Regulatory Agencies
The Joint Commission - The Joint Commission is an independent, not-for-profit organization which is the largest healthcare accrediting body in the nation, accrediting and certifying more than 18,000 health care organizations and programs in the U.S. The Joint Commission has been given the authority by the Centers for Medicare & Medicaid Services (CMS) to assess the compliance of health care organizations with national standards.
In July 2005, The Joint Commission enacted standards which increased the amount of tracking and tracing healthcare facilities must perform on human tissue products (biologic implants). The intent of the regulations is to standardize the management of biologic implants in facilities across the country and to assign accountability for each step in the process in order to improve patient safety. To summarize, these standards require that facilities must be able to track and trace each product from the supplier to the recipient, documenting handling and storage conditions with each movement through the supply chain.
To download a copy of the Joint Commission Transplant Safety Chapter which includes the current tissue standards, click here
American Association of Tissue Banks (AATB) - The American Association of Tissue Banks (AATB) is a professional, non-profit, scientific and educational organization. It is the only national tissue banking organization in the United States, and its membership totals more than 100 accredited tissue banks and 1,000 individual members. The overwhelming majority of the human tissue distributed for transplants comes from AATB-accredited tissue banks.
Since its beginning, the AATB has been dedicated to improving and saving lives by promoting the safety, quality and availability of donated human tissue. To fulfill that mission, the AATB publishes standards and accredits tissue banks. Beginning in 1986, the AATB initiated a mandatory Accreditation Program for its institutional members to ensure that tissue-banking activities are performed in a professional manner in compliance with its Standards.
To reach the American Association of Tissue Banks (AATB), click on the following link: AATB
FDA - Human tissues intended for transplantation have been regulated by the FDA since 1993. The FDA is given jurisdiction over these tissues by the Department of Health and Human Services, and has specific regulatory authority over human tissue procurement, donor suitability testing, tissue processing, product manufacturing, and product distribution. The FDA’s oversight of the tissue industry is intended to improve patient safety by preventing the transmission or spread of communicable diseases. Relative to tissue, the FDA has minimal jurisdiction over healthcare facilities such as hospitals and surgery centers. In general, FDA oversight begins when the donor tissue is procured and ends once the tissue product arrives at the hospital. However, hospitals transferring tissue between partner/sister facilities are required to register with FDA has tissue distributors.
The FDA Tissue and Tissue product webpage can be reached by clicking on the following link: FDA Tissue and Tissue Product Webpage
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