Undergoing Surgery? What You Should Know About Tissue Sterilization

(BPT) – Having surgery can be overwhelming, and one of the most important things people can do to prepare is talk with their surgeon to learn more about available options. For instance, people undergoing certain types of procedures, including anterior cruciate ligament (ACL) reconstruction, meniscus transplantation and fracture repair, may receive a tissue-based implant. There are several types of tissue-based implants, including allograft and autograft.

  • Allograft is tissue surgically transplanted from one person (the donor) to another, and may include bone, tendons, cartilage, skin, heart valves and veins. Allografts have been used successfully in various medical procedures for more than 150 years, and about 1.5 million allografts are transplanted each year in the United States.[i]
  • Autograft is tissue surgically removed from one area of a person’s body and transplanted to another part of their body. Autograft is used frequently, but because it creates two surgery sites on the body it may lead to additional pain, risk and a possible longer hospital stay.

One important consideration for people receiving allograft is whether the tissue has been sterilized. Despite certain infections associated with unsterilized allograft tissue, sterilization is not required or consistently performed.[ii] While there is some risk of disease transmission for all donated human tissue, sterilization provides a measure of added safety beyond tissue screening and testing alone.[iii]

RTI Surgical’s validated, proprietary BioCleanse® Tissue Sterilization Process advances beyond aseptic processing to address the risk of donor-to-recipient disease transmission. Potential donors are screened for risk factors and eligibility is determined by RTI’s medical director, a licensed physician. The BioCleanse Process is used to sterilize grafts and is validated to inactivate or remove a panel of viruses, including HIV and hepatitis, as well as bacteria, fungi and spores. RTI recently reached the milestone of providing more than 8 million tissue-based implants processed through its three proprietary sterilization processes (including the BioCleanse Process) with zero confirmed incidence of implant-associated infection.

“The BioCleanse Process offers sterility and quality — it’s that simple,” said Dr. Patrick Joyner, an orthopedic surgeon in Naples, Fla. “While some methods of cleaning grafts can make them weaker, the BioCleanse Process sterilizes tissue without compromising its strength.”

The BioCleanse Process sterilizes tissue to a sterility assurance level (SAL) of 10-6 (which indicates a one-in-one million likelihood of an organism surviving to the end of the process)[iv] using a complex, proprietary combination of mechanical and chemical processes, working in conjunction with each other.

The BioCleanse Process:

  • Is effective against a wide range of microorganisms including viruses, bacteria, fungi and spores*
  • Thoroughly penetrates tissue to sterilize the entire graft*
  • Maintains structural integrity and biocompatibility[v]
  • Is validated to SAL 10-6 using most difficult case scenario organism (spores) and tissue (Achilles)*
  • Is scientifically proven and clinically successful[v]

Tendons that have gone through the BioCleanse Process are not terminally sterilized (a process in which an implant is sterilized in its final container or packaging). Studies suggest allograft tendons are negatively impacted by terminal sterilization.[v] [vi] [vii] Instead, following the BioCleanse Process, tendons are aseptically packaged to preserve the biomechanical properties and clinical performance.[vi]

“For a graft that’s both strong and sterile, the best option is one that has gone through the BioCleanse Process,” said Dr. Joyner.

To learn more about the BioCleanse Process, talk with your surgeon and visit www.rtix.com/biocleanse.

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[i] Data on file at RTI Donor Services, Inc.

[ii] Kainer et al. “Clostridium Infections Associated with Musculoskeletal-Tissue Allografts.” New England Journal of Medicine, 2004. Online at https://www.nejm.org/doi/full/10.1056/nejmoa023222.

[iii] Data on file at RTI Surgical, Inc. Why Choose RTI Surgical Tendons?

[iv] Woedtke and Kramer. “The limits of sterility assurance.” GMS Krankenhhyg Interdiszip. 2008. Online at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2831250/.

[v] Schimizzi, et al. “Effects of a Novel Sterilization Process on Soft Tissue Mechanical Properties for Anterior Cruciate Ligament Allografts.” American Journal of Sports Medicine, 2007. Online at https://pdfs.semanticscholar.org/0de6/83e4751a4bf58179f92598a863d489c162c6.pdf.

[vi] Indelicato et al. “Aseptically processed and chemically sterilized BTB allografts for anterior cruciate ligament reconstruction: a prospective randomized study.” Knee Surgery Sports Traumatology Arthroscopy, 2012. Online at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3751503/.

[vii] AAMI TIR37:2013, Sterilizaton of health care products – Radiation – Guidance on sterilization of biologics and tissue-based products. Online at http://my.aami.org/aamiresources/previewfiles/TIR37_1407_preview.pdf.

*Data on file at RTI Surgical, Inc.

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