Safety/Quality

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September 2025
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FDA designates Class I recall for disposable surgical stapler cartridge correction

Editor's Note The US Food and Drug Administration (FDA) has designated the recall of Ethicon Endo-Surgery, LLC’s Endopath Echelon Vascular White Reload for Advanced Placement Tip a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 25 announcement,  the recall…

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By: Matt Danford
July 28, 2025
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FDA designates Class I recall for arterial cannulae due to exposed wire risk

Editor's Note The US Food and Drug Administration (FDA) has designated a Class I recall—the most severe category indicating risk of serious injury or death—for several models of arterial cannulae manufactured by Edwards Lifesciences. Affected products include OptiSite Arterial Perfusion Cannula models OPTI16 and OPTI18, as well as Peripheral Femoral…

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By: Matt Danford
July 25, 2025
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FDA designates Class I recall for mobile lift component

Editor's Note The US Food and Drug Administration (FDA) has designated Baxter’s recall of the Q-Link 13 mobile lift component a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 23 announcement, the optional component connects to sling bars on…

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By: Matt Danford
July 24, 2025
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Fast-track ENT days boost surgical volume, cut backlog at UCSF Benioff Children’s

Editor's Note Designating underused neurosurgery blocks for straightforward ENT procedures increased surgical volume and reduced wait times at UCSF Benioff Children’s Hospital San Francisco, according to a July 3 report from the Children’s Hospital Association’s 2025 Transforming Quality Conference. The initiative began in early 2024, when ENT leaders and surgical…

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By: Matt Danford
July 24, 2025
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CMS payment overhaul could cut specialist pay

Editor's Note A “quiet transformation” in how Medicare pays doctors could reduce payments for specialty care, including rates for billing codes associated with surgery, diagnostic imaging, outpatient care, pain management, and orthopedics, Modern Healthcare July 22 reports. According to the article, The Centers for Medicare and Medicaid Services (CMS) 2026…

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By: Matt Danford
July 24, 2025
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Navigating OR construction design, compliance, approval in a booming ASC market

Editor’s Note: This page is a companion piece to the main article, Proper planning prevents OR construction, renovation cost creep. It brings together four focused updates on OR and ambulatory surgery center (ASC) construction and renovation: Regulatory shifts: The Joint Commission's updated safety and sustainability requirements for hospitals and ASCs, including new…

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By: Uyen Vo
July 23, 2025
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FDA issues safety alert for Baxter Novum IQ large volume pumps

Editor's Note The US Food and Drug Administration (FDA) issued an early alert for Baxter’s Novum IQ Large Volume Pumps (Model 40700BAXUS) due to potential for underinfusion when transitioning from a flow rate to a higher flow rate (eg, rate change or bolus).   According to the agency’s July 22…

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By: Matt Danford
July 23, 2025
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Report: AI, third-party risks open gaps in healthcare cybersecurity

Editor's Note Serious cybersecurity vulnerabilities remain in healthcare despite significant improvements in recent years, according to a July 16 MedCity News report on recent data from cybersecurity firm Fortified Health Security. Fortified’s research, which reportedly draws on NIST CSF data and first–hand experience from the field, assesses the state of…

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By: Matt Danford
July 23, 2025
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Providers call for deeper reform despite CMS proposing payment hikes in 2026

Editor's Note CMS is boosting 2026 Medicare outpatient payments by 2.4%, but provider groups warn the increase barely scratches the surface of mounting financial strain. Alongside the payment bump, the agency is proposing a two-track physician reimbursement model that ties rates to value-based care participation. While some see these moves…

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By: Tarsilla Moura
July 23, 2025
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Study: Private equity pushes colonoscopy costs higher without improving care quality

Editor's Note Private equity ownership drives up colonoscopy prices without delivering better patient outcomes, according to a large retrospective analysis. While independent and private equity-acquired gastroenterology practices show no significant difference in quality, prices at private equity practices rose sharply, especially in highly consolidated markets. The study, published in JAMA…

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By: Tarsilla Moura
July 23, 2025
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