Living donor bone banking: processing and discarding--from procurement to therapeutic use.

Skeletal muscle and osteoarticular tissue banks are responsible to procure, process, store and distribute tissues, from living and cadaveric donors. The procedures involve the application of protocols covering all aspects of the banking, ensuring the best tissue quality and maximum safety for the recipient. An analysis on the causes of bone tissue discarded by Biotar Tissue Bank between January 2005 and December 2012 was carried. Bone tissue was obtained from both hip and knee replacement (femoral heads and tibial plateau respectively) in living donors treated at different medical-surgical institutions in Argentina. These tissues were processed at the Bank to produce both frozen and lyophilized cancellous bone. Out of 3413 donated bones received by the Bank, 77.55 % resulted in final product, while the remaining 22.44 % was discarded in compliance with the quality standards of both the Bank and the regulatory authority. Comparing the last and the first year of the studied period, the number of discarded tissue increased 3.6 times, while the number of collected bones was approximately 10 times higher. Related to total disposed tissue, reactive serology was the most frequent cause (62.14 %), followed by inappropriate collection/storage of blood sample (30.81 %). A progressive reduction in the percentages of total discard was observed, and this was proportional to inappropriate collection/storage of blood sample. No significant differences were found in the discard rates due to positive serology throughout all the years studied. The success of a tissue bank requires full commitment of all the personnel especially the team members responsible for donor selection and the processing of allografts. It is important to critically screen donors in the early stages of donor recruitment. All of the procedures carried out by the tissue bank are parts of the quality control system which must be strictly carried out. Biotar Tissue Bank is continuously committed to ensure safety to the recipients.

Assessing bone banking activities at University of Malaya medical centre.

The main advantage of establishing in-house bone banks is its ability to readily provide allograft bones for local surgeries. Bone procurement activities of our university bone bank during the 10 years of operation were reviewed. Socio-demographic data of donors, types of bone procured, cases of rejected bones and types of allograft bones transplanted are presented. From 179 potential donors, 73 % were accepted with 213 procured bones. Femoral head was the common bone transplanted (45 %), as it was also the most common procured (82 %). Bones were rejected mainly due to non-technical reasons (83 %) rather than positive results of microbiological (13 %) and serological (4 %) tests. Comprehensive data could not be obtained for further analysis due to difficulties in retrieving information. Therefore, quality assurance system was improved to establish more systematic documentations, as the basis of good banking practice with process control hence allowing traceability.

A retrospective study on annual evaluation of radiation processing for frozen bone allografts complying to quality system requirements.

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.

Variability in tissue bank practices regarding donor and tissue screening of structural allograft bone.

STUDY DESIGN: A standardized questionnaire was directed to medical directors of US structural allograft bone providers regarding their practices in screening potential donors and allograft bone itself for parameters potentially affecting mechanical strength. OBJECTIVE: To determine the uniformity of practices within the US allograft bone industry regarding parameters related to structural allograft bone mechanical strength. SUMMARY OF BACKGROUND DATA: Despite oversight with respect to disease transmission and contamination, few guidelines exist regarding donor eligibility and bone itself for issues potentially affecting the mechanical integrity of structural allograft bone. METHODS: A survey regarding donor and tissue screening practices impacting mechanical strength of structural allograft bone was administered to medical directors of American Association of Tissue Banks-accredited structural allograft bone providers. Results are reported as the percentage of all tissue banks using a given donor or tissue screening method and the percentage of the total US supply of structural allograft bone affected. RESULTS: Eighty-one percent (14 of 16) of bone-processing banks completed the survey, accounting for 98% of the US supply of structural allograft bone. Approximately 76% (18,712 of 24,671) of all tissue donors are used as a source of structural bone allograft. Thirty-nine percent (6 of 14) of tissue banks have no upper age limit or accept structural allograft bone donors up to age 80. Fifty percent (7 of 14) of banks exclude donors with a diagnosis of osteoporosis. Sixty-four percent (9 of 14) of banks require a minimum cortical dimension of structural bone allograft, representing 81% (15,110 of 18,712) of the US supply. No tissue bank performs dual energy x-ray absorptiometry scans of potential bone donors. CONCLUSION: Substantial variability exists in screening practices of US tissue banks regarding mechanical strength of structural allograft bone. Reported variations may reflect the lack of regulatory standards regarding these issues. Further data regarding these variables' impacts on allograft strength and clinical outcomes would be helpful in developing appropriate standards.

