Bone bank: Future of orthopaedic reconstruction

Bone has a unique tissue capability of regeneration, i.e. it can form or stimulate new bone at the recipient site by process of osteogenesis, osteoinduction and osteoconduction.[1] Autografts and allografts, when placed in the tissue bed appropriately and in a favourable environment, can stimulate new bone formation at the recipient site.[2] This property of the bone is very useful to fill the bone defects in various orthopaedics surgeries where bone grafting is necessary such as complex primary and revision arthroplasties, spinal fusions, skeletal reconstructions after tumour excision, pathological fractures, trauma surgeries with bone loss, arthrodesis, non-union and reconstructive surgeries. Due to donor site pain, extended surgical time and limited amount of available dispensable bone graft in auto-grafting, it may not be sufficient enough to fulfil the requirement of the amount of the bone graft needed and in such case allogenic bone grafts are extremely useful and necessary. These allografts are provided by the bone banks. Thus Bone bank is facilities that provides allografts and are engaged in donor screening retrieval, processing, storage and distribution of the bone tissues.[3] Act and Legal Governing Bodies The bone banks are licensed and governed by the Transplantation on the Human Organs and tissues Act 2014, which regulated brain stem dead donors, deceased donors and living donors.[4] Although the act deals with the transplantation of tissue, including blood and its products, the act lack specific consideration related to bone tissue transplant. In view of absence of specific guidelines related to bones, the bone tissue transplant and bone banks are still governed by the same rules as similar to other tissue banking. As per the act, Bone banks in India should be non-profitable, non-commercial facility, without any incurring costs to the donor or the recipient for allografts. But recipients are required to pay a minimal fee to cover for the running of bone bank, expense of procurement, processing, storage and sterilization of graft and screening donors for blood-borne diseases. Permission to establish a bone bank is initiated towards the state organ and tissue transplant organisation (SOTTO), which on inspection and on satisfaction of fulfilment of all the necessary requirements needed under Transplantation of Human Organs and Tissues Act (THOTA), 1994 grant legal permission to run a bone bank. Non-compliance with the law carries severe consequences. Advisory Board, Management Board and Staff Advisory Committee headed either by head of the institution or by the departmental head may initiate the establishment of the bone bank. The other members can be included from the department of orthopaedics, pathology, microbiology or from any other related department. The management board can be formed from various members of the institution and it looks into the proper management and functioning bone bank. Finally bone bank requires proper trained staff necessary for operation and upkeep of the bone bank which can be comprised of a faculty member (in-charge), two nurses (one from OT), resident (senior/junior) and a technician.[3,5,6] Although these staff members are responsible for the overall running of the bone bank, but all the members of the orthopaedic department are expected to assist in acquiring, maintaining, and utilizing bone grafts as necessary. Equipment The bone bank essentially requires a deep freezer (-800 C), which is principally used for graft storage. Other necessary requirements are power backup to prevent power cut-offs, stainless steel storage jars, normal saline, 70 % alcohol solution, stationary and cabinets.[3] Documentation Accurate labelling and thorough documentation are imperative for the effective functioning of any tissue transplantation. Every graft is registered and maintained in a separated file containing details of the graft, like size, site, date of allocation along with the reports on erythrocyte sedimentation rate (ESR), culture, histology, and bacteriology etc. All grafts are meticulously assigned a unique registration code tracked only by the Bone Bank Administrator and each file signed by the administrator. The graft is stored for a minimum of 6 months and if no anomalies are detected the graft is deemed ready for transplantation. Grafts with incomplete or abnormal data file are destroyed in accordance with the hospital policy. There are array of documents necessary for the bone bank are operating manual of the bone bank, patient information sheet for both donor and recipient, Patient record for donor and recipient, consent forms for both live donor and recipient, Donor Screening form, Recipient record form and graft removal form.[2] Along with these forms, separate record registers are maintained for donors and recipient to maintain anonymity between donor and recipient along with a master register with include details of both donor and recipients which is a connection between the two. Donors’ Selection Criteria Depending on the type and facilities available in bone bank, the source of bones for the bone bank can be living, cadaveric or both. The living donors are patients of hip and knee arthroplasty or amputations. Normally the removed bones during these surgeries are discarded in absence of bone bank but in bone bank these can be process, preserved and utilized as allografts. The Cadaveric bones can also be used as allograft but the procurement process is more sophisticated which includes the procurement to be done within 12 hours and respecting the cadavers with filling the gap after taking bone with wood. The donor exclusion criteria are age less than 18, active infection/sepsis, tuberculosis, hepatitis B or C, HIV positive, haemophilic, Syphilis, rheumatoid arthritis, metabolic diseases, connective tissues disorders and tumors. Hence before the donor is selected, the donor should be screened for all these above disease by investigations. Hence prior investigations needed are Blood group, Rhesus factor, ESR, CRP, screening for hepatitis B, C, HIV, syphilis and Malaria parasite along with culture, serology and histopathologic report.[3,5-7] Procurement, Processing and Storage After fulfilling all the prerequisites donors criteria’s and filling the Donor consent form, Donor record form, donor screening form and patients information sheet for donors, the donor is planned for the surgery and requisite graft is harvested. Firstly the procured bone is washed thoroughly with normal saline profusely under sterile conditions, to remove blood and other fluids and cleaned of any attached soft tissue using knife and nibblers. Then a small piece of bone is taken from harvested graft and sent for aerobic, anaerobic & fungal culture to microbiology lab & one for histopathology to pathology lab to rule out possibility of infection, autoimmune disease or malignancy. Following this graft is washed thrice first with antibiotic solution (1 gram vancomycin in 100 ml saline), followed by Hydrogen peroxide and finally with saline. Then the procured bone or graft is measured and placed into the pre-autoclaved sterile inner jar which is the placed into slightly larger sterile outer jar and sealed and labelled (double sterile jar storage method). Then this closed sterile labelled double jar is send for storage in -80 deep refrigerator for a minimum period of 6 month and maximum of 5 years.[3,5-7] The surgeon and team now complete the process by filling the graft disposal form and signing it. Graft Dispersal If the surgeon intends to use to use the graft, he should complete and submit all the documentation required for the recipient, like recipient consent form, patient information recipient sheet, and recipient record form. Before opening the graft pack, the surgeon/ nurse should verify the expiration date and after confirmation the graft is defrosted in physiological saline for 30 min and thawed. Following this graft is washed thrice first with normal saline, then with antibiotic solution (1 gram vancomycin in 100 ml saline), followed immersion in normal saline. Then the graft to be used is the sized and shaped as per requirement and implanted.[3,5-7] Fee As per the act, Bone bank is not permitted solicit or accept any payments for the bone from donors or recipients, except for the nominal charges from the donor which are expected to bear the cost of testing. Further Bone bank should not be involved in any commercial activities and is not allowed to sell bone grafts to any individual, entity, or facility.[4] To conclude, Establishment of bone banks are facing challenges, particularly in developing nations like ours, due to lack of legal frameworks and specialized infrastructure. There is an urgent need for more robust, standardized guidelines for the operation of these banks, as well as a need to increase awareness regarding bone donation. Bone banks are need of the hour to meet the growing requirement of the bone grafts, which virtually can supply unlimited biological material tailored to the patient’s needs. But it is important that the grafts, obtained from bone donors go through rigorous sterile processing, quick procurement, and donor screening along with proper documentation so as to ensure safe and efficient functioning, ensuring the biological characteristics of the tissue are maintained while eliminating the risk of infection. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.