Posted by Michael Wonder on 04 Dec 2018
FDA promotes the development and adoption of innovations that can ensure the continued safety of the U.S. blood supply
4 December 2018 - Today the U.S. FDA updated a draft guidance entitled, “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion.”
The draft guidance provides recommendations for additional measures to help control the risk of bacterial contamination of room temperature stored platelets intended for transfusion. Helping ensure that the U.S. has one of the safest blood supplies in the world is one of the FDA’s most important priorities.
The recommendations in the draft guidance, which incorporate feedback from discussions held during the July 2018 Blood Products Advisory Committee meeting and update the previous draft guidance from 2016, reflect broader FDA efforts to advance and encourage new developments to enhance product safety. Last week, the agency held a public workshop to encourage a scientific discussion on a range of pathogen reduction topics, including the development of novel technologies.
