Risk of Toxic Exposures from Dialysis Systems Results in FDA Warning Letter to Health Care Providers

The agency indicates it is still analyzing the potential health risk of toxic exposures from the affected dialysis systems.

Federal health officials are expanding a prior warning about toxic exposures from dialysis systems, advising health care providers that problems may impact additional hemodialysis and peritoneal dialysis machines manufactured by different companies.

In May 2022, the FDA issued a warning about the risk that Fresenius hemodialysis machines may expose patients to toxic compounds, which could lead to neurobehavioral changes and hormone problems. The source of those chemicals came from silicone tubing used as part of the hydraulics in the dialysate lines.

This week, the agency issued a new letter to health care providers expanding on that warning and indicating that the FDA is aware of other hemodialysis and peritoneal dialysis systems that may contain similar parts.

Hemodialysis and peritoneal dialysis systems manufactured with chlorinated peroxide cured silicone may cause toxic exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs). For individuals with kidney injury or kidney failure undergoing dialysis treatments, the compounds could enter their blood and result in serious side effects.

Hemodialysis Toxic Exposure Risks

NDL PCBs are compounds containing chlorine, carbon, and hydrogen chemicals. NDL PCBAs are an acid of NDL PCBs found in soil and wastewater and are harmful to humans and animals.

The chemicals are a byproduct from the manufacturing of resin using polymeric material. Side effects of NDL PCB exposure can include endocrine dysfunction, damage to the liver, neurobehavioral changes, and male reproductive effects.

Following the first warning, Fresenius modified the silicone tubing used in their hemodialysis machines to platinum catalyst silicone tubing. After the change, Fresenius said no NDL PCBAs and NDL PCBs were detected in machines with the modified silicone tubing.

The FDA then became aware of other hemodialysis and peritoneal dialysis systems that have parts made of chlorinated peroxide cured silicone, but the agency indicates it is uncertain if they pose a risk of exposure to the toxic compounds.

The agency is evaluating the risk of exposure from other systems and working with manufacturers to evaluate the risk of exposure to patients. More testing is needed to determine if the toxic compounds are present in other systems and can expose patients to harmful chemicals, FDA officials say.

Hemodialysis and peritoneal dialysis are procedures used to treat patients who develop serious kidney injury or end-stage kidney disease. During hemodialysis, needles are placed in a patient’s arm and a machine is used to pump blood and filter it outside the body to remove waste and extra fluid. The blood is then returned to the body.

During peritoneal dialysis, a surgeon places a tube in a patient’s abdomen so dialysis fluid can flow into the belly through the peritoneal membrane, the lining of the abdomen, which filters blood inside the body.

The FDA recommends healthcare providers:

• Continue to provide dialysis treatment to patients.
• Remain alert for updates and recommendations from the FDA and manufacturers.
• Report concerns with hemodialysis or peritoneal dialysis systems to the FDA, including adverse events to patients.

As new information becomes available about the risk of toxic exposures from different dialysis systems becomes available, the FDA indicates that it will provide an update.