FDA Says It Will Dig Deeper into Risk from Dialysis System Tubing

The FDA says more testing and analysis is needed to determine the risk of exposure to toxic compounds from tubing used in any hemodialysis or peritoneal dialysis system that has parts made of chlorinated peroxide cured silicone.

In an update to its May 2022 advisory statement to healthcare providers, the agency said it will “develop strategies to address the issue, if needed.”

The tubing presents a risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBA) and NDL polychlorinated biphenyls (PCB). The chemicals have been linked in animals to endocrine dysfunction, hepatic effects, neurobehavioral alterations, and male reproductive effects.

In May 2022, the FDA raised concerns about Fresenius Medical Care Renal Therapies’ 2008 Series hemodialysis machines’ silicone tubing. The company’s replacement tubing for the Fresenius machines, cleared by the FDA in December 2022, is made of platinum catalyst silicone and eliminates detectable levels of these chemicals.