Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
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Los Angeles Times (12.21.02) - Monday, December 23, 2002
Charles Ornstein; Megan Garvey
The FDA cited more than 200 safety violations and deficiencies in its preliminary inspection report, the latest since the Red Cross was first ordered by a federal court nearly a decade ago to correct systemic problems - including testing and tracking of donations. Officials said they were still trying to determine whether the latest violations, affecting a small portion of the Red Cross' inventory, resulted in patients becoming sick from transfusions of contaminated blood.
"I am troubled by the apparent lapses in blood safety practices," said Dr. Mark McClellan, FDA commissioner, in a statement released Friday. "Our observations appear to show continuing evidence of a culture that is willing to accept noncompliance, as in many previous inspections."
The FDA's findings, contained in a 45-page report, were the result of an eight-month inspection at Red Cross biomedical headquarters in the Washington, D.C. area. Regulators said the organization was unable to account for small amounts of blood infected with HIV and human cytomegalovirus, a common infection potentially fatal for newborns of newly infected women and those with compromised immune systems. Inspectors also found evidence of employees falsifying records and shipping orders without completing testing, as well as instances of blood products that were labeled unsuitable for release and then released anyway. The report noted that employees who saw problems feared coming forward because of possible retaliation.
FDA officials say there is no risk associated with donating blood. They also encouraged people needing blood transfusions to get them. "The risk of not receiving a blood transfusion far outweighs the risk of receiving blood," said FDA spokesperson Jason Brodsky.
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