Common Myths
Myth: I could get a disease such as HIV or cancer from donated tissue.
Allografts have been used successfully in various medical procedures for more than 150 years. About 1.75 million allografts are transplanted each year in the United States. The risk of disease transmission through tissue transplantation is believed to be very low and with an increased demand for allograft tissue, the availability of safe allografts has become a focus of the tissue industry, surgeons and patients alike. While risk of disease transmission remains for all donated human
tissue, sterilization adds a measure of added safety above screening and testing alone. Tissue processing is highly regulated by organizations such as the U.S. Food and Drug Administration (FDA) and the American Association of Tissue Banks (AATB) to ensure that tissue meets regulatory requirements.
The safety of any tissue is contingent upon three stages: donor screening, laboratory testing and tissue preparation validated to address the risk of potential disease transmission.
The donor screening process includes, but is not limited to, a donor risk assessment interview, medical record/hospital record review, the medical examiner/coroner’s report (when performed), and laboratory, pathology and radiology reports (when available).
Laboratory testing includes an extensive panel of infectious disease and microbiological testing to screen for potential contamination and to provide confirmation of tissue suitability for transplant. These results are subject to stringent acceptance criteria in order to release the allograft implant for implantation.
To better address the risk of donor-to-recipient disease transmission, many tissue processors have advanced beyond the use of aseptic processing, which does not ensure the removal or inactivation of microorganisms inherent to the donor or tissue.
Allografts can be processed in several different ways to address the risk of donor to recipient disease transmission.
| Allograft Treatment | Description of Processing |
|---|---|
| Aseptic processing | Not a sterilization process. Chemical treatment with alcohols, antibiotics, or detergents to attempt removal of cellular elements from donor tissue. |
| Gamma irradiation | Form of electromagnetic radiation that kills bacteria, but may not address viruses. |
| BioCleanse® Tissue Sterilization Process (RTI Surgical) | Sterilization process that achieves a sterilization assurance level (SAL) of 10-6* (after a BioCleanse Process cycle) without the use of gamma irradiation for tendons. The BioCleanse Process addresses donor bacteria, viruses, fungi and spores. |
| Cancelle® SP DBM Sterilization Process | Sterilization process that has a terminal irradiation dose for most demineralized bone matrix-based grafts to achieve SAL 10-6. |
| Tutoplast® Tissue Sterilization Process | Chemical sterilization methodology to sterilize and preserve tissue such as soft tissue augmentation grafts, membrane and bone particulate for implantation. Low dose gamma irradiation ensures sterility of the final packaged graft. |
* Sterility assurance level (SAL) – The probability of a single item in a batch being non-sterile after being subjected to a sterilization process. SAL of 10-6 indicates a 1 in 1,000,000 likelihood of an organism surviving to the end of the sterilization process. The ultimate goal is to have the lowest probability, or 10-6, of non-sterile units.
Myth: Allograft tissue wouldn’t work as well as my own tissue (autograft).
Surgeons have the choice of autograft, which takes tissue from one part of the body for transplantation to another part.
Allograft tendons present certain benefits for some procedures. For example, they can eliminate the need for a second surgery site, avoiding additional pain, risk and possibly a longer hospital stay. Allograft implants act as a scaffold; the patient's body recognizes the implant as human tissue and begins laying the patient's own new tissue cells over it.
Myth: Metals and synthetics are better than allografts.
Allografts are a natural alternative to synthetic or metal implants. Human tissue is favored by many surgeons over metals or synthetics, which sometimes weaken and stress adjoining bone. Additionally, the body usually incorporates the transplanted allograft tissue as if it were its own.
Myth: Tissue is taken from a human donor without the donor’s consent or donor family’s authorization.
Legal authorization is required before recovery takes place. The standards by which tissue banks operate require staff to give each family the opportunity to ask for more information throughout the interview process and to give a phone number and contact person should the family want additional information at a later date.
In the case of consent, the decision to donate organs and/or tissues is made by the donor during his or her lifetime, or by a family member after death, and it is the organ and tissue-recovery organization’s role to ensure his or her wishes are carried out.
Tissue banks are committed to being responsible stewards of the gift of donation. These organizations have standards and protocols in place that are meant to protect donor families, recipients and the integrity of the entire donation process.
Myth: The tissue banking industry is unregulated.
Under federal law, all establishments that recover, process and distribute donated human 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 (cGTP). Registered tissue banks are subject to periodic inspections by the FDA.
Some tissue banks have voluntarily submitted to an accreditation process through the American Association of Tissue Banks (AATB), which also includes periodic inspections.
Additionally, tissue banks must 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 at www.aatb.org.
Myth: There is no way to trace which allograft implants came from which human donor.
Each tissue donor is assigned a unique identifier used to trace the tissue and associated laboratory specimens through every stage of screening, testing, processing and distribution. All medical and manufacturing records associated with the donor also refer to this unique identifier. Each allograft package label is required to include a unique identifier that links to the donor and may also include a serial number that allows tracking of individual grafts. Records are maintained showing the transfer of the graft to the implanting health care facility.
The health care facility may use implant identification labels to transfer graft identification information to the patient’s medical chart. Return of the record to the tissue processor completes the tissue traceability from donor to recipient.
Myth: Tissue banks sell human tissue, which is illegal.
The sale of human organs or tissue is illegal in the United States. The cost associated with an allograft implant includes the expense to prepare the donated tissue before it can be used for transplantation.
Myth: Using allograft is experimental and not very common.
Second only to blood, musculoskeletal (allograft) tissue is the most commonly transplanted tissue, with more than one million grafts surgically implanted annually in the U.S. alone. The use of allograft tissue has seen significant advances in the last few years as a direct result of the development of precision processing technologies.
Myth: My body might reject allograft tissue since it’s not my own.
Most processors take steps to remove all blood and other organisms from the tissue to reduce the risk of rejection. The allograft is a clean, natural scaffold that allows for remodeling with the patient’s own tissue. If you want to know more about possible rejection, you can speak with your surgeon about how the tissue they use is processed.
1 Hampton et al., “Effect of Donor Age on Patellar Tendon Allograft ACL Reconstruction.” Orthopedics. 2012.
Swank et al., “The Effect of Donor Age on Structural and Mechanical Properties of Allograft Tendons.” American Journal of Sports Medicine. 2014.
