Dive Brief:
- The Food and Drug Administration warned healthcare providers Friday about interruptions to the supply of hemodialysis bloodlines.
- The letter said the disruption is expected to impact patient care, may require adjustments to the management of hemodialysis patients and could continue through the early fall of 2025.
- The FDA linked to a letter B. Braun sent to customers in January. B. Braun said “additional supply and labor constraints over the holidays” had reduced production and it would run out of product on Jan. 20.
Dive Insight:
The B. Braun letter discussed the production of SL-2000M2095 Streamline FMC Bloodlines. The devices are plastic tubes that take blood from the body to a dialyzer, which removes toxins and excess fluids from the blood.
Citing issues at its supplier, B. Braun said it had Streamline FMC stock through Jan. 20, but after that no additional releases of the devices were planned for the foreseeable future. The company told customers to seek alternative sources and named Fresenius and Nipro products as suitable replacements.
Now, the FDA has added hemodialysis bloodlines to the Medical Device Shortages List. The agency said it is “aware that the U.S. is experiencing interruptions in the supply of hemodialysis bloodlines because of recent supplier issues.” The disruption is expected to impact patient care.
To mitigate the impact, the FDA is asking healthcare providers to consider strategies to conserve the use of hemodialysis bloodlines when possible. Providers should use their clinical judgment when creating and implementing conservation strategies that preserve supplies for patients at highest risk, the FDA said.
The agency said clinicians should continue to provide dialysis treatments to their patients and monitor current and future supplies of bloodlines. The FDA is working with manufacturers and dialysis providers to monitor the current situation and evaluating potential solutions to limit the impact on patients. Providers should “remain alert” for FDA updates and report any disruptions.
Fresenius Medical Care manufactures bloodlines in Mexico, China, Turkey and Serbia. B. Braun named two Fresenius products, plus two devices sold by Japan’s Nipro, as suitable alternatives to its bloodlines.
