Proven Record of Safety
Some companies rely only on donor screening, laboratory testing and aseptic processing for the safety of their implants. The safety of any tissue is contingent on three stages – donor screening, laboratory testing and tissue preparation validated to address potential disease transmission.
Wherever possible,* RTI has advanced beyond the use of aseptic processing, which does not ensure the removal or inactivation of microorganisms inherent to the donor or tissue, to better protect recipients from the risk of donor-to-recipient disease transmission. RTI’s proprietary, validated sterilization processes are scientifically proven to address donor-to-recipient disease transmission risk while preserving tissue strength and biocompatibility. These processes have a proven track record of more than five million implants sterilized with zero incidence of implant-associated infection.
BioCleanse® Tissue Sterilization Process
RTI’s allograft and xenograft constructs / spacers and sports medicine soft tissue implants are sterilized through its patented BioCleanse Tissue Sterilization Process, an automated, pharmaceutical grade process. BioCleanse is used on grafts that provide a natural biologic scaffold in orthopedic, spine and sports medicine procedures.
The BioCleanse system sterilizes tissue using a complex, proprietary combination of mechanical and chemical processes, working in conjunction with each other. The mechanical component applies oscillating positive and negative pressure in the presence of the chemical agents (including detergents and sterilants), which gently perfuse the tissue. This combination removes blood and lipids, and inactivates or removes pathogenic microorganisms. Repeated rinses throughout the process remove debris, and final rinses remove residual chemicals, leaving the tissue biocompatible. The BioCleanse process does not sterilize using excessive heat or irradiation.
Tutoplast® Tissue Sterilization Process
The Tutoplast process is a chemical sterilization methodology originally developed more than 30 years ago by Tutogen (which merged with RTI in Feb. 2008) to sterilize and preserve tissue for implantation. Membrane and soft tissue augmentation grafts, as well as bone particulate, sterilized through Tutoplast are used in dental, urological and other procedures.
During the Tutoplast process, osmotic, oxidative and alkaline (membrane tissue only) treatments break down cell walls, inactivate pathogens and remove bacteria. Solvent dehydration results in room temperature storage of tissue without damaging the collagen structure. Low dose gamma irradiation ensures sterility of final packaged product.
Cancelle® SP DBM Sterilization Process
DBM-based pastes and putties are sterilized through the Cancelle SP process, which is designed to preserve protein activity. Their osteoinductive (OI) potential** is verified by 100 percent lot testing after sterilization. In their final form, the DBM implants serve as bone void fillers in many applications, including spinal, general orthopedic, joint reconstruction and dental surgeries.
Cancelle SP is a proprietary process that sterilizes DBM pastes and putties while simultaneously allowing them to maintain their osteoinductive potential**. Through a combination of oxidative treatments and acid or alcohol washes, debris is removed and pathogens are inactivated. Cleansing rinses remove residual chemicals, maintaining biocompatibility and preserving the utility of the graft. The Cancelle SP irradiation dose is delivered terminally for pastes and putties to achieve device-level sterility (SAL 10-6).
* Fresh-stored osteochondral allografts are cleansed, processed and preserved to maintain chondrocyte viability, and therefore are not sterilized through one of these processes.
** Every DBM lot induced bone formation when implanted in a modified athymic nude rat assay. Findings from an animal model are not necessarily predictive of human clinical results.