American Red Cross Urges Tightened Restrictions 

on Blood Donors Who Resided in Europe 

Red Cross President and CEO Describes Policy As "Prudent, Cautious"

Red Cross Press Release 18jan01

WASHINGTON -- In its ongoing efforts to increase the safety of America's blood supply, the American Red Cross announced today it will encourage the Food and Drug Administration's (FDA) Transmissible Spongiform Encephalopthy (TSE) Advisory Committee to consider a further tightening of the current ban on blood donors who have traveled to or lived in the United Kingdom for a cumulative total of six months between 1980 and 1996. The Red Cross supports tightening the deferral period to less than six months in the U.K. and extending the exposure period to between 1980 and the present. Furthermore, the American Red Cross supports the logical expansion of the existing U.K. deferral to include France and Western Europe given the growing evidence of Bovine Spongiform Encephalopthy (BSE), also known as "mad cow" disease, in those countries.

"The safety of the blood supply is paramount," said Dr. Bernadine Healy, American Red Cross president and chief executive officer. "We must be prudent and cautious regarding TSE - a potential emerging threat to America's blood supply," she continued. "Any risk to the blood supply - real, or theoretical, such as TSE - must be taken seriously. While expanding the current ban will impact the supply of blood because more donors will be deferred, experience shows that in wars and disasters, the American public always responds."

Currently, according to FDA regulations, anyone who has spent a total of six months or more in the United Kingdom (England, Northern Ireland, Scotland, Wales, Isle of Man or the Channel Islands) between 1980 and 1996 is not eligible to donate blood.

Although there is no evidence of transmission of vCJD by blood in humans, evidence exists in animal models that TSE is transmissible through blood. Therefore, the Red Cross is urging caution to ensure the safety of America's blood supply for vulnerable patients.

The American Red Cross is calling for expanded research to better understand TSE pathogens and to create a TSE-specific blood screening test. No such test currently exists. "It is reasonable to anticipate a TSE-specific test being developed in the next two or three years," Healy said. "With that test, we will have a means to assess the true risk, which will better inform our donor selection criteria."

The Red Cross estimates that expanding the deferral criteria will reduce the current number of blood donors in the range of 5 to 6 percent. It will be difficult for all blood centers to make up the shortfall. The Red Cross believes that it and others who share the mission of ensuring a safe, available blood supply should embark on a sustained national public awareness campaign to educate people on the importance of donating blood to save patients. Patients in need of blood transfusions are undergoing cancer treatment, transplants, routine surgeries and being treated for serious diseases such as sickle cell anemia and hemophilia.

"We know it will take a major investment of time, money and resources to attract new donors and retain current donors to meet the increasing needs of patients nationwide," Dr. Healy continued. "We are prepared to take on this added responsibility."

The Red Cross provides almost half of the nation's blood supply (collecting more than 6 million units a year from volunteer donors) to 3,000 hospitals through its national network of 36 Blood Services regions. Dr. Bernadine Healy is president and CEO of the American Red Cross.

source: http://www.redcross.org/news/inthnews/01/1-18-01b.html 18jan01

Blood Supply Safer Than Ever

American Red Cross Position Statement to the Transmissible Spongiform Encephalopthy (TSE) Committee

Red Cross 17jan01

The safety of the blood supply is paramount and is the American Red Cross’s number one priority. The Red Cross and the Food and Drug Administration (FDA) believe it was a prudent step to ensure blood safety by deferring blood donors who have traveled to or lived in the United Kingdom based on the theoretical risk of vCJD and the lack of a blood screening test.

The current deferral is for people who have traveled to or resided in the United Kingdom (England, Northern Ireland, Scotland, Wales, Isle of Man or the Channel Islands) for 6 months or more between 1980 and 1996. The American Red Cross supports expanding this deferral to include France as well as all of Western Europe given the growing evidence of Bovine Spongiform Encephalopthy (BSE) in those countries. We believe the Transmissible Spongiform Encephalopthy (TSE) committee should consider a further tightening of the deferral period to less than six months in the U.K. We also believe the committee should examine extending the exposure period between 1980 to the present, instead of the current deferral between 1980 and 1996.

There is evidence in animal models that TSE is transmissible through blood. We must be cautious to ensure the safety of America’s blood supply for vulnerable patients.

The American Red Cross calls for expanded research to better understand TSE pathogens and to create a TSE-specific blood screening test. We believe that if this is done, in the next two to three years we will have a means to assess the true risk, which will better inform our donor selection criteria.

We estimate that expanding the deferral criteria would reduce the current number of Red Cross blood donors in the range of 5 to 6 percent. Therefore, it is our shared obligation to embark on a sustained national campaign to educate the public to increase the number of American blood donors.

The American Red Cross knows it will take a major investment of time, money and resources to attract new donors and retain current donors to meet the increasing needs of patients nationwide. We are prepared to take on this public responsibility along with others who share our mission to ensure a safe and available blood supply.

The Red Cross is prepared to implement tightened donor criteria across our national system.

source: http://www.redcross.org/bloodsafety/safer0117.html 18jan01