Transfusion/Donation Fatalities > Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2010

Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2010

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I. Background

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. Overall, the number of transfusion related fatalities reported to the FDA remains small in comparison to the total number of transfusions. In 2008, for example, there were approximately 24 million components transfused1. During the proximate period of FY2008, there were 54 reported transfusion related and potentially2 transfusion related fatalities, with subsequent reports of 66 in FY2009, and 64 in FY2010.

CBER is distributing this summary of transfusion fatality reports received by the FDA to make public the data received in FY2010, to provide the combined data received over the last six fiscal years, and to compare the FY2010 reports to the fatality reports received in the previous five fiscal years. We also include information on the infrequent reports of post-donation fatalities. Throughout this report we note changes over time, but the reader should interpret these changes cautiously, given the small numbers of reports and inherent variations in reporting accuracy. The significance of shifts in numbers derived from small populations may appear to be greater than they really are.

Refer to Sections 606.170(b) and 640.73 of Title 21, Code of Federal Regulations (21 CFR 606.170(b) and 21 CFR 640.73), for fatality reporting requirements. For information regarding the notification process, see our web page, Notification Process for Transfusion Related Fatalities and Donation Related Deaths2. For further information, see our Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion, September 2003.3

A team of CBER medical officers reviews the documentation submitted by the reporting facilities and obtained by FDA investigators, to assess the relationship, if any, between the blood donation or transfusion and the reported fatality.

If you have questions concerning this summary, you may contact us using any of the three following options.

1.Email us at fatalities2@fda.hhs.gov,
2.Call us at 301-827-6220, or
3.Write us at:
FDA/Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Inspections and Surveillance (HFM-650)
1401 Rockville Pike, Suite 200 North
Rockville, Maryland 20852-1448

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Transfusion/Donation Fatalities > Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2010