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FDA Updates Blood Donor Eligibility Guidelines

December 30, 2021

To help address the need for blood donations amid the COVID-19 outbreak, the FDA has expanded blood donor eligibility guidelines. These guideline changes were already under consideration before COVID-19, but their approval was accelerated by the pandemic.

To encourage more healthy people to donate, the agency has changed the deferral period for the following groups from 12 months to 3 months:

  • male donors who have had sex with another man
  • female donors who have had sex with a man who had sex with another man
  • people with recent tattoos and piercings
  • people who have traveled to malaria-endemic areas (or are residents of malaria nonendemic countries)

The guidance provides 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.

In addition, the agency is eliminating recommended deferrals for people 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 FDA is now recommending allowing reentry of these donors.

The American Society of Hematology (ASH) supports these policy changes. The Society promotes efforts by blood banks and centers to encourage more blood donations and is especially concerned with maintaining an adequate supply of safe blood and blood products for patients with hematologic conditions.

"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," said 2020 ASH President Stephanie Lee, MD, of Fred Hutchinson Cancer Research Center. "We look forward to continuing to partner with the FDA, blood organizations, and others to overcome the challenges of COVID-19, maintain a strong and safe blood supply, and promote judicious use of blood products while maintaining patient safety."

Sources: ASH press release, April 3, 2020; FDA press release, April 2, 2020.


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