FDA updates safety communication on bacterial contamination of platelets
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.
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.
Among the septic reaction cases that were genetically matched, the platelet components were all manufactured using blood collection and storage systems and solutions from a single manufacturer. 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.
