RESUMEN
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.
RESUMEN
Universal Hepatitis E Virus (HEV) screening of deceased organ donors was implemented by the UK national organ procurement organisation in October 2017. Donor testing for HEV infection is done post-transplant; detection of HEV ribonucleic acid (RNA) in donor plasma is therefore not a contra-indication for organ donation, with the result being used to inform recipient management. Immediate post-transplant detection of donor HEV viraemia triggers notification to transplant centres. Follow up of liver and kidney recipients has shown that transmission through solid organs is very efficient, particularly through liver grafts, as expected; no other organ types were transplanted in this cohort. Although donors with higher plasma viral load (VL > 103 IU/mL) were invariably associated with recipient infection, transmission was also documented at lower VL levels. Knowledge of donor HEV status has led to identification of transmission of infection via solid organ grafts followed by close patient monitoring and informed clinical management decisions. The purpose of this strategy is to allow early detection of infection and recurrence and treatment to circumvent the risk of accelerated liver damage from chronic HEV infection due to undiagnosed, inadvertent donor-derived transmission of infection.