FDA Cites Red Cross for Problems with Blood SuppliesNov 13, 2009 | Parker Waichman LLP
Widespread And Persistent Problems With The Storage And Distribution Of Blood.
Dow Jones News just broke with information regarding blood supplied by the American Red Cross. It seems that the U.S. Food and Drug Administration said yesterday that it discovered what it described as “widespread and persistent problems with the storage and distribution” of blood supplied by the Red Cross.
The agency investigation, which took place last year, revealed a substantial amount of violations. According to Dow Jones, over 200 significant violations were discovered at 12 Red Cross facilities nationwide. The data is part of a report posted to the FDA’s Web site.
According to the agency, it is responsible for regulatory oversight of the U.S. blood supply. FDA promulgates and enforces standards for blood collection and for the manufacturing of blood products, including both transfusible components of whole blood, pharmaceuticals derived from blood cells or plasma, and related medical devices. FDA also inspects blood establishments and monitors reports of errors, accidents and adverse clinical events. CBER (Center for Biologics Evaluation and Research) works closely with other parts of the Public Health Service (PHS) to establish blood standards, and to identify and respond to potential threats to blood safety or supply.
Blood Components Distributed With Incorrect References To Donor Gender.
Dow Jones reported that violations include blood components distributed with incorrect references to donor gender, and blood distributed in cases in which a donor was not properly cleared to give blood. "FDA regards the violations discussed in this letter to be significant," the agency said in its October 30 letter to the Red Cross, quoted Dow Jones. The FDA said it may levy fines of up to $5,000 for every unit of blood or blood component that was distributed and may have put the public's health at risk.
To date, Dow Jones indicated that documents do not state if there were any injuries reported or experienced as a result of the blood distributed by the American Red cross. Also, Red Cross spokeswoman Stephanie Millian said it has not received any reports of adverse events related to the blood products mentioned in the FDA report, said Dow Jones.
The FDA noted that from 2003 through 2008 the Red Cross had to recall 7,363 "unsuitable" blood components, said Dow Jones. Also, in a statement, the Red Cross said that over the last 18 months it has made system-wide change to address problems, and that most cited problems took place prior to 2008.
The Red Cross also argued, said Dow Jones, that the blood problems cited are just a fraction of the blood units it collects and processes annually, some six million unites. "The blood supply is safer today than ever before, and people should not hesitate to give or receive blood," the Red Cross said, quoted Dow Jones.
The Red Cross has been under intense scrutiny for more than a decade, and has been cited for similar violations by the FDA, most recently in 2005. A federal court in the 1990s ordered the Red Cross to correct systemic problems in tracking and distributing blood, according to Dow Jones. Meanwhile, the FDA's report said its investigation found the Red Cross has "repeatedly promised to implement and monitor corrective actions, but the corrective actions have not prevented recurrence of the problem."
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