NEW DONOR ELIGIBILITY CRITERIA

Effective Fall of 1999, Community Blood Services of Illinois began permanently deferring donors and potential donors who have spent a total of six months or more in the United Kingdom between 1980 and 1996. The United Kingdom includes England, Scotland, Wales, Northern Ireland, Channel Islands and the Isle of Mann.

This deferral is due to a new guidance issued by the Food and Drug Administration (FDA) to ensure that an unusual and rare brain disease called new variant Creutzfeldt-Jacob Disease (nvCJD) does not enter the U.S. blood supply. This deferral is in addition to the Creutzfeldt-Jacob Disease questions that blood centers have been asking since 1995. Additionally, anyone who has injected a non-U.S. licensed drug product made from cattle since 1980 may not donate blood. An example of this would be bovine (beef) insulin.

CJD is a degenerative, fatal brain disease. It may be acquired by brain-to-brain tissue exposure. Approximately 10% of CJD cases involve blood relatives, indicating that it may also be caused by inherited characteristics. In 1996, a previously unrecognized variant of CJD was described in the United Kingdom and was referred to as new variant CJD (nvCJD). Although to date only about forty patients have died of nvCJD, these patients were mostly in their teens and twenties and almost all were from the U.K. Laboratory and other studies have linked nvCJD to an outbreak of bovine spongiform encephalopathy (BSE), commonly referred to as Mad Cow Disease.

Can CJD or nvCJD be transmitted through a blood transfusion? In studies of blood donors and blood recipients, there have been no reported cases of CJD being transmitted by blood products. In addition, laboratory studies involving nvCJD show no evidence of spreading nvCJD through transfusion. However, since nvCJD is different from CJD, more studies need to be done before the FDA is satisfied that nvCJD can never be transmitted by transfusion.

Why are donors being deferred? Because nvCJD has only recently been identified and the FDA is committed to a "zero risk" for blood transfusion recipients, the FDA is taking a very cautious approach for blood recipients. By deferring those people who traveled to the U.K. during the height of the BSE outbreak, the FDA feels that any risk, however small, will be minimized. The cumulative six months travel time is a compromise that takes into account the fact that most cases of nvCJD were long-term residents of the U.K. and not short-term visitors. At the present time, this constitutes a permanent deferral from blood donation. If the deferral status should ever change, the blood center will contact affected individuals.

Are deferred donors at risk for nvCJD? We would like to reassure you that you should NOT be alarmed about your health, and we DO NOT believe that it is necessary for you to see your doctor if you are deferred from donation as a result of this new donor criteria. The FDA is taking a very conservative approach to make sure that this unusual and rare brain disease does not affect the U.S. blood supply. There is no evidence that travelers to the U.K., even those who may have eaten beef while traveling there, have become infected with nvCJD. Scientists do not believe that nvCJD can be transmitted through casual or even intimate (sexual) contact with an infected person.

The deferral of donors who have spent more than a cumulative total of six months in the U.K. will put a strain on our nation’s blood supply — we will definitely see some impact in east central Illinois. This new deferral will force the blood center to turn away many dedicated and potential blood donors. To the people who will be deferred, please know that we share your disappointment. As new information about nvCJD, or even a blood test, becomes available, it may be possible someday to reinstate you as a donor. For more information about this matter, please feel free to contact the blood center.

Adapted from materials provided by Mississippi Valley Regional Blood Center, AABB and FDA.