The Food and Drug Administration (FDA) is evaluating certain Fresenius Medical Care hemodialysis machines as they may potentially expose patients to polychlorinated hydrocarbon chemicals, specifically non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs).
These compounds are found in the silicone tubing used as part of the hydraulics in the machine and the dialysate lines in the 2008T, 2008K2, and 2008K models. The 2008K2 and 2008K models are no longer manufactured but may still be in clinical use.
While the silicone tubing does not directly come in contact with the blood, there is a potential for back filtering through the dialyzer into the patient’s blood circulation during treatment. Potential adverse effects of NDL PCBs based on animal studies include endocrine dysfunction, hepatic effects, neurobehavioral alterations, and male reproductive effects.
According to preliminary data, the amount of NDL PCBAs and NDL PCBs may decrease over the first month during routine clinical use. The Company is conducting additional testing to determine the degree and duration of exposure.
The FDA recommends that if available, an alternative machine be used if a new Fresenius 2008T hemodialysis machine has only been used for less than a month. However, if the new Fresenius 2008T hemodialysis machine is the only machine available, it should continue to be used so that patients have access to dialysis treatment.
Any issues with Fresenius hemodialysis devices (2008T, 2008K2, and 2008K models) should be reported to the FDA’s MedWatch program.
At this time, the FDA has not received any reports of adverse events related to NDL PCBAs or NDL PCBs associated with these hemodialysis machines.
Potential risk of exposure to toxic compounds when using certain hemodialysis machines manufactured by Fresenius Medical Care – letter to health care providers. News release. US Food and Drug Administration. Accessed May 6, 2022. https://www.fda.gov/medical-devices/letters-health-care-providers/potential-risk-exposure-toxic-compounds-when-using-certain-hemodialysis-machines-manufactured