FDA provides guidance to address need for blood donations

April 3, 2020

The Food and Drug Administration (FDA) issued new policies to address the need for blood and blood components.

“The COVID-19 pandemic has caused unprecedented challenges to the U.S. blood supply. Donor centers have experienced a dramatic reduction in donations due to the implementation of social distancing and the cancellation of blood drives,” the FDA said in a news release.

Based on recently completed studies and epidemiologic data, the FDA said it has concluded that “current policies regarding certain donor eligibility criteria can be modified without compromising the safety of the blood supply.”

As a result, the FDA is revising recommendations in three guidance documents about blood donor eligibility. The FDA said it expects the changes, which are effective immediately, to remain in place after the COVID-19 pandemic ends.

Among others, the FDA said it is making the following changes, for immediate implementation, to the December 2015 guidance, “Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products”: 

·        For male donors who would have been deferred for having sex with another man, the agency is changing the recommended deferral period from 12 months to three months.

·         For female donors who would have been deferred for having sex with a man who had sex with another man, the agency is changing the recommended deferral period from 12 months to three months.

·         For those with recent tattoos and piercings, the agency is changing the recommended deferral period from 12 months to three months. 

The FDA also is making changes to the 2013 guidance, “Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria.”  For those who have traveled to malaria-endemic areas (and are residents of malaria non-endemic countries), the agency is changing the recommended deferral period for blood donations from 12 months to three months. In addition, the guidance provides a notice of an alternate procedure that permits the collection of blood and blood components from such donors without a deferral period provided that the blood components are pathogen-reduced using an FDA-approved pathogen reduction device.

The FDA also said it is finalizing the January 2020 draft guidance, “Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components.” The final guidance includes a policy change for travelers and military personnel returning from Europe. Specifically, the FDA said that 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 agency is eliminating the recommended deferrals and is recommending allowing reentry of these donors.

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