United States of America. The Food and Drug Administration has announced the availability of a guidance document entitled “Guidance for Screening and Testing of Donors of Human Tissue intended for Transplantation”. The guidance document provides general information on the following procedures:
. Determination of donor suitability
. Evaluation of screening test performance
. Application of a plasma dilution algorithm to determine the acceptability of the blood specimen used for testing
. Screening for behavioural and high risk information
. Evaluation of clinical and physical evidence of infection with HIV or hepatitis.
The guidance document can be obtained from the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), FDA, 1401 Rockville Pike, Rockville MD 20852-1448, USA (with one self-addressed adhesive label) or from the Internet at “http://www.fda.gov/cber/publications.htm”.(1)
Because of an immediate need to protect public health, in 1993 the FDA published an interim rule on human tissue intended for transplantation to reduce the risk of transmission of human immunodeficiency virus (HIV) and hepatitis through human tissue intended for transplantation. The rule established the requirements for the testing of donors of human tissue for HIV Type 1 virus, HIV Type 2 virus, hepatitis B virus and hepatitis C virus. It also required that donors be screened for medical history, including behaviours that carry an increased risk of exposure to these viruses and for signs and symptoms of infection with these viruses. A final rule has now been published - the full text is available on request.(2)
References: 1) Federal Register 62(145): 40536 (1997).
2) Federal Register 62(145): 40429-40447 (1997).