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When addressing bone defects resulting from trauma, infection, or tumors, the use of allogenic bone is often necessary. While autografts are considered the standard, they have limitations and can lead to donor site morbidity. Consequently, there has been exploration into the feasibility of utilizing allogenic bone and bone graft replacements. Allogenic bone transplants are acquired from donors following rigorous procurement, sterile processing, and donor screening procedures. To ensure the safe storage and effective utilization of allograft material, a bone banking system is employed. Establishing and managing an orthopedic bone bank, entails navigating complex legal and medical organizational aspects. This paper examines the establishment and operation of bone banks in India, drawing upon our first-hand experience in managing one at a tertiary care center in Northern India.Level of evidence: Level IV.

Bone allografts are increasingly being used in various orthopaedic surgeries all over the world but were not readily available in Nigeria until year 2020 when the first bone bank facility was established at our hospital. The paper aimed to share our experience and the challenges faced within the first 2 years of operating the first bone bank in Nigeria. We retrospectively reviewed our experience between 1 September 2020 and 31 August 2022. The donors were selected based on American Association of Tissue Bank (AATB) guidelines and Nigerian National Blood Transfusion policy. Our preference was the use of allograft without late donor testing for HIV seroconversion. However, the allografts were treated, irradiated at 25 kGy, and stored in a freezer at -80°C. A total of 88 bone grafts were retrieved, processed and stored in the bone bank over the 2-year period. All allografts were from living donors. Of these, 55 (62.5%) bones were retrieved from female donors and 33 (37.5%) from males. The mean age of all donors was 55.9±15.34 years (range: 32-90 years). Bone grafts issued out from the bank were 28/88 (31.8%) in all. There was no single case of clinical infection reported. The challenges observed were limited long bone allografts, low patronage among surgeons, lack of institution preparedness to process bones from fresh dead donors and disinterest from some surgeons. Running of the first bone bank facility in Nigeria has been successful thus far. The challenges can be surmounted by creating awareness amongst the populace and surgeons of the availability and safety of bone allografts.

To share our experience of establishing a bone bank in Pakistan, and the clinical use of these indigenously produced bone grafts. We retrospectively reviewed our experience of the procurement, processing, and storage of bone grafts at a bone bank in Karachi, Pakistan, the first bone bank to be established in a public sector hospital in Pakistan. The bone bank was established at Sindh Institute of Urology and Transplantation (SIUT), Karachi, in collaboration with Department of Orthopaedic Surgery, Dow University of Health Sciences/Civil Hospital, Karachi (CHK) in May, 2015. Since then, a large number of bone grafts from the tissue bank have been used for various orthopedic procedures. This paper describes the problems and challenges faced in establishing and running a tissue bank in a Muslim and a developing country and the progress of the bone bank over the first 4 years. A total of 93 bone grafts were retrieved and preserved in the bone bank over the 4-year period. Among these, 56 (60.2%) bones were retrieved from male donors and 37 (39.8%) from females. The mean age of all donors was 55.9 ± 15.34 years (range: 16–90 years). All bone donors were living patients. No c bones were obtained from deceased donors. Types of bone grafts included: femoral heads, 68; head with neck of femur, 19; radius and ulna, 1; lower femur, knee joint, lower leg and foot bones, 4; and skull bone, 1. All grafts were subjected to aerobic and anaerobic bacterial cultures, as well as fungal cultures. Microbiological contamination was observed in 18/93 (19.35%). All culture positive bones were discarded. Bone grafts issued from the bank and transplanted were 51/93 (54.8%) in all. Bone grafts were used in a variety of tumor and non-tumor orthopaedic procedures in CHK. Nine bone grafts were donated to the other hospitals to be used for revision total hip replacement and tumor surgeries. There were no service charges. Two patients (3.92%) developed infections postoperatively, one superficial and one deep. No other complications were noted. This is the preliminary report on the establishment and functioning of a bone bank in a public sector hospital in Pakistan. The favorable outcome has inculcated confidence in orthopedic surgeons for greater use of bone allografts for a variety of indications in this country.

