FDA Over Sterility Issues. The U.S. Food and Drug Administration (FDA) just fined the American Red Cross $1.7 million for its failure to properly manage the nation’s blood supply. The FDA found that the Red Cross washed six units of red blood cells with hypertonic saline solution. Sterile normal saline solution should always be used for this purpose.
The defective blood cells, which were not washed with a sterile solution, were transfused to three patients in 2006 and 2007 at three Red Cross chapters in the Northeast and Southeast.
Eva Quindley, senior vice president for quality and regulatory affairs at the Red Cross, claims that patients’ lives were not in danger and no negative effects were reported. FDA spokeswoman Peper Long assured the public that panic was not called for, despite the severity of the problem, and that the American Red Cross was working to address the problem.
In September 2006, the Red Cross was penalized $4.2 million for non-compliance with federal and FDA regulations concerning the collection of blood products. In that incident, the fine was levied for the American Red Cross’s “failure to comply with requirements under Federal laws and FDA regulations relating to the collection of blood products.”
The FDA explained that the fines were “assessed under an amended 2003 consent decree that called for significant financial penalties”
The FDA explained that the fines were “assessed under an amended 2003 consent decree that called for significant financial penalties when” the American Red Cross “fails to comply with FDA regulations and consent decree provisions designed to ensure the safety of the nation’s blood supply.”
Those fines were a result of an FDA review of recalls conducted by the American Red Cross between 2003 and 2005 that found “these events were preventable.” Among other issues, the violations included breaches of Good Manufacturing Practice (GMP) such as a failure to ask appropriate donor screening questions and failure to follow manufacturer test protocols.
At the time, the FDA insisted that the Red Cross Board of Directors prioritize and support its new management’s ability to immediately address and work to improve its approach to quality.
This amended consent decree—the consent decree was entered in 2003—required the American Red Cross to “establish clear lines of managerial control over a newly established comprehensive quality assurance system in all regions; enhance training programs; and improve computer systems, records management, and policies for investigating and reporting problems, including adverse reactions.”
Since entry of the 2003 consent decree and prior to the 2006 action, the FDA issued seven similar letters and assessed a total of $5.7 million in penalties to the American Red Cross.
In February 2008, a $4.6 million fine was rendered on the Red Cross after the FDA discovered 113 incidents in which the organization collected blood from an ineligible donor, failed to undertake proper testing, or shipped the collected blood at wrong temperatures.
The Red Cross has been fined over $21 million for lapses in safety procedures over the past five years. “The organization certainly has made progress, but we are still seeing errors. And the problems are certainly serious and they need to be addressed,” said Long.