March 7, 2023

The U.S. Food and Drug Administration (FDA) is continuing to evaluate the potential risk of exposure to toxic compounds when using dialysis systems. On May 6, 2022, the FDA issued a Letter to Health Care Providers about the evaluation of the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain hemodialysis systems manufactured by Fresenius Medical Care. The source of the NDL PCBAs and NDL PCBs was from the silicone tubing used as a part of the hydraulics in the dialysate lines. Specifically, the manufacturing process of the silicone tubing used a chlorinated peroxide initiator that resulted in NDL PCBAs and NDL PCBs. The FDA worked with Fresenius Medical Care which modified the silicone tubing used in their hemodialysis machines to platinum catalyst silicone tubing. Based on information provided by the manufacturer, NDL PCBAs and NDL PCBs were not detected in machines with the modified silicone tubing.

As a part of the FDA’s ongoing evaluation and work with other manufacturers of hemodialysis and peritoneal dialysis systems, the FDA is aware of other hemodialysis and peritoneal dialysis systems that have parts made of chlorinated peroxide cured silicone but we do not know at this time whether there is any risk of exposure to NDL PCBAs or NDL PCBs. The FDA is working with these manufacturers to further collect and evaluate data to determine the risk of exposure to NDL PCBAs and NDL PCBs on patients and develop strategies to address the issue, if needed. More testing and analysis are needed to determine if NDL PCBAs or NDL PCBs are present in the systems, and if so, the amount and extent of exposure to patients of these toxic compounds. The FDA will provide an update when new information becomes available.

Recommendations

The FDA recognizes that hemodialysis and peritoneal dialysis systems are critical to patient care. 

Health care providers should:

• Continue to provide dialysis treatments to your patients. 
• Be aware the FDA is working with manufacturers to understand the potential risk of exposure to NDL PCBAs and NDL PCBs with hemodialysis and peritoneal dialysis systems and develop mitigation strategies, if needed. 
• Remain alert for further updates and recommendations from the FDA and applicable manufacturers.
• Report any concerns with hemodialysis or peritoneal dialysis systems to the FDA, including any adverse effects on patients that may be related to the potential exposure to NDL PCBAs or NDL PCBs. 

Background 

Hemodialysis and peritoneal dialysis are used to treat patients who develop serious kidney injury or end-stage kidney disease. In hemodialysis, needles are placed in a patient’s arm to use a machine that pumps blood through a filter outside the body to remove waste and extra fluid, then returns the blood to the body. In peritoneal dialysis, a surgeon places a tube in a patient’s abdomen so dialysis fluid can flow into the belly through the peritoneal membrane (lining of the abdomen) which filters blood inside the body. 

NDL PCBs are a subgroup of polychlorinated hydrocarbon (compounds containing chlorine, carbon, and hydrogen) chemicals. NDL PCBAs are an acid of NDL PCBs. PCBs, including NDL PCBs, are in the environment (such as in soil or wastewater) and pose a risk of harm to humans and animals. NDL PCBs are a byproduct from polymeric material manufacturing where a chlorinated benzoyl peroxide is used as an initiator in the polymerization of the resin. Adverse effects of NDL PCBs in animals have been reported in the literature, such as endocrine dysfunction, hepatic effects, neurobehavioral alterations, and male reproductive effects. 

A source of NDL PCBAs and NDL PCBs in silicone tubing and parts can be the manufacturing process of the silicone that uses a chlorinated peroxide initiator and may result in the generation of NDL PCBAs and NDL PCBs.

FDA Actions (as of April 25, 2024)

On April 25, 2024, the FDA determined the actions by:

• Outset Medical Inc. to address NDL-PCBAs with Tablo Hemodialysis Systems as a Class I recall, the most serious type of recall. This recall is a correction, not a product removal.
• Fresenius Medical Care to address NDL-PCBAs with the stay-safe catheter extension sets and luer lock adaptors used with peritoneal dialysis machines as a Class I recall, the most serious type of recall. This recall is a correction, not a product removal.

On October 06, 2023, the FDA determined the actions by Fresenius Medical Care to update affected 2008 Series Hemodialysis machines from chlorinated peroxide cured silicone tubing to platinum cured silicone tubing as a Class I recall, the most serious type of recall. This recall is a correction, not a product removal.

The FDA continues working with manufacturers of hemodialysis and peritoneal dialysis systems to further collect and evaluate data to determine if NDL PCBAs or NDL PCBs are present in their system, and if so, the amount and extent of exposure to patients, as well as strategies to address the issue if needed. 

In addition, the FDA continues to work with industry and external stakeholders to better understand the potential risks of using a chlorinated peroxide initiator for silicone as part of the manufacturing process by different device types. 

The FDA will inform the public when significant new information or recommendations become available.

Reporting Problems to the FDA 

The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with medical devices. Prompt reporting can help the FDA identify and better understand the risks associated with medical devices and improve patient safety.

• Health care personnel employed by facilities that are subject to the FDA's User Facility Reporting Requirements should follow the reporting procedures established by their facilities.
• Voluntary reports can be submitted through MedWatch: The FDA Safety Information and Adverse Event Reporting program.
• Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.

Contact Information 

If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).

Additional Resources 

• Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – Letter to Health Care Providers
• Centers for Disease Control and Prevention (2017) Biomonitoring Summary. Non-Dioxin-Like Polychlorinated Biphenyls. National Biomonitoring Program.