Fresenius’ Updated Tubing for Hemodialysis Machines Cleared

The FDA has granted clearance to Fresenius Medical Care Renal Therapies’ 2008 Series hemodialysis machine with updated tubing to address concerns of exposure to toxic chemicals.

The FDA raised concerns in May about the previous models’ silicone tubing which had a risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs). The chemicals have been linked in animals to endocrine dysfunction, hepatic effects, neurobehavioral alterations and male reproductive effects.

The tubing for the hemodialysis machines is now made of platinum catalyst silicone and eliminates detectable levels of these chemicals.

The company has been shipping 2008T hemodialysis machines with the updated tubing since Oct. 27.