Before the
Transmissible Spongiform Encephalopathies Advisory Committee
Deferral
of Blood and Plasma Donors for History of Transfusion in France and Other
European Countries
Presented
by M. Allene Carr-Greer, MT (ASCP) SBB
Deputy
Director, Regulatory Affairs
AABB is an international
association dedicated to advancing transfusion and cellular therapies worldwide. Our members include more than 1,800 hospital and
community blood centers and transfusion and transplantation services as well as
approximately 8,000 individuals involved in activities related to transfusion,
cellular therapies and transplantation medicine. For over 50 years, AABB has
established voluntary standards for, and accredited institutions involved in, these
activities. AABB is focused on improving health through the advancement of
science and the practice of transfusion medicine and related biological
therapies, developing and delivering programs and services to optimize patient
and donor care and safety.
The AABB believes that deferring donors who were transfused in France or other European countries would not significantly affect the blood supply. However, we are concerned about the increasing number of reasons for donor deferrals, some of them of very low risk benefit ratio. Continual addition of new questions distracts donor attention from the more significant risk questions and decreases the likelihood that donor questioning will elicit important and significant information. Although each added deferral in and of itself may not impact supply, the additive effect will almost certainly adversely affect supply, so the risk benefit must be carefully considered. It would be useful for FDA to examine all of the existing donor suitability criteria to determine whether each of these criteria is still necessary in light of current scientific knowledge and testing capability. Finally the FDA should consider whether it is essential for the blood banking community to focus efforts on this particular deferral issue, or whether there are other concerns that would yield more benefit.