Transplant News Network:

New Reports and Proposed Regulations Delve Into Tissue-Based Products

WASHINGTON, D.C. · January 15, 2001· by TNN Medical Reporter Virginia Baskerville

A recent series of government initiatives has dealt with the use of tissue-based products.

On January 5, the Food and Drug Administration proposed new regulations on good tissue practice that cover the methods, facilities, and controls used for the manufacture of human cellular and tissue-based products. The regulations are designed "to help ensure that donors of human cellular and tissue-based products are free of communicable diseases and that the cells and tissues are not contaminated during manufacturing and maintain their integrity and function," the FDA said. Under the regulations, manufacturers of all human cellular and tissue-based products would be required to report adverse reactions and certain product deviations, have adequate labeling, and allow FDA inspections to ensure compliance with regulations. See www.fda.gov/bbs/topics/ANSWERS/ANS01062.html.

Also on January 5, the Department of Health and Human Services Office of Inspector General issued two reports on human tissue. One of the reports, "Oversight of Tissue Banking," notes that some tissue banks have never been inspected by the FDA and that many tissue banks are not accredited by the American Association of Tissue Banks. The report urges the FDA to "set a realistic, yet aggressive, date" by which it would inspect all tissue banks and to determine a minimum cycle for tissue bank inspections. The other report, "Informed Consent in Tissue Donation," makes recommendations to the government and to the tissue banking industry on making families aware of practices related to tissue donation. "The special nature of this product, and the circumstances under which it is made available, call for steps to be taken above and beyond those that would apply to most other business or philanthropic enterprises," the report says. Links to both reports are posted at www.hhs.gov/whatsnew.

Please be aware that medical advice, diagnoses and physician references cannot be obtained from this site.