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FDA warns against potential risks from Fresenius dialysis units

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eMediNexus    07 May 2022

A recent letter sent by the company Fresenius Medical care to FDA stated that the dialysis unit models 2008T, 2008K, and 2008K2 have potential toxins exposure to the patient. Though models 2008K and 2008K2 models are no longer produced or distributed, several facilities may be using them. According to the FDA, clinicians should switch to alternative methods and report any adverse effects to FDA’s Med Watch program.

The problems in the model occurred when the nondioxin-like polychlorinated biphenyls and nondioxin-like polychlorinated biphenyl acids leached from the silicone tubes used in the dialysate lines. Though the lines don’t have direct contact with the patient’s blood but the chemicals may reach the circulation during dialysis treatment.  FDA stated that they are working with the agency to collect data and review the potential risks of exposure and develop directives to counter the problem.

According to the evidence-based data, the side effects of the exposure are noted as toxic effects to the skin, thyroid gland, and carcinogenic growth. The preliminary mitigation data provided by the agency showed a decline in toxic effects after the first month of use. However, additional tests are needed to confirm the results.

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