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FDA Releases Updated Deferrals

April 7, 2020 at 11:08 am
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On April 2, the U.S. Food and Drug Administration issued an updated guidance regarding blood donation deferrals for a number of risk factors, including travel to malaria-risk regions, tattoos, and risk of transmission of variant Creutzfeldt-Jakob Disease (vCJD) and HIV (which includes guidance around men who have sex with men). These changes, which are based on scientific health data, have been proposed in the wake of a national decrease in blood donations during the COVID-19 pandemic.

The shortening and elimination of these deferrals, largely to do with travel, will no doubt provide many more individuals in our community the opportunity to save lives through blood donation. We are grateful that the FDA has been looking seriously at policies that affect the safety and availability of blood, and while we are not able to implement these updates immediately, we are working to adapt our policies and procedures to the new guidance as soon as logistically possible.

Below we have outlined what the guidance has established at a national level for all blood centers, as well as what this means for our current and future collections processes at SBC.

 

SUMMARY OF CHANGES PUT FORTH IN FDA GUIDANCE 

Recommendations for Reducing the Risk of HIV Transmission
The following primary changes from the guidance would now constitute a three-month deferral rather than a twelve-month deferral:

  • engaging in sex for money or drugs
  • injecting non-prescription drugs
  • engaging in sex with anyone who has had sex for money or drugs
  • engaging in sex with anyone who has injected non-prescription drugs
  • receiving allogeneic transfusions of blood or components
  • having contact with someone else’s blood through percutaneous inoculation, such as needles stick of contact with open wound/mucous membranes
  • receiving a tattoo, ear/body piercing from any entity that is not regulated by the State of California
  • having a history of syphilis or gonorrhea (eligible 3 months from completion of treatment)
  • for men, having sex with another man
  • for women, having sex with a man who had sex with another man within the previous 3 months

Recommendations for Reducing the Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jacob Disease (vCJD)
For geographical risk of vCJD (which is related to “mad cow disease”), this change finalizes the drafted guidance put out in January and eliminates the deferral of individuals who spent time on U.S. military bases in Europe. Individuals will still be deferred for possible vCJD risk related to time spent in the UK (cumulative 3 months from 1980-1996) and time spent in France or Ireland (cumulative 5 years from 1980-2001).

Recommendations for Reducing the Risk of Transmission of Malaria
This change reduces deferral from 12 months to 3 months for travel to a malaria-endemic area. This does not, however, change deferral criteria for those who have lived in an endemic area.

To read the FDA’s full guidance, visit bit.ly/updated-deferrals.

 

IMPLEMENTATION AT SBC

We at SBC are very glad to hear that the FDA has revised deferral periods to increase the number of eligible donors while still ensuring a safe blood supply. We can assure you, we are just as eager as our donors to see these changes take effect!

Like all other blood centers in the U.S., Stanford Blood Center will immediately begin the process of implementing all of the changes outlined by the FDA. Unfortunately, that will take a bit of time.

The AABB now needs to approve changes to the federally regulated medical history questionnaire that every donor must complete. Following that, all internal processes and documentation will need to be aligned to match, and teams will need to be trained on the changes.

We can assure you that we are working as quickly as logistically possible to adapt to the new guidelines. That said, we want to be sure that our community understands that a highly regulated industry like ours doesn’t change on a dime. That’s a good thing… it’s how we can all be certain that the entire U.S. blood supply is as safe, consistent and sustainable as possible.

Once these changes are fully implemented, we will be sure to update this page as well as our eligibility page, stanfordbloodcenter.org/eligibility.

 

SPECIFIC ELIGIBILITY QUESTIONS?

If you have questions about your eligibility, call our team at 888-723-7831, or email us at givebloodsbc@stanford.edu.

 

STILL DEFERRED BUT WANT TO HELP?

While we of course would love to have you as a blood donor, there are multiple ways you can support the cause without donating transfusable products, should you be deferred.

Donate for Research
Individuals who are deferred for certain reasons, most notably travel, may still be able to donate blood for research initiatives. While you won’t be impacting a patient directly, your donation could be used to develop any number of therapies and cures, thereby transforming patient care on a global scale. Learn more at stanfordblodcenter.org/donating-for-research.

Volunteer
At Stanford Blood Center, volunteers have the unique opportunity to work directly with our donors as they help save lives through blood donation. Volunteers give back to their own communities by supporting our mission through a number of functions, including working in the canteen and at special events. Learn more at stanfordbloodcenter.org/volunteer.

Host a Blood Drive
SBC conducts mobile blood drives throughout the Bay Area, collecting approximately half its annual blood supply in this manner — and we depend on Blood Drive Coordinators to do so! As a Blood Drive Coordinator, we would work with you to set up a drive at your company, church, or even civic group to help bring the opportunity to give blood to more people. Learn more at stanfordbloodcenter.org/host-a-drive.

Spread the Word
One of the main reasons people give for not donating blood is simply that they’ve never thought of it or haven’t been asked. By talking to others or sharing content about giving blood on your social media, you are helping expose countless individuals to the possibility of serving their communities through donating. For more tips for sharing on social media, visit stanfordbloodcenter.org/social-media-toolkit.