Adverse reactions and events related to musculoskeletal allografts: reviewed by the World Health Organisation Project NOTIFY
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The use of bone and connective tissue allografts has grown rapidly and surpassed the use of autografts in many countries. Being of human origin, bone and tendon allografts carry the risk of disease transmission and complications have been reported. As part of the Project NOTIFY led by the World Health Organisation, an effort to improve recognition, reporting, tracking and investigation of adverse outcomes of allografts was initiated, achieving a comprehensive review of associated disease transmission and failures. Those involving the use of musculoskeletal allografts are reported here. A major objective is to involve orthopaedic surgeons in the improvement of the safe use of the musculoskeletal allografts.
We reviewed the medical literature, requested reports from surgeons in selected professional organisations and informally surveyed tissue bank organisations and selected tissue bank professionals to discover reported and unreported cases of adverse outcomes. We analysed each case to decide the likelihood that the complication was truly allograft related.
The efficiency of the procedures involved in bone banking and bone and tendon allograft has improved significantly during the last three decades. The evolution of the incidence of reported adverse reactions and events reflects positively on the safety of transplanted tissues. Cases of bacterial and viral transmission by bone and tendon allografts occurred mainly with those that contained viable cells, were not processed to remove cells, or were not disinfected or sterilised. We documented cases of transmission of human immunodeficiency virus (HIV), hepatitis C virus (HCV), human T-lymphotropic virus (HTLV), unspecified hepatitis, tuberculosis and other bacteria. Reporting of these adverse outcomes has led to corrective actions and has significantly improved the safety of allograft use. However, it is probable that not all cases have been reported and investigated.
Considering the high quality standards achieved in many countries, the best approach for further improvement in the safety of allografts is through a systematic reporting of all serious adverse reactions and events in the context of a global biovigilance programme.
KeywordsHuman Immunodeficiency Virus West Nile Virus Tissue Bank Human Immunodeficiency Virus Testing Bone Allograft
- 4.Burchardt H (1981) Biology of cortical bone graft incorporation. In: Friedlander G, Mankin H, Sell K (eds) Osteochonral allograft. Little and Brown, New YorkGoogle Scholar
- 10.Eastlund T, Strong DM (2003) Infectious disease transmission through tissue transplantation. In: Phillips GO (ed) Advances in tissue banking, vol 7. World Scientific, Singapore, pp 51–131Google Scholar
- 17.Grossi P, Strong DM (2009) Donor testing and donation testing. In: Warwick R, Fehily D, Brubaker S, Eastlund T (eds) Tissue and cell donation: an essential guide. Wiley-Blackwell, Oxford, pp 116–133Google Scholar
- 33.Mallick T, Mosquera A, Zinderman C, St Martin L, Wise R (2010) Reported infections after human tissue transplantation before and after new food and drug administration (FDA) regulations, United States, 2001 through June, 2010. Cell Tissue Bank 2011 Apr 9 [Epub ahead of print]Google Scholar
- 35.Centers for Disease Control (CDC) (1988) Transmission of HIV through bone transplantation: case report and public health recommendations. MMWR Morb Mortal Wkly Rep 37:597–599Google Scholar
- 49.Strong DM (2005) Effects of radiation on the integrity and functionality of soft tissue. Current situation: tendons, vessels, heart valves, etc. Changes with increasing dose/dose limits. In: Kennedy JF, Phillips GO, Williams PA (eds) Sterilization of tissues using ionizing radiations. Woodland, Cambridge, pp 163–172CrossRefGoogle Scholar
- 57.World Health Organization (WHO) and Centro Nazionale Trapianti (CNT): Report of the Global Consultation for the Project NOTIFY-Exploring Vigilance Notification for Organs Tissues and Cells. Bologna 7–9 April 2011Google Scholar
- 58.World Health Organization (WHO) and Centro Nazionale Trapianti (CNT): Report of the First Global Consultative Meeting on the Bologna Initiative for Global Vigilance and Surveillance. Geneva 5–6 July 2011 in pressGoogle Scholar
- 59.Zhang Y, Homsi D, Gates K, Oakes K, Sutherland V, Wolfinbarger L (1994) A comprehensive study of physical parameters, biomechanical properties, and statistical correlations of iliac crest bone wedges used in spinal fusion surgery. IV. Effect of gamma irradiation on mechanical and material properties. Spine 19:304–308PubMedCrossRefGoogle Scholar