Blood Supply: Transfusion-Associated Risks (Letter Report, 02/25/97,
GAO/PEMD-97-2).
The U.S. blood supply is safer today than at any time in recent history,
with risks from blood transfusions quite small compared with the
benefits of transfusion in saving lives. Improved donor screening and
education have removed from the donor many persons who are at high risk
for disease, and tests used to screen blood for viruses are considerably
more sensitive than earlier versions. However, risks remain. Eight of
every 10,000 donated units of blood carry a serious risk to the
recipient, including allergic reactions, bacteria, reactions to
incompatible blood transfusions, and viruses. GAO estimates that four
out of 1,000 patients who receive the average transfusion of five units
of blood are at risk of being exposed to contaminated blood that could
sicken or even kill them. On the other hand, as many as half of the
1,000 recipients would be at serious risk of dying immediately unless
they receive a transfusion. The risk that a surgery patient will require
blood and develop a chronic disease or die as a result of that blood is
estimated at five in 100,000. For the average person with no foreseeable
plans for surgery, the annual risk of developing a chronic disease or
dying from the transfusion is five in 1 million.
--------------------------- Indexing Terms -----------------------------
REPORTNUM: PEMD-97-2
TITLE: Blood Supply: Transfusion-Associated Risks
DATE: 02/25/97
SUBJECT: Infectious diseases
Health hazards
Health statistics
Product safety
Quality control
Medical supplies
Testing
Acquired immunodeficiency syndrome
IDENTIFIER: AIDS
**************************************************************************
* This file contains an ASCII representation of the text of a GAO *
* report. Delineations within the text indicating chapter titles, *
* headings, and bullets are preserved. Major divisions and subdivisions *
* of the text, such as Chapters, Sections, and Appendixes, are *
* identified by double and single lines. The numbers on the right end *
* of these lines indicate the position of each of the subsections in the *
* document outline. These numbers do NOT correspond with the page *
* numbers of the printed product. *
* *
* No attempt has been made to display graphic images, although figure *
* captions are reproduced. Tables are included, but may not resemble *
* those in the printed version. *
* *
* A printed copy of this report may be obtained from the GAO Document *
* Distribution Facility by calling (202) 512-6000, by faxing your *
* request to (301) 258-4066, or by writing to P.O. Box 6015, *
* Gaithersburg, MD 20884-6015. We are unable to accept electronic orders *
* for printed documents at this time. *
**************************************************************************
Cover
================================================================ COVER
Report to the Ranking Minority Member, Committee on Commerce, House
of Representatives
February 1997
BLOOD SUPPLY -
TRANSFUSION-ASSOCIATED RISKS
GAO/PEMD-97-2
Blood Supply: Transfusion-Associated Risks
(973439)
Abbreviations
=============================================================== ABBREV
ABRA - American Blood Resources Association
ARC - American Red Cross
ATL - Adult T-cell leukemia and lymphoma
CDC - Centers for Disease Control and Prevention
CJD - Creutzfeldt-Jakob disease
CMV - Cytomegalovirus
FDA - Food and Drug Administration
HAM/TSP - HTLV-I-associated myelopathy and tropical spastic
paraparesis
HAV - Hepatitis A virus
HBc - Hepatitis B core
HBV - Hepatitis B virus
HBsAG - Hepatitis B surface antigen
HCV - Hepatitis C virus
HDV - Delta hepatitis
HEV - Hepatitis E virus
HGV - Hepatitis G virus
HHS - Department of Health and Human Services
HIV - Human immunodeficiency virus
HTLV - Human T-lymphotropic virus
IGIV - Immune Globulin Intravenous
NIH - National Institutes of Health
TRALI - Transfusion-related acute lung injury
Letter
=============================================================== LETTER
B-274942
February 25, 1997
The Honorable John D. Dingell
Ranking Minority Member
Committee on Commerce
House of Representatives
Dear Mr. Dingell:
Widespread concern about the safety of the blood supply has led to
many changes in the way blood is collected, processed, and
transfused. Consequently, the risks of contracting certain diseases,
such as AIDS and hepatitis, are lower today than they were in the
mid-1980s, when the public became increasingly aware that blood
transfusions are not risk free.
You expressed concern about disparate estimates of
transfusion-associated AIDS and hepatitis cases and asked that we
determine the current risks, evaluating the content and quality of
data collected to assess these risks. In this report, we address the
risks of contracting AIDS and hepatitis from blood as well as other
known risks of blood transfusion.
You also asked us to evaluate the Food and Drug Administration's
(FDA's) layers of safety and its ability to ensure the safety of the
blood supply in light of changes in the blood industry. We provide
that information in our report entitled Blood Supply: FDA Oversight
and Remaining Issues of Safety.\1
--------------------
\1 U.S. General Accounting Office, Blood Supply: FDA Oversight and
Remaining Issues of Safety, GAO/PEMD-97-1 (Washington, D.C.: 1997).
*** End of document. ***