FDA’s safety standards

FDA’s Revised Bacterial Safety Standards Adds Pathogen Reduction Technology

In March 2016, the US regulatory agency Food and Drug Administration (FDA) issued a revised draft guidance document entitled ‘Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion’. The revision acknowledges that primary bacterial testing alone does not adequately address the issue of bacterial contamination of room temperature stored platelets. The risk of bacterial contamination of platelets is pinpointed as a leading risk of infection from blood transfusion, more than any other transfusable blood component.

Although nonbinding, the guidance document strongly recommends the implementation of additional safety measures to reduce bacterial contamination risks for platelets, proposing pathogen reduction technology as one of the options.