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ADVANCED TECHNOLOGY and improved surgical techniques have led to new therapeutic uses for allografts. DISEASE TRANSMISSION via allograft tissue transplants has prompted federal intervention in the tissue banking industry and resulted in federal regulations. NEW STANDARDS from the Joint Commission on Accreditation of Healthcare Organizations became effective July 1, 2005, and apply to all hospitals that store or implant allograft tissues. These standards include mandatory policies on all aspects of hospital transplantation programs, including tissue ordering, receipt, storage, issuance, and record keeping.

Background: Musculoskeletal tissue allotransplantation has been used as a standard approach for reconstructive surgery. The present study has reviewed the banking of musculoskeletal tissue at the Perth Bone and Tissue Bank (PBTB) and provided evidence of quality assurance on musculoskeletal tissue allotransplantation., Methods: All donor tissues were processed in accordance with the Therapeutic Goods Administration's relevant codes of good manufacturing practices. Microbiological monitoring at each step of manufacture and postoperative surveying of the musculoskeletal allotransplantations were both conducted. The possible contribution of contaminants in allografts to postoperative infections was also assessed., Results: Of the 5276 donors obtained over the last 10 years, 1672 were rejected, giving an overall donor rejection rate of 32%. Milled femoral heads were the most frequently implanted allografts, followed by whole femoral heads. In the postoperative survey an infection rate of 4.9% was found (113/2321 recipients). The infectious agents were identified in 65 cases but for 60 of these there were no correlations with the positive culture test results for the allografts. The organism most commonly identified in postoperative infections was Staphylococcus species., Conclusions: The present study shows evidence that musculoskeletal tissue allotransplantation is a safe procedure when accompanied by high standards of quality assurance.

The described system of safety assurance of cryopreserved allogeneic and xenogeneic dermoepidermal transplants comprises serological examination of deceased tissue donors, long-term storage of sera of all donors, microbiological control of prepared allogeneic and xenogeneic dermoepidermal grafts, labelling of released tissue grafts and monitoring of temperatures inside the mechanical freezer (-80 degrees C). From a total number of 76 donors from whom tissues were collected for transplantation during 1999-2001, tissues were discarded in two instances. One because of a positive HBsAg test, the others second one because of presence of anti-HTLV antibodies. In xenogeneic dermoepidermal grafts, out of a total number of 1,203 grafts prepared during the same period, 84 (6.9%) were discarded because of the presence of pathogeneic or potentially pathogeneic microbes. The system of labelling released grafts makes unequivocal identification of the pathway from recipient to donor possible, while at the same time respecting the anonymous character of the donor's data. In xenogeneic grafts it ensures the identification of the appropriate batch. Storage of cryopreserved biological skin covers at a temperature of -80 degrees C in low temperature cabinets with emergency back-up cooling with liquid nitrogen and a supplementary source of electric power, proved very useful. The system responds to the gradual implementation of the principles of Quality Management System ISO 9000 and Good Manufacturing Practice into the activities of tissue banks. Further tightening of the demands for the safety of allo- and xeno-transplantation is foreseen in conjunction with the occurrence of transmissible spongiform encephalopathy and porcine retroviruses.

The results are reported of an audit of allografts collected in the first 18 months of the Leicester Bone Bank. We retrieved 161 femoral heads at primary arthroplasty of which 103 were implanted into 59 patients. There were deep infections in two recipients and wound infections in five. In two of these cases, culture of the femoral head at implantation was positive but the organisms grown were not those which caused the clinical infection. We retrieved 22 large allografts from six cadavers. Four of these were contaminated at retrieval and required irradiation for sterilisation. There has been one clinical infection in the nine large allografts implanted so far. We recommend that all bone banks undertake prospective audit to ensure that high standards are maintained and wastage minimised.

Tissue allografts are being used more frequently, and, as a consequence, an increasing number of hospitals and physician assistants must face the difficult and perplexing task of evaluating their effectiveness and safety. Quality assurance programs are designed to enhance patient care during the transplantation process and should outline the responsibilities of both the tissue bank and the hospital using the allograft. Recommendations for the establishment of quality assurance programs at hospitals are made based on guidelines established by national certifying agencies. It is of paramount importance to recognize the areas of responsibility and to delineate acceptable standards of practice when developing and implementing quality assurance programs for tissue transplantation.