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FDA Warns Against Directed Blood Donations
(Thursday, October 26, 2023) Often patients request transfusion of blood donated exclusively from specific individuals, like relatives, friends, or those with specific characteristics (e.g., gender, sexual orientation, vaccination status, or religion). Recently, there has been a surge in directed blood donations where patients wanted blood transfusions from donors who did not receive COVID-19 vaccinations. The FDA, the American Blood Centers, and the American Red Cross released a statement that such directed blood donations could pose unreasonable risks to patients and that such practices should be discouraged. Mostly the directed blood donations are based on religious, political, or other personal views, and not due to scientific justifications. And unscrupulous businesses could take advantage of such patients. For example, there are websites that offer paid memberships for the delivery of blood and blood components from individuals who haven't received the COVID-19 vaccine. In addition to such businesses being potentially illegal, such donations are risky as frequently directed blood donations are collected by companies that are not registered with the FDA and may collect blood donations from donors who may otherwise not be eligible for blood donation due to health or infectious status. It might also delay or interfere with appropriate medical intervention and life-saving blood transfusion. There is no evidence to suggest that directed donations ensure safer blood and blood components for transfusion. All blood donors must meet FDA regulations (21 CFR Part 630), and all donations meant for transfusion undergo testing for transfusion-transmitted infections (21 CFR 610.40). It has been reported in peer-reviewed literature that directed donations may pose a higher risk of transmitting infectious diseases compared to the general blood supply due to inadequate testing owing to a limited number of donors and more frequent blood collections from a given donor. The FDA announced additional enforcement measures for owners or operators of facilities producing blood products that do not maintain registration with the FDA in accordance with section 510 of the Federal Food, Drug, and Cosmetic Act and comply with FDA regulations (21 CFR Part 607) concerning registration and blood product listing. Blood and blood components must be labeled in accordance with 21 CFR Part 606.121 and 606.122. Any labeling of blood and blood components that is false or misleading is considered misbranding and violates section 502(a) of the Federal Food, Drug, and Cosmetic Act. Regulators can try to help but, in the end, it is up to the public to educate themselves about life-saving measures such as sourcing blood for transfusions. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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