Regulators in the U.S. recently described directed blood donation considerations. The U.S. Food and Drug Administration (FDA) explained that directed blood donations should only be considered when they are medically warranted. Specifically, FDA published a communication titled “Important Information About Directed Blood Donations that are Not Medically Indicated.” The directed blood donation considerations communication comes in the wake of increased requests for directed blood donations. According to the agency’s communication, “FDA is aware that some blood establishments and hospitals have received requests from patients who need a blood transfusion and wish to receive directed blood donations only from personally chosen relatives, friends, or other individuals with certain characteristics (e.g., specific gender, sexual orientation, vaccination status, or religion). Such directed blood donations lack scientific support. There is no evidence that directed donation provides safer blood and blood components for transfusion.”
Furthermore in the communication describing the directed blood donation considerations, the FDA cautions against websites that offer memberships in return for providing blood and blood components from individuals who have not been vaccinated for COVID-19. “We advise consumers and health care professionals to exercise caution about websites offering memberships for delivery of blood and blood components from COVID-19 unvaccinated blood donors. Further, FDA reminds all owners or operators of establishments that manufacture blood products that they must register with the FDA, pursuant to section 510 of the Federal Food, Drug, and Cosmetic Act, and must comply with the requirements for registration and blood product listing in FDA regulations (21 CFR Part 607). Blood and blood components must be labeled according to the requirements of 21 CFR Part 606.121 and 606.122. Blood and blood components labeled in a manner that is false or misleading are misbranded and are in violation of section 502(a) of the Federal Food, Drug, and Cosmetic Act.”
America’s Blood Centers (ABC) recently informed the FDA that there are websites offering to provide, for a paid membership fee, blood and blood components from donors that have not been vaccinated against COVID-19. Such services are not aligned with directed blood donation considerations. The rationale for these requests and services may be based on misinformation and is not supported by any medical or scientific findings. ABC, the Association for the Advancement of Blood & Biotherapies, and American Red Cross have previously denounced these practices in a joint statement released January 27th. ABC also published a Blood Bulletin on this topic in March. Furthermore, the sources of these offerings are not licensed with the FDA so how they would obtain and distribute this product is unclear.
ABC will continue to monitor this issue and update members blood centers as appropriate. For additional information directed blood donation consideration, please see the following ABC Publications and resources:
- ABC Blood Bulletin, March 2023 Issue, Directed Donations and COVID-19 mRNA Vaccinated Blood Donors; and
- ABC Frequently Asked Questions: COVID Vaccines and Blood Donation.
(Sources: FDA Communication, 10/23/23; MCN 23-088, 10/23/23)