Potential Risk From Fresenius Dialysis Units, FDA Warns

Potential Risk From Fresenius Dialysis Units, FDA Warns

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The US Food and Drug Administration (FDA) today warned clinicians of a potential risk for patient exposure to toxic compounds associated with the use of certain models of hemodialysis machines marketed by Fresenius Medical Care.

A letter sent by the agency said the dialysis units involved are models 2008T, 2008K, and 2008K2. The 2008K and 2008K2 models are no longer in production or distribution, but they may still be in use in the United States, the FDA said.

Clinicians should continue to treat patients with dialysis, according to the FDA. If clinicians have a new model 2008T that’s been in use for less than a month, they should consider using an alternative machine if one is available. But the agency added that when no alternative option exists, use of a new model 2008T should continue to ensure uninterrupted dialysis care.

Clinicians can report any issues they encounter with the affected devices to the FDA’s MedWatch program.

The total number of affected hemodialysis machines in the United States is unclear; Fresenius did not respond to a request for comment.

Toxic Compounds May Leach From Tubing

The problem likely occurs when nondioxin-like (NDL) polychlorinated biphenyls (PCBs) and nondioxin-like polychlorinated biphenyl acids (PCBAs) leach from silicone tubing used in the machine and dialysate lines of these models, the agency said.

Although the tubing does not directly contact a patient’s blood, there remains a potential for these chemicals to reach a patient’s circulation during dialysis treatment. The FDA said that the NDL PCBs and related compounds likely appear during manufacture of the tubing.

“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,” the agency noted.

Evidence suggests that a range of adverse health effects is linked with exposure to PCBs, including toxic effects to the skin, the thyroid system, and carcinogenic effects.

Preliminary data received by the FDA from Fresenius suggest that the level of patient exposure to these toxins might decline during the first month of use, but the agency stressed that additional testing is needed to confirm this.

More information about this warning is available on the FDA website.

Mitchel L. Zoler is based in the Philadelphia region. He can be reached at @mitchelzoler.

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