July 18, 2022
This article originally appeared in AABB News, a benefit of AABB membership.
The U.S. Food and Drug Administration (FDA) recently announced the removal of outdated recommendations that for many years have required blood centers to indefinitely defer blood donors for geographic risk of possible exposure to bovine spongiform encephalopathy, the main cause of variant Creutzfeldt-Jakob Disease (vCJD).
This recommendation is just the latest evidence-based adjustment among many released by the FDA since the beginning of the COVID-19 pandemic that are designed to remove outdated donation requirements, expanding blood donor eligibility. The crucial timing of FDA’s actions carries increased significance because historically only a small percentage of those who are eligible in the United States actually donate, and in the years since the start of the pandemic, the pressure to expand the donor pool to meet patients’ needs for blood has only increased.
Many of the headlines related to blood donation in the past three years have repeated similar messages: “blood emergency,” “desperate need for donors,” and “national blood shortage.” Even as recently as January, the American Red Cross declared its first-ever “blood crisis.”
The timing of FDA’s updated requirements removing unnecessary barriers to blood donation is crucial because it is becoming clear that the pandemic may no longer be the only factor affecting this blood shortage. The American Red Cross has also noted extreme weather conditions and staffing limitations.
AABB News recently spoke with members of the blood services community to discuss these recent changes to donor eligibility and what additional changes they hope to see in the future.
In April 2020, the FDA first announced its decision “to help ensure we have an adequate blood supply, while still protecting the safety of our nation’s blood supply” with the first in a series of updated guidances removing outdated donor eligibility criteria.
“To me, the biggest change in this announcement were the changes in the HIV deferrals, and I applaud the FDA for doing it,” said Mary Townsend, MD, senior medical director of the national office at Vitalant in Scottsdale, Ariz., and chair of the AABB Donor History Task Force.
In updates to its 2015 HIV risk guidance, the FDA made a range of changes, including addressing these outdated time frames for deferrals:
Yvette M. Miller, MD, the executive medical officer for the American Red Cross Donor and Client Support Center, called this change “critically important.” “The LBGTQ+ community, and particularly the segment of men who have sex with men, has been advocating for a change to no deferral and to move to a risk-based questionnaire,” Miller said. “This was an important change moving in that direction.”
What was also important was how quickly the change came about, Miller stressed. “This quick pivot showed how quickly the FDA could make a change to these recommendations,” she said.
The 2020 announcement also included an update to remove requirements related to the potential for transmission of CJD and vCJD initiated in 1999. The recommendations, which were updated again in May 2022, said that “For those who spent time in certain European countries or on military bases in Europe who were previously considered to have been exposed to a potential risk of transmission of Creutzfeldt-Jakob Disease or Variant Creutzfeldt-Jakob Disease, the agency is eliminating the recommended deferrals and is recommending allowing reentry of these donors.” The return of these donors is expected to be impactful.
According to Townsend, this was a change the community had been waiting for a long time. “vCJD transmission though blood was so questionable and we had to defer countless donors,” Townsend said.
A study in Canada, where there were also CJD and vCJD deferral policies, estimated that 54,405 donors – including more than 26,000 repeat donors — had been deferred for vCJD since Canada’s first deferral was implemented in 1999. “These were quality donors we were having to defer,” Townsend added.
The prior recommendations excluded an estimated 4.4 million veterans, service members, and civilians stationed in certain parts of Europe between 1980 and 1996 from donating blood. “It was an infinitesimally small risk at the cost of many donors and donations,” Townsend said. AABB and other organizations have long requested this update based on data showing no transfusion-transmitted CJD cases in the U.S. blood supply over decades, as noted by FDA in the May 2022 guidance.
Deferral time frames for other transfusion-transmitted infections were also shortened. For those potential donors who have traveled to malaria-endemic areas the agency changed the recommended deferral from 12 months to 3 months. The guidance also allowed for collection of blood or blood components from people who had traveled to malaria-endemic areas or were residents of these areas, provided the components are pathogen-reduced using an FDA-approved pathogen reduction device.
“This change was also incredibly important,” Miller said. “When it is time to get out of the country and visit someplace warm and beautiful, a lot of people want to travel to places in which malaria may be endemic. This shortens how long these otherwise-eligible donors have to wait after those visits.”
