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FDA Reports Safest Blood Supply in History

September 11, 2015

Donating Blood

In the Fatalities Reported to the FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2014, the FDA reported the safest blood supply in history over the last five years.

For Fiscal Years 2011 to 2014, there were 58, 65, 59 and 56 transfusion or donor related fatalities reported, respectively. The decrease in transfusion-related fatalities is largely due to improvements in donor screening, advances in testing, automated data collection and changes in plasma and whole blood policies to reduce transfusion related acute lung injury (TRALI).  Although policy changes have reduced TRALI fatalities, 41% of transfusion-related fatalities over the last 5 years are still caused by TRALI.  Transfusion associated circulatory overload had the second highest number of transfusion-related fatalities, at 22%, followed by hemolytic transfusion reactions (total 21%; non-ABO 14% and ABO 7% incompatibilities), microbial infections (8%) and anaphylactic reactions (6%).  Over the five year period, 45 total fatalities were reported post-donation.

 

 

Reference

FDA Annual Summary for Fiscal Year 2014.  Fatalities Reported to the FDA Following Blood Collection and Transfusion, August 2015.  Accessed online September 5, 2015.  http://www.fda.gov/downloads/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/TransfusionDonationFatalities/UCM459461.pdf

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  • Adverse Events (non-infectious)
  • Blood Donation
  • News
  • Quality Control and Regulatory
  • Transfusion Transmitted Infections

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