December 1, 2010
How allograft tissue is regulated
When your OR is selecting allograft tissue, how do you know which federal regulations govern their safety? The US Food and Drug Administration (FDA) uses a tiered approach to regulating these materials, explains Scott Brubaker, CTBS, chief policy officer for the American Association of Tissue Banks (AATB). Minimally processed tissue Conventional allografts, such as bone, tendons, ligaments, skin, and fascia lata, are regulated solely under Section 361 of the Public…
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