Safety you can rely on

Since 1991, Osteotech has produced over 4 million grafts, from over 66,000 donors, with no confirmed report of disease transmission.

The FDA and American Association of Tissue Banks (AATB) have oversight inspection of Osteotech's establishment and practices. Aseptic surgical techniques are utilized when recovering and processing donor tissue.


Testing


When tissue is recovered, samples are obtained and evaluated to ensure the tissue does not contain certain bacteria and microorganisms.

All potential donors are tested for communicable diseases. Some of the key tests and screenings include HIV-1, HIV-2, Hepatitis B, Hepatitis C, and Syphilis. All testing is done under FDA guidelines. Any donor that tests positive for any of the above diseases is immediately rejected as a potential donor.

Aseptic Recovery


All musculoskeletal tissues are aseptically recovered from the donor in accordance with AATB standards. Osteotech was the first company to utilize aseptic processing methods exclusively for all musculoskeletal tissue–and was instrumental in making them an industry standard.

Processing


Osteotech processing has been demonstrated to produce consistently effective products that follow the highest safety standards. There are a number of in-process checks and balances to assure that all tissue is processed within guidelines as set forth by the FDA and AATB. All tissue processing is done one donor at a time.