FDA safeguards blood supply from SARS

Though it's still unclear whether the disease is transmissible by blood, experts say donor protocols are appropriate.

By Victoria Stagg Elliott, amednews staff. June 2/9, 2003.

The Food and Drug Administration is recommending that people suspected of carrying the coronavirus --the believed cause of severe acute respiratory syndrome -- be deferred from donating blood.

Those who actually have SARS should not donate for a month, and those who may have been exposed should not give for two weeks, according to an FDA guidance issued in April. The agency also asked donors to contact the blood bank if they develop SARS after giving blood.

Deferring to SARS
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U.S. blood industry response to the guidelines has been mixed. Experts said the move was appropriate despite the fact that there is little evidence that SARS is transmissible via blood and the infection remains a small threat in the United States. But, more importantly, it is unknown whether there is a period during which a person may be infectious but asymptomatic and, therefore, would not be screened out by the first question asked prospective donors: Are you well today?

"It's prudent until we know more," said Louis Katz, MD, immediate past chair of the transfusion-transmitted diseases committee for the American Assn. of Blood Banks and the president of America's Blood Centers.

Still, the industry appears to be experiencing a collective weariness as a result of the growing list of infectious disease deferrals. Last year, deferrals for Creutzfeldt-Jakob were expanded. West Nile virus shifted from a theoretical to a real possibility of transmission through donor blood. And the vaccination of first responders against smallpox also added issues that must now be considered.

"We are training our staff continuously and developing new procedures nonstop," said Nora Hirschler, MD, medical director of Blood Centers of the Pacific in San Francisco. "In the past year, the speed of change has increased tremendously. The FDA is more proactive, and I don't remember seeing so many new viruses in such a short period."

New donor protocols should defer only 0.1% to 0.4% of donors.

There is also concern about lengthening the donor screening process. The SARS issue adds a few more questions to an already crowded form.

"For people who have traveled to places where there is a lot of SARS, it's reasonable to ask if they have SARS," said Dr. Katz, the medical director of the Mississippi Valley Regional Blood Center in Davenport, Iowa. "Asking 15 million donors over the next year if they've had SARS in the past month is maybe a little bit more than we needed to do."

The FDA estimates that the new guidance will only defer 0.1% to 0.4% of donors. But, for an industry that always seems to be in short supply of its main product, especially during the summer months, any loss would be viewed as problematic.

"The real risk in the blood supply these days is that units aren't going to be on the shelf when someone needs one," said John W. Burch, MD, chief medical officer at the American Red Cross Blood Services, New York-Pennsylvania region. "We have enough eligible people in the population that, if they were all to donate, we would be safe. The issue is that only about 5% of those who are eligible donate."

There is also concern that if the disease ever makes inroads into the United States, the impact on the blood supply could be significant.

Most experts hope the development of a screening test will be speedy and mediate any impact.

The World Health Organization in May recommended that, in countries where the disease is not endemic, people diagnosed with SARS be precluded from donating for as long as three months. Those with possible exposure should be deferred for three weeks.

ADDITIONAL INFORMATION:

Deferring to SARS

The Food and Drug Administration has offered guidelines to protect the blood supply:

People who have had SARS should be deferred from donating blood for a month.
Those who have had close contact with SARS patients but are not sick should be deferred for two weeks.
People who have traveled to an area where the disease is endemic should not donate for two weeks after their return to the United States.
Donors should be asked to contact the blood bank if they develop SARS within two weeks of donating.

Weblink

Food and Drug Administration's "Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome or Exposure to SARS" (www.fda.gov/cber/gdlns/sarsbldgd.htm)

World Health Organization recommendations on SARS and blood safety (www.who.int/csr/sars/guidelines/bloodsafety/en)