6-9 December 2022
Since April 2016, the FDA has been providing a regularly updated communication on septic transfusion reactions. This provides a way for the FDA to keep blood establishments and transfusion services informed about reactions attributable to apheresis platelets contaminated with Acinetobacter species and certain other bacterial species in combination.
FDA has long sought to increase the safety of platelets or platelet preparations - as previously reported under FDA Strategies for Bacterial Safety of Platelets or FDA Draft Guidance on the risk of Bacterial Contamination of Blood Platelets. Until the cases reported at that time, Acinetobacter spp. was actually rarely recognised as a contaminant in apharesis platelets. The Center for Disease Control (CDC) and the FDA continue to follow such reports, especially regarding recent cases involving pathogen-reduced platelet preparations.
Since the 2019 update, FDA is aware of three additional septic transfusion reactions involving either Acinetobacter spp, Staphylococcus saprophyticus, Leclercia adecaboxylata, or combinations thereof. Genetic testing of the microorganisms found by the CDC indicated a possible relationship. In these cases in the states of North Carolina, Virginia and Ohio - two of which were fatal - the contaminations occurred in platelet-added solutions that had actually been further processed with a pathogen reduction device.
Other reports of possible septic transfusion reactions and positive bacterial cultures with Acinetobacter species and certain other bacterial species are under investigation. Thus, since 2018, the FDA has seven reported cases associated with Acinetobacter species and certain other bacterial species occurring in combination, with additional genetic testing indicating that the organisms are related. Therefore, a common source cannot be ruled out. For this reason, CDC and FDA continued their investigations.
From this, the FDA and CDC derive the following recommendation:
"These unusual cases demonstrate that it is important for blood establishments and transfusion services to recognize the residual risk of bacterial contamination of platelets, including pathogen-reduced platelet components. Signs and symptoms of potential septic transfusion reactions include fever, chills, hypotension, or unexplained tachycardia. Suspected reactions should be immediately reported to the transfusion service and blood supplier. Blood establishments and transfusion services, as appropriate, must conduct and record a thorough investigation of suspected septic transfusion reactions and notify FDA as soon as possible when a complication of transfusion is confirmed to be fatal (21 CFR 606.170).
To facilitate further investigation, we encourage blood establishments and transfusion services to contact FDA when they identify suspected contamination of platelets with Acinetobacter spp., Staphylococcus saprophyticus, or Leclercia adecarboxylata, or suspected septic transfusion reactions involving pathogen-reduced platelet components, and report the cases via MedWatch or by emailing CBER%20at%20%20CBEROBRRBPBInquiries@fda.hhs.gov."
Further details can be found directly on the FDA website under "Important Information for Blood Establishments and Transfusion Services Regarding Bacterial Contamination of Platelets for Transfusion".