The FDA has sent a letter to health care providers warning that silicone tubing used in certain Fresenius Medical Care dialysis machines may contain toxins.
The FDA investigation, being done in cooperation with Fresenius, includes hemodialysis machine models 2008T, 2008K2 and 2008K, and involves non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) that are in the silicone tubing used in the dialysate lines and the mechanical components of the machines.
“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,” according to the FDA letter.
Two of the models — the 2008K2 and 2008K — are no longer being made by Fresenius, according to the FDA letter, but may still be in use.
In a field notification to dialysis providers, Fresenius said it discovered during development of the 2008 Series that NDL-PCBAs “may leach from silicone tubing manufactured with a peroxide-based catalyst (‘peroxide catalyst tubing’).
“Silicone tubing is widely used in the medical industry, and Fresenius uses it in the internal hydraulic tubing in Fresenius 2008 Series hemodialysis machines,” the company said in the field notification. “Fresenius’s investigation into this issue, its potential impact on patient health, and mitigation strategies is ongoing.”
According to Fresenius and the FDA, the groups have not received any related reports of adverse events.
“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,” according to the FDA letter. “However, additional testing is needed, and the manufacturer is conducting further testing and analysis to determine the degree and duration of exposure.”
Fresenius said in its field notification that testing to meet standards set by the International Organization for Standardization showed that chemicals could leach from the silicone tubing.
“The testing was performed by multiple analytical techniques on specimens of purified water run through the machines under typical chronic outpatient treatments conditions, but without filtering through a dialyzer,” Fresenius said in the field notification. “The testing results unexpectedly identified NDL-PCBAs in high amounts that were determined to have leached from peroxide catalyst tubing in the machines’ internal hydraulic tubing.”
The company added, “Based on the factors and considerations described above, Fresenius concludes that NDL PCBAs found in peroxide catalyst tubing used in the internal hydraulic tubing of its hemodialysis machines do not pose an immediate risk to patients’ health when balanced against the need of the substantial chronic hemodialysis patient population for frequent and continuing treatment.
“On the other hand, Fresenius recognizes the similarity in general chemical structure between identified toxins in the family of NDL-PCBs and NDL-PCBAs and the consequent concern that the NDL-PCBAs represent a currently uncertain risk to patient health.”
The company said it put a temporary distribution hold on new dialysis 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.”
Potential risk of exposure to toxic compounds when using certain hemodialysis machines manufactured by Fresenius Medical Care – Letter to health care providers. Letter to health care providers. Published May 6, 2022. Accessed May 10, 2022.
Silicone tubing in dialysis machines. Silicone tubing in dialysis machines. Published May 10, 2022. Accessed May 10, 2022.
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