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.3
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):
- 2° Culture on Day ≥3 at Day 5 OR
- 2° Culture on Day ≥4 at Day 71 OR
- 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)
- 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: Guidance for Industry, September 2019.