This article deals with the FDA risk classification continued evaluation of the potential risk of hazardous chemical exposure when utilizing dialysis devices. The FDA has issued a letter to health care providers to assess the risk of exposure to non-dioxin-like polychlorinated biphenyl acids and NDL polychlorinated B1F. The FDA risk classification recognizes the importance of hemodialysis and peritoneal dialysis systems in patient care.
Providers of health care should:
- Maintain your dialysis services for your patients.
- Be aware that the FDA is collaborating with manufacturers to better understand the possible risk of NDL PCBA and NDL PCB exposure with hemodialysis and peritoneal dialysis systems and to develop mitigation techniques as appropriate.
- Keep an eye out for additional updates and recommendations from the FDA and relevant manufacturers.
- Report any problems with hemodialysis or peritoneal dialysis systems to the FDA, including any harmful effects on patients that might be caused by NDL PCBAs or NDL PCBs.
Background
Hemodialysis and peritoneal dialysis are used to treat kidney injury or end-stage kidney disease. NDL PCBs are a subgroup of polychlorinated hydrocarbon chemicals containing chlorine, carbon, and hydrogen. They are found in the environment and pose a risk of harm to humans and animals. Old PCBs can be produced in silicone tubing and parts through the manufacturing process using a chlorinated peroxide initiator. Adverse effects of NTL PCBs in animals have been reported in the literature.
FDA Measures
The FDA is working with manufacturers of hemodialysis and peritoneal dialysis systems to evaluate data to determine if NDL PCBAs or NLD PCBs are present in their systems, and to assess the amount and extent of exposure to patients. The FDA will also 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. Finally, the FDA will inform the public when significant new information or recommendations become available.
Reporting Issues to the FDA
The FDA encourages health care providers to report any adverse events or suspected adverse events associated with medical devices in order to help identify and reduce risks while also improving patient safety.
- The FDA requires health care personnel to follow reporting procedures.
- Voluntary reports can be submitted through MedWatch.
- Manufacturers and user facilities must comply with MDR Regulations.
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Source : Potential Risk of exposure to toxic compounds when using dialysis systems