Background & objectives: Standard processing of the bone grafts involves deep-freezing and sterilization with gamma irradiation which may alter mechanical properties of the bone graft. This study was aimed at measuring the effect of bone bank processing on the mechanical properties of bone allograft and its correlation with bone mineral density [BMD, dual-energy X-ray absorptiometry (DEXA Scan)] and histomorphometric indices. Methods: Femoral heads retrieved from patients undergoing hip replacement surgeries were used as the material. Twenty femoral heads were under taken in the study. Each femoral head was cut into two equal cubes. One cube was subjected to BMD measurement using DEXA Scan followed by unilateral compression test. Histomorphometric indices such as trabecular number (Tb. N.), trabecular separation (Tb. S.), trabecular thickness (Tb. T.) and bone volume (B.V.) were calculated on the same specimen by a computer software. The other cube was kept in deep freezer (−76°C) for a minimum of three weeks, followed by gamma irradiation and subjected to similar tests. Results: Results were compared in pre- and post-processed bone specimens. A significant loss of biomechanical strength (P<0.001) with mean a loss of 18.90 per cent was found in post-processed samples in uniaxial compression tests. Similarly, BMD (mean decrease by 13.8%, P<0.01) and histomorphometric indices such as Tb. T. (mean decrease by 12.37%, P<0.01), Tb. S. (mean increase by 12.60%, P<0.001) and B.V. (mean decrease by 20.84%, P<0.01) were found. However, Tb. N. was not significantly affected. Interpretation & conclusions: The current method of processing of bone allografts i.e. deep-freezing and gamma irradiation appeared to cause a significant reduction in the biomechanical strength of allogenic bone which was more suitable to be use in the morselized form. Appropriate consideration for decreased strength needs to be given when using allogenic bone graft as a structural graft.

Bone banks are necessary for providing biological allografts for a series of orthopedic procedures. As nations cope with new realities driven by the 2019 coronavirus disease (COVID-19) pandemic, health-care providers, institutions, and patients share a particular concern about the effect of COVID-19 on organ donation and transplantation. Here, we describe the management of the Kitasato University Bone Bank during the state of emergency declared in response to COVID-19. Living donors received pre-operative screening by PCR, and allograft bone from COVID-19-negative donors was cryopreserved as transplantable tissues. The weekly rate of infection gradually increased from February 2–9 to April 5–11 in the dead donor-derived allograft bone-harvesting region covered by the Bank. It is becoming clear that the virus can be transmitted by asymptomatic patients, and that this route may have facilitated the spread of COVID-19. Therefore, the Bank stopped dead donor donation to consider the safety of medical staff. Three recipients received bone allografts following pre-operative COVID-19 screening by PCR. All patients were asymptomatic after bone allograft. Our experience may provide helpful information for the management of tissue banks.

Bone allografts have been used widely to fill up essential void in orthopaedic surgeries. The benefit of using allografts to replace and reconstruct musculoskeletal injuries, fractures or disease has obtained overwhelming acceptance from orthopaedic surgeons worldwide. However, bacterial infection and disease transmission through bone allograft transplantation have always been a significant issue. Sterilization by radiation is an effective method to eliminate unwanted microorganisms thus assist in preventing life threatening allograft associated infections. Femoral heads procured from living donors and long bones (femur and tibia) procured from cadaveric donors were sterilized at 25 kGy in compliance with international standard ISO 11137. According to quality requirements, all records of bone banking were evaluated annually. This retrospective study was carried out on annual evaluation of radiation records from 1998 until 2012. The minimum doses absorbed by the bones were ranging from 25.3 to 38.2 kGy while the absorbed maximum doses were from 25.4 to 42.3 kGy. All the bones supplied by our UMMC Bone Bank were sterile at the required minimum dose of 25 kGy. Our analysis on dose variation showed that the dose uniformity ratios in 37 irradiated boxes of 31 radiation batches were in the range of 1.003–1.251, which indicated the doses were well distributed.

The design and management of an orthopaedic bone bank is a complex process in which medical organisation and legislation intertwine. Neither in the Netherlands, nor in any other European country, there are official guidelines for the organisation and management of an orthopaedic bone bank. In the Netherlands, the recently modified ‘law of security and quality for using human materials’ (WVKL) dictates requirements for technical and organisational aspects for the use of human tissue and cells. The bone bank procedures include a thorough questionnaire for donor selection, extensive serological, bacteriological and histopathological examination, as well as standard procedures for registration, processing, preservation, storage and distribution of bone allografts. This article describes the organisation of an accredited bone bank and can be used as a proposition for an official guideline or can be useful as an example for other orthopaedic bone banks in Europe.

