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FDA updates blood donor referral policy

Tuesday, December 22, 2015

The FDA has issued final guidance outlining updated blood donor deferral recommendations to help ensure continued safety of the blood supply by reducing the risk of human immunodeficiency virus (HIV) transmission by blood and blood products.

“The FDA’s responsibility is to maintain a high level of blood product safety for people whose lives depend on it,” said Acting Commissioner Stephen Ostroff, M.D. “We have taken great care to ensure this policy revision is backed by sound science and continues to protect our blood supply.”

The agency reviewed its policies regarding HIV transmission through blood products to determine appropriate changes based on the most recent scientific evidence. Moving forward, the FDA will continue to reevaluate its blood donor deferral policies as new scientific information becomes available.

Using the approach of following the best available science together with use of donor education materials, specific deferral questions and advances in HIV donor testing has helped the FDA reduce the HIV transmission rates from blood transfusion from one in 2,500 to one in 1.47 million.

As part of the finalized blood donor deferral guidance, the FDA is changing its recommendation that men who have sex with men (MSM) be indefinitely deferred—a policy that has been in place for about 30 years—to 12 months since the last sexual contact with another man. The updated recommendations better align the deferral period for MSM with the deferral period for other men and women at increased risk for HIV infection, such as those who had a recent blood transfusion or those who have been accidentally exposed to the blood of another individual. The agency examined a variety of recent studies, epidemiologic data and shared experiences from other countries that have made recent MSM deferral policy changes.

The guidance also recommends that blood establishments make corresponding revisions to donor educational materials, donor history questionnaires and accompanying materials, as well as donor requalification and product management procedures.

Additionally, the guidance reflects a change in the rationale for deferring people with hemophilia or related clotting disorders who have received clotting factor concentrates. Previously, potential donors with hemophilia or related clotting disorders were deferred due to the increased risk of HIV transmission to potential recipients. Based on new scientific evidence, those potential donors are still deferred, but not due to the risk of HIV transmission—instead, for their own protection due to potential harm from large needles used during the donation process.

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