FDA Warns of Toxic Risk from Fresenius Hemodialysis Machines

The U.S. Food and Drug Administration (FDA) is assessing the risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) present with 2008T, 2008K2, and 2008K hemodialysis machines made by Fresenius Medical Care.
 
The source of these toxic compounds is from silicone tubing that is part of the machine’s hydraulics and dialysate lines. The company said testing to meet ISO-10993:2020 standards showed the chemicals could leach from silicone tubing made with a peroxide-based catalyst.
 
The silicone tubing doesn’t directly contact the blood but there is a risk of back filtering through the dialyzer into the blood during treatment.
 
The company issued a Field Safety Notification regarding the potential risk. The 2008K2 and 2008K models aren’t manufactured anymore but may still be in use. The company said it has enacted a temporary distribution hold on new hemodialysis machines and parts with peroxide catalyst tubing on April 21 and “is working to transition from catalyst tubing in internal hydraulic systems to tubing manufactured with a platinum catalyst (‘platinum catalyst tubing’) as quickly as possible.”
 
The FDA hasn’t yet received reports of adverse events related to NFL PCBAs or NDL LCBs associated with use of Fresenius Medical Care hemodialysis machines. Based on an animal studies, potential adverse effects of NDL PCB exposure can include endocrine dysfunction, hepatic effects, neurobehavioral alterations, and male reproductive effects.
 
The agency recommended that healthcare providers consider using alternative machines if they have new 2008T hemodialysis machines that have been in use for less than a month. However, FDA advised that dialysis treatments shouldn’t be discontinued if using the Fresenius machines is their only option.
 
The FDA is working with Fresenius Medical Care to collect and evaluate data as well as determine the exposure risk of the toxic compounds on patients. Preliminary data provided by Fresenius Medical Care has suggested the amount of the toxic compounds may decrease over the first month during routine clinical hemodialysis machine use.
 
However, further testing is needed, which Fresenius is conducting to figure out the degree and duration of exposure. The FDA will issue an update as new information becomes available.