SAFETY & QUALITY

No Tissue Bank Has A Better Safety Record. Period.

The donation of tissue from one person to another requires an extraordinary level of care to provide safety for recipients. At MTF, we have built every procedure and facility from the ground up with patient safety in mind. From the procurement of tissue, to processing and storage, to a surgeon's use of an allograft in a recipient's surgery, the highest safety standards are observed at all times.

We believe that safety starts with the quality of donors you accept. That's why every year we reject more potential donors than every other tissue bank—it's the only way we can meet our high standards. Orthopaedic surgeons establish our stringent criteria, and we maintain the highest safety standards of any tissue bank.

Because of the meticulous level of care that governs everything we do, MTF possesses an unrivaled safety record, and we have over 3 million distributed grafts to prove it.

Safety in Allograft 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 American Association of Tissue Banks (AATB) standards; processing and packaging of tissue is performed aseptically in sterile Class 10 (certified) Clean Rooms.

MTF has validated its processing procedure to prevent any contamination or cross contamination of tissue we distribute. We perform final sterility cultures, which must be negative, before the tissue is released.

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 certified under the Clinical Laboratory Improvement Amendments of 1988 or have equivalent certification.

MTF maintains a documented quality management system designed and implemented to fulfill requirements of 21CFR Parts 1270 and 1271 and the Validation Guidance of the FDA, as well as the current AATB standards. MTF is also ISO 9001 certified.

How Safe Are Allografts?

We use the most complete and technically advanced testing available, including NAT and DNA testing, to assure the safety of every allograft we supply. The only confirmed transmissions of viruses through transplanted tissue occurred at other tissue banks in the mid-1980’s, before current testing procedures were available, with unprocessed tissues. The most recent statistical studies available today estimate the risk of transmitting a virus through transplantation to be less than 1 in 1.67 million. These studies do not include the newest testing modalities that are used in the industry today. Compared to many everyday activities, the risk is virtually nonexistent. MTF continues to develop procedures—including comprehensive screening of donors and extensive testing of all donated bone and soft tissue—to reduce the odds even further.

MTF also utilizes Nucleic Acid Testing (NAT by TMA) on every donor. NAT is the most complete and technically advanced testing available. Since our inception in 1987, with over 3 million grafts distributed, MTF maintains an unrivaled safety record.

If you would like more information about allografts and safety testing, please ask your surgeon or contact MTF Customer Service at 1-800-433-6576.