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FDA Proposes Changes to Blood Donation Procedures

By Michael Wheeler Jan 30, 2023 | 1:04 PM

The United States Food and Drug Administration announced Friday it is proposing changes to its blood donation procedures. Currently, the FDA uses time-based deferrals for sexually-active gay men. Put simply, the new procedures would use individual, risk-based assessments in preventing transfusion-transmitted HIV.

“We have an incredibly safe blood supply,” said Dr. Jed Gorlin, Medical Director of Nebraska Community Blood Bank in a conversation with KLIN News. “It’s safe, both because we ask donors lots of questions, but we also have lots of testing. The current risk of HIV, Hepatitis B, or Hepatitis C are so small, we can’t even measure them.”

Men who have sex with men were originally deferred indefinitely, because they were at higher risk for HIV. With advances in testing, that indefinite deferral became shortened to about five years about 10 years ago, then down to one year about five years ago, and then to three months near the beginning of the COVID-19 pandemic.

“Our infectious disease testing can generally catch things very, very early,” said Dr. Gorlin.

Now, the FDA has made draft recommendations to replace time-based deferrals with risk-based assessments, which are similar to policies used by Canada and the United Kingdom. The new assessments would ask specific lifestyle questions to those who want to donate blood, and follow-up questions would be asked in response to certain answers. Dr. Gorlin says this would open up donation opportunities to those who have been unable to donate blood in the past, but it wouldn’t be a dramatic increase.

“There are certainly men [that have been] in monogamous relationships for years that are at no higher risk than many other people,” said Dr. Gorlin.

The proposed changes have numerous hurdles to complete, and the earliest any changes would be made would be toward the end of the year. Blood continues to be safe in Canada and the United Kingdom. See the full news release from the FDA here.