Platelet components and bacterial contamination: hospital perspective 2022

Area of Science:

• Transfusion Medicine
• Microbiology
• Public Health

Background:

• Bacterial contamination of platelet units is a leading cause of transfusion-transmitted infections, resulting in annual fatalities reported to the US Food and Drug Administration (FDA).
• Platelet collection, manufacturing, and storage at 20°C–24°C increase the prevalence of bacterial contamination.
• Existing mitigation strategies have been developed over three decades to reduce risks associated with contaminated platelet transfusions.

Purpose of the Study:

• To describe strategies implemented by blood centers and transfusion services since October 2021 to comply with FDA guidance on bacterial contamination.
• To highlight the challenges and limitations of FDA-proposed approaches due to market forces and feasibility.
• To discuss the adoption of progressive strategies by hospitals to ensure the availability of safe platelet products.

Main Methods:

• Strict adherence to collection techniques to prevent initial bacterial contamination.
• Enhancement of bacterial detection through rapid testing and large-volume, delayed bacterial cultures.
• Implementation of pathogen reduction technologies to inactivate bacteria and other pathogens in platelet units.

Main Results:

• Limited practical solutions have emerged due to market forces and feasibility concerns regarding FDA-proposed methods.
• Blood product availability has necessitated the adoption of more progressive strategies by healthcare facilities.
• Ongoing efforts focus on balancing safety requirements with the practical need for sufficient platelet supply.

Conclusions:

• A multi-faceted approach combining prevention, improved detection, and pathogen reduction is crucial for minimizing bacterial contamination risks in platelet transfusions.
• Collaboration between regulatory bodies, blood centers, and healthcare providers is essential for developing and implementing effective strategies.
• The evolving landscape requires adaptive and innovative solutions to ensure patient safety while maintaining adequate blood product availability.