Adjusting to Change
The primary change required to implement these blood donor history questionnaires, according to Miller.
“How easy or difficult that change is really depends,” Miller said. “There are some larger centers that are tightly bound to certain procedures and are only open to revision of procedures on a periodic basis, and there may be smaller centers that have the ability to pivot fairly quickly.”
Regardless of the size of the center, any change to the questionnaire usually requires a financial commitment, Townsend said, since the majority of questionnaires are electronic. “Any time the questionnaire is changed it involves making changes in the computer system, and that is costly,” Townsend said. “It can be painful, but it is worth the price.”
Miller also pointed out that it is difficult to know how easy or difficult these adjustments were for blood centers because they were occurring in an era of constant change. “There was so much going on in relation to COVID-19 – no longer allowing walk-ins, patient screening at the door, questions about vaccine, etc. – it is hard to know if these changes would have been made any faster in other circumstances,” she said.
Change did occur though, and both Miller and Townsend said that they expect all of the changes put into place are likely to stay. “I can’t picture the FDA going backward on these,” Townsend said.
As for how many more donors were successfully able to donate because of these changes, Townsend said it is too soon to know, but she is sure blood centers are attempting to gather that data.
More Changes Ahead
There are two related but separate areas where additional changes to donor eligibility may occur in the coming years.
Miller pointed out that in 2015, the FDA recommended that blood establishments allow donors to self-identify as male or female for the purpose of blood donation.
“Eligibility was not determined by birth gender,” Miller said. “Now we are having a lot of conversations about how to screen donors who are non-binary. The FDA is leaving it to each blood collection organization, but a simple solution could be to ask all screening questions to all donors.” Miller referenced the fact that right now donors may be asked different questions if they are male or female. However, some donors object to be asked questions not related their gender.
Townsend agreed, “Non-gender-based questions and risk-based assessments are the most exciting potential changes out there.”
Individual risk-based assessment refers to the approach adopted by certain countries, including the United Kingdom and Canada, to move from gender-based questions to questions that assess eligibility based on each individual's recent sexual activity, regardless of gender.
In April, Health Canada approved the Canadian Blood Services’ request to replace donor eligibility criteria specific to men who have sex with men with an individual risk assessment for all donors regardless of sexual orientation. The change is expected to be in place by Sept. 30.
“These questions are gender-neutral in that all donors are asked about sexual behavior with a partner whether they are male or female,” said Mindy Goldman, MD, medical director of donor and clinical services at Canadian Blood Services in Ottawa, Ontario.
Potential donors will be asked if they have had a new or multiple sexual partners in the past three months. If the answer is yes to either, they will be asked if they have had anal sex with any of these partners. If they have, they will be required to wait three months from when they last had anal sex to donate.
According to Goldman, this was the culmination of a years-long process that included gathering evidence to support the proposal. For each change, she said a mathematical model was utilized to calculate the additional risk of HIV in the blood supply.
Canadian Blood Services also looked at how many donors could be deferred if it moved to an alternative approach. For example, in one large study they asked donors the proposed risk-based questions and calculated how many people who were currently eligible would be deferred if the risk-based assessment was implemented.
“We could not defer everyone with a new partner or multiple partners without asking about anal sex because we would lose too many donors,” Goldman said. “It would have been about 6%, and we couldn’t make up that loss.”
The current proposal would result in about a 1% loss of donors. “But it may make more donors eligible, so it may end up being less than a 1% loss,” Goldman said.
Townsend, who also serves as chair of the AABB Donor History Task Force, said she was excited to share with the AABB community that the Task Force recently launched a project to look into the use of an individual risk assessment donor questionnaire in the U.S.
“All donors, no matter the gender, would be asked the same questions in the same way,” Townsend said. The process will take time, she said, and will have to have the blessing of the FDA before it is rolled out.
“We are in the process of communicating with our colleagues in the U.K., the Netherlands and France about their questionnaires and looking at the associated data,” Townsend said. She noted the Task Force will be examining data to ensure any potential changes would not impact the safety of the blood supply. The AABB Task Force must ensure that the questionnaire complies with all FDA requirements before submission for FDA’s review. Once FDA permits, the questionnaire can be used by all donor centers in the U.S. regulated by FDA.
“We have only just started down this road,” she said. “But I am thrilled that we are going down it.”