FDA provides updated guidance to address the urgent need for blood during the pandemic

The FDA has concluded that current policies regarding certain donor eligibility criteria can be modified without compromising the safety of the blood supply

FDA, Urgent need for blood, Pandemic, Blood supply, U.S. Food and Drug Administration, The American Red Cross, Male donors

As part of the U.S. Food and Drug Administration’s ongoing commitment to fight the Coronavirus Disease 2019 (COVID-19) pandemic, the agency has issued guidance for immediate implementation to address the urgent and immediate need for blood and blood components.

It states that maintaining an adequate blood supply is vital to public health. Blood donors help patients of all ages – accident and burn victims, heart surgery and organ transplant patients and those battling cancer and other life-threatening conditions. The American Red Cross estimates that every two seconds, someone in the U.S. needs blood.

“People who donate blood are part of our critical infrastructure industries. More donations are needed at this time and we hope people will continue to take the time to donate blood. We have also encouraged, and continue to encourage, state and local governments to take into account the essential nature of donating blood - and that it can be done safely and consistently within social distancing guidelines - when considering travel and business restrictions, and we encourage them to communicate that to their citizens. At the FDA, we want to do everything we can to encourage more blood donations, which includes revisiting and updating some of our existing policies to help ensure we have an adequate blood supply, while still protecting the safety of our nation’s blood supply,” it states.

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. Therefore, the FDA is revising recommendations in several guidances regarding blood donor eligibility. 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. At this time, the alternatives to certain donor eligibility requirements being provided generally will apply only for the duration of the declared pandemic.


Among others, the FDA has made the following changes, for immediate implementation, to the December 2015 guidance:

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 3 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 3 months.
For those with recent tattoos and piercings: the agency is changing the recommended deferral period from 12 months to 3 months.

It has also revised recommendations to reduce the risk of transfusion-transmitted malaria.

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