FDA Issues Emergency Guidelines Regarding HIV, Hepatitis C Testing of Donated Blood
To speed the transportation of blood products to areas affected by Tuesday's terrorist attacks, the FDA on Sept. 11 released new emergency guidelines allowing donated blood to be shipped to crisis areas before HIV and hepatitis C testing is complete. An FDA statement says that due to the "recognized need for rapid and high volume blood collections under non-routine circumstances," some blood may have to be shipped before all testing is complete. The agency normally requires all blood donations be tested for such diseases before the blood is shipped. The emergency guidelines state that if the blood products are shipped before FDA testing has been completed, the product must be labeled "For Emergency Use Only" and must list the tests that have not yet been completed. The blood must indicate if screenings for HIV-1, HIV-2 and hepatitis C are not complete. The tests for the viruses should be completed "as soon as possible" and "appropriate actions taken in the event of a reactive screening test result," the statement concludes (FDA statement, 9/11).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.