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FDA updates blood donation guidelines
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:
The FDA is currently finalizing the January 2020 draft guidance, which also includes the following change:
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.