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Abstract: SA-PO562

Bisphenol Levels in Hemodialyzers

Session Information

Category: Dialysis

  • 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Grobe, Nadja, Renal Research Institute, New York, New York, United States
  • Haq, Zahin Sultana, Renal Research Institute, New York, New York, United States
  • Wang, Xin, Renal Research Institute, New York, New York, United States
  • Cheng, Joann, Fresenius Medical Care Holdings Inc, Waltham, Massachusetts, United States
  • Ferreira Dias, Gabriela, Renal Research Institute, New York, New York, United States
  • Moore, Christoph, Fresenius Medical Care AG & Co KGaA, Bad Homburg, Hessen, Germany
  • Piecha, Dorothea, Fresenius Medical Care AG & Co KGaA, Bad Homburg, Hessen, Germany
  • Kotanko, Peter, Renal Research Institute, New York, New York, United States
  • Ho, Chih-Hu, Value Stream Dialyzers, Fresenius Medical Care, Ogden, Utah, United States
Background

Bisphenol A (BPA)-based materials are widely employed across various industries, including dialysis. As concerns for BPA’s health risks rise, bisphenol S (BPS)-based materials are increasingly used. However, BPS safety requires further evaluation. To support thorough risk assessments on bisphenols and their exposure for hemodialysis patients, extractables (E) and leachables (L) from 8 commercially available dialyzers were tested.

Methods

For E, dialysate and blood sides of each dialyzer were incubated statically at 37°C with 95% ethanol (EtOH) and collected after 72 hrs. For L, bloodlines, dialysate and blood sides were filled with 17.2% EtOH and recirculated at 300 mL/min and 37°C for 24 hrs. Bloodline controls were run using the recirculation setup. Bisphenols were quantified by liquid chromatography-mass spectrometry using standard addition and stable-isotope labeled standards.

Results

BPA (0.43 - 32.82 µg/device) and BPS (0.02 - 2.51 µg/device) were detected in E from dialyzers and housings made with BPA- and BPS-containing materials (Figure 1). In L, BPA was only detected in one dialyzer made of BPA-containing membrane and housing material. BPS (0.08 - 1.44 µg/device) was detected in L of dialyzers made with BPS-based materials. BPA/BPS were not detected in bloodline controls, cellulose-based membranes, and in Fresenius Medical Care’s FX CorAL 120 dialyzer, a member of the recently FDA-cleared CorAL dialyzer family.

Conclusion

Dialyzers have varied bisphenol amounts based on raw materials and manufacturing process used for housing and membranes. FX CorAL exhibited no detectable bisphenols, as opposed to other dialyzers with synthetic membranes, where varying amounts of bisphenols were detected. To understand the BPS toxicological profile, additional studies should be performed and evaluated as rigorously as BPA.

Funding

  • Commercial Support – Fresenius Medical Care