended for Transfusion. 
 
    First off, while it has been clearly shown that certain populations of
transfusion recipients benefit from receiving leukocyte reduced blood
components, it has not been shown that all transfusion recipients will
benefit from leukocyte reduced blood components. Leukocyte reduction adds a
significant cost to the price of blood components. Transfusion services are
having a hard enough time at present to get equitable reimbursement for
their products. Chances are likely that insurance and government
reimbursement will not cover the extra cost for leukocyte reduction.
 
    I question why the proposed monthly quality control for leukocyte
reduced blood components must be 20 per month when for all other components
it is 1% of the products produced or 4 per month, whichever is greater. Why
can't leukocyte reduced blood components follow the same guideline? The
number of components drawn at the UCSF Blood Center is small. There are many
times when less than 20 Plateletpheresis are drawn in a month.
 
    In the same vein, requiring 60 consecutive products be sampled during
the validation process could take us a long time for certain products due to
the low volume of our draw. 
 
    I hope that you reconsider making blood suppliers go to universal
leukocyte reduction and I hope that you reconsider the number of products
that need to be sample for validation and monthly quality control.
 
    Sincerely,
    Ellen Eagan MT(ASCP)SBB 
 
Please note my new address - ellen.eagan@clinlab.ucsfmedctr.org
<mailto:ellen.eagan@clinlab.ucsfmedctr.org>