The U.S. Food and Drug Administration (FDA) released its guidance document entitled “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion” several months ago. Since that time, blood banks have been developing plans to implement the new guidance.
An unfortunate consequence of room temperature platelet storage is the risk of bacterial growth within the product. The results of transfusing a contaminated unit are severe, leading to transfusion-transmitted sepsis and in some cases an immediate fatal outcome. Bacterial contamination of platelets continues to be a leading risk of infection from a transfusion, despite the implementation of various interventions.
The FDA issued the guidance document to provide blood banks with recommendations on how to limit the risk of bacterial contamination for platelet products intended for transfusion. It applies to platelet products stored at room temperature in plasma or additive solutions, including platelets manufactured by automated methods (apheresis platelets), as well as whole blood derived (WBD) single and pooled units. Prior to the release of this document, a primary bacterial culture was required. Implementation of the guidance requires additional safety measures.
The guidance provides an array of strategies for minimizing the risk of bacterial contamination. It includes single-step approaches (which can be completed at the blood center) and two-step approaches (which would involve both the blood center and the transfusion service). The document provides a range of alternatives from which facilities can choose an approach that works well for them. Some facilities may have already adopted part or all of one of these strategies.
Platelets collected by apheresis may be pathogen reduced or undergo either secondary culture or secondary rapid testing after the primary culture. Alternatively, large volume delayed sampling (LVDS) of platelets collected by apheresis can be cultured no sooner than 36 hours.
The guidance also outlines conditions for extending platelet storage up to 7 days:
- Large volume delayed sampling ≥ 48 hours
- Large volume delayed sampling ≥ 36 hours + secondary rapid testing
- Large volume delayed sampling ≥ 36 hours + secondary culture ≥ day 4
- Primary culture ≥ 24 hours + secondary culture ≥ day 4
- Primary culture ≥ 24 hours + secondary rapid testing
The guidance formalizes risk reduction efforts that have been in process over the years. It acknowledges that some recommendations may take time to put into practice and identifies 18 months as a reasonable time frame for implementation.
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Helmer Scientific supports blood centers and hospitals, the patients they serve, and their efforts to keep the blood supply safe. We have offered high quality storage equipment for more than 40 years and are here to help you properly store and monitor your platelet products. To learn more about what to consider when choosing platelet storage equipment for your facility, download our Best Practices Guide for Selecting Platelet Incubators and Agitators.