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We provide an additional measure of safety by adhering to strict donor screening criteria and tissue preparation methods validated to address potential disease transmission.

Donor Screening

RTI receives donated tissue from independently-licensed recovery agencies that 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
• HIV-I /HCV/HBV NAT

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.