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Standards & Policies

FDA Guidance For Bacterial Mitigation In Platelets

Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry (December 2020)

Transfusion services are responsible for the safety of the blood products they transfuse.

Pathogen reduction is one of FDA’s recommended strategies for blood centers to control the risk of bacterial contamination in platelets.

The INTERCEPT® Blood System is the only FDA approved pathogen reduction platform for platelets and has become an integral component of US Blood Safety Policy.

FDA Guidance

The FDA issued final Guidance on December 2020. This document is based on knowledge gained over 15 years of regulating bacterial detection devices, and their use in blood establishments. Room temperature stored platelets are associated with a higher risk of sepsis and related fatality than any other transfusable blood component. The risk of bacterial contamination of platelets is a leading risk of infection from blood transfusion.Bacterial risk per transfused unit on the day of transfusion is ~1:1,500 -2,500,7 and fatal transfusion reactions from undetected contaminated platelet collections continue to occur.8

The Guidance acknowledges that “[bacterial contamination] risk has persisted despite numerous interventions including the widely used method of primary culture to test platelets prior to transfusion.9-12 The reported rates of septic transfusion reactions from platelets vary from 1:100,000 by passive surveillance and 1:10,000 by active surveillance when testing with primary culture alone.7,13 Surveillance data on platelets stored up to 5 days showing that 95 percent of platelet transfusion-related septic reactions,9,10,14  and 100 percent of associated fatalities, occur with transfusion of day 4 and day 5 stored platelets.9 Currently this risk can be mitigated by various methods of bacterial testing, including culture based or rapid detection tests; or pathogen reduction.

In this Guidance, the FDA outlines comprehensive recommendations to control the risk of bacterial contamination of platelets. The methodologies considered are summarized on the graphic below. The usable shelf life of each of option is represented by the green shaded area.

1. FDA. Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Final Guidance for Industry. In: CBER, ed. Silver Spring, MD: US Food and Drug Administration; 2020. 2. Aerobic and Anaerobic. 3. At the time of the finalization of this guidance, the instructions for use of the culture-based device currently labeled as a “safety measure” require a primary culture and secondary test to extend dating of platelets. Therefore, the LVDS no sooner than 48 hours strategy for 7-day dating period cannot be implemented until appropriately labeled devices are available. 4. Platelets may only be stored beyond day 5 and up to day 7 if each component is tested using a bacterial detection device cleared by FDA and labeled for use as a “safety measure” according to its instructions for use, and if the platelet storage container has been cleared or approved for 7-day storage. 5. Aerobic. 6. Rapid testing practices vary and should be performed according to bacterial testing device instructions for use. Institutions may test daily to ensure availability of units (non-reactive test valid 24 hours prior to transfusion) or may choose to quarantine unit then test within 24 hours of transfusion. (Harm S.K., et al. Transfusion. 2018 Apr;58(4):938-942. Ruby K.N.,, et al. Transfusion. 2018 Jul;58(7):1665-1669). 7. Benjamin, R.J., Transfusion-related sepsis: a silent epidemic. Blood, 2016. 127(4): p. 380-1. 8. Fuller, A., et al., Bacterial culture reduces but does not eliminate the risk of septic transfusion reactions to single-donor platelets. Transfusion, 2016. 49(12): p. 2588-93. 9. Dumont, L.J., et al., The bioequivalence of frozen plasma prepared from whole blood held overnight at room temperature compared to fresh-frozen plasma prepared within eight hours of collection. Transfusion, 2015. 55: p. 476-484. 10. Benjamin, R.J., et al., Bacterial contamination of whole-blood-derived platelets: the introduction of sample diversion and pre-storage pooling with culture testing in the American Red Cross. Transfusion, 2008. 48(11): p. 2348-55. 11. Benjamin, R.J., et al., Skin disinfection with a single-step 2% chlorhexidine swab is more effective than a two-step povidone-iodine method in preventing bacterial contamination of apheresis platelets. Transfusion, 2011. 51(3): p. 531-8. 12. Eder, A.F., et al., Bacterial screening of apheresis platelets and the residual risk of septic transfusion reactions: the American Red Cross experience (2004-2006). Transfusion, 2007. 47(7): p. 1134-42. 13. Walther-Wenke, G., et al., Effect of Safety Measures on Bacterial Contamination Rates of Blood Components in Germany. Transfusion Medicine and Hemotherapy, 2011. 38(4): p. 231-235. 14. Blood Products Advisory Committee, Considerations for Options to Further Reduce the Risk of Bacterial Contamination in Platelets in 104th Meeting of Blood Products Advisory Committee 2012, BPAC: Rockville, MD.