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Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – Letter to Health Care Providers
Today, the U.S. Food and Drug Administration (FDA) is issuing a Letter to Health Care Providers to share information about the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) with the following hemodialysis machines manufactured by Fresenius Medical Care: the 2008T, 2008K2, and 2008K models. The 2008K2 and 2008K models are no longer manufactured but may still be in clinical use.
The source of the NDL PCBAs and NDL PCBs is from the silicone tubing used as a part of the hydraulics in the machine and the dialysate lines. Although the tubing for the dialysate lines does not directly contact the blood, there is the potential for back filtering through the dialyzer into the patient’s blood circulation during treatment.
Currently, the FDA has not received any reports of adverse events related to NDL PCBAs or NDL PCBs associated with the use of hemodialysis machines manufactured by Fresenius Medical Care. 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 FDA recognizes that hemodialysis machines are critical to patient care, and providers should continue to provide dialysis treatments to their patients. The Letter to Health Care Providers includes important information including:
- Recommendations for health care providers.
- Actions the FDA is taking.
- Instructions for reporting problems with these devices.
Questions?
If you have questions about this Letter to Health Care Providers, contact the Division of Industry and Consumer Education (DICE).
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