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Abstract: SA-PO443

Evaluation of Bacteriology of Bicarbonate Dialysis Solution (BDS) From Hemodialysis (HD) Clinics That Have Adopted Ferric Pyrophosphate Citrate (FPC; Triferic )

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis


  • Currier, Helen, Rockwell Medical Inc, Wixom, Michigan, United States
  • Zaleski, Julie, Ascend Clinical, Redwood City, California, United States
  • Hoffman, Marc L., Rockwell Medical Inc, Wixom, Michigan, United States

Despite broad advocacy in clinical guidelines, concerns remain that intravenous iron may increase the risk of infection by promoting pathogen growth and predisposing patients to infection (Shah, 2021). FPC is an iron (III)-citrate-pyrophosphate oligomeric complex that does not contain a carbohydrate shell and that delivers iron directly to transferrin via BDS. FPC experience at 98+ hemodialysis clinics and over 500 months (mos.) of exposure has not been associated with any report of bacterial growth from the BDS exceeding the Association for the Advancement of Medical Instrumentation (AAMI) standards.


As a quality assurance project evaluating the risk of bacterial growth and to supplement FPC safety data, the bacteriology of conventional BDS from 8 independent HD clinics was evaluated for positive evidence. These microbiological cultures of HD water and fluid are routine safety measures in US HD clinics. Collection is standardized by “clean-catch” and sent out by expedited mail. Permissions were obtained from individual dialysis facility medical directors to use their proprietary data in the analysis. The data was collected from a single clinical laboratory that exclusively provides ESRD services. The 8 FPC user clinics represented rural/urban areas from 4 states. Deidentified Water Analysis Reports collected and reported for routine Quality Assessment Performance Improvement surveillance [Total Viable Microbial Count (CFU/mL) and Limulus Amebocyte Lysate (LAL)] were analyzed for potential microbial growth pre- and post-adoption of FPC. Data included 12 mos. pre-FPC adoption to present. CMS regulations reference AAMI RD62:2006 for maximum allowable levels (MAL) in both culture and endotoxin. The MAL in water used for HD is 200 CFU/mL and 2 endotoxin unit (EU)/mL.


Neither cohort of BDS cultures exceeded MALs. One LAL pre-FPC exposure exceeded the MAL.


This retrospective analysis demonstrates that FPC delivered in its different form does not contribute to microbial growth in the BDS.

Shah AA, Donovan K, Seeley C, et al. Risk of infection associated with administration of intravenous iron: a systematic review and meta-analysis. JAMA Netw Open. 2021;4(11):e2133935.

Water Analysis Reports' Results