In December 2014, the FDA has published a Draft Guidance for Industry on Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion. This document should provide recommendations for initial testing (primary testing) for bacterial contamination of platelets. It is intended for transfusion, and includes additional considerations for blood collection establishments and transfusion services for subsequent retesting (secondary testing) prior to transfusion. The draft guidance, when finalized, is intended to supersede the recommendation in section VII.A.2, in regard to bacterial contamination testing in the document entitled “Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods” dated December 2007.
Platelets are associated with a higher risk of sepsis and related fatality than any other transfusable blood component, and the risk of bacterial contamination of platelets stands out as a leading risk of infection from blood transfusion. This risk has persisted despite numerous interventions including the introduction, in the last decade, of analytically sensitive culture-based bacterial detection methods that are widely used to test platelets prior to their release from blood collection establishments to transfusion services. The FDA is issuing this guidance based on the knowledge they have gained over the past 14 years regulating bacterial detection devices and their use in blood establishments. The document includes an Appendix with more details on the background, history, and science of bacterial contamination of platelets.
Amongst the Introduction and Background, the draft document contains the following chapters:
and additionally the Appendix with the following contents:
For further details, please see the draft of the Guidance "Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion".