13 Investigating Harm to Recipients - Infections

The transmission of infections or malignancies to recipients of solid organs, tissues, and eye grafts is well documented [19-21]. A wide spectrum of viruses, bacteria, and parasites have been associated with allograft-associated infection, with transmissibility depending on the type of graft, processing of the graft, and the immunocompetence of the recipient and many malignancies have been transmitted by organ transplantation.
The recognition of allograft-associated infections has importance in terms of the health of the recipient as well as the health of other recipients of tissues derived from the same donor. This observation increases the importance of prevention of disease transmission as well as the recognition and full microbiological evaluation of transmission events when they occur. In addition, transmission events require:

  • Recognition on the part of clinicians employing tissue allografts in clinical practice that infection may occur in recipients and that, as such, require careful microbiological evaluation.
  • Mandatory and timely reporting of transmission events to procurement organizations, tissue and eye establishments and public health authorities. Clinicians require education on reportable events including specified clinical syndromes and the mechanisms available for these reports. In general, allograft recipients with evidence of unexplained infection early after graft placement, with recovery or recognition of common or unusual organisms, or with uncommon clinical syndromes (e.g., encephalitis) merit reporting. Confirmation of transmission events is needed to assure the adequacy of epidemiologic data.
  • A “culture of safety” should be promoted that will focus on the prevention of disease and improvement in clinical practice rather than punitive approaches to reporting of possible transmission events.
  • Coordination of information between public health authorities, competent authorities, clinical centers, patients, and between tissue and organ procurement groups must be facilitated. Standard paradigms must be developed for the investigation of transmission events to expedite treatment for other recipients possibly impacted by affected tissues.
  • Agreement must be reached regarding the optimal panel of clinical microbiological assays for use in screening eye, organ and tissue donors based on the tissues procured, post-procurement processing, and the expected use of such tissues. Flexibility must exist in the specific testing paradigms to allow for shifts in microbiologic epidemiology and variations in endemic infections. Decisions must be made regarding the types of assays to be performed and the sensitivity and specificity of each assay.