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Some surgical procedures require the use of bone or tissue grafts. In some instances your surgeon may be able to use your own bone (autograft) for your surgery; however for complex procedures a donated graft (allograft) may be required, and your surgeon will request this from PlusLife.
The use of allograft (tissue donated by another person) is necessary due to the limited availability of your own bone. It can eliminate the necessity of your surgeon performing a second operation to retrieve your own bone, which reduces the time under anaesthetic, additional pain from the second surgical site, loss of mobility, and risk of infection at the secondary site.
29 October 2014
02 September 2014
All Australian Tissue Banks are regulated and licensed by the Therapeutic Goods Administration, which is the regulatory body of the Commonwealth Department of Health and Ageing.
Where does the graft material come from?
You may be aware that many people choose to donate their organs and tissues. There are two types of bone donation:
1. Patients having hip replacement surgery can donate the ball part of the hip joint (femoral head).
2. Alternately during their lifetime, people may indicate a wish to donate organs and tissue. These otherwise healthy people may become donors as a result of an unexpected death. With the consent of their next of kin, they can donate musculoskeletal tissue (long bone and associated tissue such as tendons, ligaments & fascia) after death.
Donated bone is very useful for patients who may require a bone graft e.g. for spinal deformity and bone tumours, complex joint revision surgery and a variety of general orthopaedic procedures. Bone graft can be used in many ways to aid patients who have bone defects. Use of tissue grafts such as tendons and ligaments are also common.
It is not necessary for the donor and recipient to be tissue matched as is needed for the transplant of organs. However, the Rhesus factor is matched where possible for female recipients of child bearing age.
Bone grafts are often used in conjunction with prosthetic implants such as metal hip implants, plates & screws. Once implanted into the recipient, the bone graft does not grow, but can stimulate the recipient's own bone to grow into the graft to repair areas of lost bone.
There are strict donor selection criteria and regulatory controls related to the screening and testing of donors and donated material. A thorough review of the donor's medical and social history is obtained.
A variety of laboratory specimens are collected from the donor for routine testing, to exclude infectious diseases. The donor's blood is tested in the Laboratory for a wide range of diseases including:
Hepatitis B & C
Swabs and bone chips are cultured to ensure that there has been no contamination during the collection process. A bone chip is also examined by a pathologist to exclude any diseases which could be transmitted to a recipient.
Donated bone & tissue is frozen at -70°C awaiting clearance. In most instances, tissue is processed in our clean room to produce special types of graft which meet surgical requirements; and to reduce wastage of this precious material.
Processing involves removing soft tissue from the bone under strict environmental controls, then cutting and packaging it into individual graft items. Checks for microbial contamination are conducted throughout processing, then the graft is irradiated as the last processing step, before release for transplantation.
Bone graft procedures are very common. The demand for human graft materials is growing, and bone & tissue donations assist many patients undergoing complex surgical procedures, thereby improving mobility and function.
There is a remarkable record of safety with tissue grafts, and strict regulatory controls monitor the donation and transplantation of tissue in Australia.
Although rigorous steps are taken to ensure screening, testing and processing are performed according to strict guidelines, there remains an exceedingly low chance of disease transmission.
PlusLife requires a specific recipient consent to be signed by the surgeon and the patient, before graft will be released for transplantation. Your Surgeon, or a Doctor in the Hospital, will discuss the use of graft for your operation with you. You will be required to read and sign our Consent to Receive Allograft form.
If you are uncomfortable with any detail in the consent form, or have any questions, you should discuss this with your Surgeon.
After the transplant the bone and tissue grafts do not grow; they are incorporated into the recipient's body by a process of conversion into the graft. Unlike patients who receive organ transplants (such as kidney or heart transplants), it will not be necessary for you to take any medications specifically related to tissue rejection. You may however be prescribed other medications such as antibiotics following your surgery.
No payment is made to the donor or donor family for the donated material, nor is there any cost to them. Australian Law prohibits the sale of human tissue. However, a "fee for service" is approved by the Commonwealth for each graft transplanted. Graft fees are fully recoverable through the private health funds, or through Medicare if the surgery is performed in a public hospital.
