FDA Cautions Hemodialysis Tubing Shortage Could Persist into Fall

The FDA has issued a letter addressed to healthcare providers warning that the ongoing shortage of hemodialysis bloodlines may extend into the autumn months.

Also referred to as dialysis catheters, hemodialysis bloodlines are sets of tubes inserted into a vein during dialysis treatment. They connect the patient’s bloodstream to the dialysis machine, which filters the blood to remove waste and excess fluid in patients with impaired kidney function.

The FDA has added the bloodlines to its official medical device shortage list.

The supply disruption, initially identified in late 2024, has been attributed to a combination of global supply chain constraints and manufacturing delays.

The disruption is anticipated to affect patient care and could necessitate adjustments in the clinical management of patients undergoing acute or chronic hemodialysis, the FDA outlined in its letter.

In January, B. Braun issued a letter updating customers about the market disruption in the production of some of its bloodlines, namely SL-2000M2095 Streamline FMC Bloodlines.

The company noted that supply and labor constraints over the holidays were significant factors leading to the market disruption. B. Braun said its inventory was expected to run out by January 20.

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In the letter, the device maker provided available market alternatives for the products, including bloodlines from Fresenius and Nipro.

Fresenius Medical Care manufactures its bloodlines in countries such as Mexico and China, where US imports have been affected by federal government tariffs. To date, there have been no publicly reported disruptions to the dialysis components.

The FDA is encouraging healthcare providers to conserve device use, including adjusting treatment schedules and optimizing available supplies to ensure continued patient care. However, these measures may not be sustainable in the long term if the shortage persists.

To address the crisis, the FDA said it is working with manufacturers and dialysis providers to monitor the situation to help ensure hemodialysis bloodlines remain available for patients when medically necessary.

The agency is also assessing potential solutions for “mitigating patient impact” and said it is providing the public with updates as new information emerges.

It is also urging providers to report supply issues and adverse patient outcomes linked to the shortage, which will help the agency assess the situation and coordinate further responses.

Healthcare facilities are also being encouraged to plan accordingly and explore potential alternative solutions, such as utilizing compatible components from different manufacturers.

Patients undergoing dialysis are advised to stay informed by communicating with their healthcare providers about any potential changes to their treatment schedules.