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New Donation Rules Begin Taking Effect in U.S. Blood Banks

New Donation Rules Begin Taking Effect in U.S. Blood Banks

The revised guidelines focusing on personal risk from the U.S. Food and Drug Administration have now been adopted by the American Red Cross, signaling a new era for blood donation.

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Written by Kara Mason on August 18, 2023

Revised blood donation rules that do away with a rule that defers men who have sex with men (MSM) to abstain from sex for three months prior to donating blood are beginning to be implemented into blood banks throughout the country.

The American Red Cross announced on Aug. 7 that it has adopted the U.S. Food and Drug Administration’s (FDA) updated final guidance, approved in May, on individual donor assessment for all blood donors regardless of gender or sexual orientation. It’s a move that many in health care have been awaiting, says Mary Berg, MD, professor of clinical practice in the Department of Pathology at the University of Colorado School of Medicine and medical director of transfusion services.  

“By the year 2000, people were already starting to say it was time to revisit the rules that were set in the 1980s because of the HIV epidemic,” she says. “We knew that within 90 days we would be able to detect HIV, so the question became why people were being banned indefinitely. Now our testing is even better so we can see an infection within 10-12 days of it starting.”

In 2020, the FDA changed its rules from deferring indefinitely to three months.

The most recent set of rules passed in 2023, signal a new era for blood donation that the FDA and physicians, including Berg, say is based on evidence and more inclusive to LGBTQI+ communities.

New guidelines invite new questions for donors

“Right now, when you go to donate blood, before they stick a needle into the vein or do anything else, they go through a long list of questions,” Berg explains of the donor process. “It starts with how you’re feeling that day and then they ask about medication, travel, and a bunch of other factors that might affect eligibility.”

The new guidelines eliminate screening questions specific to MSM and women who have sex with MSM. Instead, the new policy recommends asking every donor the same set of screening questions that address personal risk, including behavior that raises risk for HIV. After the screening, potential donors will either be allowed or not based on risk factors for HIV and other diseases that can spread through transfusion.

All prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, and anal sex in the past three months, will be deferred to reduce the likelihood of donations by individuals with new or recent HIV infection, the agency says. People taking medications to treat or prevent HIV infection, such as antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) will also be deferred.

Other diseases found in the blood are now more worrisome to those in transfusion circles, Berg says. Hepatitis C , a virus in the liver that spreads through contact with blood from an infected person, is becoming a bigger concern than HIV, which is highly treatable in the U.S.

“Hepatitis C leads to a lot of cases of hepatocellular carcinoma when not detected,” Berg explains. “There are other more uncommon concerns as well, like Chagas disease, which is caused by a parasite in South America and can lead to heart failure. Malaria can also be transmitted by blood, but we don’t let people donate until we know that they don’t have these diseases.”

The same now goes for HIV with the new rules.

Changes forthcoming for blood banks

Vitalant, the most prominent blood supplier in Colorado, says it’s working to make the transition to the FDA’s guidance as quickly as possible and is currently updating donation materials and computer systems.

“Everybody wants to implement these rules, but there are a lot of internal processes that have to change,” Berg explains. “The blood donation sector is tightly regulated by the FDA so that we can avoid and mitigate infection, and that’s what causes this new change to take time to implement. These blood banks just need some additional time to update questionnaires.”

The American Red Cross, which supplies about 40% of the nation’s blood, says the organization looks forward to welcoming those who may be newly eligible to give blood and recognizes the impact the previous FDA policy had on the LGBTQI+ community.

“Changing this policy means that allies of the LGBTQ community are probably more open to donating in general now, too” Berg says. “It’s an overall positive change.”

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Mary Berg, MD