Audit of the Douglas Hocking Research Institute bone bank: ten years of non-irradiated bone graft.

BACKGROUND: An audit performed in the use of non-irradiated femoral head bone graft at the Geelong Hospital over a 10-year period. While it is thought the non-irradiated bone graft provides a better structural construct there is theoretical increased risk of infection transmission. METHODS: We performed a retrospective review of prospectively collected data in the use of non-irradiated bone allograft used from the Geelong Hospital Douglas Hocking Research Institute bone bank over a 10-year period. The review was performed using data collected from the bone bank and correlating it with the patient's medical record. All complications, including infections, related to the use of the allograft were recorded. RESULTS: We found that over the 10 years to 2004 that 811 femoral heads were donated, with 555 being used over 362 procedures in 316 patients. We identified a total of nine deep infections, of which seven were in joint replacements. Overall this was a 2.5% deep infection rate, which was lowered to 1.4% if the previously infected joints that were operated on were excluded. CONCLUSION: The use of non-irradiated femoral head bone graft was safe in a regional setting.

[Analysis of the effectiveness of an internal hospital bone bank]. / Effektivitätsanalyse einer klinikinternen allogenen Knochenbank.

BACKGROUND: The EU guidelines 2004/23/EG and 2006/17/EG and their national implementation redefine the framework for allogenic bone banking and transplantation. Against this background an established internal hospital bone bank was analysed concerning threshold of allogenic bone and cost effectiveness in comparison to alternative methods. METHOD: Over a 30-month period we registered all arrivals and outgoings of our bone bank and their destination. We further noted all declined donations. We analysed all costs incurred and calculated costs for alternative methods. RESULTS: By means of our bone bank we are currently able to meet our own demand for bone substitutes. The maintenance costs are below the prices of alternative methods. Some donations (8%) have to be discarded due to procedural errors. CONCLUSION: Maintaining an internal hospital bone bank utilizing fresh-frozen allogenic bone is an efficient and cost-effective method of supplying bone substitutes even under the new EU guidelines if the existing process covers most conditions of the producer authorisation according to section sign 13 AMG. By harmonizing the organizational process it is possible to further improve its effectiveness.

Prevalence of histologic otosclerosis: an unbiased temporal bone study in Caucasians.

BACKGROUND: 'Histologic otosclerosis' refers to a disease process without clinical symptoms or manifestations that can only be discovered by sectioning of the temporal bone at autopsy. 'Clinical otosclerosis' concerns the presence of otosclerosis at a site where it causes conductive hearing loss by interfering with the motion of the stapes or of the round window membrane. Various authors have studied the prevalence of histologic otosclerosis on laboratory collections of temporal bones. Some 12-15% of the temporal bones with histologic otosclerosis have demonstrated stapedial fixation. Using these figures for calculating the prevalence of clinical otosclerosis gives an extrapolated clinical prevalence of 0.99-1.2%. This does not correlate well with the clinical data on otosclerotic families from which a clinical prevalence of 0.3% has been estimated. OBJECTIVE: To study the prevalence of histologic otosclerosis in an unselected series of temporal bones. STUDY DESIGN: During a 1-year period, 118 consecutive pairs of temporal bones of deceased patients at a tertiary center were collected to determine the prevalence of otosclerosis. Although histology remains the gold standard for evaluation of otosclerosis, the gross observation of temporal bone slices combined with microradiography was used to screen for otosclerotic lesions more rapidly and with a lower cost-benefit ratio. The temporal bones with suspected otosclerosis shown with these techniques were further analyzed by conventional histology. RESULTS: 2.5% of the 236 temporal bones (or 3.4% of patients) studied demonstrated histologic otosclerosis. CONCLUSIONS: Although the prevalence of 2.5% is much lower than previously published figures on histologic otosclerosis, the extrapolated data (extrapolated clinical prevalence = 0.30-0.38%) correlate well with clinical studies of otosclerotic families. The previous studies based on laboratory collections were likely biased by the presence of hearing loss or other otological diseases.

