FDA investigating potential risk from dialysis systems, revises EUA for surgical masks

The Food and Drug Administration is investigating whether silicone tubing in certain hemodialysis and peritoneal dialysis systems may expose patients to non-dioxin-like polychlorinated biphenyl acids and polychlorinated biphenyls, the agency announced yesterday. FDA is working with the manufacturers to determine the risk of exposure, and recommends providers continue to provide dialysis treatments and report any concerns to the agency. FDA last May alerted health care providers to a similar problem in certain hemodialysis machines made by Fresenius Medical Care. The company has since modified the tubing to address the issue, the agency said.
 
In other news, the FDA this week revised its umbrella emergency use authorization for surgical masks used in health care settings during the COVID-19 pandemic to limit the EUA to currently approved devices, meaning manufacturers who would like to bring new surgical masks to market must follow FDA’s traditional premarket pathways.