The US Food and Drug Administration (FDA) on Wednesday released updated guidance for establishments that make donor eligibility determinations for those donating human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations for screening donors for infection with Zika virus.
FDA notes that infections can be associated with a risk for developing neurologic complications, including Guillain-Barré syndrome. Deaths have been reported in association with the Zika virus infection, and the disease also causes microcephaly and other abnormalities in infants born to mothers with the infection during pregnancy.
Local mosquito-borne transmissions of Zika virus “are actively occurring or have recently been reported in three U.S. territories (Puerto Rico, U.S. Virgin Islands, and American Samoa) and specific counties in the continental U.S,” FDA said. “Furthermore, travel associated cases, as well as cases in their sexual partners, have occurred throughout the continental U.S.”
This guidance notes that it updates information in the March 2016 guidance
“1) providing findings from more recent epidemiological studies including impact on public health;
2) reporting new data that informs the potential for transmission of ZIKV [Zika virus];
3) discussing the current status of availability of ZIKV tests;
4) updating sexual contact risk factors;
5) updating when an area is considered to have an increased risk for ZIKV transmission; and
6) providing additional scientific references. This update supports the continuation of recommendations to screen living donors of HCT/Ps for risks of infection with ZIKV based on geographic areas with risk.”
FDA’s recommendations for living and deceased HCT/P donors remain unchanged from the previous guidance, and the agency still recommends that establishments implement the recommendations in this guidance as soon as feasible, but not later than 4 weeks after its issue date.