NYBCe Statement on Updated FDA Guidance Addressing Urgent Need for Blood During COVID-19 Pandemic
For over five decades, New York Blood Center Enterprises (NYBCe) has been deeply committed to serving the critical blood supply needs of our diverse communities. We greatly value the continued support and guidance from the U.S. Food and Drug Administration (FDA), particularly during this COVID-19 pandemic, and our organization is very pleased to acknowledge the revised FDA guidelines, issued on April 2, 2020, which include changing the deferral period for men who have sex with men (MSM) and making individuals who spent time in numerous European countries, or on military bases in Europe, eligible to donate. We have advocated for these changes for many years because safely expanding the number of eligible donors is crucial to maintaining an adequate blood supply during the COVID-19 pandemic and beyond.
We are working hard to implement the changes as quickly as possible, but Blood Centers will require time to update policies, operational procedures, and information systems, train staff, and revise donor questionnaires. We expect the new changes to be implemented in June, and we sincerely apologize to donors who thought they could donate as soon as the FDA announced the updated guidelines. Once the changes have been implemented, we will revise our eligibility criteria and be ready to welcome newly eligible donors.
Revised FDA Recommendations
- MSM donor deferral period changing from 12 months to 3 months.
- Female donors previously deferred for having sex with a man who had sex with another man deferral period changing from 12 months to 3 months.
- People with recent tattoos and piercings deferral period changing from 12 months to 3 months.
- Travelers to malaria-endemic areas (and those who are residents of malaria non-endemic countries) deferral period from 12 months to 3 months, and 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.
- People who have 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 CJD or Variant CJD, the recommended deferrals will be eliminated, and reentry of these donors is recommended.
NYBCe is driven by a dedication to saving lives and strengthening the health of our communities. We wholly support these updated guidelines and will continue to advocate for further changes to ensure a diverse and ample donor pool as well as a safe and reliable blood supply for patients in need. We will continue to work 24/7 to strengthen our coordinated COVID-19 response efforts during this unprecedented and challenging time.