The U.S. Food and Drug Administration (FDA) is continuing to evaluate the potential risk of exposure to toxic compounds when using dialysis systems.
On May 6, 2022, the FDA issued a Letter to Healthcare Providers about the evaluation of the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain hemodialysis systems manufactured by Fresenius Medical Care.
The source of the NDL PCBAs and NDL PCBs was from the silicone tubing used as a part of the hydraulics in the dialysate lines. Specifically, the manufacturing process of the silicone tubing used a chlorinated peroxide initiator that resulted in NDL PCBAs and NDL PCBs. The FDA worked with Fresenius Medical Care which modified the silicone tubing used in their hemodialysis machines to platinum catalyst silicone tubing. Based on information provided by the manufacturer, NDL PCBAs and NDL PCBs were not detected in machines with the modified silicone tubing.
As a part of the FDA’s ongoing evaluation and work with other manufacturers of hemodialysis and peritoneal dialysis systems, the FDA is aware of other hemodialysis and peritoneal dialysis systems that have parts made of chlorinated peroxide cured silicone but does not currently know whether there is any risk of exposure to NDL PCBAs or NDL PCBs. The FDA is working with these manufacturers to further collect and evaluate data to determine the risk of exposure to NDL PCBAs and NDL PCBs on patients and develop strategies to address the issue, if needed. More testing and analysis are needed to determine if NDL PCBAs or NDL PCBs are present in the systems, and if so, the amount and extent of exposure to patients of these toxic compounds. The FDA will provide an update when new information becomes available.
The FDA says healthcare providers should continue to provide dialysis treatments to your patients, and to be aware that FDA is working with manufacturers to understand the potential risk of exposure to NDL PCBAs and NDL PCBs with hemodialysis and peritoneal dialysis systems and develop mitigation strategies, if needed.
