FDA Information on bacterial Contamination of Platelets for Transfusion

Recently, the FDA released an update for blood collection facilities and transfusion centers regarding the occurrence of bacteria contamination in blood platelets for transfusions. Since April 2019, the FDA has been publishing information for blood collection facilities and transfusion services regarding the investigation of septic transfusion reactions related to apheresis platelets that were contaminated with Acinetobacter species and certain other bacteria types. An update was already released in 2021. The FDA and the Centers for Disease Control and Prevention (CDC) have been working together on these investigations since 2018.


Since 2018, the FDA has received a total of seven reports of septic transfusion reactions (from a total of six donations) involving either Acinetobacter spp., Staphylococcus saprophyticus, Leclercia adecarboxylata, or combinations thereof. Additional genetic investigations of the isolates collected by the CDC revealed that the organisms detected were related to each other and may have a common source. The cases occurred in multiple states and despite the components being subjected to various risk reduction strategies, including tests using classical culture methods and some rapid microbiological tests prior to release or processing. The FDA has also received reports of contamination found in product units that were not intended for transfusion. The organisms found in these units had a high degree of genetic match with the isolates from the clinical cases. This suggested that the contamination may have occurred prior to the additional testing or reduction measures for potential pathogens and not after the component was released for use. Additionally, bacteria were detected in the environment during the production of apheresis collection sets that also had a genetic match with the contaminants.

To investigate the cases, the FDA is collaborating with blood collection facilities, the manufacturer of the platelet collection and storage system, and manufacturers of other related products, including bacterial test devices and pathogen reduction devices. The FDA reports:

"The components involved included units prepared in platelet additive solution, units prepared in 100% plasma, units not treated with pathogen reduction devices, and units treated with pathogen reduction devices. In cases of septic reactions that had a genetic match, the platelet components were all prepared using blood collection and storage systems and solutions from a single manufacturer."


Therefore, the FDA also recommends monitoring for potential symptoms of transfusion reactions such as fever, shivering, hypotension or unexplained tachycardia in tested or pathogen-reduced platelet components.

Blood donation facilities and transfusion services are also instructed to contact the FDA if they suspect septic transfusion reactions of platelets with polymicrobial contamination or contamination with Acinetobacter spp., Staphylococcus saprophyticus or Leclercia adecarboxylata, and to report the cases through MedWatch.

Further Details can be found at FDSa Website under  "Important Information for Blood Establishments and Transfusion Services Regarding Bacterial Contamination of Platelets for Transfusion".

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