FDA announcement
The US Food and Drug Administration (FDA) issued an announcement on March 7 to update its May 2022 letter to healthcare providers regarding the potential risks of exposure to toxic compounds when using hemodialysis and peritoneal dialysis. This update is important for healthcare providers who prescribe and administer dialysis to patients with kidney failure.
Background
Hemodialysis and peritoneal dialysis are two methods used to treat kidney injury or end-stage kidney disease. In hemodialysis, blood is pumped through a filter outside the body to remove waste and extra fluid. In peritoneal dialysis, dialysis fluid flows into the belly through the peritoneal membrane to filter blood inside the body.
Exposure to chemicals
NDL PCBs are a subgroup of polychlorinated hydrocarbon chemicals that pose a risk of harm to humans and animals. These chemicals are a byproduct from polymeric material manufacturing and are found in the environment. NDL PCBAs and NDL PCBs can be found in silicone tubing and parts that use a chlorinated peroxide initiator in the manufacturing process. Adverse effects of NDL PCBs in animals have been reported, including endocrine dysfunction, hepatic effects, neurobehavioral alterations, and male reproductive effects.
The FDA has become aware of cases where dialysis patients have been exposed to a group of chemicals called polycyclic aromatic hydrocarbons (PAHs) and halogenated aromatic hydrocarbons (HAHs). These chemicals can be found in certain dialysis products, including some dialysis membranes and dialysate concentrates.
Exposure to these toxic compounds can lead to serious health problems, including cancer and liver disease. The FDA is advising healthcare providers to take steps to reduce the risk of exposure for their patients.
Recommendations to healthcare providers
One of the key steps that healthcare providers can take is to review the labeling and instructions for use of the dialysis products they are using. They should also be aware of the potential sources of exposure, such as contaminated water used in the dialysis process.
In addition, the FDA recommends that healthcare providers consider using alternative dialysis products that do not contain these toxic compounds. They should also monitor patients for signs of exposure and report any adverse events to the FDA.
Patient awareness
Patients who receive dialysis should be aware of the potential risks and should talk to their healthcare provider if they have any concerns. They should also be vigilant in monitoring their own health and reporting any symptoms to their healthcare provider.
FDA commitment
The FDA is committed to ensuring the safety of medical products, including dialysis products. This update serves as a reminder to healthcare providers to take steps to reduce the risk of exposure to toxic compounds during dialysis. By working together, healthcare providers and patients can help prevent the harmful effects of exposure to these chemicals.
Announcement and updates
Read the announcement and updates here.