Quality and Safety
Tissue Processing and Quality Standards.
Quality and Safety standards of our processing partners are written to meet regulations established by the U.S. Food and Drug Administration (FDA), Standards of the American Association of Tissue Banks (AATB), and other state guidelines as appropriate.
Our partners use CLIA-certified and FDA-registered testing laboratories and process tissue in ISO certified clean rooms designed with HEPA-filtered and environmentally and microbiologically monitored air. Reagents, equipment, instruments, and packaging materials used in processing meet the same standards as those used in the operating room.
Allografts are processed following stringent safety guidelines and in accordance with current Good Tissue Practices prescribed by federal and state regulatory agencies and industry governing bodies.
Our processors have robust quality systems built into every stage of allograft production starting with donor screening and eligibility determination. Quality standards are established to meet or exceed the regulations and guidelines of the U.S. Food and Drug Administration, the American Association of Tissue Banks, and individual state health departments.
Processing starts with a comprehensive donor screening procedure that includes behavioral and lifestyle risk assessments, medical and social history evaluations, and a detailed physical assessment. Extensive microbiological testing is conducted to further reduce the risk of disease transmission. Tissue samples are evaluated by a CLIA certified, FDA registered laboratory for the following:
HIV-I & II antibodies
Hepatitis B surface antigen
Hepatitis B core antibody
Hepatitis C antibody
HIV-I, HBV, and HCV nucleic acid test
Syphilis antibody
Aerobic and anaerobic microbiological cultures
Accreditations, Registrations,
& Licensure
Evolution Medical Technologies allograft tissue processing partners carry the following licensure, registration, and accreditations.
To request a copy of any or all, please click the button below or email your request.
American Association of Tissue Banks (AATB)
U.S. Food and Drug Administration (FDA)
State of California
State of Florida
State of Illinois
State of Maryland
State of New York
State of Oregon
Canada