The Bloodworks Northwest president is criticizing competitors at the American Red Cross for failing to heed FDA guidelines for testing individual blood donations to ensure they’re free of Zika virus. Red Cross officials say the FDA has not objected.
A Seattle blood-center official is sharply criticizing competitors at the American Red Cross, saying the agency is failing to heed federal guidelines that call for testing individual units of donated blood to make sure they’re free of Zika virus.
Dr. James AuBuchon, president and chief executive of Bloodworks Northwest, said Monday that Red Cross officials have indicated they will test small batches of pooled donated blood for the virus in low-risk states, a method he said could miss up to a quarter of contaminated donations.
“My understanding is that they’re not meeting the FDA’s recommendation,” said AuBuchon, who originally objected to testing each unit. “They aren’t putting the same effort that we put into it.”
Red Cross officials fired back, saying the agency has discussed a “phased implementation plan” with federal Food and Drug Administration officials.
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“We take strong exception with the safety allegations made by Bloodworks Northwest that irresponsibly and erroneously stokes public health fears,” said Susan Stramer, Red Cross vice president of scientific affairs, in an email to The Seattle Times. “The FDA understands our approach and has expressed no concern with our timeline.”
The FDA on Aug. 26 announced new guidance recommending that all U.S. blood centers test individual units of blood for Zika to ensure safety. The guidance is nonbinding, but blood banks and donation centers typically follow the agency’s request.
Zika virus is primarily spread by mosquitoes but can also be transmitted by sex and through blood transfusions, causing devastating birth defects. The virus also has been linked to Guillain-Barré syndrome in adults.
AuBuchon shared a Sept. 19 letter to hospital medical directors from Stramer, which stated that the Red Cross would implement individual testing in high-risk states by Oct. 3, but that pooled testing would be conducted in all other states, including Washington, by Nov. 14.
Stramer’s statement confirmed that information and added that those states would be migrated to individual testing before the end of the year.
AuBuchon criticized the FDA’s guidance at the time it was announced, calling it “misguided.” He objected to individual donation testing and said it would cost his agency $2.5 million in the coming year, in a state where the mosquitoes that spread Zika virus aren’t found.
But AuBuchon said Bloodworks would comply nonetheless, with testing of individual donations beginning before the FDA’s Nov. 18 deadline.
AuBuchon said he raised questions about the Red Cross policy with FDA Commissioner Dr. Robert Califf, who was in Seattle last week, saying that the move creates “two levels of Zika safety” and jeopardizes public confidence in the blood supply.
In an email supplied by AuBuchon, Peter Loge, a senior adviser to Califf, said the FDA is working with blood-collection agencies to make sure the policy is “ultimately implemented.”
“In brief, there is one standard for all blood collection establishments in the U.S.,” Loge said in the email.
FDA officials provided no additional comment Monday.
Donated blood is routinely tested for viruses including HIV, hepatitis B and C, West Nile and more. Mini-pools of six or more samples are often combined and tested. If the combined sample is positive, the donations are tested individually.
AuBuchon said latest data suggest that pooled testing could miss up to 25 percent of Zika-infected blood donations, putting people at risk.
About 6.8 million blood donors provide nearly 14 million units of whole blood and red blood cells in the U.S. each year.
AuBuchon said he brought the issue to light not to criticize the Red Cross, a competitor that collects 40 percent of the supply, but to ensure that all U.S. blood-collection agencies are following the same rules.
“All patients deserve safe blood, regardless of who supplies it,” he said.