Objective. To report two cases of pancreatic islet transplantation-rel
ated septicemia, and the results of an investigative protocol to ident
ify potential sources of contamination. Design. Case series. Setting.
University hospital clinical investigational islet transplantation pro
gram. Results. The last two of our first seven islet transplantation r
ecipients developed Enterobacter cloacae septicemia within hours of is
let infusion. Both had received thawed cryopreserved islet infusions.
No source of infection apart from islets could be identified. Pancreas
harvesting and islet isolation protocols provided multiple opportunit
ies for contamination. Environmental cultures during a mock islet isol
ation procedure failed to identify a source of Enterobacter. Previousl
y cryopreserved islet lots were thawed and submitted for culture, 14/4
7 grew micro-organisms including E. cloacae in four instances. Followi
ng revision of protocols for aseptic handling of islets during process
ing and cryopreservation 55 consecutive pancreata undergoing processin
g were evaluated; 7 grew microorganisms on arrival and in 3 cases thes
e persisted through to cryopreservation. Conclusion. Two of seven isle
t transplantation recipients developed septicemia, likely related to i
nfusion of contaminated cryopreserved islets. Using existing technolog
y, for isolating islets from donor pancreata, recipients will remain a
t risk for this complication. Prevention should entail strict adherenc
e to aseptic technique, and, possibly, use of surveillance microbial c
ultures during the islet isolation process.