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Operational and financial aspects of a hospital bone bank.

Although bone banks have existed for many years, the elements of organizing and maintaining a hospital bone bank have not been well documented. The experience with a bone bank at the Massachusetts General Hospital between 1971 and 1980 provides a model on which to base an explanation and discussion of methods of procurement, storage, and retrieval, and the costs associated with such a facility. In 1979, the procurement rate averaged one donor per month; during that year a total of ninety-one bones were stored and six different surgeons utilized more than twenty allografts from the bank. During the same year, the approximate cost of maintaining the bank was more than $50,000. On the basis of the number of bones used, the cost averaged more than $2000 per implant. Such a hospital facility offers the benefits of quality control of the banked bone but is expensive and may not be feasible for many hospitals.

Adolescent

Gas-sterilized cadaver bone grafts for spinal fusion operations. A simplified bone bank.

Cadaver bone for spinal fusion operations is as safe as autografts. The author's 35 years' experience using cadaver bone for interbody spinal fusion operations has led to the development of a simplified bone bank method. Unsterile bone removed from young, fresh cadavers is cut into appropriate sizes and shapes, washed clean, packaged and sterilized with ethylene oxide gas, then aerated and stored at room temperature. The results of spinal fusion, both cervical and lumbar, using 187 gas-sterilized bone grafts in 58 patients operated on over the past year and half, were reviewed and compared with fusions using autografts or banked bone from proven methods. The rate and percentage of fusion of gas-sterilized bone was comparable to other bone grafts with no untoward complications.

Bone Transplantation

Understanding bone banking.

Allograft bone tissue is frequently used in orthopaedic reconstructive surgery. At many major medical centers, this procedure is as routine as the implantation of manmade metallic prosthetics. The harvesting, preparation, and delivery of bone used for transplantation is a complex and intricate process coupled with varying practices among different bone banks. This article provides the reader with information on current standards and practices in bone banking and transplantation. This will help the perioperative orthopaedic nurse deliver safe patient care during procedures using cadaveric bone and tissue.

Bone Banks

1983 bone bank procedures.

Bone banks large enough to support an allograft program require dedicated medical personnel to manage them. A large potential donor population, extensive financial resources, and modern storage facilities are necessary. Infected donors and contamination of procured bones during storage and retrieval must be avoided at all costs. Detailed record keeping is of vital importance to clinical investigations, especially for evaluating complications. These considerations must be taken into account before embarking on an institutional bone banking program, to provide safe and satisfactory allogeneic bone for clinical use.

Bone Transplantation

Comparison of talonavicular dowel arthrodesis utilizing autogenous bone versus defatted bank bone.

A simple dowel arthrodesis of the talonavicular joint in an early stage of destruction can reduce pain and prevent the development of valgus deformity in the rheumatoid hindfoot. Previously, we used autogenous dowels made from the iliac crest. In order to facilitate the operation and to get a better fitting dowel, we tried defatted cancellous allograft dowels from which marrow tissue had been removed. The dowels were prepared from femoral heads in our surgical bone bank. At operation, the dowels were embedded in fresh marrow aspirate from the iliac crest and the arthrodeses were stabilized with a staple. Results were evaluated by clinical examination and radiography. The results of four patients were compared with an earlier study of eight patients using autogenous dowels taken from the iliac crest. With both techniques, the patients were relieved of pain in the talonavicular joint, but some had pain from other hindfoot joints. With autogenous dowels, all eight patients healed with radiographic bony union, but with allogenous dowels, the four patients developed fibrotic nonunion. The results indicate that talonavicular arthrodesis should be made using only autologous dowels.

Adolescent

Preparation of bank bone using defatting, freeze-drying and sterilisation with ethylene oxide gas. Part 1. Experimental evaluation of its efficacy and safety.

We devised a method of sterilising bone allografts which consists of defatting in chloroform and methanol, freeze-drying and sterilisation with ethylene oxide gas. The purpose of defatting and freeze-drying was to facilitate subsequent sterilisation by eliminating the barrier to diffusion of the gas into bone, to lower residual levels of ethylene oxide and its toxic by-products, to eliminate alloantigens and to make storage possible at room temperature. The efficacy and safety of the method were evaluated by testing the sterilisation of infected bone from 6 patients with active chronic osteomyelitis, the penetration of ethylene oxide into human femoral heads treated by this or by freeze-drying or freeze-thawing, and the desorption of ethylene oxide and its toxic by-products from pieces of bone treated by these methods. All the samples of infected bone tested negative for bacteria after treatment. The gas penetrated into the central area of the femoral heads in a few hours. Residual levels of ethylene oxide and its toxic by-products were much lower in the treated bone than in freeze-dried or freeze-thawed bone, and decreased quickly in flowing air. Prior defatting and freeze-drying facilitated penetration of ethylene oxide into bone during sterilisation and the desorption of ethylene oxide and its toxic by-products after sterilisation. Preparation under clean, but not sterile, conditions and storage at room temperature make bone banking more practical and efficient.

