FDA's Strategies for Bacterial Safety of Platelets

In the middle of December, the FDA issued an update to their guidance document "Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion." This guide is intended to provide blood establishments and transfusion services with updated recommendations on the bacterial safety and availability of platelets or platelet products when stored at room temperature.

The guidance covers all platelet products stored at room temperature in plasma or additive solutions, including platelets prepared by automated methods (apheresis platelets).  Single-donor and pooled (before and after storage) platelets derived from whole blood are also covered.
In addition, the document contains information for licensed blood establishments, on the subject of manufacturing and labeling changes under Title 21 of the Code of Federal Regulations (CFR) 601.12 and how to report them.

Particularly in the context of the current situation due to COVID-19, but also beyond that, the FDA has received a great deal of feedback from blood establishments requesting that the timeframe set for implementation of the directive be extended. The FDA is responding both with an extension and with additional information on, for example, prior authorizations and equipment shortages.

Background for the recommendations

The background to all of this, of course, is that platelets stored at room temperature are associated with a higher risk of sepsis and related deaths than any other transfusable blood component. The risk of bacterial contamination of platelets is an infectious risk in blood transfusion that cannot be ignored. This is also shown by corresponding reference literature. Thus, the residual bacterial risk per transfused unit on the day of transfusion is about 1/2,500 and fatal transfusion reactions due to undetected contaminated platelet donations are still detectable today. This risk persists despite the implementation of numerous measures, including the commonly used method of a single test culture performed no sooner than 24 hours after platelet collection.

Looking at the reported data of septic transfusion reactions in platelets, the values vary from 1/100,000 with passive monitoring to 1/10,000 with active monitoring (when monitored by single cultures after not less than 24 hours after donation). Monitoring data on platelets stored for up to 5 days have shown that 95% to 100% of septic reactions associated with platelet transfusions and 100% of associated deaths are associated with transfusion of platelets stored for 4-5 days.

Therefore, the FDA has issued regulations for this area to control bacterial contamination of platelets. In accordance with 21 CFR 606.145(a), blood establishments and transfusion medicine facilities must ensure that the risk of bacterial contamination of platelets is adequately controlled by using FDA-approved or cleared devices or other reasonable and appropriate methods deemed acceptable by the FDA for this purpose.

Further details, including methodology, can be found directly in the guidance document entitled "Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion."

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