Bio-Implant Solutions, LLC was formed in 2010 as a consulting business in the biotech field. AMS's primary goal is to assist medical and transplant facilities in the US with their tissue and medical device needs. We bring over 13 years of experience in the tissue banking industry and provide a one-stop solution for your surgical implant needs.
Bio-Implant Solutions has contracted with reputable AATB certified Tissue Banks to help provide you with the safest and highest quality allografts available. By contracting with multiple agencies, we have access to a wide variety of allografts including tendons for Sports Medicine, spine constructs and other conventional tissue used in Orthopedic surgeries. Thus, we are able to better meet the needs of your surgeons with regards to specifications and scheduled surgery dates. In addition, We partner with independent representatives and distributors throughout the US in an effort to assist with bone and tendon allograft needs.
For your convenience, we have listed below additional information regarding the tissue processing the tissue banks use for sterilization purposes to ensure your patients are receiving the safest tissue possible. More in-depth information is available upon request for each process. In addition, each tissue bank that Bio-Implant Solutions partners with are registered with the FDA and are ATTB accredited. Furthermore, each tissue bank's credentials and licenses are also available upon request.
Processing of donor tissue follows stringent safety guidelines and good manufacturing practices prescribed by federal and state regulatory agencies and industry governing bodies.
Grafts processed with the Allowash® method allow allografts to be cleaner and safer while maintaining their clinical effectiveness. Viral inactivation studies indicate that the processing of allograft tissue using Allowash® technology is highly effective for the inactivation of both RNA and DNA enveloped viruses of the Retro, Flavi, and Herpes families. Allowash® technology does not affect the osteoinductivity of bone allografts and adds a greater measure of assurance to physicians and patients.
Allowash Technology® involves a series of mechanical and reagent cleaning and disinfection steps to reduce any potential bioburden. This process includes the use of Allowash® solution, a combination of biological detergents that work in conjunction with traditional treatments such as alcohol and hydrogen peroxide to enhance the solubilization and removal of bone marrow, blood, and lipids (elements that may possibly act as a reservoir for disease transmission). In addition, antibiotics (Bacitracin and Polymyxin B) are also utilized in the processing of allografts. Tissue to be demineralized is further processed using Hydrochloric Acid and Sodium Phosphate Buffer.
Allografts bearing the SteriGraft™ label fulfill the discriminating surgeon's desire to extend extraordinary patient care. A superior level of allograft processing begins with rigorous Donor Screening and meticulous Donor Recovery Procedures, Certified Laboratory Testing, validated Tissue Cleansing, Sterile Packaging, and a meticulous Quality Assurance & Documentation system that ranks second to none. These combine to form the proprietary, GraftShield™ allograft processing system, designed to set an entirely new standard in allograft sterilization. This system offers scientifically validated tissue sterilization (validated to SAL 10-6 in accordance with ISO 11137-2 Method 1) which virtually eliminates the risk of bacterial disease transmission.
The Graftshield™ process makes improvements at multiple steps in the tissue processing system. Our processing partner, Texas Human Biologics utilizes a state of the art processing facility which makes the following steps possible.
•Tissue Cleansing - To prepare for processing, tissues are sanitized using GraftCleanse™. This proprietary blend of cleansing compounds significantly reduces bio-burden and allows for an aesthetic, white appearance.
• Sterilization - GraftShield™ utilizes a low dose radiation sterilization method that is validated in accordance with ISO 11137-2 Method 1. Terminal sterilization is achieved with allografts in their final packaging.
• Custom Processing Machines - We have designed and built custom equipment that enables individual equipment sterilization between cases, thus eliminating the risk of cross contamination - a significant advance in the safety of processing human tissue allografts.
• Allograft Performance - Each allograft is evaluated at the time of processing, packaging, labeling, and again just prior to release to ensure that high quality tissue is being made available for transplantation.