FDA Guidance on Bacterial Contamination
Bacterial contamination of platelet products is the most significant infectious risk in transfusion today.7 About 1 in 1,500 platelet units is estimated to contain bacteria, even after culture detection,8 translating to a 1 in 250 per patient risk.7
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.1
View the FDA Guidance on Bacterial Contamination (pdf)
FDA Guidance1 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)2,4
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 55 OR
- 2° Culture on Day ≥4 at Day 72,4 OR
- POI on Day 4 (?) at Day 74,6
(Click image below to open a larger version)
Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry. US FDA; Sept 2019.
Aerobic and Anaerobic
At the time of the finalization of this guidance, the instructions for use of the culture-based device currently labeled as a “safety measure” require a primary culture and secondary test to extend dating of platelets. Therefore, the LVDS no sooner than 48 hours strategy for a 7-day dating period cannot be implemented until appropriately labeled devices are available.
Platelets may only be stored beyond day 5 and up to day 7 if each component is tested using a bacterial detection device cleared by FDA and labeled for use as a “safety measure” according to its instructions for use, and if the platelet storage container has been cleared or approved for 7-day storage.
Rapid testing practices vary and should be performed according to bacterial testing device instructions for use. Institutions may test daily to ensure availability of units (non-reactive test valid 24 hours prior to transfusion) or may choose to quarantine unit then test within 24 hours of transfusion. (Harm SK, et al. Transfusion. 2018 Apr;58(4):938-942. Ruby KN, et al. Transfusion. 2018 Jul;58(7):1665-1669).
- 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.