Collecting allogeneic units from donors with hemochromatosis?

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ADDENDA October 29, 2000

10. I am a retired pediatrician with 30 years of experience at Kaiser Permanente in Harbor City, as well as having been a clinical professor at Harbor-UCLA Medical Center and past chair of the research committee, and chair of the board of directors of the REI. I can see no logical reason why blood banks should not take donations from patients with hemochromatosis, if those individuals have no other contraindications to donation. I was diagnosed two years ago with hemochromatosis, after having symptoms of the disease that were missed for over 15 years. I had typical symptoms and had been seen by many doctors at both Kaiser and UCLA. I missed the diagnosis too. Early diagnosis would have saved over half a million dollars in hip replacement surgery, cardioversions, consultations and arthritis treatment, not to mention the pain and suffering I have had. Interestingly, prior to my diagnosis I had given over 80 units of blood to the Red Cross, Kaiser and UCLA. Since my diagnosis I have had nearly as many units of blood phlebotomized and thrown away. Hemochromatosis is not a problem with a donor's blood but one of iron absorption. There is no logical reason to throw away these valuable units. One in 200 people in this country have the problem and while most of them are not being diagnosed, this is rapidly changing. I hope that blood banks change their policies to allow individuals who are healthy, except for a genetic predisposition for hemochromatosis, to be regular blood donors. We need such a policy to save this precious product. I do not feel that money is a reason to not take the donation. In most cases insurance pays and in my case Medicare pays between $300 and $600 a donation to the hospital lab (our tax dollars at work). Thanks for your interest and I will be willing to help in any way I can.

ADDENDA Nov. 2, 2000

11. The Rhode Island Blood Center has received a variance approval from the FDA to accept hemochromatosis donors. We are currently working to implement this sometime early next year.

ADDENDA Nov. 9, 2000

The following comment has been submitted by blood center physician, who attended the recent AABB Annual meeting in Washington DC.

12. As we are pondering how to address this issue, there are many other issues to consider besides the ones laid out by the physician who is advocating that we accept people with hemochromatosis. Briefly, they are:
    1. Jay Epstein informed membership at the AABB "Ask the FDA" session, that physician evaluation (similar to that required for directed donors who donate whole blood more than once every eight weeks) would apply to donors with hemochromatosis who donate more frequently than every eight weeks. This means that a blood center doctor would have to evaluate by "touch and feel" such donors on the day of donation. This would present logistic difficulties for both physicians and donors.
    2. Jay Epstein also said that the FDA would like voluntary collection of "safety data" (not yet defined) on such donors. This adds an administrative burden, should a center choose to collect such data.
    3. Plasma fractionators will not accept plasma from therapeutic phlebotomies, including those with hemochromatosis. This represents a potential financial loss for blood centers (I don't think anyone would disagree with the importance of blood centers behaving in a financially responsible way).
    4. At an AABB workshop (sorry - can't cite which one), legitimate concerns were raised about whether it was fair/ethical to provide therapeutic phlebotomy services at no charge only to donors with hemochromatosis, while excluding patients who also could benefit from therapeutic phlebotomy. Blood centers could face problematic PR issues as a result.
    5. The increase in blood availability that would be realized by our center is quite small (overall, we collect about 75,000 units of whole blood annually). Based on a review of one hundred donors with hemochromatosis from our center (representing most of our pre-SafeTrace donors with hemochromatosis), we would have only 120 usable units per year, and we would have to toss almost twice that from donors whose blood would be medically or infectious disease test ineligible for allogeneic transfusion. I have not costed this out yet, but if we broke even, it would only be by a small amount. We may not be representative of other blood centers, but as far as I know we are the only ones who have done this kind of detailed evaluation.
    6. It is not known how many patients, who now are phlebotomized in hospitals or their doctors' offices would begin coming to blood centers for the free service. It is certainly possible that many of these potential donors would not qualify to serve as allogeneic donors. So this is a bit of a wild card and could add to the financial risk that blood centers would incur by offering "free for all" services."
       
       
13. AND YET ANOTHER PHYSICIAN RESPONDS TO THE ABOVE REMARKS Nov. 10, 2000
    1. Each blood center submitting a variance may decide what to apply for. Our variance requested that donations more frequently than every 8 weeks prescribed by a referring physician not require a physician examination. However, self-referred donors presenting more frequently than every 8 weeks would require a physician examination.
    2. Our data will consist of infectious disease testing information.
    3. Each center would do well to check with the specifications of the plasma fractionator. The ZLB states that donor selection shall be performed according to FDA-approved procedures and for centers that receive variances, the hemochromatosis donor has been FDA-approved. These donors are no longer therapeutic donors.
    4. I agree with this concern so our variance provides free phlebotomy regardless of diagnosis.
    5. This number may differ from center to center. We collect about 70,000 annually. At our center based on phlebotomies over the last 2 years I estimate about 280 additional donations from 68 individuals. Based on pre-safetrace information and deferral information, we can add 270 new eligible donors. In addition, there may be hospitals in your areas performing phlebotomy and if you apply and receive a variance, there may be unexpected numbers of individuals who will be eligible to donate. My view is that even if we only break even, but we improve the blood supply, it's worth the effort.
    6. Yes, this is true. We will see what happens. At this time, we are gearing up for implementation of the variance.

Maybe next year we will be able to present our experience.

AND ANOTHER ... Nov. 10, 2000

14. "Based on lack of true gain of a significant amount of donations and logistical problems, I don't think it's viable to begin accepting patients with hemochromatosis for donation."

ADDENDA Aug. 29, 2006

15. An otherwise healthy adult male in California asks if he can be a blood donor, even though he is currently undergoing periodic therapeutic phlebotomy to prevent the organ damaging effects of hemochromatosis.
    This link lists blood establishments that have been granted approval for a variance to 21CFR640.3(d) and 21CFR640.3(f) in order to collect blood and blood products from patients with hemochromatosis. The federal codes mentioned in the variance are:
    
    21 CFR 640.3(d) - blood withdrawn in order to promote the health of a donor otherwise qualified under the provisions of 640.3, shall not be used as a source of Whole Blood unless the container label conspicuously indicates the donor's disease that necessitated withdrawal of blood
    
    21 CFR 640.3(f) - a person may serve as a source of Whole Blood more than once in 8 weeks only if at the time of donation the person is examined and certified by a physician to be in good health, as indicated in 640.3(b).

ADDENDA Sept. 1, 2006

16. A colleague at the Pacific Northwest Region of the American Red Cross reports that they have received a variance from the FDA to collect these units, and that they have implemented the process successfully.
    
    
17. The editors note that the following publications may be germane to this discussion:
    • Leitman SF, Browning JN, Yau YY, Mason G, Klein HG, Conry-Cantilena C, Bolan CD. Hemochromatosis subjects as allogeneic blood donors: a prospective study. Transfusion. 2003 Nov;43(11):1538-44.
      
      
    • Comment on the above publication: Newman B. Hemochromatosis blood donor programs: marginal for the red blood cell supply but potentially good for patient care. Transfusion. 2004 Oct;44(10):1535-7; author reply 1537-8.

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