FDA Inspection Finds Safety Lapses in Nation's Blood Supply

The American Red Cross failed to investigate 134 cases of patients diagnosed with hepatitis after receiving blood it distributed, according to a 45-page report released Dec. 20 by the Food and Drug Administration. After a months-long investigation, the FDA found more than 200 violations of its laws and regulations.

"The 134 cases of suspected post transfusion hepatitis ... emphasize the dangerously cavalier attitude of previous ARC statements of assurance about the safety of the blood supply," Public Citizen's Health Research Group Director Sidney Wolfe said Monday in a letter to Sen. Edward Kennedy (D-Mass.), the ranking minority member of the Senate Health, Education, Labor and Pension Committee.

"The FDA and the Red Cross agree that the nation's blood supply today is safer than it has ever been in our nation's history," Red Cross official Ramesh Thandani said in a Dec. 20 statement. "However, the Red Cross understands more work needs to be done to further strengthen our processes and procedures, and we are fully committed to working collaboratively with the FDA to enhance our systems."

The suspected post-transfusion hepatitis cases occurred between Jan. 1, 2000 and June 30, 2002. The FDA said that by not investigating these cases, the Red Cross violated a 1993 consent degree ordering it to clean up its blood division.

Unless a member region requests otherwise, the Red Cross does not investigate hepatitis cases when more than 10 blood donors are involved. In January 2001, the Northern Ohio Region asked the Red Cross to allow it to investigate the case of a patient who tested positive for hepatitis after receiving blood from 36 donors. The Ohio region's investigation revealed that one of the donors had been involved in a previous case of suspected post-transfusion hepatitis.

Even when fewer donors are involved and an investigation is conducted, the Red Cross does not dig deeply enough, the FDA report said. In a statement after the inspection report was released, FDA Commissioner Mark McClellan said, "I am troubled by the apparent lapses in blood safety practices."

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