Fees for the supply of graft items incorporate the many costs associated with providing the material, including laboratory costs, operational costs including maintenance and operation of a clean air processing room, consumables used in the retrieval and processing of the graft, regulatory and quality system costs, and administration costs such as staff wages and professional indemnity insurance.
Click here to download a brochure.
PlusLife is a not-for-profit organisation which is responsible for the collection, screening, storage and distribution of donated human bone and tissue grafts for transplant purposes. We also conduct research to ensure that the grafts we supply are of the highest standard.
Surgery which requires bone graft is common and the demand for graft material continues to grow. Your donation can assist people who need surgical procedures such as spinal surgery for adolescents, hip and knee revisions, bone tumours, and repair of bone defects.
Can you donate a Femoral Head?
The femoral head is the ball part of the hip joint, and is normally removed during hip replacement surgery. With your consent, this bone can be donated to PlusLife and used for transplant purposes. Bone donation is voluntary and does not in any way alter how your hip replacement surgery is performed. There is no age limit, and no cost to you. Your Surgeon or the Hospital needs to refer you to our Donor Liaison staff, who will contact you to explain the donation process to you and assist you to complete the required documentation. If you have donated before and wish to do so again at the time of your second hip replacement, we encourage you to contact our Donor Liaison yourself.
You will be required to complete a femoral head donation questionnaire (similar to the one required for blood donation). This form is available at the surgeon's rooms, hospital pre admission clinics, or from PlusLife. Once you have completed the questionnaire, it should be signed by you. This form must then be mailed to PlusLife. It is a legal requirement that we have your permission to collect your bone and to conduct the required laboratory tests. Our Donor Liaison staff will interview you over the telephone and record your consent at the completion of the interview. An Interpreter service is available if required for your convenience.
All the questions in the consent form relate to your medical and social history. These questions are necessary to enable us to obtain a full medical history from you, and to assist us to reduce the risk of transmitting disease to patients who may require bone grafts. Occasionally we may need to contact your GP to obtain further medical history. You can withdraw consent at any time if you change your mind, or have any concerns about the process. Simply notify the Donor Liaison officers. No questions will be asked.
If you would like to become a femoral head donor, or would like further information about bone donation, call our Donor Liaison on Freecall 1800 801 997 or click here to download a brochure.
Unfortunately not everyone is able to donate. A history of various risk factors and diseases may exclude donation. These include but are not limited to the following:
Having lived in the United Kingdom (UK) for 6 months or more between 1980 and 1996, including having made frequent visits during this time which add up to 6 months or more; or having had a blood transfusion in the UK since 1980 (exclusion for Creutzfeldt-Jakob disease, commonly known as Mad Cow's Disease).
Malignant cancers including skin cancers such as Melanoma and Squamous Cell Carcinoma (Basal Cell Carcinoma and some Cervical cancers are accepted).
Rheumatoid Arthritis (Osteoarthritis is accepted) and various other autoimmune disorders.
Neurological disorders: Multiple Sclerosis, Dementia, Alzheimer's, and Parkinson's Disease.
Type 1 Insulin dependent diabetes mellitus (Type 2 diabetes is accepted).
Patients who have received an organ transplant , corneal graft, or human derived growth hormone.
Hepatitis B or C, HIV (AIDS).
If you agree to donate your femoral head when you have your hip replacement, blood and bone samples will be collected and tested in the laboratory.
Your blood is tested for a range of diseases which include:
Hepatitis B & C
Microbiology and histopathology tests are conducted on the bone samples.
Your bone will be sent to us and is stored in a frozen state in quarantine for 6 months until a follow up blood test has been taken.
We will contact you to arrange the follow up 6 month blood test which is a necessary part of the donation process. Your donation cannot proceed unless this follow-up blood test is completed.
