Addressing Bacterial Contamination

Delivering Safe and Effective Blood Products for Patients

FDA 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

On September 30, 2019, the FDA issued 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 Guidance on Bacterial Contamination (pdf)

FDA Guidance3 recommends the following strategies:

Measures likely to be performed at the Blood Center,
providing Transfusion-Ready platelets to Hospitals (Single Step Strategies):

1. Pathogen Reduction

with 5 day expiry; no further measures necessary

2. Large Volume Delayed Sampling (LVDS)1

36 hrs w/12 hr hold, to Day 5 OR
48 hrs w/12 hr hold to Day 73

Measures likely to be performed at both the Blood Center and Hospital (Two Step Strategies):

Step One: 1° Culture ≥ 24 hr1 w/12 hr hold OR LVDS ≥ 36 hr1 w/12 hr hold Plus One of Following

Step Two:
      1. 2° Culture on Day ≥3 at Day 5 OR
      2. 2° Culture on Day ≥4 at Day 71 OR
      3. POI on Day 4 (?) at Day 72

1. Aerobic and Anaerobic, 2. To extend to 7-Day POI or secondary culture must be labeled as “Safety Measure”; Currently can only go to 7-Day w/plts in 100% plasma  3. Not yet approved/available per BactAlert label (not a Safety Measure)

(Click image below to open a larger version)

FDA bacterial guidance figure Cerus click for full size image

  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: Guidance for Industry, September 2019.