The U.S. Food and Drug Administration (FDA) is evaluating the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) with the following hemodialysis machines manufactured by Fresenius Medical Care: the 2008T, 2008K2, and 2008K models. The 2008K2 and 2008K models are no longer manufactured but may still be in clinical use.
The source of the NDL PCBAs and NDL PCBs is from the silicone tubing used as a part of the hydraulics in the machine and the dialysate lines. Although this silicone tubing does not directly contact the blood, there is the potential for back filtering through the dialyzer into the patient’s blood circulation during treatment.
Currently, the FDA has not received any reports of adverse events related to NDL PCBAs or NDL PCBs associated with the use of hemodialysis machines manufactured by Fresenius Medical Care. Adverse effects of NDL PCBs in animals have been reported in the literature, such as endocrine dysfunction, hepatic effects, neurobehavioral alterations, and male reproductive effects.
The FDA is working with the manufacturer to further collect and evaluate data to determine the risk of exposure to the NDL PCBs and NDL PCBAs on patients, as well as develop strategies to mitigate this issue. Preliminary data provided by the manufacturer to date suggest that the amount of NDL PCBAs and NDL PCBs might decrease over the first month during routine clinical use of the hemodialysis machine. However, additional testing is needed and the manufacturer is conducting further testing and analysis to determine the degree and duration of exposure. The FDA will provide an update when new information becomes available.