​Fresenius—2008 Series Hemodialysis Machines: Non-Dioxin-Like Polychlorinated Biphenyl Acids May Leach from Silicone Tubing

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Problem:

In a letter submitted by ECRI member hospitals, Fresenius states that during machine development testing designed to satisfy the ISO-10993 (2020) standards, the firm has discovered that non-dioxin-like polychlorinated biphenyl acids ("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 the above devices. For further information on Fresenius's testing, see the letter. Fresenius states that it has received no reports of adverse events related to NDL-PCBAs and NDL-PCBs. Based on the factors and considerations described in the letter, 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. However, Fresenius also recognizes the similarity in general chemical structure between identified toxins in the family of...