COMMERCE COMMITTEE DEMOCRATS
Congressman John D. Dingell, Ranking Member



Statement of the Honorable John D. Dingell
On the General Accounting Office Reports on Blood Safety
March 12, 1997

Each year, about four million patients in the American health care system receive critical transfusions of blood. The blood is donated by some eight million people from around the nation.

In the late 1980s, the Oversight and Investigations Subcommittee that I chaired began to look at the safety of our blood supply. What we found was alarming. Tests for AIDS and hepatitis were not being performed. Records and tracking of contaminated blood were haphazard. Donors were not being screened adequately to guard against potential risks. The flaws in the blood collection system were matched by lax oversight on the part of the Food and Drug Administration.

In response to our investigation, FDA tightened its procedures, and the American Red Cross, which handles nearly half our blood supply, embarked on a $300 million program to improve safety.

In 1993, I asked the General Accounting Office to conduct an extensive study of efforts to improve blood safety. They have produced two landmark reports which are likely to remain as the most comprehensive look at these issues for some time.

The reports contain good news. The risk of a serious problem from viruses, bacteria and other medical complications from transfused blood is lower today than at any time in recent history. In fact, the risks from blood transfusions are lower than those from other, serious but preventable health risks confronting hospital patients every day. The GAO also generally commends the efforts of FDA and the blood industry to overcome problems identified by the Oversight Subcommittee.

The risks of blood transfusion may never be eliminated entirely, in part because of the biological nature of blood. GAO notes that FDA and the blood industry can still improve donor screening and deferral, the system for notifying transfusion recipients, and their regulatory procedures. These matters should be addressed quickly and efficiently by FDA and industry.

Unfortunately, blood safety issues have received relatively little attention from the new majority in the 104th and 105th Congresses. The new majority has devoted considerable time and energy to a study of, among other things, the travel records of former FDA Commissioner Kessler. Continued inquiry into developments in blood safety would be far more constructive and beneficial to the American people.

(Contact: Dennis Fitzgibbons 202/225-3641)


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