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Medscape

Medscape

FDA Sends Warning About Fresenius Dialysis Machines

FDA Sends Warning About Fresenius Dialysis Machines

The FDA has released a statement to address concern regarding potential toxins released from Fresenius dialysis machines.


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Do you know what kind of hemodialysis machine you or a loved one uses in treatment? The U.S. Food and Drug Administration (FDA) recently released a statement discussing the potential risk from certain dialysis machine models manufactured by Fresenius Medical Care. Read more about the risk, and what you can do to protect yourself as a patient.* 

What is the risk?

Some Fresenius dialysis machines use silicone tubing that contains non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs). These chemicals have caused negative effects in animal studies, including liver dysfunction, thyroid alterations, behavior changes, and male reproduction issues. 

While these dangerous chemicals should not directly contact the blood during dialysis treatment, there is some concern that they may nevertheless be able to reach a patient’s blood circulation. The FDA is working with Fresenius to complete additional testing to confirm the exposure risk. Early data suggests that the level of patient exposure to the dangerous chemicals might decline during the first month of machine use. 

What dialysis machines are affected?

Certain of Fresenius’ hemodialysis machines, including the 2008k2, 2008T, and 2008K, are at risk for exposing patients to dangerous chemicals. The 2008k2 and 2008k models are no longer being produced, but may still be in use at dialysis clinics throughout the U.S. 

What can I do as a patient?

First, ask your nurse or dialysis teammate what kind of dialysis machine is being used for your treatment. If you are being treated with a potentially affected machine, talk to your nephrologist (kidney doctor) and see if there is an alternative machine available in your clinic. If there is not, the FDA currently recommends that you continue dialysis care with your usual machine. 

*Zoler, M. (2022, May 6). Potential Risk From Fresenius Dialysis Units, FDA Warns. Medscape. https://www.medscape.com/viewarticle/973612

Hemo 11-16-17.” by Monirb is licensed under CC-BY-SA-3.0

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