Potential impact on blood availability and donor iron status of changes to donor hemoglobin cutoff and interdonation intervals

Abstract

Background: A minimum male hemoglobin (Hb) level of 13.0 g/dL becomes a Food and Drug Administration requirement effective May 2016. In addition, extending whole blood (WB) interdonation intervals (IDIs) beyond 8 weeks has been considered to reduce iron depletion in repeat blood donors. This study estimates the impact these changes might have on blood availability and donor iron status.

Study design and methods: Six blood centers participating in Retrovirus Epidemiology Donor Study-II (REDS-II) collected information on all donation visits from 2006 to 2009. Simulations were developed from these data using a multistage approach that first sought to adequately reproduce the patterns of donor return, Hb and ferritin levels, and outcomes of a donor's visit (successful single- or double-red blood cell donation, deferral for low Hb) observed in REDS-II data sets. Modified simulations were used to predict the potential impact on the blood supply and donor iron status under different Hb cutoff and IDI qualification criteria.

Results: More than 10% of WB donations might require replacement under many simulated scenarios. Longer IDIs would reduce the proportion of donors with iron depletion, but 80% of these donors may remain iron-depleted if minimal IDIs increased to 12 or 16 weeks.

Conclusion: Higher Hb cutoffs and longer IDIs are predicted to have a potentially large impact on collections but only a modest impact on donor iron depletion. Efforts to address iron depletion should be targeted to at-risk donors, such as iron supplementation programs for frequent donors, and policy makers should try to avoid broadly restrictive donation requirements that could substantially reduce blood availability.

Fig 1

Modeled estimates for change in hemoglobin deferral risk, hemoglobin levels, and iron levels in low- and high-intensity donors following donation Red line = Males; Green line = Females < 50 years-old; Blue line = Females ≥ 50 years-old. Panels 1A-B show estimated change in risk for Hb deferral (Odds ratio) for those with 1–3 donations (1A) and 4+ donations in prior 2 years (1B); comparisons for Hb deferral risk are intra-group. For low- and high-intensity donors (similarly defined), Panels 1C–D show estimated recovery of Hb levels (g/dL) and Panels 1E-F recovery of iron levels (% decrease in ferritin). For Panels 1C-F, the vertical line reflects the current deferral period.

Fig 2

a: Change in Red Cell Collections, Hb Deferrals, and AIS at Donation by Gender under 3 alternate scenarios b: Change in Red Cell Collections, Hb Deferrals, and AIS at Donation by Race under 3 alternate scenarios Sim 1: Male Hb = 12.5, Female Hb = 12.5, Male Interval = 12 weeks, Female Interval = 12 weeks Sim 4: Male Hb = 13.0, Female Hb = 12.0, Male Interval = 8 weeks, Female Interval = 8 weeks Sim 8: Male Hb = 13.5, Female Hb = 12.5, Male Interval = 12 weeks, Female Interval = 12 weeks

Fig 2

a: Change in Red Cell Collections, Hb Deferrals, and AIS at Donation by Gender under 3 alternate scenarios b: Change in Red Cell Collections, Hb Deferrals, and AIS at Donation by Race under 3 alternate scenarios Sim 1: Male Hb = 12.5, Female Hb = 12.5, Male Interval = 12 weeks, Female Interval = 12 weeks Sim 4: Male Hb = 13.0, Female Hb = 12.0, Male Interval = 8 weeks, Female Interval = 8 weeks Sim 8: Male Hb = 13.5, Female Hb = 12.5, Male Interval = 12 weeks, Female Interval = 12 weeks