SEIU-United Healthcare Workers West has petitioned the FDA to recall some Fresenius dialysis machines to protect patient safety. SEIU-UHW Health Justice Director Hortencia Armendariz said in a statement that modifications are needed to the machines to protect dialysis patients. The union wants Fresenius 2008K2, 2008T, and 2008T BlueStar Hemodialysis machines recalled and modified. Photo courtesy of Hortencia Armendariz LinkedIn
Jan. 20 (UPI) -- The union SEIU-United Healthcare Workers West said Friday it has petitioned the Food and Drug Administration to recall some Fresenius dialysis machines to protect patient safety.
"We need these modifications to protect dialysis patients and help them make informed choices about the care they receive," said Hortencia Armendariz, Healthcare Justice Director at SEIU-UHW, in a statement. "Patients deserve to have life-saving information disclosed about this vital treatment."
The issue with the machines, according to the union, is the speed, or ultrafiltration rate, of the machines. SEIU-UHW said academic literature shows that faster rates are associated with higher mortality risk and other adverse consequences.
Fresenius makes more than half of the dialysis machines used worldwide, according to the company.
The machines the healthcare worker's union wants recalled are the Fresenius 2008K2, 2008T, and 2008T BlueStar Hemodialysis machines.
The union called for specific remedies in its petition, including:
- A modification to include an ultrafiltration settings screen that calculates a patient's ultrafiltration rate (UFR) in terms of ml/kg/hr and displays the result of that calculation throughout the dialysis session.
- A modification to include a distinctive alarm when the UFR exceeds 10 ml/kg/hr.
- A relabeling requirement to include a Black Box warning with the following language: "Ultrafiltration rates above 10 ml/h/kg are associated with an increased risk of death."
- A relabeling requirement, requiring labeling to include disinfection procedures for the hemodialysis machines, is proposed in the petition, too.
According to the union, U.S. mortality rates for dialysis patients is higher than in Australia, New Zealand, Canada, France, Germany, Italy, Japan, Sweden, and Britain.
One in five U.S. dialysis patients die within a year of initiating dialysis, the union said. Less than half survive five years.