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AABB News Flash - July 28, 2016

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FDA Releases 'Advice to Blood Collection Establishments on Non-Travel Related Cases of Zika Virus in Florida'

FDA is requesting that blood collection facilities in Miami-Dade and Broward counties cease collecting blood immediately in consideration of the possibility of an emerging local Zika virus (ZIKV) outbreak.

FDA requests that blood collection facilities located in the identified areas “cease collecting blood immediately” until the blood collection facilities “implement testing of each individual unit of blood collected in the two counties with an available investigational donor screening test for Zika virus RNA, or until the blood establishments implement the use of an approved or investigational pathogen inactivation technology.”

Further, FDA recommends that blood collection facilities in nearby counties, including Palm Beach, Hendry, Collier and Monroe, cease collecting blood as soon as possible and implement testing as described above. 

For blood collection facilities located outside of the identified areas, FDA suggests that donors who have traveled to Miami-Dade and Broward Counties during the previous four weeks be deferred from donating. Although not stated in today’s communication, AABB recommends in Association Bulletin #16-04 that donors who have traveled to an area with active ZIKV transmission be deferred for four weeks following the departure from that area.

FDA is aware that implementation of these measures will result in additional questions and is planning to provide updates as more information becomes available. Those with questions may contact regulatory@aabb.org. AABB is working with FDA to address questions about this ongoing situation.

Additional Resources
The Centers for Disease Control and Prevention maintains an up-to-date web page listing areas with active mosquito-borne transmission of Zika virus.

  • To view areas with active mosquito-borne ZIKV transmission in U.S. states and territories, visit Areas with Zika: United States.

  • The Areas with Zika page contains a link to Information for Blood and Tissue Collection Centers.

  • The Information for Blood and Tissue Collection Centers page provides links to FDA recommendations, other resources and a link to Areas at Risk.

  • On the Areas at Risk web page, viewers can register to receive email updates when new information about ZIKV becomes available. 

AABB encourages members to visit the CDC web page frequently for updates.

AABB will update the Tracking Zika Travel Notices table so blood establishments will know the date of this notice as a reference for management of postdonation information, donor eligibility, product suitability and product recall.

AABB Association Bulletin #16-04, “Zika, Dengue, and Chikungunya Viruses,” which is quoted above, focuses on recommendations for members whose collection activities are NOT in locations currently listed on the CDC’s Zika-Affected Areas web page. Recommendations are included for screening donors for travel to Zika-affected areas using Zika Additional Questions and pre-donation and postdonation screening materials.

Many of the resources mentioned in this News Flash are accessible from AABB’s Zika Virus web page, as well.


 


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