FDA loosens constraints on blood donations from MSM, other groups because of COVID-19
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The FDA has revised its deferral policy for blood donations by men who have sex with men, or MSM, and their partners, as well as individuals with tattoos and piercings and other groups, in order to help maintain the blood supply during the COVID-19 pandemic, according to a statement from the agency.
“The COVID-19 pandemic has caused unprecedented challenges to the U.S. blood supply,” Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research, wrote. "Donor centers have experienced a dramatic reduction in donations due to the implementation of social distancing and the cancellation of blood drives.”
The deferral policy has been reduced from 12 months to 3 months for the following groups: male donors who would have been deferred for having sex with another man; female donors who would have been deferred for having sex with a man who had sex with another man and individuals with recent tattoos and piercings.
The revised guidelines also put forth changes to the donation policies for individuals who have traveled to a malaria-endemic area or are residents of malaria nonendemic countries, with a reduction in the deferral period for these groups from 12 months to 3. The guidance for this group has been updated further to include “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.”
Lastly, the statement finalizes draft guidance from January 2020 that applied to individuals who spent time in certain European countries or on military bases in Europe who may be at risk for exposure to potential transmission of Creutzfeldt-Jakob Disease or Variant Creutzfeldt-Jakob Disease. The FDA is rescinding the suggested deferral periods for such individuals and recommending re-entry of these donors.
The revisions were based on recent studies and epidemiologic data that demonstrate that “certain donor eligibility criteria can be modified without compromising the safety of the blood supply,” according to Marks.
“These changes are being put forth for immediate implementation and are expected to remain in place after the COVID-19 pandemic ends, with any appropriate changes based on comments we receive and our experience implementing the guidances,” he wrote. “At this time, the alternatives to certain donor eligibility requirements being provided generally will apply only for the duration of the declared pandemic.”
The agency believes the changes will have “a significant and positive” impact on the nation’s blood supply.
“We expect that the updated guidance and alternative procedures will help increase the number of donations moving forward, while helping to ensure adequate protections for donor health and maintaining a safe blood supply for patients,” Marks wrote.
Reference:
FDA. Coronavirus (COVID-19) update: FDA provides updated guidance to address the urgent need for blood during the pandemic. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-updated-guidance-address-urgent-need-blood-during-pandemic. Accessed April 2, 2020.
Perspective
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Paul A. Volberding, MD
Current HIV tests are among the most accurate medical assays ever developed. Their use in screening donated blood essentially eliminates any risk of transmitting HIV through blood transfusions. The rule that MSM are not allowed to donate blood until 12 months after their last sexual contact never made sense; even the proposed 3-month interval now in place is not necessary. Given the COVID-19 crisis and a serious blood shortage, we should be doing everything possible to allow volunteers to perform the vital public service of blood donation. But — 3 months is better than 12 months and we can continue to hope that eventually, the FDA will trust current screening assays rather than self-reports of sexual abstinence to truly protect transfusion recipients.
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