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February 2025
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Superpotency concerns spur recall of IV bags for vancomycin, phenylephrine, and fentanyl

Editor's Note:  Englewood, Colo,-based Leiters Health is voluntarily recalling 33 lots of vancomycin, phenylephrine, and fentanyl IV bags due to concerns that they may contain twice the labeled amount of drug, according to a January 8 safety alert from the US Food and Drug Administration (FDA). “The semi-automated IV bag…

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By: Matt Danford
January 11, 2024
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FDA issues statements on VHP sterilization; hip surgery device safety

Editor's Note Recent announcements from The US Food and Drug Administration (FDA) validate vaporized hydrogen peroxide (VHP) as an established device sterilization method and warn against the use of the Synovo Total Hip Replacement system. Issued January 8, the announcement about VHP is part of the agency’s multi-pronged approach to…

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By: Matt Danford
January 9, 2024
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Investigation reveals medical device safety testing concerns

Editor's Note Published December 21, a year-long investigation by KFF Health News into medical device malfunctions found that the FDA allows the sale of most medical devices, including many implants, without requiring tests for safety or effectiveness. Instead, manufacturers need to show only that they have “substantial equivalence” to an…

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By: Brita Belli
January 8, 2024
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Brain stimulation improves surgeon dexterity with robotic tools

Editor's Note Mild electric stimulation to the back of surgeons’ heads could enhance robotic surgery accuracy and precision, according to findings published in the journal Scientific Reports on December 20. The study tasked 36 participants – approximately half male, half female, none of whom had experience with robotic surgery –…

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By: Brita Belli
January 3, 2024
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Study on cholecystectomy robotic surgery raises safety concerns

Editor's Note Despite the increasing prevalence of robotic-assisted surgery, recent data on cholecystectomy results indicates minimally invasive laparoscopic methods could be a safer option. Published in JAMA Surgery on September 20, the nationally representative study of Medicare beneficiary cholecystectomy patients showed a higher rate of bile duct injury (0.7%) for…

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By: Matt Danford
December 22, 2023
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CDC, California OSHA at odds over N95 rules

Editor's Note Guidelines for the Centers for Disease Control (CDC) about when healthcare workers should wear N95 masks are less stringent than those from California’s Division of Occupational Safety and Health (OSHA), Medical Xpress reported on December 21. Specifically, the CDC’s advisory committee has suggested that health workers wear surgical…

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By: Brita Belli
December 21, 2023
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Burns prompt recalls of airway scopes, electrosurgical pads

Editor's Note Reports of burn injuries have prompted two medical device recalls: one for Megadyne patient return electrodes and one for Olympus bronchofiberscopes and bronchovideoscopes. According to a December 21 notice from AORN, the former recall is a voluntary correction on the part of Megadyne Medical Products, Inc. Following reports…

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By: Brita Belli
December 21, 2023
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Breakthrough navigation system enables radiation-free spinal surgery

Editor's Note Spinal surgeons seeking a better standard of care now have an alternative to traditional scanning that exposes patients to levels of radiation equivalent to multiple X-rays. Highlighted in LA Weekly on December 19, the PathKeeper 3D optical and navigation system uses high-resolution 3D optical cameras to provide real-time…

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By: Brita Belli
December 21, 2023
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FBI disrupts major ransomware group, Blackcat

Editor's Note The FBI has infiltrated the ransomware group BlackCat—the group responsible for a February cyberattack on the Lehigh Valley Health Network—and issued a decryption tool enabling victims around the world to restore their systems, according to a December 19 Justice Department press release.   Emerging during the past 18…

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By: Brita Belli
December 20, 2023
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Study: AI model explanations fail to combat bias

Editor's Note New data raise questions about the effectiveness of image-based AI model explanations in helping clinicians recognize systematic bias when diagnosing hospitalized patients. The findings appeared in JAMA on December 19. Researchers looked at the diagnostic accuracy of 457 hospital physicians, nurse practitioners, and physician assistants in diagnosing patients…

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By: Brita Belli
December 20, 2023
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