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FDA rules mandates expanded screening criteria for each blood donation.

All blood drawing facilities in the US must screen each donation of blood or a blood component for HIV types 1 and 2, hepatitis B (HBV), hepatitis C (HCV) and human t-lymphotropic virus (HTLV) types 1 and 2, according a final rule published June 11 in the Federal Register by the US Food and Drug Administration (FDA).

The new rule was developed to assure the safety of the US blood supply, assure consistency in screening, and adds HCV and HTLV testing to the current regulations.

In addition the final rule requires further testing via an FDA-approved product, of all blood samples that test "reactive" for infection due to any of the communicable diseases.

In a separate ruling also published on the 11th, the FDA announced that all blood-drawing facilities must make "reasonable attempts" to notify blood donors who test positive for a communicable disease or whose donation is otherwise unsuitable that they are deferred from future donations.

Under the FDA's final rule, blood centers that accept unusable blood must inform the donor what other types of donations he or she should not make. The center must also provide the donor with the test results, information on his or her condition, and counseling.

The rule, which takes effect September 11, also requires blood centers to develop standard operating procedures for notifying unsuitable donors and autologous donors, as well as an autologous donor's referring physician.

All blood centers are required to keep extensive documentation for each donation including records that it did notify the donor or made a reasonable attempt to do so.

A full copy of the rule can be found on the FDA Web site at
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Comment:FDA rules mandates expanded screening criteria for each blood donation.
Publication:Transplant News
Article Type:Brief Article
Geographic Code:1USA
Date:Jun 30, 2001
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