The shortage is expected to impact patient care, prompting the FDA to recommend conservation strategies for health care providers.
The US Food and Drug Administration (FDA) has added hemodialysis bloodlines (product code FJK) to the Medical Device Shortages List due to recent supplier issues.
The disruption in availability of this device is expected to impact patient care and may require adjustments to the clinical management of patients requiring acute or chronic hemodialysis, according to the agency. The FDA expects the duration of this shortage to extend through early fall of 2025.
The FDA is recommending health care providers experiencing delays in the supply of hemodialysis bloodlines consider strategies to conserve their use. Health care providers should use their clinical judgment in development and implementation of conservation strategies.
In a letter to health care providers, the FDA suggests the following strategies to preserve the supply for patients at highest risk:
- 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 [email protected].
In addition, the FDA is updating the Medical Device Shortage List to remove blood culture media bottles (product code MDB) and Container, IV (product code KPE). The FDA has determined that the shortage of these products have been resolved, and conservation strategy recommendations for using these devices are no longer needed.
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