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Healthcare developments · November 4, 2026

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Published November 4, 2026 · Reporting window October 25–31, 2026, Pacific. Later developments are labelled. Source coverage is incomplete; the complete reports describe the limitations.

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CMS increases the dialysis base rate and changes low-volume, home-training and quality policies for 2027

CMS set the 2027 Medicare dialysis base rate at $297.52 per treatment and revised low-volume, pediatric, home-training and quality policies. Eligible facilities seeking the 2027 low-volume adjustment face a December 31, 2026 attestation date; individual payment effects depend on facility circumstances.

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FDA early alert: Medline beds and accessories

FDA’s device-safety listing identifies an October 29 early alert concerning Medline-brand beds and associated products. A subsequently viewed FDA alert describes electrical overheating and fire risks as well as separate entrapment or asphyxiation risks associated with accessories, a pendant or loose rails. FDA says all Medline-brand beds and associated components are affected, including home-care, bariatric and long-term-care beds. FDA reports that covered beds, rails, mattresses and accessories may remain in use under the updated instructions until the bed is repaired or replaced. The later-observed precautions include unplugging beds except when needed for repositioning, avoiding extension cords and, whenever possible, having a second person assist with use and movement. FDA advises against repairing, modifying or altering a bed except through the specified Medline-authorized process.

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FDA clarifies safety steps for StatStrip Gen 2.0 glucose meters

FDA says prior patient or quality-control information can remain on the affected meter screen and, if accepted, assign a glucose result to the wrong record. The agency says users with an alternative meter should stop using the affected meter until it is updated. Where no alternative is available, users should follow the manufacturer’s interim safeguards, including the identification checks described in the FDA communication. FDA reported one serious injury and no deaths as of October 5.

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FDA early alert: selected B. Braun Dialog+ bloodlines

FDA’s device-safety listing identifies an October 27 early alert for selected B. Braun Streamline Bloodline Sets for the Dialog+ hemodialysis system. The later-viewed FDA alert identifies model SL-2010M2096 and lots A2600099, A2600128 and A2600136. FDA describes a potentially inadequately bonded dialyzer connector that could detach or leak during priming or dialysis, risking blood loss or interrupted treatment. FDA says to ensure all users are informed and to identify and quarantine affected devices. Its description of B. Braun’s October 20 letter says to inform users, have distributors forward the notice to consignees, determine inventory, stop use, quarantine and return affected product to the manufacturer.

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FDA recall: selected HemosIL HIT assay lots

FDA’s device-safety listing identifies an October 30 confirmed recall of selected lots of HemosIL AcuStar HIT-IgG(PF4-H), used with other information to aid assessment of heparin-induced thrombocytopenia. In the FDA page captured November 2, part 0009800127 is associated with lots B40005 and B38062, and part 0009802028 with lots B40006 and B38063. FDA describes a negative bias of 20–35% that may produce results below the 1.00 U/mL cutoff and be interpreted as HIT IgG antibody negative. The page also contains internally inconsistent error-type wording; its title and device-use description use different assay terminology.

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