The Zika outbreak continues to have a wide-ranging impact on the the healthcare community as unflagging concerns have led the U.S. Food and Drug Administration (FDA) to take the rare step of calling for all blood donations be screened for the virus. While hardly unprecedented, the measure is reserved for the most significant and rampant infectious diseases. On its own, the directive from the FDA is a signal of the elevated level the public health threat has reached.
There are two timeframes for compliance in the advisory. The FDA calls for Zika testing within four weeks for eleven states: Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina, and Texas. The government suggests that expedited implementation is needed in these areas because of the confirmed presence of the virus or the greater likelihood of travelers arriving from affected areas.
All other states and U.S.-held territories are given 12 weeks to get up to speed. Universal testing of donated blood for the Zika virus is already taking place in Florida and Puerto Rico, the two areas under FDA jurisdiction hardest hit in the outbreak thus far.
Though few doubt the need for urgency, there is understandable fretting about the system’s capability to meet the deadline.
Dr. Jeffrey McCullough, professor emeritus in the Department of Laboratory Medicine and Pathology at the University of Minnesota, elaborated on the challenge in an interview with the New York Times. “This is a bombshell, because this is extremely rapid introduction of a new test nationwide that’s almost unprecedented,” McCullough told the Times. “To try to implement this, in four weeks, is really, really difficult.
There are currently two different tests being used to screen blood for the Zika virus, both of which are technically not fully cleared by the FDA. Instead, they are being used on a provisional basis.
In a statement, the American Red Cross detailed their efforts thus far, including suspension of blood donations from those who have traveled to Miami-Dade county. They further note the donor deferral will expand to include those who’ve been in Florida’s Palm Beach County and any similarly impacted areas.
Filed Under: Industry regulations