Proven Record of Safety
Screening & Testing
RTI’s primary goal is to ensure patient safety. We adhere to strict donor screening criteria, laboratory testing and tissue preparation validated to address potential disease transmission to ensure the safety of our implants. In the event that any one of these stages is challenged, RTI’s tissue processing system includes built-in redundancies to ensure patient safety.
Donor Screening
After consent for donation is obtained, potential donors are screened for risk factors associated with infectious diseases and medical conditions that would rule out donation. This screening includes:
- Family / next of kin interview
- Medical / hospital record evaluation
- Physical assessment of the donor
Once this preliminary screening is satisfactorily completed, recovery may begin.
Laboratory Testing
Beyond donor screening, RTI performs 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.
The blood specimens from the donor are subject to an extensive panel of serological infectious disease tests performed in a CLIA-certified laboratory. Serological testing includes:
- HIV Antibody
- HIV 1 & 2 Antibody
- HTLV-I and HTLV-II Antibody
- HCV/NAT
- HBV Surface Antigen
- HBV Total Core Antibody
- RPR for Syphilis
- HIV-I NAT
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.
Donor Eligibility
The final determination on whether donated tissue is suitable for transplant is made by an RTI Medical Director, a licensed physician.
In order to determine donor eligibility, the Medical Director reviews all available records. These records include, but are not limited to, recovery records, the donor physical assessment, the donor risk assessment interview, hospital / ER records, laboratory / pathology reports, infectious disease testing results and the medical examiner/ autopsy report, if performed.