FDA updates guidance to address blood shortage
To address the novel coronavirus (COVID-19) pandemic, the U.S. Food and Drug Administration (FDA) issued new guidance yesterday for immediate implementation to address the urgent and immediate 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.
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 the FDA hopes people will continue to take the time to donate blood. The FDA has also encouraged state and local governments to consider 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.
The FDA is making several changes to its guidance, including:
- 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.
- 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 from 12 months to three months. In addition, 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.
- 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 FDA is also providing notice of alternatives to certain requirements regarding blood donor eligibility for the duration of the COVID-19 pandemic. Blood establishments are not required to implement the changes in the FDA recommendations or the alternative procedures.