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Hepatitis


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FDA Guidance Document on Re-entry Method for Donors Deferred for Hepatitis B Virus

FDA Guidance Document on “Lookback” for Hepatitis C Virus (HCV)

FDA Final Rule on Current Good Manufacturing Practice for Hepatitis C Virus Infection (“Lookback”)
 
CMS Interim Final Rule on HCV and Medicare and Medicaid Programs – Hospital Conditions of Participation: Laboratory Services

FDA Hepatitis C Hearing (National AIDS Treatment Advocacy Project) – 10/10/06

CDC: A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States – 12/06

“Face-to-Face Pre-Donation Screening: No Effect on Detected HCV Infections,”  TRANSFUSION, 8/06
 
Overview
Hepatitis is inflammation of the liver that can be caused by different toxins, immunologic processes or infectious agents, including viruses. There are five identified types of viral hepatitis — hepatitis A, hepatitis B, hepatitis C, hepatitis D and hepatitis E — with HAV, HBV and HCV the most common in the U.S. While viral hepatitis can be spread in different ways, all forms have the potential to be transmitted through blood transfusions.

Implementation of improved tests and stringent screening criteria for donors has helped dramatically reduce the risk of transfusion or transplantation transmission of the virus in the United States. According to the AABB Technical Manual, 15th edition, the risk of HCV transmission is less than one in 2 million units transfused.

On behalf of the transfusion medicine and cellular therapies community, AABB works directly with the FDA or through government advisory committees as part of ongoing, collaborative efforts to protect against the transmission of hepatitis through blood and human cells, tissues, and cellular- and tissue-based products. In addition, AABB provides guidance to establishments while working with public health officials to monitor infection outbreaks.

Recent Actions:

5/21/08
FDA issues a draft guidance document proposing a method that blood collection establishments can use to re-enter donors deferred based on previously reactive tests for hepatitis B core when later tests revealed they were false positives and there was no evidence of infection with hepatitis B.

Archived Actions

Last modified on 6/9/2008 10:51:27 AM
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2008 AABB Annual Meeting & TXPO Online
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