Background: A biovigilance program that has oversight of the entire organ and tissue donation and transplantation pathways underpins the quality and safety system in the United Kingdom.
Method: A synopsis of the microbiological characterization of potential deceased organ donors and the processes for notification and investigation of possible donor-derived infections are described. A summary of the outcome of investigations performed over a 10-year period and a subset data frame of 5 years showing the proportion of infection incidents in relation to other incident types are also presented.
Conclusion: A single, centralized system overseeing the entire donation and transplantation pathway has become an essential part of transplantation practice across the United Kingdom. Revision of processes and management options, awareness of clinical conditions, and review of guidance are some examples of benefits gained over time. Transmission figures provided reflect the UK setting; these should be interpreted in context, as donor and recipient epidemiology differs across regions and nations. Despite a well-established system in place, under reporting of cases continues to occur, with ongoing efforts to reassure professionals and patients of the true benefits of biovigilance in driving improvements in practice and patient outcomes.
Keywords: biovigilance; donor characterization; infection; organ transplantation; serious adverse event; serious adverse reaction; transmission.
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