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STERILIZATION

Return to Article: New Gamma Methods Increase Options for Allograft Materials

It is critical that any company working with human allograft tissue as a biomaterial ensures that all donations are obtained from ethical and safe sources. Here are some tips for mitigating risk:

• Work with a tissue bank accredited by an organization such as the American Association for Tissue Banking in McLean, VA. An experienced tissue bank, processor, and sterilization service can provide most of the specialized information you require.
  
  
• Develop a flow chart of the movement of the tissue, including storage conditions and labeling at each step. Mitigate any risk of mix-ups, loss of traceability, or contamination by utilizing procedural or engineering controls.
  
  
• Ensure that all processors and sterilizers are registered with FDA or applicable regulatory authorities.
  
  
• Become aware of the size and strength limits of the various tissue types. Some tissue banks or processors can shape materials to meet specifications, but tolerances are typically larger than with metals and polymers.
  
  
• Formulate a training plan so that all levels of your organization understand the ethical implications of using donor allograft tissue. Materials are available from most tissue banks.