American Red Cross fined for failure in blood safety

The American Red Cross has been fined for poor and unsafe blood management practices, failing to correct violations of blood-safety rules, MSNBC reported.

The Food and Drug Administration slapped a $9.59 million fine on the the American Red Cross after inspections at 16 blood centers between April and October 2010 showed ongoing problems that could endanger donors and potentially allow contaminated blood to get into the country’s supply, MSNBC reported.

The American Red Cross has been cited 14 times since 2003 and fined close to $46 million for similar reasons, Bloomberg reported. The organization also didn’t ensure that its entire staff has been adequately trained in blood safety. It also hasn’t created a complete list of prospective donors who were disqualified from giving blood, according to a letter the FDA made public on January 13.

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“FDA cannot definitively say there was never any danger to the blood supply since the violations can create conditions that could lead to potential safety consequences,” said Patricia El-Hinnawy, FDA spokeswoman, MSNBC reported.

The American Red Cross supplies 40 percent of the nation’s blood. The letter also doesn’t rule out at the potentially infected blood has already been transfused, USA Today reported.

But the FDA has yet to find any evidence that points to any serious health consequences for blood recipients, Bloomberg reported.

“The safety of the nation’s blood supply is one of our top priorities, and we have no reason to believe that it has been compromised,” said Mary Malarkey, head of compliance at the agency’s Center for Biologics Evaluation and Research, Bloomberg reported. “It’s very important to note that people who need transfusions should continue to take their doctors’ advice, and we encourage people to donate blood.”

A Red Cross spokeswoman has also said in a statement that the problems the FDA points out in its 32-page letter are centered on an inspection at a Philadelphia blood center conducted 15 months ago, MSNBC reported.

“We are disappointed that the FDA believed it necessary to impose a fine for an inspection conducted so long ago,” wrote Stephanie Millian, director of biomedical communications, MSNBC reported. “We are not aware of any adverse donor reactions or patient issues due to the problems in the FDA report.”

However, a fine in June 2010 was for similar failures in the organization.