Nephrology ·
CMS finalizes rule tightening oversight of organ procurement organizations; FDA flags B. Braun Dialog+ bloodline sets over connector leaks
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The Centers for Medicare and Medicaid Services (CMS) finalized a rule that defines unsound medical practices so it can decertify poorly performing organ procurement organizations sooner. The Food and Drug Administration issued an early alert on B. Braun's removal of Streamline bloodline sets for the Dialog+ hemodialysis system.
THE DETAILS
- Policy Oct 30, 2026The Centers for Medicare and Medicaid Services (CMS) said Oct. 30 it finalized a rule building on its 2020 organ procurement organization (OPO) rule, defining unsound medical practices to clarify when it may immediately decertify a noncompliant OPO. OPO medical directors must hold a license in a state or territory the OPO serves, and pancreata used only for islet cell research no longer count toward the transplantation rate. The rule does not change the tier structure used for recertification, according to a CMS fact sheet. CMS said donations rose 36% and transplants 30% since the 2020 rule.Sources: CMS, CMS fact sheet
- FDA Oct 27, 2026The Food and Drug Administration (FDA) posted an early alert Oct. 27 on B. Braun's removal of three lots of the Streamline Bloodline Set for Dialog+ (model SL-2010M2096) after a solvent step was skipped during assembly, leaving the dialyzer connector poorly bonded. The connector may detach or leak, risking blood loss, clotting and occlusion of the extracorporeal circuit, and air entry could in extremely rare cases cause air embolism and death. B. Braun reported no serious injuries or deaths and told customers Oct. 20 to stop using and quarantine affected sets.Source: FDA
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