Allograft Tissue Safety

Allograft Tissue Safety

RTI Surgical has always led the way for tissue safety in our industry. We continue to set the standard of safety for biologic implants, always keeping the patient in mind. Our commitment to tissue safety is evident by our redundant safeguards – safeguards other processors do not have. RTI gives both patients and surgeons the greatest assurance possible. How do we know? Our track record proves it. We have sterilized more than eight million implants through our validated, proprietary sterilization processes with zero confirmed incidence of implant-associated infection.

Not all companies can match the level of tissue safety offered by RTI. When receiving a biologic implant, be sure to ask your surgeon for tissue from RTI Surgical.

The Science of Sterilization

Where possible, RTI has advanced beyond aseptic processing, which does not ensure the removal or inactivation of microorganisms inherent to the donor tissue, to better protect patients from the risk of donor-to-recipient disease transmission. To achieve sterilization, individual processes should be validated by tissue type. RTI uses proprietary, validated tissue sterilization processes to provide an additional level of safety. Our three sterilization processes are – the BioCleanse® Tissue Sterilization Process, the Tutoplast Tissue Sterilization Process and the Cancelle SP® DBM Sterilization Process.

Patient Safety

Patient safety is our primary goal. We provide an additional measure of safety by adhering to strict donor screening criteria and tissue preparation methods validated to address potential disease transmission. In the highly unlikely event of a break down in one stage of the process, RTI’s tissue processing system includes built-in redundancies to ensure the implant is safe. With respect to tissue safety, the stages are (1) donor screening, (2) pre-processing laboratory testing and (3) tissue preparation methods validated to address potential disease transmission, and post-processing laboratory testing.

Donor Screening

RTI receives donated tissue from independently-licensed recovery agencies which screen for safety prior to recovery, including conducting an interview with the family/next of kin and a behavioral/lifestyle risk assessment. Following receipt of tissue from the recovery agency, RTI evaluates records from the recovery agency and performs the following donor risk assessment:

Donor Risk Assessment
Medical record / hospital records review
Medical examiner / coroner’s report (when available)
Laboratory, pathology and radiology reports (when available)

Laboratory Testing
As part of its processing-related donor screening, each donor undergoes an extensive panel of serological and microbiological tests. These results are subject to stringent criteria in order to release the donor tissue to the processing stage.

Tests on the blood specimens from the donor are performed in a CLIA-certified laboratory. Infectious disease testing includes:

  • HIV-1/HIV-2 Antibody
  • Hepatitis C Virus Antibody
  • Hepatitis B Surface Antigen
  • Hepatitis B Core Antibody (Total)
  • Syphilis
  • Human T-Cell Lymphotropic Virus I/II Antibody

In addition to infectious disease testing on the donor’s blood, microbiological testing is used throughout the process (where appropriate) to screen for potential contamination and provide confirmation of tissue suitability for transplant.

* Clinical Laboratory Improvement Amendments

Donor Eligibility

The final determination of donor eligibility is made by RTI’s medical director – a licensed physician – using all provided, relevant information.

Donor Criteria

Tissue banks screen donors according to strict donor medical, behavioral and physical criteria provided by the U.S. Food and Drug Administration (FDA) and the American Association of Tissue Banks (AATB). Tissue banks may implement additional criteria based on their individual implant portfolio, processing methods and/or tissue availability. RTI implements extensive scientific testing, biomechanical evaluation and sterilization capabilities, giving many families the option of participating in tissue donation.

Where possible, RTI does not use arbitrary criteria such as donor age to determine tissue utilization. Instead, tissue is evaluated by individual donor based on tissue type and defined implant specifications. Donor and/or tissue requirements are established through scientific methods such as biological properties, biomechanical testing and clinical evaluations.

By investing in extensive research and development initiatives and advanced engineering expertise, RTI is able to truly honor each donation by helping as many patients as possible have an improved quality of life.