AlloSource's Safety Record
AlloSource’s number one goal is to provide safe, high-quality allografts. Accordingly, our recovery standards and screening and processing procedures comply with FDA and industry body guidelines. There has never been a confirmed incident of disease transmission from AlloSource tissue.
AlloSource safety credentials and procedures:
- Accredited by American Association of Tissue Banks (AATB)
- Clinical Laboratory Improvement Amendments (CLIA)-certified testing laboratory
- Fully compliant with the FDA’s current Good Tissue Practices (cGTP)
- ISO 9001:2008 Compliant
- Tissue processed in ISO Class 5 clean rooms with HEPA filters and environmentally/microbiologically monitored air
- Equipment, instruments and packaging meet standards for sterility
- An independent Medical Advisory Board is responsible for reviewing safety and quality procedures. The Medical Advisory Board, chaired by AlloSource Medical Director Ross Wilkins, M.D. is comprised of physicians specializing in orthopedics and tissue transplantation.
- Extensive verification of a donor’s medical/social history and comprehensive physical assessment identifies and eliminates high risk donor tissue.
- AlloSource utilizes a validated bioburden reduction cleaning process.
- AlloSource allografts are sealed in sterile pouches and clearly labeled with a unique donor and tissue ID, product ID code, allograft description, size, expiration date and storage instructions.
- AlloSource allografts are sterile to 10-6 sterility level.*
*Allografts labeled Sterile R are aseptically processed and packaged and then subjected to gamma or electron beam irradiation. AlloSource has validated the sterility of it irradiated allografts in accordance with a technical standard published jointly by the American National Standards Institute (ANSI), the Association for the Advancement of Medical Instrumentation (AAMI), and the International Organization for Standardization (ISO). The FDA Standards Program recognizes the standard, AMI/ANSI/ISO 11137, as a Consensus Standard. The Sterility Assurance Level (SAL) of tissue labeled Sterile is 10-6.