Safety/Quality

Latest Issue of OR Manager
July 2024
Home Safety/Quality

FDA announces Class 1 recalls for upper airway stimulation system, MRI components

Editor's Note A manufacturing defect in a critical component of an upper airway stimulation (UAS) system and coils prone to overheating during magnetic resonance imaging scans (MRIs) prompted The US Food & Drug administration to issue two Class 1 recalls June 8. Class 1 is the most severe category, indicating…

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By: Matt Danford
July 10, 2024
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Healthcare industry groups criticize federal cybersecurity reporting rule

Editor's Note Healthcare industry groups are calling for the federal government to streamline and ease the recently proposed cybersecurity incident reporting rule by the Cybersecurity and Infrastructure Security Agency (CISA), Fierce Healthcare reported July 8. According to the report, CISA's proposal imposes enhanced reporting requirements for critical infrastructure entities, including…

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By: Matt Danford
July 9, 2024
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Study: Secondary conditions go unaddressed in female heart surgery patients

Editor's Note Female patients undergoing heart surgery are less likely than male patients to have concomitant procedures—that is, having additional ailments addressed during cardiac procedures—despite guidelines recommending such treatments, according to two studies led by Michigan Medicine. News-Medical.Net reported the news June 28. The first study, involving over 5,000 patients…

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By: Matt Danford
July 3, 2024
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Justice Department announces nationwide action on healthcare fraud enforcement

Editor's Note On June 27, The Justice Department announced the 2024 National Health Care Fraud Enforcement Action, leading to criminal charges against 193 defendants, including 76 medical professionals across 32 federal districts in the U.S. for their involvement in various health care fraud schemes. These schemes accounted for approximately $2.75…

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By: Matt Danford
July 3, 2024
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New research shows health risks of smoke exposure in gastrointestinal endoscopy

Editor's Note Research presented at this year’s Digestive Disease Week in May highlights the potential health risks posed by smoke generated during tissue-cutting ablations in gastrointestinal (GI) endoscopy, Gastroenterology & Endoscopy News May 18 reports. Unlike surgeons in ORs, who follow specific regulations to mitigate smoke exposure, GI endoscopy procedures…

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By: Tarsilla Moura
July 3, 2024
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New requirements for ASCs on life safety, patient rights effective August

Editor's Note Starting August 1, ambulatory surgical centers (ASCs) will need to comply with new and revised requirements for Life Safety Code® and patient rights, a June 26 news update from The Joint Commission reports. These updates align with the Centers for Medicare & Medicaid Services (CMS) Conditions for Coverage.…

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By: Tarsilla Moura
July 3, 2024
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Vasectomies, tubal ligations rise after Supreme Court actions

Editor's Note New research highlights sharp, nationwide increases in both male and female sterilization procedures since the Supreme Court overturned landmark decision Roe vs. Wade in 2022. Published in JAMA Health Forum, the research on how many 18- to 30-year-olds were getting sterilized before and after the ruling was the…

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By: Matt Danford
July 2, 2024
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Healthcare cybersecurity earns B+, but vulnerabilities remain

Editor's Note Although SecurityScorecard gave the US healthcare a “better than expected” B+ rating for cybersecurity in 2024, the supply chain cybersecurity firm also highlighted significant risks in application and endpoint security, HealthcareIT News reported June 25.   Overall, 35% of third-party data breaches in 2023 affected healthcare organizations, the…

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By: Matt Danford
July 1, 2024
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FDA announces Class 1 recalls for ventilators, LVAS monitors

Editor's Note The US Food and Drug Administration has announced class 1 recalls—the most severe category indicating risk of serious injury or death—for Abbot Medical’s HeartMate System Monitor and Philips Respironics OmniLab Advanced+ (OLA+) ventilator. According to the agency’s June 28 report, the recall of the HeartMate System Monitor, part…

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By: Matt Danford
July 1, 2024
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Povidone iodine noninferior to chlorhexidine gluconate for preoperative skin antisepsis

JAMA (healthcare publication) Network logo

Editor's Note Amid continued debate about the best choice of preoperative skin antiseptic, findings published in JAMA June 17 show that povidone iodine in alcohol offers similar outcomes to chlorhexidine gluconate when used in alcohol. The randomized clinical trial included 3,360 patients in 3 tertiary care hospitals in Switzerland, 2,187…

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By: Matt Danford
June 28, 2024
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