Le Lézard
Classified in: Health
Subjects: NPT, PSF

Healthcare Workers File Petition Asking FDA to Recall Fresenius Dialysis Machines to Protect Patients

OAKLAND, Calif., Jan. 20, 2023 /PRNewswire/ -- SEIU-United Healthcare Workers West has submitted a petition to the head of the Food and Drug Administration (FDA) to issue a corrective recall requiring modifications to dialysis machines manufactured by Fresenius in order to provide safer dialysis treatments for patients and consumers.

"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. "Patients deserve to have life-saving information disclosed about this vital treatment."

Dialysis is a life-sustaining treatment for over half of a million patients in the United States suffering from kidney failure, and it is the only alternative to kidney transplantation.

The speed at which dialysis is provided is known as the ultrafiltration rate. Academic literature shows that faster ultrafiltration rates are associated with higher mortality risk and other adverse consequences, such as permanent damage to the heart and loss of cognitive function. People subjected to faster ultrafiltration rates may also suffer debilitating short-term symptoms such as dizziness, headaches, cramping, and nausea following treatment.

More than half of the dialysis machines used worldwide are made by Fresenius Medical Care, according to the company. Petitioners are urging the Commissioner of Food and Drugs to issue a corrective recall requiring certain modifications to the Fresenius 2008K2, 2008T, and 2008T BlueStar dialysis machines, saying those machines currently lack adequate safeguards to ensure patient safety vis-à-vis two significant dialysis measurements: ultrafiltration rate and conductivity.

The petition requests that the FDA Commissioner better protect the public health and welfare by issuing a corrective recall requiring the following corrections to all Fresenius 2008K2, 2008T, and 2008T BlueStar Hemodialysis Machines:

In the last ten years, Fresenius dialysis machines have had a variety of adverse events reported to the FDA that have resulted in recalls. In May 2022, the FDA took action against Fresenius-manufactured dialysis machines due to a potential risk of exposure to toxic compounds that resulted in a warning letter to healthcare providers.

The mortality statistics for dialysis patients in the United States are particularly grim when compared to other countries. One in five dialysis patients die within a year of initiating dialysis; less than half survive to five years. The mortality rate in the United States is higher than in Australia, New Zealand, Canada, France, Germany, Italy, Japan, Sweden, and the UK, and persists through all stages of dialysis.

Copies of the petition sent to the FDA are available upon request.

SEIU-United Healthcare Workers West (SEIU-UHW) is a healthcare justice union of more than 100,000 healthcare workers, patients, and healthcare activists united to ensure affordable, accessible, high-quality care for all Californians, provided by valued and respected healthcare workers. Learn more at www.seiu-uhw.org.


SOURCE SEIU-United Healthcare Workers West

These press releases may also interest you

at 12:35
Gilead Sciences, Inc. today announced longer-term overall survival (OS) results from the Phase 3 TROPiCS-02 study evaluating Trodelvy® (sacituzumab govitecan-hziy) versus comparator chemotherapy (physicians' choice of chemotherapy, TPC) in patients...

at 12:15
MEDiC Life Sciences ("MEDiC"), a Silicon Valley biotech startup, today announced that it entered into a research collaboration with Bristol Myers Squibb . In the collaboration, MEDiC is using its scalable 3-dimensional tumor models to perform CRISPR...

at 12:05
Ellipses Pharma ("Ellipses"), a global drug development company focused on accelerating the development of new oncology treatments, today announces its intention to expedite further global clinical development of the next generation selective RET...

at 12:05
At ASMS 2023, SCIEX, a global leader in life science analytical technologies, launches the Intabio ZT system, the first fully-integrated microfluidic chip-based platform combining imaged capillary isoelectric focusing (icIEF) separation and UV...

at 12:05
More than 81 million Americans who suffer from chronic seasonal allergies could be in for a long haul this year ? and in the years to come ? as warmer temperatures are leading to prolonged pollen...

at 12:02
(Family Features) While people may think about heart disease and kidney disease as two different health problems, there are many links between them....

News published on and distributed by: