FDA 'Mad Cow' Rule Could Reduce US Blood Supply
Dateline: 04/17/00
The United State's blood supply, already facing all-time low levels, takes another hit today as a recent FDA ruling takes effect.
The FDA "Guidance for Industry," issued in August 1999 requires U.S. blood banks to turn away all donors who have spent a cumulative total of six months or more in the United Kingdom during the period from Jan. 1, 1980 through Dec. 31, 1996. Countries involved include England, Scotland, Wales, Northern Ireland, Isle of Man, and Channel Islands. The Republic of Ireland is not included.
The action is being taken due to the FDA research indicating that persons who resided in the United Kingdom during the above period may be at risk of acquiring New Variant Creutzfeldt-Jakob Disease (nvCJD), commonly known as Mad Cow Disease. The transfusion of blood donated by a person infected with Mad Cow Disease could infect the recipient.
Worldwide, there has never been a recorded case of Mad Cow Disease being transmitted through the blood transfusion process.
Blood banking industry estimates suggest that up to five-percent of America's potential donor population may be prevented from giving blood due to the new Mad Cow Disease donor deferral rule.
According to the American Association of Blood Banks, over four million Americans a year require blood transfusions. Blood is essential for the treatment of surgery patients, accident victims and patients of cancer, hemophilia and other diseases.
In September 1999, the National Blood Data Resource Center (NBDRC) issued a report projecting that the demand for blood will outstrip available supplies during 2000. The NBDRC report was presented as testimony to the House Commerce Subcommittee on Oversight and Investigations on Sept. 23, 1999.
Human blood, plasma and other therapeutic products made from blood are regulated by the FDA as prescription drugs. Under FDA requirements, every unit of blood donated in the U.S. undergoes at least twelve tests to insure it is free of disease and other impurities. In addition, each blood donor is screened with dozens of personal health and lifestyle questions in order to determine their qualification to donate.
Cattle infected with Mad Cow Disease shake uncontrollably, often unable to stand, before suffering an inevitable death. In humans, dementia and paralysis precede death from the disease for which there is no know cure. While there have been no reported cases of Mad Cow Disease in the United States, researchers think it may sometimes be misdiagnosed as Alzheimer's.Scientists suspect that cattle contract Mad Cow Disease by eating feed made from body parts of infected sheep -- a practice officially banned in England in 1989. A similar ban went into effect in the U.S. in 1997. (See Washington Post story - June 4, 1997)
Reference Links
FDA Guidance to Industry on Mad Cow Disease
Text of the FDA's notification to blood banks requiring the deferral of persons potentially exposed to Mad Cow Disease.FDA Center for Biologics Evaluation and Research (CBER) - Blood Action Plan
CBER is responsible for regulatory oversight of the U.S. blood supply.About Blood - Everyone has it. Everyone needs it.
Explains the many uses of blood products in the medical practice. From the Sacramento, CA Blood Centers.National Blood Data Resource Center
The primary source of nationwide blood supply monitoring data.Blood Donor Screening and Deferral
Steps taken by U.S. blood banks to guarantee the safety of our blood supply. From the American Association of Blood Banks.Giving Blood
The process and safety measures of donating blood from the American Red Cross.
Media Links
Cord Blood Banking and Transplantation
Cord blood is blood from a baby's circulation that remains in the umbilical cord and placenta after birth. It is a source of stem cells that can rebuild the blood and immune system. From About.com's Guide to Pediatrics.Artificial Blood - Avoiding Blood Transfusions in Surgery
A look at blood transfusion in surgery, its complications, and alternatives that might abolish the use of blood transfusions in surgery, from your About.com Guide on Surgery.Blood From a Plant
Researchers have produced human blood proteins from tobacco plants. From your About.com Guide to Biology.
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