Otosclerosis and associated otopathologic conditions.

Otosclerosis occurring with other pathologies has received little attention in the literature although these concomitant occurrences can be clinically relevant. We studied the clinical and histopathological characteristics of 182 cases of otosclerosis from our human temporal bone collection, and found 81 (44%) to have associated pathologies. Clinical pathological findings included vestibular symptoms and findings (e.g. Ménière's syndrome), otitis media in various forms, and to a lesser extent labyrinthine anomalies, tumors and other associated pathologies. Whether these coexisting pathologies are coincidental (usually) or causative as in the case of Ménière's syndrome with extensive otosclerosis, appropriate diagnosis and treatment of the patient with otosclerosis requires recognition of these potential clinical pathological relationships.

Procedimentos de um banco de ossos e a aplicabilidade dos enxertos por ele proporcionados / Procedures of a bank bones and aplicability of the grafts offered by surch bank

Os autores demonstram neste estudo a viabilidade e funcionabilidade de um Banco de Ossos e a experiência da utilização durante as dezessete anos de sua criação. O objetivo deste estudo é demonstrar a importância da manutenção de um serviço de Banco de Osso, bem como mostrar suas utilidades nos diversos tipos de intervenções ortopedicas. Ficando demostrado, o protocolo para obtenção de possíveis doadores, métodos para retirada e armazenagem desses ossos, e sua utilização em diversos procedimentos ortopédicos.

Twenty-five years of clinical experience with bone banking in Israel.

BACKGROUND: Bone banking and the clinical use of banked tissue are the most common forms of allopreservation and transplantation in modern medicine. OBJECTIVES: This article reviews 25 years (1973-98) of experience in bone banking in Israel. METHODS: A nationwide survey on the clinical application of the banked musculoskeletal tissues during 1996 was conducted by means of a written questionnaire sent to all orthopedic departments in Israel. RESULTS: The response rate to the questionnaire was 84%. A total of 257 cases were allocated bone allografts: the majority comprised 225 spongy bones, 26 were massive bone allografts and 6 were soft tissue allografts. CONCLUSION: Improvement of quality control and quality assurance of the banked tissues, together with development of skills in the use of osteoinductive and osteoconductive materials, cast the future of musculoskeletal tissue banking.

Bone bank service in Finland. Experience of bacteriologic, serologic and clinical results of the Turku Bone Bank 1972-1995.

560 bones were harvested by The Turku Bone Bank between 1972-1995. It was started with massive allografts for bone tumor surgery, but today most are femoral heads for hip revision surgery. The increase in harvested bones nearly trebled from 1984-1989 to 1990-1995. Only 1 positive hepatitis C test was found. There were no hepatitis B or HIV positive donors. The incidence of discarding after screening was 24%, with positive bacterial growth (8%, usually Staphylococcus epidermidis) as the commonest reason. 2 massive grafts with negative cultures when harvesting were positive after thawing and resulted in deep infection. 369 allografts were transplanted. The infection rate of massive allografts for bone tumor surgery was 5/63 in 1973-1995, and 2/52 in 1985-1995. The infection rate for hip revision surgery was 3.4%. The clinical functional results correspond to those reported in larger international series.

Three years' audit of a bone bank.

A three years' practice of a hospital-based non-commercial bone bank is presented. Altogether 121 allografts were collected from primary hip arthroplasties for osteoarthritis. Altogether 41 of the grafts were used in our hospital, 47 grafts were transported to other hospitals at a non-profit basis. The grafts were stored fresh-freezed at -80 degrees C. The allograft recipient patients in our hospital were reviewed. Main indication for the use of allografts was revision arthroplasty of the hip or knee. Other indications included difficult nonunions, arthrodeses of the knee or spine, difficult major primary fractures in osteoporotic bone and a large bone cyst. Of the nonunions, 3/10 failed to unite and of the revision arthroplasties, 1/19 had to be reoperated on. Three infections were recorded, all of which were unrelated to the allograft transplantation. The infections all healed without surgical intervention.