FDA urged to tighten blood rules; mad cow disease seen as a growing threat.
If the recommendations are approved by the FDA, they could reduce the available pool of US blood donors by up to 5.3%, according to agency estimates, and would cut the risk of mad cow disease entering the blood supply by up to 91%.
Health officials warned that tougher restrictions would cause blood shortages, especially in New York, as it is it is the only state that imports blood from Europe, specifically from Holland, Germany, and Switzerland. Already desperately short of blood, the New York City area stands to lose at least 25% of its blood sources under the proposed guidelines. Hospital representatives and blood bank officials in the region said that the donor restrictions would force metropolitan hospitals to cut back on surgical procedures ranging from hip replacements to heart bypass operations.
"Countless lives will be lost," if blood supplies are cut further, Jeffrey Doughlin, MD, a surgeon at Jamaica Hospital in New York, told the FDA advisory panel.
The committee voted 10-7 to recommend the exclusion of donors who have spent a cumulative 3 months or more in Britain from 1980 through the end of 1996. The plan also would exclude donors who have had cumulative time of travel or residence of 5 years or more in any other European country. Current regulations forbid collecting blood from donors who have lived in Britain for 6 months or in some European countries for 10 years.
Supporters of the restrictions, including the American Red Cross, maintain it is better to err on the side of caution, given the spread of mad cow disease in Europe. Regardless of the FDA's decision, the Red Cross, which collects and distributes half of the nation's donated blood, already has decided to adopt similar donor screening restrictions. FDA officials said these could reduce US blood donors by up to 9%.
The other half of the nation's blood is collected by America's Blood Centers, composed of independent blood banks, including the New York Blood center. Celso Bianco, MD, the executive vice president of the national organization, opposed the new restrictions as unnecessary, noting that there has been no documented case in which the human form of mad cow disease was spread through a blood transfusion. Bianco said the measure would force the New York region to tap into the national blood supply to make up for the losses, straining an already tight supply.
The FDA is not bound by the recommendations of its advisory panels but frequently follows them. A final decision is expected in the next few months.
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|Comment:||FDA urged to tighten blood rules; mad cow disease seen as a growing threat.|
|Article Type:||Brief Article|
|Date:||Jun 30, 2001|
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