FDA releases draft of changes to blood donor questions

March 2, 2020
fda_donor_questions_changes

The Food and Drug Administration has issued a draft of changes to the blood donor questionnaire that potentially could increase the number of eligible donors in South Texas.

Currently, anyone who received treatment with human growth hormone or bovine insulin for diabetes cannot donate blood. Those restrictions could be eliminated under the proposal.

Dr. Samantha Gomez Ngamsuntikul, Associate Medical Director at BioBridge Global, said the change could increase the number of eligible donors, though the size of the increase was difficult to estimate.

“Donors previously deferred for time spent on a military base may be eligible for reentry (to the list of eligible donors),” she said. “Donors previously deferred for bovine insulin are also potentially eligible for reentry.”

The deferrals from donating were put in place following the outbreak of Variant Creutzfeldt-Jakob disease (vCJD) in Europe.

The restrictions on vCJD (the human form of bovine spongiform encephalopathy) also were for anyone who lived for three months or more in the United Kingdom from 1980-96, or five years in Ireland or France from 1980-2001, or anyone who received a blood transfusion in those countries since 1980.

America’s Blood Centers, the trade group for independent blood centers, has been advocating for the changes. The deferral from donating includes citizens of those countries and U.S. military personnel and Department of Defense employees stationed in those countries.

The proposal for the changes will be open for comments from the blood collection industry, as well as the public at large, through March 31.

“Depending on the comments, the draft will either become finalized or edited,” Ngamsuntikul said.

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