Addressing Bacterial Contamination

Delivering Safe and Effective Blood Products for Patients

FDA Draft Guidance on Bacterial Contamination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.

View the FDA Draft Guidance on Bacterial Contamination (pdf)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

FDA guidance bacterial contamintation mitigation strategies

  1. Kleinman S et al. Transfusion 2013;53:1603-1618.Kleinman S et al. Transfusion 2013;53:1603-1618.
  2. Dumont, LJ et al. Transfusion. 2010 Mar;50(3):589–99.
  3. 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Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Draft Guidance for Industry, December 2018.