Bone Transplantation

Bone banking. A cost effective method for establishing a community hospital bone bank.

Both cost effectiveness and safety can be realized in the operation of a community bone bank by adoption of the following measures: deep freezing, rather than freeze drying; allogenic bone is collected from femoral heads excised from total hip arthroplasties; and careful donor and graft selection controls ensure an allograft free of disease which can be transmitted to the recipient. Two-year follow-up data reveal no complications or infections from implantation of 101 allografts.

Bone Transplantation

Banked bone.

Many forms of banked bone allograft are available to the surgeon. Among the grafts available are fresh, fresh-frozen, freeze-dried, and demineralized bone. Each one of these grafts carries risks and has unique limitations and handling properties. In order to use these materials appropriately, the surgeon must be familiar with the properties of each and must feel confident that the bone bank providing the graft is supplying a safe and sterile graft. In the future, allograft bone will become obsolete. In place of banked bone, surgeons will use synthetically produced bone morphogenic protein that has been incorporated into an absorbable matrix. These materials will exist in a time-release form that will allow the graft material to grow and mature with the patient. Until this goal is achieved and is available clinically, surgeons must be familiar with the capabilities and limitations of banked bone graft.

Bone Banks

Infection associated with the use of allograft bone from the north east Scotland Bone Bank.

To assess the rate of infection associated with use of banked allograft bone, the case records of patients receiving banked bone over one year were reviewed. The notes of patients undergoing autografting procedures during the same period were reviewed as controls. Eighty-two patients received 98 banked allograft femoral heads and there were 10 proven infections (12.2%). Fifty-seven patients had autograft procedures, with two cases of infection (3.5%). The results of bacteriological surveillance of grafts harvested during the same period were analysed; there was a discard rate due to bacterial contamination of 1.3%, and two patients received three contaminated grafts, one of these patients suffering a postoperative infection. The failure rate of procedures was 50% where there was postoperative infection and 4.2% where there was none. Procedures using banked allograft bone have a substantial infection risk, and this is associated with a much higher rate of failure of the procedure. Prospective audit of allograft use should be applied to reduce this risk.

Bone Banks

[5-year experience with a central bone bank].

Since December 1988 the Leiden Bone Bank Foundation, in cooperation with the BIS Foundation, makes allogeneic bone and related soft tissue available for transplantation. Bone banking has become a scientifically high level medical activity in which international standards are established in order to provide safe and effective allografts. Careful donor selection and extensive laboratory testing are the cornerstones for the prevention of disease transmission. In the first 5 years of the existence of the Leiden Bone Bank 450 deep frozen massive bone allografts, of which 221 osteoarticular and intercalary allografts, were shipped to different clinics inside and outside the Netherlands. Furthermore, 322 deep frozen soft tissues, 1877 units of freeze dried bone grafts and 5629 units of demineralized grafts were distributed. The number of transplants with allogeneic bone and related soft tissue from the Leiden Bone Bank increased each year by at least 30% Bone and related soft tissue allografts were used in orthopaedic surgery, neurosurgery and maxillofacial surgery. There are no known cases of transmission of infectious diseases by grafts distributed by the Leiden Bone Bank.

Bone Transplantation

The Ontario Temporal Bone Bank program and the University of Toronto Temporal Bone Histopathology Laboratory.

The first temporal bone histopathology laboratory in Canada was established at the University of Toronto in 1966. Its organization is outlined. More than 600 bones have been processed and more than 45 publications produced. These are broadly classified as new discoveries, new techniques of temporal bone processing, clinical pathological case reports, and papers on clinical entities. The laboratory has a major teaching role for the trainee in otolaryngology. The history of the temporal bone bank program in North America and of the Ontario Temporal Bone Bank is outlined.

California

A simplified protocol for banking bone from surgical donors requiring a 90-day quarantine and an HIV-1 antibody test.

The banking of femoral heads from patients who undergo total hip arthroplasty provides a valuable resource for orthopedic surgery. Quality assurance of the banked bone used in clinical procedures requires documented policies for screening, procuring, storing and distributing. Potential donors are screened at the time of donation for malignant disease, possible communicable disease, sepsis and high-risk life-styles. After negative culture results are confirmed and appropriate documentation has been completed, the bone is frozen at -70 degrees C. A quarantine period of 90 days follows. The donor is followed up 90 days or more postoperatively. At that time written consent is obtained for donation of the recovered tissue to the bone bank and for serology testing for human immunodeficiency virus (HIV-1) antibody, hepatitis B surface antigen (HBsAG), hepatitis B core antibody (HBcAb) and syphilis, and the donor is rescreened for contraindications. This protocol meets or exceeds all existing standards. The combination of obtaining consent and serology testing at 90 days streamlines the logistics of banking bone from surgical donors.

