The rising number of Zika cases within the U.S. has prompted the Food and Drug Administration (PDF) to recommend all blood donations undergo testing for the virus. But the move comes just after the nation's major blood donation organizations said the inventory levels were "critically low."
The recommendation issued Friday updates guidance the FDA issued in February (PDF) recommending testing for blood donated in active areas for Zika transmission. The new guidance recommends blood donation in all states screen individual units of donated whole blood and blood components. The guidance also recommended blood collections cease in areas where local transmission of the virus has been reported, raising questions over whether blood supplies in those affected areas could be disrupted.
“As new scientific and epidemiological information regarding Zika virus has become available, it's clear that additional precautionary measures are necessary,” said Dr. Luciana Borio, the FDA's acting chief scientist, in a statement.
States that are likely to see local transmission of the virus through mosquitoes, which include California, Alabama, Arizona, Georgia, Hawaii, Louisiana , Mississippi, New Mexico, New York, South Carolina, and Texas, are advised to follow the recommendations within the next four weeks, while the rest of the country is recommended to begin screening for Zika within the next 12 weeks.
More than 2,500 cases of Zika, which is relatively harmless for adults but is linked to birth defects during pregnancy, have been reported within the continental U.S. as of Aug. 24, according to the Centers for Disease Control and Prevention. More than 2,400 cases have been associated with contracting the virus while traveling outside the country, while 22 were sexually transmitted.
In July, the first cases within states of infection acquired through local mosquito-borne cases were reported in Florida's Miami-Dade County, an area which has already undergone blood screening the last few months. That same month, the country's largest blood donation organizations, including the American Red Cross and American's Blood Centers, released a statement calling for more blood and platelet donors due to “critically low” levels in the nation's banks.
Donors who test positive for Zika will be prohibited from donating blood for 120 days after the test or after symptoms have subsided.
In an emailed statement, Dr. Louis Katz, chief medical officer for America's Blood Centers, said the organization felt the guidance would have no impact on supply unless a substantial number of potential donors began to refuse to consent to Zika testing, which would make them ineligible to donate blood.
“Members of ABC are committed to the safest possible blood supply and will work with the test manufacturers to comply with FDA Guidance,” Katz said. “We believe that the current approach of testing in high risk areas and in areas with established local transmission has afforded excellent safety to date.”
Testing all donated blood could prove to result in a cost burden for healthcare providers, according to Ashley Thompson, senior vice president of public policy for the American Hospital Association. She estimated the added screening could increase the cost of blood by as much as $8 to $10 per unit.
“Blood is a critical and necessary resource for hospitals and the AHA supports a safe and available blood supply,” Thompson said in an email response. “The costs of this testing most likely will be passed on to hospitals - this is yet another area of increasing costs that hospitals must absorb in order to ensure safe, timely and high quality care for our patients.”