FDA Draft Guidance on Bacterial Contamination
Bacterial contamination of platelet products is the most significant infectious risk in transfusion today.1 About 1 in 1,500 platelet units is estimated to contain bacteria, even after culture detection,2 translating to a 1 in 250 per patient risk.1
In December 2018, the FDA issued a draft guidance1 which includes options that blood centers and/or hospitals can use to mitigate the risk of bacterial contamination, including pathogen reduction.3
View the FDA Draft Guidance on Bacterial Contamination (pdf)
FDA Draft Guidance3 recommends the following strategies:
Measures likely to be performed at the Blood Center,
providing Transfusion-Ready platelets to Hospitals:
1. Pathogen Reduction
2. Delayed Large Volume Culture (DLVC)
Measures likely to be performed at both the Blood Center and Hospital:
3. Primary Culture with 2° culture
4. Primary Culture with point of issue
- Kleinman S et al. Transfusion 2013;53:1603-1618.Kleinman S et al. Transfusion 2013;53:1603-1618.
- Dumont, LJ et al. Transfusion. 2010 Mar;50(3):589–99.
- Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Draft Guidance for Industry, December 2018.