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FDA issues guidance on Severe Acute Respiratory Syndrome to further safeguard the blood supply

FDA today issued guidance to the nation's blood establishments on measures for further safeguarding the blood supply against Severe Acute Respiratory Syndrome (SARS). FDA is taking this interim measure to assure the safety of the blood supply while more is learned about the disease. At this time, it is unknown whether SARS can be transmitted through blood.

Current FDA regulations require that a donor be in good health at the time of donation. Standard procedures already in place should serve as an effective safeguard against donation by a potential donor with symptoms.

The new SARS guidance sets forth measures for temporarily deferring potential donors who may have been exposed recently to SARS or have experienced acute SARS. These measures include limited additional questioning of potential donors to help ascertain if they may be at elevated risk for SARS, due to recent travel to known high risk areas as defined by CDC or due to exposure to a person with SARS or suspected SARS.

In addition, the guidance calls for blood establishments to actively encourage those who have already donated to report any SARS-related exposure that occurred within 14 days before donation or SARS illness or treatment occurring within 28 days prior to their donation. Donors should also be encouraged to report SARS illness or treatment that occurs within 14 days after donation. Donated units identified as having come from potentially SARS-exposed or infected donors will be quarantined and indefinitely kept out of the general blood supply.

Under the guidance, potential donors who have recently been to areas of the world in which a relatively large number of cases of SARS have been reported (at present, People's Republic of China; Hanoi, Vietnam; and Singapore), but showing no symptoms of the disease, will be deferred from donating blood for 14 days after their return to the US from those endemic areas. Those who have suffered from an acute case of SARS, as evidenced by a combination of symptoms and travel history, will be deferred from donating until 28 days after their symptoms are resolved and any treatment is completed.

The agency recommends that blood establishments implement the guidance as soon as possible and no later than 30 days after its issuance.

Because the guidance only calls for a marginal increase in procedures already in effect to protect the blood supply against other diseases, it is expected to have a minimal effect on the number of available blood donors and on the quantity of the blood supply. Based on current travel estimates, it is believed that 0.1 percent to 0.2 percent of potential donors, and at most 0.4 percent, will be deferred as a result of the guidance at this time.

The guidance reflects consultation with the Centers for Disease Control and is intended as an interim measure to protect against the potential risk to the blood supply posed by SARS. At this time, there are no known cases of SARS transmission via blood products. However, detection of the genes of the possible causative virus in blood has been reported in a patient with SARS. Also, as in some other viral infections, persons with SARS could potentially have virus in their blood early in infection without any symptoms. Therefore, transfusion transmission of SARS may be possible.

FDA will continue to monitor this evolving situation and intends to make any revisions or additions as needed to preserve the safety and availability of the blood supply, based on the best available information. For example, FDA's guidance may be modified based on further scientific research on whether the causal agent of SARS may be present in blood of the types of persons subject to this interim deferral.

Those interested in commenting on the guidance may submit their comment to Dockets Management Branch (HFA-305) Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

As always, FDA strongly encourages eligible donors to give blood regularly. Blood transfusion is often life-saving, and the blood supply is limited. For patients who need blood transfusions, the benefits outweigh the risks.


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