James AuBuchon, MD, president and CEO of Seattle-based Bloodworks Northwest, leveled criticism at the American Red Cross on Monday, arguing that his organization's competitor is failing to adhere to federal guidelines set for testing samples to ensure donated blood is Zika-free, according to The Seattle Times.
On Aug. 26, the Food and Drug Administration issued revised guidance recommending all U.S. blood centers test individual units of blood for Zika to reduce the risk of transmitting the virus via transfusions.
"My understanding is that they're not meeting the FDA's recommendation," said Dr. AuBuchon, who originally objected to testing each unit, according to the Seattle Times. "[The Red Cross isn't] putting the same effort that we put into it."
Dr. AuBuchon's initially categorized the FDA's revised guidance as ill-advised since Zika-carrying mosquitoes aren't found in Washington State. The Bloodworks Northwest CEO argued the guidance would cost his organization $2.5 million in the coming year. Still, Dr. AuBuchon said his organization would comply with the new requirements before or by the FDA's Nov. 18 deadline.
In an email to the Seattle Times, Susan Stramer, Red Cross vice president of scientific affairs, said, "We take strong exception with the safety allegations made by Bloodworks Northwest that irresponsibly and erroneously stokes public health fears. The FDA understands our approach and has expressed no concern with our timeline."
According to a letter obtained by the Seattle Times courtesy of Dr. AuBuchon, dated Sept. 19, Red Cross planned to implement individual testing in high-risk states by Oct. 3, and continue conducting pooled testing in all other states, including Washington, until Nov. 14.
Dr. AuBuchon has raised concerns about the issue with the FDA. In an email, provided to the Seattle Times by Dr. AuBuchon, Peter Loge senior adviser to FDA Director Robert Califf, MD, said the FDA is working to make sure the policy is implemented by all blood-collection agencies across the country.
"In brief, there is one standard for all blood collection establishments in the U.S.," said Mr. Loge.
As of Aug. 12, there have been nearly 4,000 cases of Zika reported in the U.S., nearly 900 of which have occurred in pregnant women, according to the CDC.
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