Evaluation of donor hemoglobin (HB) or hematocrit performed during the donor eligibility process helps ensure the donor can safely experience the loss of blood that results through blood donation. The loss of red blood cells and the resulting potential for postdonation iron deficiency is addressed by AABB’s recommendations in
Association Bulletin #12-03 “Strategies to Monitor, Limit, or Prevent Iron Deficiency in Blood Donors.”
Minimum donor HB requirements are addressed in FDA’s final rule, “Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,” effective May 23, 2016. FDA evaluated the normal range of HB levels to help prevent iron depletion in male allogeneic donors and revised the eligibility requirements accordingly. The Final Rule established a new minimum HB requirement of 13.0 g/dL, or a hematocrit value that is ≥39%, that aligns more closely with the low range of normal levels for men.
Likewise, FDA evaluated the normal range of HB levels in female allogeneic donors. Although the Final Rule maintained current requirements for HB and hematocrit levels for female donors at a minimum of 12.5 g/dL and 36%, respectively, the FDA recognizes that HB levels lower than 12.5 g/dL are also within the normal range for women. 21 CFR 630.10(f)(3)(i)(A) authorizes blood collections “from female allogeneic donors who have a hemoglobin level between 12.0 and 12.5 grams per deciliter of blood, or a hematocrit value between 36 and 38 percent, provided that you [the establishment] have taken additional steps to assure that this alternative standard is adequate to ensure that the health of the donor will not be adversely affected due to the donation, in accordance with a procedure that has been found acceptable for this purpose by FDA.”
AABB has released Association Bulletin (AB) #17-02, Updated Strategies to Limit or Prevent Iron Deficiency in Blood Donors. This bulletin supersedes AB #12-03. Developed by the AABB Donor Health and Safety Committee and approved by the AABB Board of Directors, the bulletin recommends actions to prevent or mitigate post-donation iron deficiency.
Members of the Food and Drug Administration’s Blood Products Advisory Committee (BPAC) heard presentations on a wide range of issues related to managing the risk for iron deficiency in blood donors. AABB issued a
statement announcing that the association has been actively examining these issues through its Donor Health and Safety Committee and is ready to facilitate discussions to formulate recommendation strategies. The statement also emphasized AABB’s position to develop standards, promote donor awareness, and provide educational materials.
AABB posted proposed strategies for
Management of risk for iron deficiency in female blood donors with HB levels of 12.0 - <12.5 to assist blood collections establishments with developing SOPs for submission to FDA as part of a prior approval supplement.