FDA Updates Guidelines to Reduce Zika Risk via Blood Transfusion

Tuesday, August 30, 2016

Source: FierceBiotech

The FDA is expanding its Zika guidelines, now recommending that risk reduction measures be implemented outside areas of active local transmission.

The initial guidance, issued in February, called for areas with active Zika virus transmission to test all whole blood and blood component donations for Zika virus or to use pathogen-reduction devices. If this isn’t possible, the agency recommended blood centers in those areas to stop blood collection and instead obtain blood from areas free of active virus transmission.

The revised guidance recommends all U.S. states and territories screen blood and blood components using a test authorized for use under the FDA’s investigational new drug application, or a licensed test, when that becomes available. Pathogen-reduction devices may also be used for plasma and some platelet products, the agency said.

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