Bone and Bones

[Deep freeze bank bone material for maxillofacial reconstructions].

The use of deep freeze bank bone grafts in maxillofacial surgery is described. The prerequisites for establishing a bone bank and the selection of bone graft material and donors are discussed. The use of deep freeze graft material is possible in virtually any area of maxillofacial surgery. Thus, patients with minor defects can be spared the stress of autogenous bone removal. The potential risk of disease transmission is emphasized.

Bone Transplantation

Organisation, operational aspects and clinical experience of National University of Singapore Bone Bank.

The National University of Singapore (NUS) Bone Bank was started in October 1988 and is the first such bank in Singapore. Two Revco Freezers were installed to store bones at -80 degrees C. The NUS Bone Bank Protocol follows the multi-centre protocol in USA with Massachusetts General Hospital as the Central Registry. It strictly follows the guidelines for banking of musculo-skeletal tissues set up by the American Association of Tissue Banks. Strict donor selection is practised including screening for Aids, hepatitis, syphilis and infection. It does not provide for storage of articular cartilage. Currently, procurement is obtained from living donors. Mainly femoral heads have been obtained (63 donors to date). One whole tibia, one whole fibula, one lower end of femur have also been procured. Bone allograft transplantation has been safely performed in 14 recipients--mainly spinal fusions (seven cases), Sub-talar joint fusion in children (three cases) and packing Giant Cell tumors (two cases). Other cases include revision hip surgery (one case) and augmenting of hypoplastic mandible (one case). The biggest problem faced by the NUS Bone Bank is lack of donors. There is definitely a need for bone allografts in Singapore where such transplantation is legal. Presently, there is also a demand for whole bones to bridge large bone defects resulting from tumour resection and for reconstructing post-traumatic defects. This can only be met if we can procure more whole bones especially from cadaveric donors.

Bone Transplantation

[Cost analysis of a bone bank].

The costs of a bone-bank working in accordance with the guidelines of the german federal chamber of physicians are described. Establishing a bone-bank storing deep-frozen bone is not very expensive. The main costs are due to laboratory costs for excluding HIV, hepatitis, syphilis and bacterial contamination of bone grafts. In our experience with 206 bone grafts about 20% of them are to be discharged because of positive laboratory tests. The costs of each bone graft are DM 327. A second HIV-Test of the donor 3 months after explantation of a bone graft will cause rising of costs up to 47%. About 20-30% of bone graft donors will probably not carry out this test. In this case discharging of the bone graft is necessary.

Bacteria

[Bone bank management using a thermal disinfection system (Lobator SD-1). A critical analysis].

In the study presented on 380 allogenic bone donations from living and organ donors, we analyzed the safety of allograft handling bone-band documentation, logistics and costs. For transplant treatment we routinely used a thermal disinfection system (Lobator SD-1). From 380 allograft donors, 400 bone transplants were gained. The rejection rate was 12.2%. After thermal disinfection for 1 h at 80 degrees C, the grafts were cryopreserved at -80 degrees C and released from the bone bank for potential transplantation after 14-16 days. Five of 730 microbiological specimens showed bacterial contamination after thermal graft decontamination. The bacterial species found on the allografts normally have an inactivation temperature under 80 degrees C. Therefore, only secondary contamination can explain the positive bacteriological test results. With reform of the health care system the economical aspects of bone banking have triggered more interest. The cost for one bone transplant released from the bone bank was 424.75 DM: the overall cost for the bone bank in one year was 75,076 DM. Laboratory (58.2%) and material costs (22.5%) were the major factors. Personnel costs and apparatus costs were relatively low (< 20%). With introduction of the thermal disinfection system (Lobator SD-1) into the bone bank, the safety of allogenic bone transplants was greatly improved. Clinical and serological donor screening must be performed according to international bone bank directives. Considering the low rejection rate and the short turnover rate, the economical costs could be reduced. Using an appropriate disinfection system (thermal disinfection at 80 degrees C), laboratory tests covering venereal diseases, malaria and cytomegalia are no longer required. Also, secondary HIV testing of living donors can be omitted without reducing the safety of the transplant.

Bone Banks

[Bone banks: medicolegal aspects].

Heterologous bone grafting has increased considerably due to improved preservation and the development of bone banks. We analyzed the forensic aspects of organ procurement, transformation, processing and preservation specifically related to bone grafts. Topics considered included the organization of the responsible authorities and their activities in the context of ethical medical considerations. The surgeon is often faced with a complex heterogeneous situation without clear legal requirements.

Bone Transplantation