Important note: Information in this article was accurate in 1990. The state of the art may have changed since the publication date.
Food and Drug Administration, U.S. Department of Health and Human Services - December 5, 1990
Brad Stone - (301) 443-3285
"The strengthened program will enhance, rather than replace, the current procedures used to safeguard the blood supply," Dr. Sullivan said. "By shifting the focus of screening procedures to cover a broader range of risk factors, FDA will build upon the safety of the blood supply while providing all healthy and willing individuals the opportunity to donate blood."
Every blood donor will continue to be tested for infection with the AIDS virus and other blood-borne infectious agents. All potential donors will continue to be asked deferral questions about behaviors or medical conditions that may put them at higher risk for AIDS or other infectious diseases.
"Because of improvement in donor screening procedures and the use of a variety of new tests in the last few years, the blood supply today is safer from infectious diseases -- including AIDS -- than it has been at any other time," said HHS Assistant Secretary for Health James O. Mason, M.D., Dr. P.H.
The FDA letters say the blood establishments should enhance their procedures for determining blood donor suitability in the following ways:
"1. Blood establishment personnel should talk with each candidate donor to ensure comprehension concerning the risk of HIV infection, i.e., information about these risks should be presented orally as well as in writing. Donors should not be considered suitable unless information about these risks is available in the language appropriate to each donor and is constructed to be culturally sensitive to promote comprehension. The focus should be on behavior and not on stereotypes (e.g., many men who have had male-to-male sexual experiences do not identify themselves as "homosexual," "gay," or "bisexual").
"2. The oral and/or written interaction between potential donors and blood establishment personnel should include direct questions concerning risk behaviors for HIV infection.
"3. Donor medical history should include a question about having had or having been treated for syphilis or gonorrhea (including appropriate synonyms for these diseases) during the preceding l2 months. Donors who provide positive responses should be deferred for 12 months after diagnosis.
"4. Existing exclusion of six months for a person who has received a transfusion of blood or blood products should be extended to l2 months. Note: This general measure is expected to reduce the transmission of hepatitis C, because seroconversion may occur more than six months after infection.
"5. Existing exclusion of six months for a person who has exchanged money or drugs for sex (i.e., had sex with a prostitute) should be extended to l2 months."
The new recommendations for donor selection were developed by FDA with the Office of the Assistant Secretary for Health and the Centers for Disease Control, and are consistent with April 1990 recommendations of FDA's Blood Products Advisory Committee.
FDA today is sending detailed information on the new blood safety program to all of the nation's registered blood establishments. Blood and plasma centers are expected to quickly establish these new measures as part of their standard operating procedures, and their full compliance will be carefully monitored through the agency's inspectional program.
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SOURCE: Food and Drug Administration (FDA).
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