Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2009

Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2009
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Background
As previously mentioned in the annual summary of fatalities reported to the FDA in Fiscal Years (FY) 2005 through FY2008, the blood supply is safer today than at any time in history. Due to advances in donor screening, improved viral marker tests, 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 2006, for example, there were approximately 30 million components transfused.1 During the proximate period of FY2006, there were 73 reported transfusion related and potentially2 transfusion related fatalities, with subsequent reports of 63 in FY2007, 54 in FY2008, and 66 in FY2009.

CBER is distributing this summary of transfusion fatality reports received by the FDA to make public the data received in FY2009, to provide the combined data received over the last five fiscal years, and to compare the FY2009 reports to the fatality reports received in the previous four 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.

Email us at fatalities2@fda.hhs.gov,
Call us at 301-827-6220, or
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
1Whitaker BI, Green J, et al. The 2007 Nationwide Blood Collection and Utilization Survey Report. Washington (DC): Department of Health and Human Services; 2008.
2Transfusion could not be ruled out as the cause of the fatality.
3Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion, September, 20033.




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Results
During FY2009 (October 1, 2008, through September 30, 2009), we received a total of 80 fatality reports. Of these reports, 74 were transfusion recipient fatalities and 6 were post-donation fatalities.

Of the 74 transfusion recipient fatality reports, we concluded:

44 of the fatalities were transfusion-related,
22 of the fatalities were cases that transfusion could not be ruled out as the cause of the fatality,
8 of the fatalities were unrelated to the transfusion.
We summarize the results of our review in the following sections. Sections A through D of this document present the transfusion-related fatalities. Sections E and F and Table 5 present the fatality reports which were unrelated to the transfusion, or in which we could not rule out the transfusion as the cause of death. Section G presents the post-donation fatality reports.

Overall Comparison of Transfusion-Related Fatalities Reported from FY2005 through FY2009
Transfusion Related Acute Lung Injury (TRALI)
Hemolytic Transfusion Reactions (HTR)
Microbial Infection
Transfusion Not Ruled Out as Cause of Fatality
Not Transfusion Related
Post-Donation Fatalities

el documento es muy extenso y sólo se reproduce una pequeña parte, abrir aquí para acceder al pdf de 11 páginas:
http://www.fda.gov/downloads/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/TransfusionDonationFatalities/UCM205620.pdf