Platelets for Transfusion - Bacterial Detection Testing by Blood Establishments

Recommendation

7/8 May 2024

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals - Live Online Training
Regulatory Requirements and Practical Implementation

On 15 March, the FDAs Center for Biologics Evaluation and Research has published a Draft Guidance for Industry "Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion".  This document should give blood collection establishments and transfusion services recommendations for the primary/initial testing for bacterial contamination of platelets intended for Transfusion. Additionally it provides considerations for blood collection establishments and transfusion services for the secondary testing/subsequent testing prior to transfusion.

Amongst these recommendations, the guideline includes information about the use of secondary testing of platelets as the basis to extend the dating period of platelets and recommendations to licensed blood establishments for submitting Biologics License Application (BLA) supplements to include bacterial testing of platelet components.

Such recommendations are important because 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. The draft guidance, when finalized, is intended to supersede the recommendation in section VII.A.2, in regard to bacterial contamination testing in the document entitled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.

Amongst an introduction and some background information, the guideline will cover the follwing content:

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
XI. TRANSFUSION SERVICES-REGISTRATION AND BLOOD PRODUCT LISTING
XII. IMPLEMENTATION

APPENDIX
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

Please be aware that this draft guidance does not address the use of platelets processed with pathogen reduction devices.

More details can be found directly in the draft guidance "Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion"