Tissue Banks: Standards and Accreditation

At present, there are about 167 tissue banks operating across the United States.1 Their role is vital to ensuring the quality, safety, and availability of allografts, as tissue banks are responsible for screening donors and preparing acceptable tissues for surgical use. While all tissue banks are expected to be registered with the FDA, there are no regulations for greater transparency and only limited federal standardization of policies and procedures.

Into this void of accountability stepped the American Assoc. of Tissue Banks. Established in 1976 by the same group of doctors and scientists who started the nation’s first tissue bank with the U.S. Navy, the association’s mission is “improving and saving lives by promoting the safety, quality and availability of donated human tissue.2”

The association is responsible for establishing the highest level of modern day tissue bank operations and has created guidelines for standard practice. The areas covered by these guidelines include all tissue bank activities and operations from procurement to donor testing, from processing and sterilization to packaging. The association has helped quality tissue banks by crafting a framework to establish their own internal Standards of Practice (SOPs).

Only roughly 71% of tissue banks in the United States are actually accredited by the association. It is a voluntary process that requires a lengthy inspection and external review of the tissue bank’s policies and procedures. It is only those banks adhering to the high standards can achieve accreditation. Furthermore, this process must be repeated every three years during accreditation renewal to ensure that accredited tissue banks maintain those high standards of professional practice.

You can check if your tissue bank provider is accredited here and see which specific products and activities they are able to perform (e.g. acquisition, processing, storage, distribution).

Have you ever wondered what types of standards are for tissue procurement and processing? You can learn more about the Standards of Practice followed by America’s best tissue banks in our next blog post: What Makes a Tissue Bank “Good”?