Hemochromatosis

Issue
Hereditary hemochromatosis is a blood disorder that causes the body to absorb excessive amounts of iron. As part of treatment for this condition, therapeutic phlebotomies are performed regularly to reduce iron levels in the body. The American Red Cross defers people with hemochromatosis from donating blood for use in transfusion.

Facts
Current Food and Drug Administration (FDA) policy allows blood collection agencies to release for transfusion, with certain stipulations, blood collected through therapeutic phlebotomies from people with hemochromatosis without having to conspicuously label products as being from a donor with hemochromatosis. In the past, this blood had to be specially labeled to alert the transfusion recipient's physician that the source had not been from a volunteer blood donor.

Most physicians would not accept these units for their patients. The FDA has now said that it would consider removing the special labeling requirement for blood centers that requested the change, but only for blood from patients with hemochromatosis and only if the blood center provided the collection service free of charge for all patients with hemochromatosis, including those who were not eligible to donate blood for transfusion.

The Red Cross does not have, nor have plans to begin, a program of providing phlebotomy services for hemochromatosis patients. The Red Cross will continually reevaluate this issue as more information and experience at other blood centers accumulate.

We are aware that hemochromatosis is an iron storage defect and that the disease cannot be transmitted by transfusion. The sources of our concerns are the requirement to handle patients and donors together in such a program.

The FDA included the requirement that services be free for all hemochromatosis patients whether or not their blood could be used for transfusion. In a sense, the Red Cross would have to provide free medical services for hemochromatosis patients who were not eligible as blood donors in order to use the blood collected from hemochromatosis patients who did qualify to donate.

The Red Cross relies solely on volunteer blood donors who donate blood purely for altruistic reasons. This is the first step in a multi-barrier system that the Red Cross uses to ensure the safety of the blood it provides to hospitals nationwide. It is our belief that non-altruistic incentives to donate blood, such as avoiding a charge for a medical procedure, compromise the safety of the blood supply.

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