FDA Revises Guidance for Blood Donation Deferral

The FDA has lifted the indefinite deferral of blood donation for men who have sex with men.

Continuing efforts to reduce the risk of human immunodeficiency virus (HIV) transmission, the FDA recently released updated guidance on blood donation practices.1

Currently, the risk of HIV transmission through blood and blood products is reduced through the use of primary scientific research, deferral questions asked to patients prior to donation, donor education materials, and HIV testing of donated blood. The FDA continually evaluates new scientific research that is available to revise practices in an evidence-based manner in an effort to reduce and eliminate the risk of transmission.

Previously, men who have sex with men were indefinitely deferred from blood donation. Under the revised guidance released on December 21, 2015, however, the FDA modified its recommendation to reduce their deferral criteria to 12 months since the last sexual encounter with another male.

These recommendations were based on recent data from research studies recommended by the Interagency Blood, Organ & Tissue Safety Working Group. The data collectively concluded that there was no risk to the blood in reducing the deferral period to 12 months in this patient population.

The FDA also pointed to Australia’s similar policy change from indefinite deferral of men who have sex with men to 12 months. Surveillance data in Australia from 5 years before and 5 years after implementation of the revised deferral policy showed there was no difference in the risk to the blood supply in this patient population.

Other patient populations in which revisions were made to recommendations include individuals with hemophilia or other related clotting disorders who have received clotting factor concentrates. These patients were previously deferred indefinitely due to a presumed increased risk of HIV transmission.

Although new data suggest that these patients are not at a higher risk for HIV, the revised guidance still recommends indefinite deferral for patient protection due to the large needles used for collecting blood during donation.

The guidance also provides revisions to donor educational materials, the donor history questionnaire, donor requalification, and the retrieval and quarantine of blood products, including disposition and labeling.

Recommendations to defer patients indefinitely remain in place for the following populations:

  • Individuals ever testing positive for HIV
  • Individuals ever exchanging sex for money or drugs
  • Individuals ever engaging in injection of non-prescribed substances

In the case of transgender individuals, the FDA recommends that for the purposes of the donor history questionnaire, male or female gender should be self-identified and self-reported.

The HIV Medicine Association (HIVMA) released a statement supporting the revised guidance.2 However, it also recommended that any blood donor be deferred if they tested positive for HIV, injected non-prescribed substances, or engaged in sexual activity with an individual with HIV or unknown HIV status within the previous 6 months.

References

1. FDA. Revised recommendations for reducing the risk of human immunodeficiency virus transmission by blood and blood products. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM446580.pdf. December 2015. Accessed January 6, 2016.

2. HIV Medicine Association. HIVMA hails progress in revised blood donor guidance, calls for further evidence-based updates. http://www.hivma.org/Dec2015BloodDonation.aspx. December 21, 2015. Accessed January 6, 2016.