Safety/Quality

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March 2025
Home Safety/Quality

FDA designates Class 1 recall for pacemakers

Editor’s Note The US Food and Drug Administration (FDA) has designated Boston Scientific Corporation’s recall of Accolade Pacemaker devices a Class 1, the most severe category indicating serious risk of injury or death. According to the agency’s February 21 announcement, the recall was motivated by a manufacturing issue that could…

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By: Matt Danford
February 24, 2025
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Chinese medical devices threaten US healthcare cybersecurity

Editor’s Note Backdoors in Chinese-made medical monitors could put patients at risk and compromise hospital networks across the US, according to security agencies quoted in a February 23 report from CNBC. The article cites the popular Contec CMS8000 patient monitor as an example. Both the US Food and Drug Administration…

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By: Matt Danford
February 24, 2025
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Preoperative SGLT2i use does not raise DKA risk in emergency surgery

Editor’s Note Preoperative use of sodium-glucose cotransporter 2 inhibitors (SGLT2i) does not increase the risk of postoperative diabetic ketoacidosis (DKA) in patients undergoing emergency surgery, according to a study published February 19 in JAMA Surgery. These findings challenge the current FDA recommendation to withhold SGLT2i medications for at least three…

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By: Matt Danford
February 24, 2025
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AI boosts accuracy in surgical reports, outperforming surgeons

Editor's Note AI-generated operative reports for robotic-assisted radical prostatectomy (RARP) were more accurate than those written by surgeons in a study published February 7 in the Journal of the American College of Surgeons. Analyzing 158 cases from a tertiary referral center, researchers tested an AI computer-vision algorithm on surgical video…

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By: Matt Danford
February 21, 2025
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AI models improve prediction of surgical complications using preoperative clinical notes

Editor’s Note Large language models (LLMs) outperformed traditional methods in predicting postoperative complications, according to a study on artificial intelligence (AI) in perioperative risk assessment published February 11 in the journal Nature. Results indicate AI-driven models could enhance patient safety and streamline clinical workflows by detecting complications earlier. Researchers analyzed…

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By: Matt Danford
February 21, 2025
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Healthcare M&A faces tighter review as FTC retains guidelines

Editor’s Note In a setback for healthcare mergers and acquisitions (M&A), the Federal Trade Commission (FTC) will continue enforcing strict antitrust guidelines established under the Biden administration, Healthcare Dive February 19 reports. Bucking expectations of a more lenient approach under the new administration, FTC Chair Andrew Ferguson confirmed the decision,…

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By: Matt Danford
February 20, 2025
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Healthcare giants prioritize shareholder payouts over patient care

Editor’s Note Shareholder payouts by publicly traded healthcare companies have surged 315% since 2001, raising questions about financial priorities in the sector, according to a February 19 article in Healthcare Finance. A research letter published in JAMA Internal Medicine and co-authored by Yale University researchers found that major healthcare corporations…

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By: Matt Danford
February 20, 2025
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Texas abortion ban linked to spike in pregnancy complications, maternal death

Editor’s Note Pregnancy complications—including life-threatening sepsis—surged in Texas after the state banned abortion in 2021, according to a ProPublica analysis of seven years’ worth of state hospital data. In a February 20 report, the outlet details how sepsis rates for women hospitalized after second-trimester pregnancy loss rose by more than…

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By: Matt Danford
February 20, 2025
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AI streamlines documentation, frees time for nurses at Cedars-Sinai surgical unit

Editor's Note An artificial intelligence (AI) tool is showing significant promise in reducing the administrative workload for nurses and clinical partners on a 48-bed surgical unit at Cedars-Sinai, according to a February 12 Cedars-Sinai Newsroom Q&A with Rachel Coren, MPH, MS, vice president and associate chief information officer, and Peachy…

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By: Matt Danford
February 19, 2025
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Study identifies potential non-surgical treatment for inguinal hernias

Editor's Note Researchers at Northwestern University successfully reversed hernias in male mice and restored normal anatomy without surgical intervention, according to a February 5 university announcement. The study also found that human hernia tissue shared the same molecular characteristics observed in the mouse model, suggesting a similar biological mechanism. According…

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By: Matt Danford
February 19, 2025
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