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Experience with a bone bank operation and allograft bone infection in recipients at a medical centre in southern Taiwan.

To assess the contamination rate of allograft bones at retrieval and the infection rate of the implanted allograft bone, we audited a bone bank retrospectively and reviewed the medical charts of allograft bone recipients between June 1999 and June 2000 at a medical centre in southern Taiwan. The bone bank did its utmost to minimize allograft contamination with hospital-acquired pathogens by adopting purposefully designed criteria for selection of donors. This protocol included sterilization with soaking of the retrieved allograft in a solution of a first-generation cephalosporin before storage and prophylaxis in recipients with first-generation cephalosporin. The contamination rates at allograft retrieval from living and cadaveric donors were 2.7% and 12.4%, respectively (P<0.001). Culture of 262 specimens taken at allograft implant revealed 12 (4.6%) positive for culture. Of the 12 patients implanted with allograft bones positive for culture, nine (75.0%) had allograft bone infection, while three (25.0%) did not. Among the 250 recipients with sterile allograft bones, four (1.6%) were found to have allograft infection. None of the cases of infection required removal of the allograft bones, and all cases were successfully treated with tailored antimicrobial therapy based on susceptibility tests on isolated bacteria. The overall infection rate was 5.0%, which compared favourably with those in other series. A prospective cohort study is needed to determine which of the varied sterilization methodologies gives the best and/or most cost-effective outcome.

Adult↗

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.

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↗

Bone bank service in Odense, Denmark. Audit of the first ten years with bone banking at the Department of Orthopaedics, Odense University Hospital.

There has been an increase in the demand for allograft bone in recent years. The Odense University Hospital bone bank has been in function since 1990, and this paper outlines our results during the 10 year period 1990-1999. Potential donors were screened by contemporary banking techniques which include a social history, donor serum tests for HIV, hepatitis B and C, and graft microbiology. The bones were stored at -80 degrees C. No type of secondary sterilisation was made. 423 femoral heads were approved and donated to 300 patients,1-6 heads/operation. The allografts have been used mainly to reconstruct defects at revision hip arthroplasty (34%), and for fracture surgery (24%). 7 % of all transplanted patients were reoperated because of infection. In the hip revision group the infection rate was 4 %. There were no cases of disease transmission. During the 10 year period there was a change in the clinical use of the allografts. In the first years the allografts were mainly used for spinal fusion surgery, but today the majority are used in hip revision and fracture surgery. The clinical results correspond to those reported in larger international series.

Journal Article↗

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↗

Inactivation of HIV by application of heat and radiation: implication in bone banking with irradiated allograft bone.

We developed methods for inactivating the human immunodeficiency virus by heat and ionizing radiation and tested the effects of these treatments on the mechanical strength of bone. Simultaneous use of heat and radiation caused a considerably greater inactivation of HIV than the additive effects of the two separate treatments, but also caused a significant reduction in the maximum load sustained by the bone specimens tested with an Instrom machine. Application of the same doses but given in the sequential fashion of radiation followed by heat also caused marked inactivation of HIV and had less effect on the mechanical strength of the bone.

Biomechanical Phenomena↗

[Consequence of European Directive 2004/23/EC for bone banks in Germany].

Allogenic bone grafting is an established method in revision surgery of artificial joint replacement and spinal surgery in case of bone defects. In Germany, femoral heads from living donors undergoing total hip replacement are frequently used. These grafts are processed according to the "Guidelines for the management of bone banking" issued by the Federal Medical Board. Bone grafts are drugs according to German law. Local bone banks are excluded from the regulations of the federal law on drugs [Arzneimittelgesetz (AMG) section sign 4a (4)] if certain requirements are fulfilled. The Directive 2004/23/EC of the European Parliament and of The Council on Setting Standards of Quality and Safety for the Donation, Procurement, Testing, Processing, Preservation, Storage and Distribution of Human Tissues and Cells has to be implemented into national law within 2 years. The exception of section sign 4a (4) will no longer be possible. Thus a legal construction has to be found which allows running local bone banks in compliance with the new legal settings. Three conditions will be possible: (1) a single physician procures a graft for another patient of his, (2) grafts are procured in one hospital and are used exclusively in this hospital: a license from the local authorities and a strict quality assessment according to GMP-rules is required, (3) if the grafts are distributed to other hospitals, a license from the local authorities and registration as a drug by the federal authorities are necessary.

Bone Banks↗

Hospital-based allogenic bone bank--10-year experience.

Bone banking in a hospital provides resources of allogenic bone grafts. However, they may transmit infection from donor to recipient. We found few reports discussing the infection rate and monitoring processes associated with bone banks. The discard rate using the screening test was 18.5% (309/1674) in this series. The leading cause was hepatitis B antigen (HBsAg) positive donor serum (67%), followed by Venereal Disease Research Laboratory (VDRL) positive donor serum (15%), and anti-hepatitis C virus (HCV) positive donor serum (12%). The overall infection rate in the recipients was 1.3% (17/1365). Among 1353 implanted allografts, 22 cases (1.6%) had a positive swab culture result after thawing. Only four out of these 22 cases (18.2%) developed infection. However, the wound cultures of the infected recipients were different from the swab culture of thawing allografts except in one case. Among the 1331 recipients with sterile allograft bones, 13 (1%) were found to have infection. In conclusion, our bone bank operates under a strict monitoring system which results in a low infection rate. The recipient's status, the aseptic technique and environment during operation is likely to be more critical in prevention of allograft-related infection.

Adolescent↗

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 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↗

Demineralized bone matrix supplied by bone banks for a carrier of recombinant human bone morphogenetic protein (rhBMP-2): a substitute for autogeneic bone grafts.

Four commercially available preparations of demineralized freeze-dried human bone powders (DFDB) were investigated for endogenous bone morphogenetic protein (BMP) as observed by osteoinductive activity. Composites of DFDB without and with 1 microgram or 10 micrograms of recombinant human bone morphogenetic protein-2 (rhBMP-2) were implanted into the hindquarter muscles of Swiss-Webster mice. The four batches of DFDB without rhBMP-2 were placed also in hindquarter muscles of athymic mice. Three weeks after implantation, the area of induced bone and cartilage formation was measured by radiographic and histomorphometric methods. In normal mice, without rhBMP-2, DFDB implants induced development of dense fibrous connective tissue with minimal, if any, new bone. In athymic mice, DFDB induced development of small patches of appositional new bone. In contrast, in normal mice, composites of DFDB and rhBMP-2 induced development of large areas of heterotopic bone and bone marrow formation. The bone morphogenetic response occurred with a statistically significant difference (p < 0.0001) between implants of 1 microgram and the 10-microgram rhBMP-2 composites. Thus, DFDB from all four bone banks demonstrated comparable capacity to serve as a carrier for rhBMP-2.

Analysis of Variance↗

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↗