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.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.

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):

Step One: 1° Culture ≥ 24 hr2 w/12 hr hold OR LVDS ≥ 36 hr2 w/12 hr hold Plus One of Following

Step Two:
      1. 2° Culture on Day ≥3 at Day 55 OR
      2. 2° Culture on Day ≥4 at Day 72,4 OR
      3. POI on Day 4 (?) at Day 74,6

(Click image below to open a larger version)

FDA bacterial guidance figure Cerus Sept 2019 click for full size image

  1. 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.

  2. Aerobic and Anaerobic

  3. 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.

  4. 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.

  5. Aerobic.

  6. 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).  

  7. Kleinman S et al. Transfusion 2013;53:1603-1618.Kleinman S et al. Transfusion 2013;53:1603-1618.
  8. Dumont, LJ et al. Transfusion. 2010 Mar;50(3):589–99.