FDA publishes annual Fatalities Report regarding Blood Collection and Transfusion

As in the years before, the FDA published their summary report of fatalities in blood collection and transfusion for the fiscal year 2010. As previously mentioned in the annual summary of fatalities reported to the FDA in Fiscal Years (FY) 2005 through FY2009, the blood supply is safer today than at any time in history. Due to advances in donor screening, improved testing, automated data systems, and changes in transfusion medicine practices, the risks associated with blood transfusion continue to decrease.

As the authority states, "during FY2010 (October 1, 2009, through September 30, 2010), we received a total of 76 fatality reports. Of these reports, 71 were transfusion recipient fatalities and 5 were post-donation fatalities.

Of the 71 transfusion recipient fatality reports, we concluded:

  • 40 of the fatalities were transfusion-related,
  • 24 of the fatalities were cases that transfusion could not be ruled out as the cause of the fatality,
  • 7 of the fatalities were unrelated to the transfusion."

An overview and comprison of the years 2005 - 2010 is provided in the following table:

*In FY2007, the review committee began using the Canadian Consensus Conference criteria for evaluating TRALI cases - these numbers includes both "TRALI" and "possible TRALI" cases
**Other:
FY2005: Includes 1 case of Graft vs. Host Disease (GVHD) and 1 therapeutic plasma exchange (TPE) error (use of a treatment column contraindicated due to patient's medical history)
FY2009: Hypotensive Reaction
FY2010: Includes 1 case of GVHD

Please also see the complete report with more details and data.

Author:
Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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