Committed to Blood Safety for Your Patients

Cerus Final Intercept United States 3

Frequency of Contamination

  • An estimated 1:1,500 platelet units may contain bacteria1.
  • During treatment cycles where six units of platelets are transfused, the risk of a patient receiving a contaminated unit may be ~1:250 to 1:4001,5
  • Assuming an active surveillance (vs. passive surveillance) of sepsis occurrence, rates of sepsis risk can be ~1:5,000 units, or about 1:1,000 per patient risk.7

 

Bacterial Contamination
Risk
  Known / Unknown Viral and Parasite Infectious Risk

bag

~1:1,500 Units
to
~1:2,500 Units1,5

 

bag Zika
Yellow Fever
Babesia

patient  

~1:250 
to
~
1:400 Patients5,7

 

patient Chikungunya
Dengue
Plasmodium

 

 

Transfusion Related Sepsis is Underreported

Due To Passive vs. Active Surveillance Methods

  • Bacterial contamination of platelets is an ongoing issue...1-6
  • …but passive surveillance using diagnostic criteria for septic transfusion reactions rarely identifies these events5
  • Over 7 years of active surveillance at a major academic institution, patients continued to receive bacterially-contaminated platelets yet all resulting septic transfusion reactions were missed.5

Active Surveillance: 2007-2013, University Hospitals Case Medical Center5:


51,440 platelet units
transfused
– all negative by culture

platelets clean


20 out of 51,440 (~1:2,500)
transfused platelets units
were contaminated with bacteria.

platelet bacterial growth


5 out of 20 patients who received contaminated platelets
developed a septic transfusion reaction 9-24 hours post transfusion.

Patient in hospital bed 25


None of these reactions were reported by passive surveillance


1.Dumont, LJ et al. Transfusion. 2010 Mar;50(3):589–99.

2.Pearce, S et al. Transfus Med. 2011 Feb;21(1):25–32.

3.Murphy, WG et al. Vox Sang. 2008 Jul;95(1)13–9.

4.Walther-Wenke, G et al. Vox Sang. 2011 May;100(4):359–66.

5.Hong H, et al. Blood. 2016;127(4):496-502.

6.FDA. Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry. In: CBER, ed. Silver Spring, MD: US Food and Drug Administration; 2019

7.Kleinman S, et al. Transfusion 2013;53:1603-18.