In exciting news for the Central Texas community and We Are Blood, the FDA has issued revised guidance, effective during the coronavirus pandemic, for a selection of deferrals that affect eligibility to donate blood or platelets. The FDA announced on April 2, 2020, that based on recently completed studies and epidemiologic data, they have concluded that the current policies regarding the eligibility of certain donors can be modified without compromising the safety of the blood supply during this crisis.
We Are Blood welcomes these science-based decisions to change deferral periods, especially during the coronavirus pandemic. Once implemented at We Are Blood, this new guidance will allow additional Central Texas community members to donate blood or platelets and help protect the blood supply for patients at over 40 hospitals and clinics in our area.
“We Are Blood collects blood and platelet donations to protect a vibrant and diverse community in Central Texas. The FDA’s new guidance allows us to welcome additional community members as blood and platelet donors, which will strengthen our blood supply during the coronavirus pandemic,” said Nick Canedo, VP of Community Engagement at We Are Blood.
WHEN WILL THE CHANGES BE EFFECTIVE AT WE ARE BLOOD?
While we are anxious to welcome newly eligible donors, the implementation of the new guidance will not happen overnight. All new guidance from the FDA will require internal protocols and systems to be adjusted within We Are Blood. Implementation of the changes at We Are Blood will require approximately 6-8 weeks to update our software for screening new donors with the new criteria.
Currently deferred donors will need to submit requests for changes to eligibility HERE before attempting to donate when the new updates have been implemented in approximately 6-8 weeks.
WHAT IS CHANGING?
The primary changes in the FDA’s guidance are, essentially, changing deferral times from 12 to 3 months in the following areas:
- Defer for 3 months after most recent sexual contact of a man who had sex with another man
- Defer for 3 months after most recent sexual contact of a woman who had sex with a man who had sex with another man within the previous 3 months
- Defer for 3 months from the last transfusion of blood or components
- Defer for 3 months from last exposure individuals who had contact with blood through percutaneous inoculation such as needles stick of contact with open wound/mucous membranes
- Defer for 3 months from the most recent tattoo, ear/body piercing excluding tattoos applied by a non-Texas state-regulated parlor using sterile needles and non-reusable ink and body piercing using single-use equipment
- Defer for 3 months after completion of treatment an individual with a history of syphilis or gonorrhea
- Defer for 3 months from last event anyone who engaged in non-prescription injection drug use
- Defer indefinitely individuals with hemophilia or other related clotting factor deficiencies for donor safety reasons
- Reduces deferral time for travel by individuals who have never lived in a malarial endemic area but who travel to such an area from 12 months to 3 months
- Lifting deferrals for geographical risk of Creutzfeldt-Jakob disease for U.S. military bases in Europe excluding time in the U.K. from 1980-1996 (cumulative 3 months), and France or Ireland from 1980-2001 (cumulative 5 years).
HOW CAN I HAVE MY DEFERRAL PERIOD CHANGED FOR THE ABOVE CRITERIA?
Donors with currently active deferrals in our system related to the above criteria will need to submit a reentry request form to request a change, which can be done online HERE.
Your response will be entered into a queue, as a revision to your deferral period will require a medical director review of your submitted information and a manual update if a change is determined appropriate.
The timeline for implementation of system updates is approximately 6-8 weeks with additional time as necessary depending on when a request is submitted for review of an individual’s current deferral change request.
WHAT IF I HAVE NEVER ATTEMPTED TO DONATE BEFORE?
New donors without currently active deferrals in our system will be able to attempt to donate using the above criteria after the implementation of system updates that will change the questions and criteria within our screening software. The timeline for this process is approximately 6-8 weeks.
ARE THE CHANGES PERMANENT?
The new FDA guidance is expected to remain in place after the COVID-19 public health emergency ends, however, the FDA intends to revise and replace the guidance documents within 60 days following termination of the public health emergency. We Are Blood will implement any additional changes advised by newly issued FDA guidance at the conclusion of the coronavirus pandemic.
We Are Blood will be doing everything possible to expedite the implementation of these newly revised deferral periods. We thank you for your patience and understanding.