FDA MedWatch: Disruptions in Availability of Hemodialysis Bloodlines

FDA MedWatch—Updates to Medical Device Shortage List

Disruptions in Availability of Hemodialysis Bloodlines - Letter to Health Care Providers

KCER Release Date: March 17, 2025

To: KCER Distribution list- including ESRD Network EDs and QIDs

March 17, 2025

The U.S. Food and Drug Administration (FDA) is aware that the U.S. is experiencing interruptions in the supply of hemodialysis bloodlines because of recent 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 hemodialysis. The FDA expects the duration of this shortage to extend through early fall of 2025. The FDA recommends health care providers consider strategies to conserve the use of hemodialysis bloodlines when possible.

On January 8, 2025, B. Braun issued a customer letter detailing an interruption in the production and supply of certain hemodialysis bloodlines as well as available market alternatives for these products. 

Recommendations

The FDA recommends health care providers experiencing interruptions or shortages in supply of hemodialysis bloodlines develop strategies to conserve their use. Providers should use their clinical judgment when developing and implementing conservation strategies.  

In developing strategies to preserve the supply for patients at highest risk, please consider the following: 

• Continue to provide dialysis treatments to your patients.
• Monitor current and future supplies of bloodlines.
• Develop plans and implement strategies to conserve the supply of bloodlines and reduce the impact on patient care.
• Be aware the FDA is working with manufacturers to understand the availability of devices and develop mitigation strategies, if needed.
• Remain alert for further updates and recommendations from the FDA and applicable manufacturers.
• Refer to the following guidelines for best practices for the care of patients receiving hemodialysis:
  
  • Kidney Disease Outcomes Quality Initiative (KDOQI) Update of the KDOQI Clinical Practice Guideline for Hemodialysis Adequacy. 

Voluntarily report any concerns with supply chain and/or shortages of hemodialysis bloodlines to the FDA at deviceshortages@fda.hhs.gov.

The FDA will keep health care providers and the public informed as new or additional information becomes available.

Background

The FDA is updating the Medical Device Shortages List to include hemodialysis bloodlines (product code FJK). Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires the FDA to maintain a publicly available, up-to-date list of the devices the FDA has determined to be in shortage.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

FDA Actions

The FDA is:

• Working with manufacturers and dialysis providers to monitor the current situation in order to help ensure hemodialysis bloodlines remain available for patients when medically necessary.
• Evaluating potential solutions for mitigating patient impact.
• Informing the public as new information becomes available.

The FDA reviews each notification received under section 506J of the FD&C Act and uses this information, along with any additional details about the supply of and demand for a device, to determine whether the device is in shortage.

Reporting Problems to the FDA

The FDA encourages health care providers to report any supply chain challenges or suspected adverse events experienced with hemodialysis bloodlines.

• You can submit information on potential shortages or interruptions in availability to deviceshortages@fda.hhs.gov.
• You can submit voluntary reports through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
• Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
• Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

By promptly reporting device availability issues and potential shortages, you can help the FDA understand the scope of the problem and when possible, mitigate the issue.

Contact Information

If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE)