Dive Brief:
- The Food and Drug Administration has classified Fresenius Medical Care’s work to avoid exposing users of its hemodialysis machines to toxic compounds as a Class I recall.
- FDA officials wrote to healthcare professionals last year to highlight the potential for silicone tubing to expose patients to toxic compounds, and sent a second letter earlier this year after expanding the investigation to cover other manufacturers.
- Fresenius received 510(k) clearance for a modified device designed to mitigate the risk in October 2022. The company is still working to remove older, but little used, tubing from the market, leading to the Class I notice.
Dive Insight:
The safety concerns center on the use of chlorinated peroxide cured silicone tubing with Fresenius’ 2008T, 2008K2 and 2008K hemodialysis machines. Fresenius no longer manufacturers the 2008K2 and 2008K models, but they’re still in clinical use, the FDA said in its letter to healthcare providers.
Last year, the FDA issued an alert about the potential for the tubing to expose patients to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs). At the time, the FDA had not received any reports of adverse events related to NDL PCBAs or NDL PCBs associated with the hemodialysis machines, but had seen animal data showing exposure to some of the compounds can cause problems such as endocrine dysfunction and neurobehavioral alterations.
Fresenius resolved the situation within months of the FDA notice by switching to platinum catalyst silicone tubing. While the switch mitigated the risk for new devices, older machines with chlorinated peroxide cured silicone tubing remained on the market.
Fresenius sent an Urgent Medical Device Correction last month, asking customers to contact the company if they had chlorinated peroxide cured silicone tubing that had been used for less than 36 days or 486 total hours. The company said it will replace the tubing.
Data provided by the manufacturer showed that the health risks of exposure may decrease over the first month that the machines are in routine clinical use, according to the recall notice. However, the FDA wrote in its broader safety notice that “additional testing is needed and the manufacturer is conducting further testing and analysis to determine the degree and duration of exposure.”
The recall affects 207 devices distributed in the U.S. between August 21, 2008, and June 6, 2022. There have been no reports of death, but the FDA did warn the tubing “may cause serious adverse health consequences months to years after exposure.”