Definitions & FAQs

Definitions & FAQs



Definitions

Allograft
Tissue surgically transplanted from one person to another. Bone, tendons, cartilage, skin, heart valves and veins are common types of tissue used to help patients in many different types of surgeries.

Aseptic
Use of methods to prevent, restrict or minimize contamination with microorganisms from the environment, personnel and/or equipment.

Aseptic Processing
Handling implants 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)

Autograft
Tissue surgically removed from one area of a person’s body and transplanted in another site on the same person. Using autograft creates two surgery sites on the body, which may lead to additional pain, risk and a longer hospital stay.

Microorganism
Entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses.
(AAMI 11137 3.21)

Standards for sterility
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.

Sterile
Free from viable microorganisms.
(AAMI 11137 3.36 / ANSI 14160 3.17)

Sterilization
Validated process used to render a product free of all forms of microorganisms.
(AAMI 11137 3.39 / ANSI 14160 3.18)

Xenograft
Tissue derived from one species to be implanted in another. Animal-derived tissue (usually from cattle or pigs) can be transplanted into a human recipient in many different types of surgeries.

FAQs

How safe are allograft implants?
Allografts are used in about one million surgical procedures in the United States every year.

Although the risk of disease transmission through allograft implants is low due to screening and testing methods, RTI’s proprietary, validated sterilization processes give patients and surgeons the greatest level of assurance possible. These processes – the BioCleanse® Tissue Sterilization Process, the Cancelle® SP DBM Sterilization Process and the Tutoplast® Tissue Sterilization Process – have a proven combined record of more than five million implants sterilized with zero confirmed incidence of implant-associated infection.

How do you screen donors of allograft tissue for potential infections that can be transmitted?
In accordance with Food and Drug Administration (FDA) regulations and American Association of Tissue Banks (AATB) 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.

Where can I learn more about where allograft implants come from and tissue donation?
Similar to organ donation, most allograft tissue is recovered surgically after someone dies. Consent for tissue donation is strictly voluntary and must be generously given by the donor prior to death or the donor’s family. For general information about tissue donation, the following web sites can provide helpful information:

Donate Life America: www.donatelife.net
American Association of Tissue Banks: www.aatb.org

How do I make the decision to use allograft or xenograft for my surgical procedure?
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 examples of questions to ask your surgeon.

How long does an allograft implant last?
Allograft tissue is a natural option for surgery that has the potential to 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.

Is there a chance of rejection from biologic implants? Will I have to take anti-rejection drugs?
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.

How is tissue prepared for implantation?
Tissue is processed into implants 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. RTI’s proprietary tissue sterilization processes, such as the BioCleanse® Tissue Sterilization Process, the Cancelle® SP DBM Sterilization Process, and the Tutoplast® Tissue Sterilization Process are validated to sterilize tissue without compromising the strength or biocompatibility.

What laws and regulations govern the recovery, processing and distribution of allograft tissue in the U.S.?
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 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 (AATB), 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, visit the AATB website.

How is allograft tissue recovered?
Tissue is surgically removed from the donor by tissue recovery agency technicians 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 given to benefit others.

What is the process of allograft tissue donation from recovery to implantation?
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. Within 24 hours of asystole (no cardiac activity), donated tissue is recovered by a tissue recovery agency using aseptic surgical techniques. 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.