FDA: Red Cross mishandling of blood products resulted in 134 hepatitis infections
The American Red Cross received reports that 134 people, including one who died, got hepatitis B after transfusions with blood from Red Cross donation centers, but the organization did not investigate the infections, federal regulators say. The Food and Drug Administration, which uncovered the hepatitis infections in a recent inspection of Red Cross blood donation centers, is pushing the organization to find out if hepatitis-tainted blood really caused all of the infections. "We will insist that they follow up," said FDA spokesman Brad Stone.
The hepatitis discovery was one of more than 200 violations of federal safety rules the FDA found during its inspections. The FDA report also reveals that some Red Cross employees were instructed to skip required safety steps and that others altered records to allow release of blood that had failed safety testing. In some cases, blood samples that had tested positive for HIV antibodies also could not be accounted for, according to the report.
The hepatitis infections show that "the blood supply is much less safe than the Red Cross, and even to some extent the FDA, has led people to believe," said Sidney Wolfe, MD, of the consumer advocacy group Public Citizen, which is urging a congressional investigation of Red Cross problems. A statement by the Red Cross in response to the FDA's report stated, "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."
FDA commissioner Mark McClellan noted that while the report shows that there is considerable room for improvement at the Red Cross, the FDA still considers the nation's blood supply to be safe. Experts say the chance of getting HIV from donated blood is one in 2 million to 3 million transfusions.