Understanding Your Decision
Why is tissue safety important?
Every surgical procedure involves risk from multiple factors. The question is how to reduce that risk to an absolute minimum. RTI Biologics does its part by continuously raising the bar of science and safety for biologic implants, with patient safety being top of mind. Although the risk of disease transmission through allograft transplantation is low, regardless of the source, RTI has developed proprietary methodologies and sterilization techniques to give both the patient and physician the greatest assurance possible as to the safety of their allograft.
Redundancy is the key to safety. Even in the highly unlikely event of a break down in one stage of the process, the safeguards created by the other stages act as a counterbalance. With respect to tissue safety, these different stages are (1) donor screening, (2) laboratory testing, and (3) tissue preparation validated to address potential disease transmission.
After donor consent is obtained, donor history screening and laboratory testing is performed in accordance with FDA regulations and AATB Standards. RTI also uses proprietary, validated tissue sterilization processes to provide an additional level of safety. These three sterilization processes – BioCleanse®, Tutoplast® and Cancelle™ SP – have a proven combined record of more than four million implants distributed with zero incidence of implant-associated infection.
Not all companies can match the level of tissue safety offered through RTI. When receiving an allograft implant, be sure to ask your surgeon for tissue from RTI Biologics.
Screening and Testing for Patient Safety
A complete medical/social history must be performed for every donor including:
- Cause of death – donors are only accepted if cause of death is established
- Medical / Social History:
- Family / next-of-kin interview
- Medical record / hospital review
- Behavioral / lifestyle risk assessment
- Medical examiner / coroner’s report (autopsy report, when available)
- Laboratory, pathology and radiology reports
The final determination of donor eligibility is made by RTI’s medical director – a licensed physician – using all available, relevant information.
Beyond donor screening, RTI performs an extensive panel of serological and microbiological tests. These results are subject to stringent acceptance criteria in order to release the donor tissue.
In addition to serological testing on the donor’s blood, microbiological testing is used throughout the process (where appropriate) to screen for potential contamination and to provide confirmation of tissue suitability for transplant.
The Science of Sterilization
When 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. To achieve sterilization, individual processes should be validated by tissue type. Validation should include viral inactivation, elimination of a wide range of organisms using worst-case testing and maintenance of biocompatibility and tissue functionality.
Note: Fresh-stored osteochondral allografts are cleansed, processed and preserved to maintain chondrocyte viability and therefore are not sterilized through one of these processes.