On Dec. 21, the FDA issued final recommendations(www.fda.gov) updating its blood donor deferral policy to reflect the latest scientific evidence on reducing the risk of 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 FDA Acting Commissioner Stephen Ostroff, M.D., in a news release.(www.fda.gov) "We have taken great care to ensure this policy revision is backed by sound science and continues to protect our blood supply."
The FDA said that applying the best available science, offering donor education materials and asking specific deferral questions, together with advances in HIV testing, have helped reduce the rate of HIV transmission via blood transfusion from one in 2,500 to one in 1.47 million.
What Physicians Need to Know
The new policy changes the recommendation regarding blood donations by men who have sex with men (MSM) from an indefinite deferral to a deferral of 12 months since last sexual contact with another man.
- The FDA has changed its recommendation regarding blood donations by men who have sex with men (MSM) from an indefinite deferral to a deferral of 12 months since last sexual contact with another man.
- The agency recommends that blood donation establishments revise their materials, questionnaires and procedures to reflect the change.
- In addition, the FDA said patients with hemophilia or similar clotting disorders should be deferred from donating blood because of the potential harm from large needles used during donation.
This recommendation better aligns with the deferral periods for others at increased risk for HIV infection, such as those who have had a recent blood transfusion or who have accidentally been exposed to another person's blood.
To assess its policy, the FDA reviewed recent studies, epidemiologic data and recommendations from other countries that recently made changes to their MSM blood donation deferral policies.
"In reviewing our policies to help reduce the risk of HIV transmission through blood products, we rigorously examined several alternative options, including individual risk assessment," said Peter Marks, M.D., Ph.D., deputy director of the FDA's Center for Biologics Evaluation and Research, in the news release. "Ultimately, the 12-month deferral window is supported by the best available scientific evidence, at this point in time, relevant to the U.S. population. We will continue to actively conduct research in this area and further revise our policies as new data emerge."
Several countries, including the United Kingdom and Australia, currently have 12-month blood donation deferral periods for MSM.
When Australia changed its blood donation policy for MSM from an indefinite to a 12-month deferral, studies evaluated more than 8 million units of donated blood and found no change in risk to the blood supply. Similar data were not available for shorter deferral intervals.
The FDA guidance recommends that blood donation establishments revise their donor educational materials, donor history questionnaires and accompanying materials, as well as procedures for donor requalification and product management, to reflect the 12-month deferral period for MSM.
In addition, the FDA changed the rationale for deferring patients with hemophilia or similar clotting disorders who have received clotting factor concentrates. Previously, these deferrals were based on an increased risk of HIV transmission. But new evidence suggests these patients should be deferred instead to protect them from the potential harm of large needles used during the donation process.
The FDA's frequently asked questions resource(www.fda.gov) on its revised recommendations includes a full list of potential blood donor deferrals.
The agency also has implemented a blood supply safety monitoring system with assistance from the NIH's National Heart, Lung and Blood Institute, which will help inform future actions on blood donor policies.
The AAFP supported the proposed change to the MSM deferral policy in an April 8, 2015, letter(1 page PDF) from (then) Board Chair Reid Blackwelder, M.D., of Kingsport, Tenn., to Margaret Hamburg, commissioner of the FDA's consumer affairs branch.
The letter noted the Academy's support for standards that are based on sound scientific evidence, and said the United States -- where it is estimated that a blood transfusion is required every two seconds -- has a critical need for blood donations.
"The current standards excluding men who have ever had sexual contact with another man since 1977 is not scientifically justifiable and excludes a large population of potential donors," the letter said.
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