Understanding Your Decision
Tissue surgically transplanted from one person to another is called allograft. Bone, tendons and cartilage, skin, heart valves and veins are common types of tissues that are used for transplant to help patients in many different types of surgeries.
The use of methods to prevent, restrict or minimize contamination with microorganisms from the environment, personnel and/or equipment.
Handling devices in a controlled environment, in which the air supply, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels. (ISO 13408-1:1998(E) 2.7)
Tissue surgically removed from one area of a person’s body, such as the iliac crest (in the hip), and transplanted in another site on the same person is called autograft. Using autograft creates two surgery sites on the body, which may lead to additional pain, risk, and a possible longer hospital stay.
Entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses. (AAMI 11137 3.21)
Standards for sterility mean the current standards of the Association for the Advancement of Medical Instrumentation (AAMI) and the American National Standards Institute, Inc. (ANSI) for sterility of cells, tissues or cellular or tissue-based products.
Free from viable microorganisms. (AAMI 11137 3.36 / ANSI 14160 3.17)
State of being free from viable microorganisms. (AAMI 11137 3.37 / ANSI 14160 3.16)
Validated process used to render a product free of all forms of microorganisms. (AAMI 11137 3.39 / ANSI 14160 3.18)
Tissue derived from one species to be implanted in another is called xenograft. Animal-derived tissue (usually from cows or pigs) can be transplanted into a human recipient in many different types of surgeries.
Human Tissue Donation to Implantation
Always talk to your surgeon about any questions or concerns before giving your consent to surgery. Knowing the facts about tissue transplantation is important in making your decision to use this gift of donation. View some examples of questions to ask your surgeons.
Unlike organs, most tissue implants undergo extensive preparation prior to transplantation. During this process, living cells such as blood and bone marrow are removed from the tissue. The absence of living cellular material makes the chance of rejection extremely low, and anti-rejection drugs are usually not prescribed. Patients should discuss these concerns with their physicians prior to surgery.
Allograft tissue is a natural solution for surgery that will incorporate into your body over time. Through the incorporation process, your body replaces the donor material with your own cells, using the implant as a scaffold to regenerate your own tissue.
Tissues are processed into implantable allografts in a strictly controlled clean environment, minimizing the risk of airborne and other contaminants. Tissues are cleaned, sectioned and formed into precision-shaped implants, demineralized bone matrix (DBM) implants or conventional allografts.
Wherever possible, RTI has advanced beyond the use of aseptic processing, which does not remove or inactivate microorganisms inherent to the tissue or donor. RTI’s proprietary tissue sterilization technologies, such as BioCleanse®, Tutoplast®, and Cancelle™ SP are validated to sterilize tissue without compromising the strength or biocompatibility.
Under federal law, all establishments dealing with recovery, processing and distribution of human donated tissue operating in the United States must be registered with the Food and Drug Administration (FDA) and must adhere to applicable FDA regulations, including the Current Good Tissue Practices (cGTPs). Periodic inspections by the FDA are part of the registration process.
Some tissue banks have voluntarily submitted to an accreditation process through the American Association of Tissue Banks, which also includes periodic inspections. RTI is accredited by the AATB and adheres to AATB Standards for Tissue Banking.
Tissue banks must also comply with the applicable laws of the states in which they operate. For a list of current state requirements for licensure, see the AATB site.
Tissue is surgically removed from the donor by technicians from a tissue recovery agency using aseptic surgical techniques, which reduce the chance for bacterial contamination. Legal consent must be obtained and documented from the donor or donor’s family for all tissue recovered. Recovery is done with care and respect and in such a way that all funeral options are still possible. There is no cost or compensation to the donor or donor’s family for tissue donation. It is a generous gift made to benefit others.
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. Donated tissues are recovered by a tissue recovery agency using aseptic surgical techniques for up to 24 hours after a person’s heart stops beating.
The tissue is then sent to a tissue processing facility, which prepares the tissue for transplantation. Laboratory testing to screen for infectious diseases is performed on each donor’s blood and a licensed physician makes a final determination of donor suitability.
Trained technicians then clean and process the tissue into usable biologic implants. The finished implants are distributed to healthcare facilities for surgeons to use as a safe, natural solution for patients.
Millions of tissue transplants have been performed and have improved the quality of life for recipients.
Biologic implants are a natural alternative to synthetic and metal implants. However, unlike synthetic and metal implants, biologic implants incorporate into the patient’s body.
Allograft is natural and biocompatible, allowing your body to remodel it into your own tissue over time. Using allograft tissue rather than an autograft – or tissue from your own body – eliminates a second surgical site, allowing you to avoid additional pain, risk, and a possible longer hospital stay. Patients should discuss their individual treatment options with their physicians.
Similar to organ donation, most allograft tissue is recovered surgically after someone dies. The gift of tissue donation is strictly voluntary and must be generously given by the donor prior to death or the donor’s family.
Allograft Tissue Safety
No, some companies rely on donor screening, laboratory testing and aseptic processing for the safety of their implants.
Wherever 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. RTI’s proprietary, validated sterilization processes provide an additional measure of safety to biologic implants.
RTI is committed to advancing tissue safety through science and innovation. For more information on RTI’s tissue safety, visit the Why is Tissue Safety Important page.
Allografts are used in about one million surgical procedures in the United States every year.
Although the risk of disease transmission through allograft transplantation is low due to screening and testing methods, RTI’s proprietary, validated sterilization processes give patients and their surgeons the greatest level of assurance possible. These processes – BioCleanse®, Tutoplast® and Cancelle™ SP – have a proven combined record of more than two million implants distributed with zero incidence of allograft-associated infection.
In accordance with Food and Drug Administration regulations and American Association of Tissue Banks Standards, RTI adheres to strict donor screening criteria. Potential donors are screened for risk factors associated with infectious diseases and medical conditions that would rule out donation.
Beyond donor screening, RTI performs an extensive panel of laboratory tests. These results are subject to stringent acceptance criteria in order to release the donor tissue to the processing stage.
In addition to laboratory 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.