Devices

More Hemodialysis Toxic Compound Analysis Needed: FDA

FDA says that more testing and analysis are needed to determine if several toxic compounds are present in additional hemodialysis and peritoneal dialysis systems. Updating its 5/6/22 letter to healthcare providers on the evaluation of the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (BCPs) when using certain Fresenius Medical hemodialysis systems, FDA says it has become aware of other hemodialysis and peritoneal dialysis systems that have parts made of chlorinated peroxide cured silicone and it is unknown at this time whether there is a risk of exposure to NDL PCBAs or NDL PCBs.

The update says that in the Fresenius systems, the source of the toxic compounds was the silicone tubing used as part of the hydraulics in the dialysate lines. “Specifically,” it says, “the manufacturing process of the silicone tubing used a chlorinated peroxide initiator that resulted in NDL PCBAs and NDL PCBs.”

FDA says Fresenius modified the silicone tubing to platinum catalyst silicone tubing and the company reported that NDL PCBAs and NDL PCBs were not detected in machines with the modified tubing.

The notice says FDA is working with the additional manufacturers to further collect and evaluate data to determine the risk of exposure to NDL PCBAs and NDL PCBs in patients and develop strategies to address the issue if needed.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome