The American Red Cross has been fined $21m before this misdemeanourAmerican Red Cross fine reignites blood worries
Contaminated blood campaigners are concerned that “pertinent lessons” have not been learned after the American Red Cross was fined for blood regulation errors.
The American Red Cross was fined $16m (£10.7m) by the U.S. Food and Drug Administration (FDA) after violations of national blood safety standards.
The fine opens up old wounds after TaintedBlood, a British campaign group for victims who were given American contaminated blood products in the 1970s and 80s, claim the American Red Cross “procrastinated” over surrogate testing in 1986.
The FDA said in a statement on Thursday that they fined the charity “$9.79m (£6.6m) for violations related to mismanagement of certain blood products and $6.39m (£4.3m) for Good Manufacturing Practice violations.”
The FDA discovered several infringements after performing a routine inspection of the Red Cross and its operations. These included “mislabeling of blood, failing to record complete information about donors and potential air contamination,” during 2008 and 2009.
The Red Cross also reportedly failed to take precautionary steps to prevent safety hazards from arising during processing. The American Red Cross admit they are:
"Disappointed that the FDA believed it necessary to fine us for prior violations dating back several years.”
Both the FDA and American Red Cross point out that no patients have suffered any adverse conditions or injuries.
The American Red Cross say that the decision applies to 0.0775% of their blood products:
“The [American] Red Cross collects and processes approximately 43% of the nation’s blood supply, about 6.5m units of blood each year.”
Since 2003, the FDA imposed over $21m (£14m) in fines on the American Red Cross, before this latest $16m fee.
This marks another blight in the history of blood regulation for haemophiliacs who were victim to the Factor VIII scandal of the 1970s and 80s, and are still fighting for the government and drugs companies to admit liability. According to TaintedBlood:
“Whilst it is reassuring to see that the FDA are monitoring the blood supply, we wonder whether all of the pertinent lessons that should have been learnt by now will ever be fully appreciated and taken on-board to ensure that the contaminated blood disaster is never repeated.”
The British counterpart of the American Red Cross does not deal in blood collection, which is done through the NHS.
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