PlusLife will provide the laboratory request form; and the tests must be performed at PathWest. Your blood is collected at your convenience, either at home, at work, or you can visit a Western Diagnostic Pathology or Pathwest Pathology collection centre. Country residents may visit their Doctor, local hospital or Pathwest pathology collection centre to have the blood specimen collected. If there are any abnormal tests identified, your Doctor will be advised.
Click here to download a brochure
Tissue donation is very much like organ donation. Following the unexpected death of a loved one, families of the deceased person are approached by a Donor Coordinator and are asked to consider the donation of tissues (such as bone, heart valves or cornea), for the purpose of transplantation.
Some persons have surgery requiring an 'allograft' - a human transplant donated by a generous donor, and sourced from PlusLife. PlusLife is responsible for retrieving bone, tendons and ligaments, then testing and processing the tissue to make special grafts available for use in surgical procedures for bone tumours, spinal deformities, treatment of joint disease caused by trauma and arthritis, and general orthopaedic conditions and facial/dental reconstructions.
After the surgery, some transplant recipients choose to write to their donor family to thank them for their gift, to share information about themselves and to let them know how the transplant has changed their life.
We encourage transplant recipients to write to their donor family if and when it feels right to them. The decision to write is a deeply personal one. There is no right or wrong time and no right or wrong way to say 'thank you' to your donor family. If you would like to do this, send a card, letter or photograph to us, we will review your communication to ensure confidentiality and if your donor family has indicated a wish to receive correspondence from recipients, we will arrange for it to be forwarded on to them.
Please enclose your name and date of surgery on a separate piece of paper in the envelope, so we can ensure we connect you with the right family. The letter to the family should not include any identifying details, i.e. no name, address, or phone details should be included.
Donor Family correspondence should be sent to:
PO Box 1125
Nedlands, WA 6009
Click here to download a brochure
Our Donor Liaison staff receive referrals of potential femoral head donors from Surgeons and pre-admission clinics, and then engage with these patients to discuss the opportunity to donate, to review their medical history, and to obtain their consent to donation. The involvement of the Donor Liaison staff has enhanced the donor process in many ways. Patients are more aware of the process of donation; and potential donors can be thoroughly screened prior to donation, thereby avoiding most unsuitable donations. All resulting in reduction of post donation failures, improved safety and a significant cost saving to the organisation.
What is bone donation?
There are two types of bone donation: Patients undergoing hip replacement surgery may donate the ball part of the joint (femoral head) to PlusLife. There is no age limit for this type of donation. Click here for information about femoral head donation. Persons who have indicated a wish to donate organs and/or tissue after their death may donate musculoskeletal bone and tissue (long bone and associated tissue such as tendons and ligaments), with the consent of the next of kin. Persons aged generally between 15 and 65 years at the time of death may donate musculoskeletal bone and tissue.
Who is PlusLife?
PlusLife is a not-for-profit organisation which is responsible for the retrieval, screening, processing, storage and distribution of donated human bone and tissue for surgical procedures. Bone graft procedures are very common, second only in number to blood transfusions. The demand for human bone graft materials is growing rapidly, and bone & tissue donations assist many patients in need. All Australian Tissue Banks are regulated and licensed by the Therapeutic Goods Administration (TGA), which is the regulatory body of the Commonwealth Dept. of Health & Ageing.
How can my bone/tissue be used?
Donated bone is very useful for patients who may require a bone graft e.g. for bone tumours, spinal surgery, hip revisions and a variety of general orthopaedic procedures. Bone graft can be used in many ways to aid patients who have bone defects. Use of tissue grafts such as tendons and ligaments are also common. It is not necessary for the donor and recipient to be tissue matched as for the transplant of organs. However, it is helpful if we know the Rhesus factor of the donor. Bone grafts are often used in conjunction with prosthetic implants such as hip prostheses, plates & screws. Once implanted into the recipient, the bone graft does not grow, but can encourage the recipient's own bone to grow into the graft to repair areas of lost bone.
How can I become a bone & tissue donor after death?
