SILVER SPRING, Md.—Today, the U.S. Food and Drug Administration (FDA) has issued new guidance, meant for immediate implementation, to address the urgent 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 blood drive cancellations and the implementation of social distancing.
People who donate blood are part of the U.S.’s critical infrastructure industries. More donations are needed at this time, and the FDA hopes that people will continue to take the time to donate blood. The agency also encourages state and local governments to take into account the essential nature of blood donation — and the fact that it can be done safely and consistently within social distancing guidelines — when considering travel and business restrictions.
The FDA says it wants to “do everything we can to encourage more blood donations…” This includes revisiting and updating some of the existing donation policies, with the hope that it will help to ensure an adequate blood supply, while also ensuring its safety.
Based on recently completed studies and epidemiologic data, the FDA has concluded that current donor eligibility criteria can be modified without compromising blood supply safety. These changes are meant to take place immediately and are expected to remain in place after the COVID-19 pandemic ends, with any appropriate changes made if deemed necessary.
Among others, the FDA is making the following changes:
- 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 has 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
- 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 3 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.
The FDA is currently finalizing the January 2020 draft guidance, which also includes the following change:
- 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.
To help address this critical need, the FDA has provided 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.
The FDA expects that the updated guidance and alternative procedures will help to increase the number of donations in the future, while helping to ensure adequate protections for donor health and maintaining a safe blood supply for patients. The updated recommendations in these guidances are based on data and analysis that the FDA believes are applicable to circumstances outside of the COVID-19 pandemic, and reflect the agency’s current thinking on this issue. When the alternative procedures are no longer in effect, the FDA plans to provide notification.
