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Towards a global system of vigilance and surveillance in unrelated donors of haematopoietic progenitor cells for transplantation

Abstract

Safety of living donors is critical to the success of blood, tissue and organ transplantation. Structured and robust vigilance and surveillance systems exist as part of some national entities, but historically no global systems are in place to ensure conformity, harmonisation and the recognition of rare adverse events (AEs). The World Health Assembly has recently resolved to require AE/reaction (AE/R) reporting both nationally and globally. The World Marrow Donor Association (WMDA) is an international organisation promoting the safety of unrelated donors and progenitor cell products for use in haematopoietic progenitor cell (HPC) transplantation. To address this issue, we established a system for collecting, collating, analysing, distributing and reacting to serious adverse events and reactions (SAE/R) in unrelated HPC donors. The WMDA successfully instituted this reporting system with 203 SAE/R reported in 2011. The committee generated two rapid reports, reacting to specific SAE/R, resulting in practice changing policies. The system has a robust governance structure, formal feedback to the WMDA membership and transparent information flows to other agencies, specialist physicians and transplant programs and the general public.

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Acknowledgements

We thank the membership for their active participation in this reporting system. We also thank Florian Krouwel for his invaluable support in managing the system.

Authors contribution

All authors were active in developing the S(P)EAR reporting system and in reaction and event review. All authors were involved in the drafting of the article or critical revision for important intellectual content.

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Correspondence to B E Shaw.

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The authors declare no conflict of interest.

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Shaw, B., Chapman, J., Fechter, M. et al. Towards a global system of vigilance and surveillance in unrelated donors of haematopoietic progenitor cells for transplantation. Bone Marrow Transplant 48, 1506–1509 (2013). https://doi.org/10.1038/bmt.2013.104

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  • DOI: https://doi.org/10.1038/bmt.2013.104

Keywords

  • unrelated donor
  • vigilance and surveillance
  • haematopoietic cell transplantation
  • serious adverse event
  • serious adverse reaction

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