Tag: Healthcare software

FDA designates Class 1 recalls for infusion pump software, ventilator software

Editor's Note The US Food and Drug Administration (FDA) designated software-related recalls for Fresenius Kabi USA’s Iveni Infusion Systems and Philips Respironics Triology Evo ventilators as class 1, the most severe category indicating serious risk of injury or death. According to FDA’s October 1 announcement, Fresenius recalled the Ivenix Infusion…

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By: Matt Danford
October 2, 2024
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Pilot project takeoff proves promise of AI staff optimization

Perioperative leaders face mounting pressures to optimize resources, reduce costs, and improve patient outcomes. However, one challenge stands out among the rest: OR staffing shortages. According to a November/December survey conducted by LeanTaaS in collaboration with OR Manager, staff recruitment and retention is a top priority for OR leaders this…

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By: Stacey Leadbeater
August 28, 2024
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FDA announces Class 1 recalls for ventilator software, electrode pads

Editor's Note The US Food and Drug Administration (FDA) has classified recalls by Hamilton Medical and Megadyne as Class 1 events, the most severe category indicating risk of serious injury or death. According to the agency’s July 11 report, Hamilton Medical is correcting software for its HAMILTON-C6 Medical Ventilator to…

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By: Matt Danford
July 12, 2024
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FDA designates Class I recall for neurosurgery software

Editor's Note The US Food & Drug Administration (FDA) has classified Medtronic’s recall of its StealthStation S8 software as a Class I, the most severe category indicating risk of serious injury or death. The StealthStation System with StealthStation Cranial software is intended as an aid for locating anatomical structures during…

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By: Matt Danford
June 5, 2024
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FDA announces class 1 recalls for premixed embolic, infusion pump software

Editor's Note The US Food and Drug Administration has classified recalls of Boston Scientific’s Obsidio Conformable Embolic and Fresenius Kabi USA’s Ivenix Infusion System Large Volume Pump (LVP) software as class 1, the most serious category and an indicator of risk of serious injury or death. No injuries or deaths…

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By: Matt Danford
April 18, 2024
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How gamification improves OR training, outcomes

Takeaways From mobile phone apps to immersive virtual reality surgery experiences, digital tools make healthcare training more interactive, more engaging, and more fun for everyone from nurses to surgeons. Modern procedures—including minimally invasive techniques and robotic surgery—require 50 to 100 cases for a surgeon to reach a safe proficiency level…

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By: Brita Belli
March 22, 2024
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AI’s pivotal role in transforming OR efficiency, now and in the future

Next-Gen Disruptors: Technologies Transforming the OR Installment #1, presented by LeanTaaS Surgical procedures are necessary steps in patient journeys—no one wants to have surgery, but most people will need it at some point for care continuity and better quality of life. To best support positive outcomes, optimal recovery periods, and…

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By: Elizabeth Stocum, BS, RN
March 22, 2024
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Augmented reality headset, AI software streamline spinal surgery

Editor's Note An augmented reality headset provided a scrub team with a detailed, mixed-reality view of a microsurgical spinal procedures to streamline surgery at Cromwell Hopsital in the UK, according to a March 14 report in Fox Business News. The headset, an Apple Vision Pro, was linked to eXeX, described…

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By: Matt Danford
March 20, 2024
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Unveiling ECRI’s 2024 top 10 health technology hazards list

What is the purpose of the top 10 health technology hazards list, released every year by ECRI? “Our number one goal at ECRI is to reduce preventable harm,” stresses Jason Launders, MSC, former director of operations, device evaluation, at ECRI. “We know that every healthcare provider has a lot they…

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By: Tarsilla Moura
February 27, 2024
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Coordinating surgical care means precise staff handoffs

In every OR, the complicated dance of surgical care coordination—the series of handoffs between stakeholders throughout the surgery lifecycle—is performed mainly in the background. Those stakeholders include physician offices, schedulers, preadmission testing, insurance verification, vendors, sterile processing, supply chain, anesthesia, and surgical staff. But what does it look like when…

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By: Carisa Brewster and Jonathan Reimer
January 23, 2024
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