Hemoglobin/Hematocrit Acceptance Standards and Interdonation Interval in Blood Donors
July 27, 2010
M. Allene Carr-Greer, Director, Regulatory Affairs
AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. Members are located in more than 80 countries.
FDA is seeking advice from the Committee on the appropriate hemoglobin or hematocrit standard for blood donors and appropriate interdonation intervals. Current AABB Standards are in agreement with the rule finalized by FDA in 1999 establishing a minimum hemoglobin requirement of 12.5g/dL or hematocrit of 38% for both male and female allogeneic donors. This rule also established the interdonation interval of eight weeks for single unit donations.
As noted in the Issue Summary prepared for this BPAC meeting the FDA published a proposed rule in November 2007 (Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use) and requested among other things comments and supporting data on the issues before the Committee today. AABB provided no comments to the issue of changing interdonation intervals. With the knowledge that the REDS II data would begin to be available to inform the discussion on acceptable hemoglobin levels AABB responded:
The issue of changing the acceptable hemoglobin/hematocrit levels for males or females is controversial and requires further investigation. It is anticipated that some relevant data will become available from the REDS II study and should inform any subsequent guidance. The study aims to evaluate the effects of blood donation on iron and hemoglobin levels among donors. It also will help identify the optimal measures for predicting iron and hemoglobin depletions that lead to blood donor deferrals. Until the results of the REDS II study are published, we believe that it would be premature to specify changes to hemoglobin or hematocrit requirements in the final rule.
More data that will be very informative to the questions asked here today are expected in the near future from the recently completed REDS-II Donor Iron Status Evaluation (RISE) study, which has completed study subject follow-up enrollment and laboratory testing and is now in the analysis phase. We believe it is critical to wait for these data so that all available scientific evidence is evaluated and incorporated into this decision making process. If the data show that gender specific acceptance standards for hemoglobin/hematocrit and/or interdonation intervals are indicated, blood centers will need to develop procedures to ensure that these new standards are fully integrated into the rigorous CGMP environment.