Background Availability of allograft tympano-ossicular systems (ATOS) provides unique reconstructive capabilities, allowing more radical removal of middle ear pathology. To provide ATOS, the University of Antwerp Temporal Bone Bank (UATB) was established in 1988. ATOS use was stopped in many countries because of safety issues concerning human tissue transplantation. Our objective was to maintain an ATOS tissue bank complying with European Union (EU) directives on human tissues and cells. Methods The guidelines of the Belgian Superior Health Council, including EU directive requirements, were rigorously applied to UATB infrastructure, workflow protocols and activity. Workflow protocols were updated and an internal audit was performed to check and improve consistency with established quality systems and changing legislations. The Belgian Federal Agency of Medicines and Health Products performed an inspection to examine compliance with national legislatives and EU directives on human tissues and cells. A sample of important procedures was meticulously examined in its workflow setting next to assessment of the infrastructure and personnel. Results Results are reported on infrastructure, personnel, administrative workflow, procurement, preparation, processing, distribution, internal audit and inspection by the competent authority. Donors procured: 2006, 93 (45.1%); 2007, 64 (20.6%); 2008, 56 (13.1%); 2009, 79 (6.9%). The UATB was approved by the Minister of Health without critical or important shortcomings. The Ministry accords registration each time for 2 years. Conclusions An ATOS tissue bank complying with EU regulations on human allografts is feasible and critical to assure that the patient receives tissue, which is safe, individually checked and prepared in a suitable environment.

The aim of the current study is to evaluate fresh-frozen human bone allografts (FHBAs) used in vertical ridge augmentation clinically and by computed tomography, and to analyze the resulting bone formation and graft resorption. Sixteen FHBAs were grafted in the maxillae and mandibles of 9 patients. The FHBAs, which were provided by the Musculoskeletal Tissue Bank of Marilia Hospital (Unioss), were frozen at −80°C. After 7 months, dental implants were placed and bone parameters were evaluated. Vertical bone formation was measured by computerized tomography before (T0) and at 7 months (T1) after the surgical procedure. Bone graft resorption was measured clinically from a landmark screw head using a periodontal probe. The results were analyzed by Student’s t-test. Significant differences existed in the bone formation values at T0 and T1, with an average change of 4.03 ± 1.69 mm. Bone graft resorption values were 1.0 ± 0.82 mm (20%). Implants were placed with varying insertion torque values (35–45 Ncm), and achieved primary stability. This study demonstrates that FHBAs promote satisfactory vertical bone formation with a low resorption rates, good density, and primary implant stability.

The introduction of a stand-alone Bone Bank in our Regional Orthopaedic Hospital has improved the availability of femoral head allograft. Benninger et al. (Bone Joint J 96-B:1307–1311, 2014 ), demonstrated their institutions bank to be cost effective despite a 30 % discard rate for harvested allograft. We sought to audit our own discard rates and subsequent cost-effectiveness of our bone bank. Donor recruitment. Before approaching a potential donor, our establishment’s nurse specialists review their clinical notes and biochemical laboratory results, available on a regional Electronic Care Records. They view femoral head architecture on radiographs against set criteria, Patient Archive and Communication system (SECTRA, Sweden). In total 1383 femoral heads were harvested, 247 were discarded giving an overall rate of 17.9 %. The most common reasons for discard of harvested graft was a positive microbiology/bacteriology result, n = 96 (38.9 %). After a rise in discard rates in 2007, we have steadily reduced our discard rates since 2006/2007 (28.2 %), 2008/2009 (17 %), 2010/2011 (14.8 %), and finally to 10.3 % in 2012/2013. In the current financial year, our cost to harvest, test, store and release a femoral head is £610. With a structured donor recruitment process and unique pre-operative radiographic analysis we have successfully reduced our discard rates bi-annually making our bone bank increasingly cost-effective.