The MTF Process

The MTF allograft tissue process (ATP) is not singular in scope, but rather a culmination of everything we do to ensure patient safety from the initial consultation with a potential donor family to a surgeon’s use of an allograft in a recipient’s surgery. The donation of tissue from one person to another requires an extraordinary level of generosity and an equally demanding level of care. We partner with organ and tissue procurement organizations to ensure the highest ethical standards and respectful procedures during tissue recovery.

Screening

Every potential donor must pass through a quality assurance process. Comprehensive medical and social histories are required for every donor. MTF only uses nurses to perform all of our social and medical history screening. Potential donors with any condition that can affect the quality and long-term performance of the bone and/or tissue are excluded, and all donations must be approved by one of MTF's Medical Directors.

MTF rejects more donors every year than any other tissue bank because these donors do not meet our strict acceptance criteria.

MTF’s standards are established by a Medical Board of Surgeons, who developed the standardized age criteria (female age 12-70; male 12-70) that allows for the selection of tissues with dense, strong cancellous constructs more commonly found in that age range.

Soft tissue age criteria were determined based on the clinical research concerning the mechanical integrity of tissue through a range of ages.

Recovery

The standard musculoskeletal recovery consists of the long bones and connective tissue (tendons, ligaments and cartilage) of the upper and lower extremities and the pelvis, but is dependent on the wishes of the family. Other tissues may be recovered depending on donor family approval and recipient needs.

All tissues used by MTF are recovered from deceased donors in accordance with AATB standards using aseptic surgical techniques. Recovery technicians are trained by MTF and receive continuing education to assure the consistent knowledge and application of MTF standards.

MTF employs an Audit Team whose sole purpose is to audit, on a routine basis, the tissue recovery organizations that MTF partners with to ensure compliance with our strict standards and protocols. MTF’s philosophy is that non-profit control of recovery and distribution are at the heart of insuring ethical stewardship of the donated gift, and MTF does not work with any for-profit tissue recovery agencies. Since 1987, we have approved and processed over 60,000 donors and distributed more than 3 million allografts.

Testing

All tissue and blood samples are tested for infectious diseases, including testing for AIDS with Nucleic Acid Testing (NAT by TMA) — the newest and most reliable test to confirm the presence or absence of HIV and HCV early following exposure. Our comprehensive battery of testing also includes: HIV-1*, HIV-2*, HTLV-I, HTLV-II, HB Core, RPR, HCV-Ab, HBs Ag*, HIV-1 NAT, HCV-NAT.

As an accredited member of the American Association of Tissue Banks (AATB), all of our testing and processing of donated tissue meet or exceed all AATB standards and FDA regulations. All test results are evaluated by a team of specialists and physicians from the infectious disease, pathology and tissue banking fields.

* Tested using FDA required test kits.

Processing

MTF’s processing is designed to establish and maintain sterility through a variety of in-process measures. Allograft tissue is supplied to MTF according to the AATB standards. MTF donors are only released to processing after all charts and records are carefully reviewed by one of our Medical Directors who are all physicians with infectious disease or pathology backgrounds.

MTF employs the use of antibiotic soaks, surfactant treatments, and ethanol soaks in processing tissue. All processing steps are validated and performed in Class 10 Clean Rooms to ensure sterility and prevent contamination and cross contamination of human tissues.

MTF tissue is tested for sterility in accordance with procedures in the current United States Pharmacopeia (USP). MTF is in compliance with current AATB standards and all microbiological sterility testing is performed by laboratories that are registered with the FDA. All tissue must pass final sterility testing before release for distribution.

MTF maintains a documented quality management system designed and implemented to fulfill requirements of 21CFR Parts 820, 1270 and 1271, and the Validation Guidance of the FDA as well as the current AATB standards. MTF provides tissue for single patient use only. The outer tray is labeled with the lot number, expiration date, product code, quantity (volume) and other pertinent information. Every tissue is computer tracked from recovery through testing, processing, packaging and distribution from the donor to each medical facility.