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ConnectLife Supports FDA Guidance Implementing Individual Donor Assessments Change

ConnectLife, WNY’s only community blood bank, supports the FDA’s final guidance establishing a blood donor screening process based on individual donor assessments. This change prioritizes the safety of the nation’s blood supply while welcoming new individuals as potential blood donors.


What’s actually changing?

Until now, men who had sex with men in the last three months were deferred from donating within three months of their last sexual encounter. That deferral had been one year until 2020 – and before 2015, no man who had ever had sex with a man was allowed to donate.


Now, all prospective donors will be asked about new or multiple sexual partners in the past three months. If they report a new sexual partner or more than one sexual partner in the past three months, they would then be asked if they engaged in anal sex over the last three months.


Those prospective donors who report having a new sexual partner or more than one sexual partner and had anal sex in the past three months would be temporarily deferred from donation. A prospective donor who does not report having new or multiple sexual partners or anal sex in the past three months may be eligible to donate, provided they meet the rest of the eligibility criteria.


Why are the rules changing?

Because science is showing that there is no safety reason to make a donor ineligible simply on the basis of being a man who has sex with men. That is backed up by studies from the Department of Health and Human Services and the FDA, as well as real-world data from similar changes in countries around the world.


It’s a major step forward in the ongoing work of bringing equality and fairness to America’s blood donation policies while maintaining the safety of the blood supply.

And it also means that at a time when only 3% of Americans give blood, more people will be eligible to give lifesaving donations. One study estimated it would increase the nation’s blood supply by 2-4% every year – that’s half a million more units of blood available for patients who desperately need them.


Will it make the blood supply less safe?

On the contrary, the questions being asked of all donors now aim to put more safety barriers in place to prevent transfusion-associated infections. Similar changes in countries including Canada and the United Kingdom show that they don’t put the blood supply at risk, and donations will continue to be screened as they always have for diseases including HIV, Hepatitis B, Hepatitis C, and Syphilis. The last instance of HIV transmission through transfusion in the U.S. happened in 2008 – there have been more than 100 million transfusions in this country since then.


What about potential donors taking medications like PrEP and PEP?

Donors taking those meds orally to prevent HIV transmission would be deferred for three months from their last dose, and injectable PrEP would lead to a two-year deferral. Those medications suppress the presence of HIV in blood, making it more difficult to detect in screenings. The FDA does not recommend stopping the use of those drugs to donate blood, and says it will continue to examine the issue for potential changes in the future.


The FDA announced the changes May 11. Why did it take so long for ConnectLife to accept donors?

Simply put, it’s a big change. ConnectLife had to overhaul our donor history questionnaire to reflect that new guidance, and get the new questions approved. We had to train dozens of staff members on the new rules so they’re ready to answer questions and concerns from new and long-time donors who come in. Despite that, we’re proud to have been ready in a matter of weeks – some blood centers in a survey estimated it could take as long as a year for them to make the change.


If you have additional questions, please give our team a call at 716-529-4270. Download our FAQs below.

Individual Risk Assessment FAQs (PDF)
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Download • 661KB


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