What will the FDA's newly loosened blood donation restrictions mean for donors, blood banks, and the safety of the national blood supply?
In the initial weeks of the COVID-19 pandemic, the U.S. blood banking system found itself facing twin challenges: More patients were being hospitalized and were potentially in need of blood transfusions, while donations dwindled as a result of the implementation of social distancing and the cancellation of blood drives. The threat to the national blood supply prompted the FDA to issue new blood donation guidelines in April 2020, lifting certain longstanding restrictions on who can donate blood – and when.1
The agency reduced the deferral period from 12 months since last exposure to 3 months since last exposure for male donors who have had sex with another man (MSM), female donors who have had sex with an MSM, those with recent tattoos or piercings, and those who have traveled to malaria-endemic areas. The agency had been considering these changes before the pandemic, but the timeline of implementation was accelerated by COVID-19.
"Based on recently completed studies and epidemiologic data, the FDA has concluded that current policies regarding certain donor eligibility criteria can be modified without compromising the safety of the blood supply," the agency explained in its announcement.
Many viewed the changes not only as a step in the right direction for improving current blood supplies, but as a welcome shift away from outdated restrictions and policies that have prevented entire segments of the population from donating blood products.
In the months and years ahead, some experts believe these guidelines will continue to evolve as tools are developed, such as automated laboratory systems and new assays, to identify eligible donors without sacrificing safety.
"Regulators and the blood community are looking into how to ensure that donor deferral policies do not unnecessarily exclude individuals who are able to donate blood safely," Eduardo Nunes, MPP, AABB's Vice President of Science and Practice, told ASH Clinical News. "Researchers are also attempting to determine the efficacy and safety of less restrictive donor deferral policies, as well as develop new safety technologies to promote donor inclusivity while ensuring the security of the blood supply."
ASH Clinical News spoke to representatives from AABB and the American Red Cross, as well as other blood donation experts, to learn more about the safety of the new guidelines, the unique challenges of collecting and providing safe blood products during a pandemic, and the downstream effects of these new rules of blood donation.
The History of Blood Banking Restrictions
To guarantee the safety of the country's donated products, every unit of blood is tested using nucleic acid testing for HIV, hepatitis B and C, and other transfusion-transmissible pathogens. Each donor is asked to complete a donor history questionnaire that provides details about his or her health, medical history, and behavioral histories, explained Dawn Ward, MD, Medical Director of the UCLA Blood & Platelet Center and Assistant Clinical Professor in the Department of Pathology and Laboratory Medicine at UCLA's David Geffen School of Medicine.
Donation restrictions for MSM and their female contacts began during the HIV/AIDS epidemic of the 1980s. When a 1983 study suggested that AIDS was caused by a bloodborne pathogen, concerns rose worldwide that this unidentified, potentially lethal pathogen could have contaminated the nation's blood bank supplies. At the time, HIV/AIDS was more prevalent among gay men than the general population, so the FDA issued a blanket, lifetime ban against MSM blood donations.2
Despite advances in HIV testing and blood screening procedures over the following decades, the ban remained in place. The policy drew increasing criticism for excluding donors based solely on sexual orientation.
It wasn't until December 2015 that the FDA revised the policy, shortening the lifetime ban to a deferral period of 12 months – meaning MSM donors must wait at least 1 year after their last sexual encounter with a man before donating blood.3
"With respect to MSM, the FDA implemented these deferrals decades ago," Mr. Nunes said. "While the agency still cites safety as the driving reason for these deferrals, there also has been an acknowledgment that the conditions the agency was initially responding to have changed significantly."
In 1994, the FDA also implemented deferral periods for people who have traveled to malaria-endemic regions and could have possibly been exposed to malaria – which can be transmitted by transfusion of blood or blood components collected from an infected donor, according to the agency's revised recommendations.4 The guidelines were issued in an attempt to prevent transfusion-transmitted malaria (TTM) in the U.S., where the disease has nearly been eradicated.
The risk of TTM is currently estimated at less than 0.1 per million red blood cell transfusions. There is no FDA-licensed test to screen blood donors for malaria, so the deferral policy likely prevented cases of TTM but "also resulted in a significant loss of otherwise-eligible donors," the FDA noted.
In its April update, the FDA also finalized January 2020 draft guidance that eliminated the recommended deferrals for those who had spent time in certain European countries or on military bases in Europe and were once considered a "potential risk" for transmitting Creutzfeldt-Jackob disease (CJD) or variant Creutzfeldt-Jakob disease (vCJD), neurodegenerative disorders that were linked to ongoing outbreaks of mad cow disease primarily in Europe in the 1980s and '90s.
