I have donated blood for years. Last year I noticed the Red Cross asking a question if I had lived in England for 6 months or more from Jan 1980 to December 1996 ? I had and so was declined to give blood. Perhaps it was from Mad Cow Sickness or Hoof & Mouth Disease. Yet the reason that the FDA gives is Creutzfeldt-Jakob Disease (CJD) that has killed 76 people in England, France & Ireland (as of 2000).
Donating Blood Questions and Answers
The blood safety system established by FDA is dependent upon: 1) accurate and complete educational material for donors so that they can assess their risk; 2) sensitive communication of the donor screening questions; 3) donor understanding and honesty; 4) quality controlled infectious marker testing procedures; and 5) appropriate handling and distribution of blood and blood products for patient use. Because of the improvements in donor screening procedures and the use of a variety of new tests in the last few years, the blood supply is safer from infectious diseases than it has been at any other time.
A person’s suitability to donate blood depends on two general considerations: that the donation will not be injurious to the donor, and that the donated blood will not be unnecessarily hazardous to the recipient. Regulations enforced by FDA require that as part of the suitability criteria, a donor be free from any disease transmissible by blood transfusion, in so far as can be determined by health history and medical examination.
Why are good donors being deferred because they have visited the U.K.?
Regulations enforced by FDA require that as part of the suitability criteria, a donor be free from any disease transmissible by blood transfusion, in so far as can be determined by health history and medical examination.
FDA periodically issues guidance providing recommendations to decrease the potential for transmission of infectious disease when new information or testing methodology becomes available. In August, 1999, FDA issued guidance for Industry entitled, “Revised Precautionary Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood Products”. After reviewing the comments received, FDA further revised the guidance on November 23, 1999. A copy of the most recent revised guidance titled: Guidance for Industry Revised Preventive Measures to Reduce the Possible Risk of Transmission of CJD and Variant CJD by Blood and Blood Products is available.
The guidance states that, “FDA believes that donors who have resided in the United Kingdom (as identified by questions in section III.D) may be at risk for exposure to nvCJD. As a precaution, FDA recommends that donors who have spent six months or more cumulatively in the United Kingdom from 1980 through 1996 (i.e., from January 1, 1980 through December 31, 1996) be indefinitely deferred.”
FDA takes a conservative approach to ensure the safety of the Nation’s blood supply and therefore, issues guidance relating to both known infectious diseases as well as potentially emerging diseases. This conservative approach may result in the deferral of otherwise acceptable donors.
FDA recognizes that the scientific technology for determining individuals at risk for CJD and nvCJD, and detecting the infectious agents in tissues and in products, is continuing to advance, and that there may be a need for future updating of the relevant guidance.
How many people have died as a result of nvCJD?
Cases of variant CJD are very rare, and most have occurred in the United Kingdom. The latest information (October 2, 2000) issued by the Department of Health, United Kingdom indicates that there have been 73 confirmed cases of vCJD in the United Kingdom. These cases have all been diagnosed since 1995. France has reported two cases. The Republic of Ireland reported one case in 1999. No cases have been recognized in other European countries, or in the United States.
Where can I obtain more epidemiological information or statistics regarding nvCJD?
Further information about the disease can be obtained from the Centers for Disease Control and Prevention (CDC):
Centers for Disease Control and Prevention
1600 Clifton Road
Atlanta, Georgia 30333