US FDA adds haemodialysis bloodlines to devices shortage list

On March 14, 2025, the US FDA published an open letter to healthcare providers citing continuing supply disruptions of haemodialysis bloodlines, an essential component of dialysis machines.

For those with kidney failure, haemodialysis can be a lifesaving treatment that removes waste products and excess fluids from the blood where the kidneys fail to do so. Haemodialysis bloodlines are just one critical component of the haemodialysis machine – they form the specialised tube system connecting a patient’s bloodstream to the haemodialysis machine.

Following a customer letter from German medical and pharmaceutical device manufacturer B. Braun, which outlined a market disruption of 8mm pre-pump bloodlines, the US FDA wrote that they were aware of the interruptions to the supply of haemodialysis bloodlines due to supplier issues. “The disruption in supply of this device is expected to impact patient care and as such may require adjustments to the clinical management of patients receiving acute or chronic haemodialysis,” wrote the US FDA.

The health agency listed several recommendations to healthcare providers on conserving use of the bloodlines and preserving supply. These recommendations included continuing to provide dialysis treatments, monitoring supplies, and developing plans to conserve the supply of bloodlines.

The US FDA also updated its Medica Device Shortages List to include haemodialysis bloodlines. The list aims to provide transparency to the public about shortages of medical devices, especially those involved in the use or purchase of medical devices.

Sources:

1. Disruptions in Availability of Hemodialysis Bloodlines – Letter to Health Care Providers [Accessed March 17, 2025] https://www.fda.gov/medical-devices/letters-health-care-providers/disruptions-availability-hemodialysis-bloodlines-letter-health-care-providers

2. Supply Disruption on FMC Streamline Bloodlines UPDATE [Accessed March 17, 2025] https://www.medline.com/media/assets/pdf/vendor-list/25-0007_Supply_Disrupt_Streamline_Bloodlines_Ltr_FINAL_010825.pdf