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Focus on Quality:
What to Look for When Choosing an Allograft or Bio-Implant Provider
Searching for an alternative tissue source? Be sure to address the following 12 questions to make an educated decision.
• Is the provider accredited by the AATB (American Association of Tissue Banks)? If so, request documentation. In a global economy, certification that is recognized worldwide is becoming a necessity. Click here to view LifeNet Health’s summary of accreditations/certifications.
• Are the musculoskeletal tissue allograft bio-implants sterile to an SAL of 10-6, as expected for a medical implant?
• Is the provider’s sterilization process validated?
• Does the provider have data indicating inactivation of viruses using the process?
• Does the provider have a return policy?
• Are all of the delivery devices for allograft bio-implants safe to come in contact with breached skin?
• Does your provider avoid the use of harsh solvents such as acetone in tissue processing?
• Are any of the allograft bio-implants irradiated prior to final packaging?
• Does the provider have an option to obtain implants at ambient temperature and fully hydrated requiring minimal rinse time?
• If the provider offers demineralized bone carriers, is the osteoinductivity tested in-process (prior to either mixing with carrier, or final packaging, or terminal sterilization) or is it tested after final packaging and sterilization and in its final state?
• Is the provider also a tissue recovery agency?
• Does the provider offer cardiovascular as well as musculoskeletal tissues?
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