FDA Draft Guidance for initial testing for bacterial contamination of platelets published

In December 2014, the FDA has published a Draft  Guidance for Industry on Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for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 The draft guidance, when finalized, is intended to supersede the recommendation in section VII.A.2, in regard to bacterial contamination testing in the document entitled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:

  • III. CONSIDERATIONS FOR BACTERIAL TESTING OF PLATELETS BASED ON EVALUATION OF THE AVAILABLE SCIENTIFIC DATA
  • IV. PRIMARY AND SECONDARY TESTING OF PLATELETS
  • V. FDA RECOMMENDATIONS FOR PRIMARY TESTING OF PLATELETS
  • VI. ADDITIONAL CONSIDERATIONS FOR INVENTORY MANAGEMENT WITHOUT SECONDARY TESTING
  • VII. ADDITIONAL CONSIDERATIONS FOR SECONDARY TESTING OF PLATELETS (i.e., FOR PLATELETS WITH PREVIOUS PRIMARY TESTING FOR BACTERIAL CONTAMINATION)
  • VIII. SUMMARY TABLE OF FDA RECOMMENDATIONS AND ADDITONAL CONSIDERATIONS
  • IX. LABELING
  • X. REPORTING IMPLEMENTATION FOR BACTERIAL DETECTION TESTING OF PLATELET PRODUCTS FOR LICENSED BLOOD ESTABLISHMENTS-REPORTING CHANGES TO AN APPROVED BIOLOGICS LICENSE APPLICATION (BLA)
  • XI. TRANSFUSION SERVICES-REGISTRATION AND BLOOD PRODUCT LISTING
  • XII. IMPLEMENTATION

and additionally the Appendix with the following contents:

  • I. CONTAMINATION OF PLATELETS WITH BACTERIA
  • II. PLATELET COMPONENT USAGE AND PLATELET DATING PERIOD IN THE UNITED STATES
  • III. METHODS TO DETECT BACTERIAL CONTAMINATION IN PLATELET COMPONENTS
  • IV. PUBLIC MEETINGS ON THE ISSUE OF BACTERIAL CONTAMINATION OF PLATELETS

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".

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