When a small number of CJD and vCJD cases were found to have been contracted through receipt of blood from an asymptomatic infected donor in the 1990s, the FDA banned blood donations from people who had spent at least 3 months cumulatively in the U.K. between 1980 and 1996, 6 months on U.S. military bases in Europe, or a total of 5 years in Europe since 1980. In addition, anyone who received a blood transfusion in the U.K. or France since 1980 was banned from donating blood in the U.S. However, given the rarity of these infections, the recent FDA update rescinds the recommendation to screen blood donors for geographic risk, receipt of a blood transfusion in certain vCJD-risk countries, certain risk factors for iatrogenic CJD, having blood relatives with CJD, and a history of injecting bovine insulin.
In addition to shortening the deferral periods for certain groups, the guidance also provided notice of "an alternate procedure that permits the collection of blood and blood components from such donors without a deferral period, provided the blood components are pathogen-reduced using an FDA-approved pathogen reduction device."
The FDA put other alternative procedures in place designed to boost the stockpile of blood products but noted that these procedures are only temporary. "Specifically, blood centers are no longer required to discard collections based on errors in blood pressure, pulse, weight, and donation interval," Mr. Nunes said. Blood centers also will now have 72 hours – rather than 24 – to clarify a donor's response on the donor history questionnaire or obtain omitted information required to determine donor eligibility.
The New Future of Blood Donation?
When the FDA modified the deferral period for MSM and those who traveled to malaria-endemic areas, it was responding to a significant decrease in the volunteer-based national blood supply amid the COVID-19 pandemic.
Blood banks across the country have taken a significant hit as more Americans are working from home and may not want to risk breaking social distancing guidelines to donate blood. Blood's limited shelf life puts a further strain on the national blood supply.
"Throughout this pandemic, the Red Cross has seen thousands of blood drive cancellations across the country due to coronavirus concerns, resulting in hundreds of thousands of fewer blood donations," Jodi Sheedy, Senior Director of Integrated Communications at the American Red Cross, told ASH Clinical News. "As community organizations, businesses, and schools restrict access to facilities once open to local events and members of the public, Red Cross blood drives at these locations also continue to be canceled."
Mr. Nunes said that several times since the COVID-19 pandemic began, significant portions of the U.S. have operated with less than one day's supply of type O blood units on hand.
"This means that a mass casualty event anywhere in the country would have been profoundly destabilizing," he said.
After the initial shortage this spring, Mr. Nunes said the blood banking community and policy makers urged people to donate, prompting a resurgence in supply. "As the pandemic progressed, hospitals stopped performing non-emergency procedures, which resulted in reduced blood utilization," he explained. "Then, as the country reopened and resumed non-emergent and elective services, blood utilization quickly escalated, and the blood supply was once again strained."
Despite the FDA's changes in guidance, Ms. Sheedy said the American Red Cross remains "steadfast in its commitment to ensure that every blood recipient has access to safe and lifesaving blood products when needed."
The organization has implemented specific measures during the pandemic to keep both donors and staff safe during the donation process. These include checking temperatures at donation sites, providing hand sanitizer before drives, social distancing, wearing face masks, disinfecting surfaces and equipment, and emphasizing the importance of appointments to control crowd sizes.
It appears that the drop in donations during the pandemic is affecting more groups than others. In September, which is Sickle Cell Awareness Month, the American Red Cross declared an urgent need for blood donations from Black donors after seeing a "significant decrease" in their numbers in the first half of 2020. For example, in 2019, more than 15,000 Black donors gave blood at educational institutions across the country; this year, in part due to in-person school closures, that number has dropped to 2,700.5
"Sickle cell patients can require multiple blood transfusions to alleviate this throughout their lifetime to help treat their disease, and Black and diverse blood donors are essential in helping [these] patients recover from crisis and prevent more serious complications like acute anemia, tissue and organ damage, and strokes," Yvette Miller, MD, Executive Medical Director for the American Red Cross's Donor & Client Support Center, said in the release.
Is 3 Months Still Too Long?
The decision to reduce the deferral period for MSM was welcomed by the blood community. The American Society of Hematology (ASH) issued a statement of support, stressing that maintaining a safe and sufficient blood supply is vital to supporting public health during the pandemic.6 "We appreciate the FDA's efforts to accelerate its plans to expand the pool of healthy blood donors at this urgent time when blood donations have decreased," 2020 ASH President Stephanie Lee, MD, MPH, of Fred Hutchinson Cancer Research Center, said. "It's important for the public to realize that these changes were already being developed prior to COVID-19 based on evidence that blood donated by these individuals is safe. COVID-19 simply accelerated the updated regulations because of the need to allow every healthy and willing person to donate."
"It is an important step toward ensuring that anyone who is able to donate blood can do so without unnecessary deferrals," Mr. Nunes added.
Dr. Ward said she was "extremely happy and grateful" the FDA implemented the new guidelines and said the U.S. now mirrors the deferral period established for MSM donations in the U.K. "We've had many questions from donors, specifically in regard to the MSM policy and how they felt that it was somewhat discriminatory," she said. "Having that decrease in the deferral from 12 months to 3 months is a move in the right direction."
Still, she acknowledged that a 3-month deferral is "not 100% percent to where donors would like it." Others have questioned whether the new guidelines are doing enough to identify healthy donors.
Jesse Ehrenfeld, MD, MPH, Professor of Anesthesiology and Health Policy at Vanderbilt University, has transfused thousands of blood products during his career, but, as a gay man in a monogamous relationship, he is restricted from donating his own blood.
"This is an issue that is so near and dear to my heart because I use these products, my patients' lives depend on these products, and yet I am unable to donate blood because I happen to be gay, even though I am married and in a monogamous relationship with my husband," said Dr. Ehrenfeld, who also is Intermediate Chair of the American Medical Association's Board of Trustees.
"There is no evidence that supports the effectiveness of the 12-month deferral period," he said, "and we know that a less stigmatized approach to blood donation criteria could simultaneously maintain the safety of the blood supply while ensuring that we have more product available."
Dr. Ehrenfeld added that, in the past 20 years, there have been no documented cases of HIV transmission through plasma-derived products in the U.S.
"Every 2 seconds, someone in America needs blood. When you think about what that means, we need to be doing everything we can while ensuring the safety of the blood supply to make sure that eligible donors aren't turned away because of an outdated policy," he said.
In a 2016 editorial, Chana Sacks, MD, laid out the policy's flawed logic: A low-risk candidate like Dr. Ehrenfeld is banned from donating blood, while a heterosexual man who has had unprotected sex in the past month with multiple women of unknown HIV status is allowed to donate.7
A low-risk MSM donor "has been told unequivocally that the medical community sees his blood as unclean, not because of high-risk behavior but because of the sex of his spouse," she continued.
Dr. Ehrenfeld pointed to the nucleic acid testing done in blood banks, which can detect HIV soon after exposure, as further evidence that the deferral window could be safely reduced even further. The risk of transmission is not zero, though: HIV NAT returns a positive result within 9 to 10 days after infection. If an individual donates soon after getting infected with HIV – during the 9-day window – before specific antibody is detectable, the screening test returns a negative result, meaning the donated unit may infect a transfusion recipient. However, with improved testing, noted Dr. Sacks, the risk of transmitting HIV through a blood transfusion is 1 in 1.5 million – lower than the risks of transmitting hepatitis C (1 in 1.1 million) and hepatitis B (1 in 282,000).
"These advances in blood safety have everything to do with improved testing technology and nothing to do with progress in deferral practices," she wrote, adding that the blood screening policies should rely "on our current best evidence rather than remaining mired in a history of our worst fears."
Instead of relying on "categorical restrictions" on certain segments of the population, Dr. Ehrenfeld would like to see the FDA develop "appropriate risk-based criteria" for donors. In the example above, the MSM at a low risk for HIV would be allowed to donate blood, while the heterosexual donor who engages in risky behavior would be ineligible.
Changes and Challenges
Instituting individual risk assessments would be a challenge for the U.S.' large blood donation system, if the experience with relatively small changes in the MSM and travel-related deferral periods is any indication.
The recommendations were revised in April, but their implementation was not immediate or universal. For example, soon after the new guidance was released, coronavirus survivor Lukus Estok tried to donate blood plasma for a test program in New York City designed to treat severely ill COVID-19 patients. He was turned away after revealing that he was gay.
"I was shocked," he told NBC News.8 "I've been through a month of hell with this virus. I'm finally recovered. I've been through a screening process that tells me I'm a potential candidate to help somebody else and now I am being told I can't."
An investigation by the news outlet revealed that Mr. Estok and other gay men were being turned away because many blood donation centers had not updated their computer systems or completed staff training to incorporate the new guidelines into their policies and practices.
It's an obstacle many blood donation centers are facing across the U.S.
"Transfusion medicine is one of the most regulated areas within medicine," Dr. Ward told ASH Clinical News. "Everything we do is by either a regulation, policy, or procedure, so to make a change, especially one of this magnitude, we had to go through pretty much all of our procedures that support the donor history questionnaire and change them."