In the event of your death, a DonateLife WA Donor Coordinator will confirm your registration status on the Australian Organ Donor Registry (AODR). After discussion with PlusLife, the Donor Coordinator will approach your senior next of kin to discuss musculoskeletal bone and tissue donation, and seek consent to donate from your family. The Donor Coordinator will specify which bones and tissues that will be retrieved. A number of questions will be asked regarding the medical and social history of the deceased. In most cases, it is not possible to donate bone and tissue unless the deceased is to undergo routine post mortem examination. This is necessary to provide information regarding the cause of death, and any abnormal pathology findings.
What sort of questions will be asked about the donor's medical history?
In order to eliminate the likelihood of transmission of infectious diseases, a thorough examination of the medical and social history is conducted. In some instances, the GP may be contacted to clarify some medical history details.
There are certain people who may not donate bone & tissue, the Donor Coordinaor wil enquire about any history of the following:
Organ or cornea transplant,
Infectious diseases risk such as HIV (AIDS), Hepatitis B or C, Intravenous (IV) non-prescribed (illicit) drug use,current active infection/unexplained fever, tattoos/body piercing within last 6 months
Disorders such as Rheumatoid Arthritis and Type 1 diabetes,
Malignant cancers including skin cancers such as Melanoma and Squamous Cell Carcinoma,
Dementia including Alzheimer's disease,
Residency in the United Kingdom (UK) for 6 months or more between 1980 and 1996 or having had a blood transfusion in the UK since 1980 (exclusion for Creutzfeldt-Jakob disease, commonly known as Mad Cow's Disease).
How is the bone & tissue retrieved after death?
At all times, the body of the deceased is handled with care and respect. Each bone and tissue is carefully removed and packaged by trained surgical staff. Using prosthetic implants, the limbs are reconstructed to restore alignment, and all wounds are sutured as for any surgical procedure. It is possible for the family to view the body following the retrieval should they wish.
What happens after the bone & tissue has been retrieved?
A variety of laboratory specimens are collected for routine testing including blood, swabs and tissue samples. These specimens are sent to a licensed laboratory for examination. Tests are undertaken for a wide range of infectious diseases, including: Syphilis, Hepatitis B & C, HIV (AIDS). The swabs and tissue samples are cultured to ensure that there has been no contamination of the donated bone & tissue during the collection process. A bone chip is also sent for examination by a Pathologist. The retrieved bone and tissue is placed in a -70°C freezer whilst awaiting clearance. Upon clearance, the bone & tissue may then be used for transplantation, or further processed to produce special types of grafts. Processing involves removing soft tissue from the bone, then segmenting and packaging into individual graft items to optimise the donation, and to reduce wastage of this precious tissue. Graft material may be stored for up to 5 years awaiting transplant.
Will the donor or (in the case of deceased donation) the donor family incur any costs related to bone & tissue donation cost?
Bone & tissue donation is a voluntary act. Neither the donor or the donor family will be charged for the tests performed as part of the donation process, nor will any payment be made for the donation.
What if the donated bone & tissue is not suitable for transplantation?
The focus of donor programs is to provide much needed tissue for transplantation. Research is a very important aspect of the work of PlusLife, to assist in the development of new processing techniques and graft material. In some instances donated tissue is not suitable for transplantation. Each femoral head donor will be asked if they agree to the use of their bone for ethical research in the event it may not be used for transplant.
Similarly, in the case of deceased donation, the Donor Coordinator will discuss this eventuality with the next of kin at the time of approaching them for donation consent. With the consent of the next of kin, this tissue may be used for ethically approved research purposes. Should you or your family not agree to research, then any tissue not suitable for transplantation will be securely disposed of.
How can I register as a donor?
If you are undergoing total hip replacement, you can ask your surgeon about bone donation, or you can contact our Donor Liaison staff directly on our freecall number 1800 801 997 or via email.
If you wish to be included on the Australian Organ Donor Registry for deceased donation, you must complete a donor registration form. Forms can be found in any Medicare Office or at www.donorregister.gov.au.