The FDA issued a notification May 10 about the potential risk of exposure to toxic compounds in Fresenius Medical Care hemodialysis machines.
The compounds are non-dioxin-like polychlorinated biphenyl acids and polychlorinated biphenyls. They can be found in silicone tubing used in the hydraulics in the machine and the dialysate lines. Although it does not directly contact the blood, there is a potential for back-filtering through the dialyzer into the patient's blood during treatment.
The agency has not received any reports of adverse events related to the machines and is working with the manufacturer to further collect and evaluate data to determine exposure risk.