The UCLA Blood & Platelet Center also had to update its donor information system, validate the changes to make sure they were correct, train approximately 80 staff members, update its donor materials in both English and Spanish, and develop marketing campaigns to educate the public about the policy changes.
"It's just a lot of pieces that need to come together," she said. But, after putting in months of work, the blood bank was able to implement the new guidelines at the beginning of August.
Ms. Sheedy told ASH Clinical News that the American Red Cross has "worked aggressively to implement these changes in an expedited manner," which often involves complex system updates, staff training, and individual donor record updates.
Fewer Restrictions = More Donors?
Time will tell how the new changes will affect the national blood supply, but experts are optimistic that increasing the number of potential donors will translate to more donations.
"We welcome these changes, which we hope will allow more individuals to donate much-needed blood and ensure we can meet patient needs during the pandemic and beyond," Ms. Sheedy said.
Dr. Ehrenfeld said no survey data have been collected to determine the effect of the 3-month deferral on potential donors, but past research has shown that a large number of people were prevented from donating when the 12-month deferral was in place.
"Around 2 million potential donors who are men who have sex with men in the U.S. were unable to donate when there was a 12-month deferral," he said.9
Surveys of self-identified MSM revealed that about 90% of respondents were interested in donating blood – yet only 9% met the 12-month deferral criteria that were still in place and 5% were willing to be abstinent for 1 year to meet the criteria.10 More than one-quarter admitted to donating blood at least once in the past, despite not meeting deferral criteria.
If the 3-month deferral period were further reduced, Dr. Ehrenfeld added, "experts believe it would allow somewhere in the neighborhood of 300,000 more pints of blood to be collected."
At UCLA, Dr. Ward said they have already seen the benefits of the new guidelines. Staff identified 2,500 new people who were now eligible to donate blood products. "One of the most common reasons we deferred donors is their travel history," she explained. "Decreasing the window for people who have traveled to malaria-endemic countries has been extremely helpful."
Many also believe that, as new research is conducted, the guidelines could undergo further changes.
"I think 3 months is a great start," Dr. Ward said. "I truly believe that we'll continue reviewing the data and, hopefully, in the future we will make additional changes." â€”By Jill Sederstrom
- FDA. Coronavirus (COVID-19) Update: FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic. Accessed August 27, 2020, from https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-updated-guidance-address-urgent-need-blood-during-pandemic.
- FDA. Memorandum: Recommendations to Decrease the Risk of Transmitting Acquired Immune Deficiency Syndrome (AIDS) from Blood Donors, March 24, 1983. Accessed September 7, 2020, from https://www.fda.gov/media/92490/download.
- FDA. Revised recommendations for reducing the risk of human immuno-deficiency virus transmission by blood and blood products – questions and answers. Accessed September 7, 2020, from https://www.fda.gov/vaccines-blood-biologics/blood-blood-products/revised-recommendations-reducing-risk-human-immunodeficiency-virus-transmission-blood-and-blood.
- FDA. Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria. Accessed August 27, 2020, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/revised-recommendations-reduce-risk-transfusion-transmitted-malaria.
- The American Red Cross. Red Cross Has Urgent Need for More Black Blood Donors to Help Sickle Cell Patients. Accessed on September 11, 2020, from https://www.redcross.org/about-us/news-and-events/press-release/2020/red-cross-has-urgent-need-for-more-black-blood-donors-to-help-sickle-cell-patients.html.
- American Society of Hematology. ASH Statement on FDA's Updated Blood Donor Eligibility Guidelines. Accessed August 27, 2020, from https://www.hematology.org/newsroom/press-releases/2020/ash-statement-on-updated-blood-donor-eligibility-guidelines.
- Sacks CA, Goldstein RH, Walensky RP. Rethinking the ban – the U.S. blood supply and men who have sex with men. N Engl J Med. 2017;376:174-177.
NBC News. Gay men still unable to donate blood and plasma despite new FDA guidelines. Here's why. Accessed August 26, 2020, from https://www.nbcnews.com/health/health-care/gay-men-still-unable-donate-blood-plasma-despite-new-fda-n1182926.
- FiveThirtyEight. FDA Suggests Rule Change That Could Allow 2 Million People To Donate Blood. Accessed September 7, 2020, from https://fivethirtyeight.com/features/fda-suggests-rule-change-that-could-allow-2-million-people-to-donate-blood/.
- Liszewski W, Terndrup C, Jackson NR, et al. The beliefs and willingness of men who have sex with men to comply with a one-year blood donation deferral policy: a cross-sectional study. Transfusion. 2017;57:2234-2239.