REGULATORY UPDATE: FDA Updates Safety Communication on Bacterial Contamination of Platelets

This article has been updated with a quote from the FDA statement. 

The Food and Drug Administration issued a second update to its April 2019 safety communication related to the investigation of bacterial contamination of platelets for transfusion with Acinetobacter species and certain other bacterial species in combination.

Since 2018, FDA is aware of seven transfusion reactions (from six total donations) involving either Acinetobacter spp., Staphylococcus saprophyticus, Leclercia adecarboxylata or combinations thereof. These cases occurred in multiple states, but genetic testing of the isolates by the Centers for Disease Control and Prevention (CDC) “found with high probability that the organisms are related.”

The implicated components were subject to various bacterial risk mitigation strategies, including bacterial culture and/or secondary rapid testing prior to release or processing with an FDA-approved pathogen-reduction device prior to transfusion. The agency also received additional reports of positive bacterial cultures during routine testing of units that were not transfused where the same organisms were also identified.

“Several of these isolates showed a genetic match to isolates from the clinical cases of septic reactions, supporting the conclusion that the contamination events appear to be from a potential common source prior to additional testing or pathogen reduction, and not from contamination after distribution of the final component," the FDA said in the statement. "In addition, environmental monitoring of the facility where apheresis collection set solutions were manufactured identified bacteria that were genetically matched to isolates from the clinical cases of septic reactions.”

FDA continues to conduct inspections of the manufacturer to ensure control of the manufacturing process and to maintain sterility of the collection sets and solutions. At this time, the strategies to assure the bacterial safety of platelet components recommended in FDA guidance remain acceptable.

In light of these rare cases, FDA reminds blood establishments and transfusion services of the importance of recognizing the residual risk of bacterial contamination of platelets, including in bacterially tested and pathogen-reduced components. Suspected reactions should be reported immediately to the transfusion service and blood supplier and be thoroughly investigated as appropriate. As described in 21 CFR 606.170, facilities must notify FDA as soon as possible following the confirmation of a fatal transfusion complication.

To facilitate investigation, FDA encourages facilities to report suspected contamination of platelets with Acinetobacter spp., S. saprophyticus or L. adecarboxylata, or suspected septic transfusion reactions involving pathogen-reduced platelet components. Facilities may report cases via MedWatch.

Separately, the Centers for Disease Control and Prevention (CDC) issued a broad agency announcement (BAA) requesting white papers on a number of topics including, Topic 15, “Increasing understanding of biofilm formation in blood platelet collection kits and the effectiveness of bacterial risk mitigation strategies in reducing the risk of bacterial contamination of platelets in presence of biofilm formation.”

The agency is interested in the development and evaluation of innovative methods to identify whether bacterial biofilms can form in blood platelet collection kits with an emphasis on Staphylococcus saprophyticus and Acinetobacter calcoaceticus-baumannii complex. Additionally, CDC is interested in the evaluation of methods to identify the effectiveness of pathogen-reduction technology and other bacterial contamination control strategies to effectively mitigate the risk of bacterial biofilm formation with an emphasis on Staphylococcus saprophyticus and Acinetobacter calcoaceticus-baumannii complex.

Potential offerors are encouraged to contact the respective CDC BAA technical point of contact noted in the table of the document to determine whether their research may warrant the submission of a white paper.

Members with additional questions may contact regulatory@aabb.org.