Statement of AABB

Before the Transmissible Spongiform Encephalopathies Advisory Committee

February 8, 2005

 

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.