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FDA Investigating Potential Risk of Exposure to Toxic Compounds When Using Hemodialysis and Peritoneal Dialysis Systems

The FDA is continuing to assess the potential risk of toxic compounds found in silicon tubing used during dialysis, according to a press release. In May 2022, the FDA found the silicon tubing was being used in dialysis machines manufactured by Fresenius Medical Care. The FDA said it worked with Fresenius Medical Care, “which modified the silicone tubing used in their hemodialysis machines to platinum catalyst silicone tubing,” according to the release. “Based on information provided by the manufacturer, NDL PCBAs and NDL PCBs were not detected in machines with the modified silicone tubing.”

Why does it matter? What was the end result? To clarify, this is a potential risk, not yet confirmed or quantified. Fresenius is not the only manufacturer of the tubing and the FDA is working with other manufacturers to determine the potential risk of exposure. Providers are also asked to "report any concerns with hemodialysis or peritoneal dialysis systems to the FDA, including any adverse effects on patients that may be related to the potential exposure to NDL PCBAs or NDL PCBs" Most importantly, the FDA is clear that providers should continue providing hemo and peritoneal dialysis to their patients.

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