Safety/Quality

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January 2025
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FDA approves single-dose propofol amid drug shortage

Editor's Note The Food and Drug Administration (FDA) approved Amneal Pharmaceuticals' Abbreviated New Drug Application for single-dose vials of propofol injectable emulsion, Anesthesiology News August 23 reports. The newly approved formulations include 200 mg/20 mL, 500 mg/50 mL, and 1,000 mg/100 mL vials. Propofol is widely used for anesthesia and…

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By: Tarsilla Moura
August 28, 2024
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Bleeding risk should dictate strategy for managing patients on direct oral anticoagulants

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Editor's Note Clinicians managing surgical patients on direct oral anticoagulants (DOACs) should adopt a different approach depending on the procedure, according to research published August 12 in JAMA Network. Used to treat patients with atrial fibrillation and venous thromboembolism, DOACs must be managed effectively to minimize risks of bleeding, researchers…

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By: Matt Danford
August 28, 2024
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Study shows decline in infections, antibiotic resistance at VA medical centers

Editor's Note A 13-year study at US Veterans Affairs (VA) medical centers found a decline in both hospital-associated infections (HAIs) and antimicrobial resistance for common pathogens, MedPage Today August 15 reports. From 2007 to 2019, the overall infection rate of nine pathogens decreased, with an average annual percentage change (AAPC)…

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By: Tarsilla Moura
August 28, 2024
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Some FDA-recalled medical devices remain in use while manufacturers implement corrections

Editor's Note A 2016 recall issued for the Abbott MitraClip cardiac device highlighted potential safety concerns, but instead of removing the product from the market, Abbott and the Food and Drug Administration (FDA) allowed continued use with revised instructions and additional training for doctors. This approach reflects a broader trend…

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By: Tarsilla Moura
August 27, 2024
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‘Surgical pause’ saving lives, expanding beyond VA hospitals

Editor's Note The “surgical pause”—a means of validating whether surgery is truly safe for patients deemed to be “frail” before starting a procedure—significantly reduces mortality rates and is changing practices at more than 50 Veterans Administration (VA) hospitals, the Pittsburgh Post-Gazette reported August 18. Developed by VA surgeons Daniel Hall…

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By: Matt Danford
August 27, 2024
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Large analysis contradicts findings on surgeon gender, patient outcomes

Editor's Note Contradicting previous research suggesting potentially improved surgical outcomes for female surgeons, the largest analysis to date finds that gender has only a small statistical, clinically marginal correlation. Appearing in the September issue of Annals of Surgery, the study involved 4,882,784 patients operated on by 11,955 female surgeons (33%…

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By: Matt Danford
August 26, 2024
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Handheld, powered surgical tools combine advantages of traditional laparoscopy, robotics

Editor's Note Combining dexterity and cost-effectiveness, handheld robotic devices offer potential to bridge the gap between traditional laparoscopy and more expensive robotic platforms, researchers concluded August 8 in the journal Surgery. The mini-review of clinical trials covered clinical applications of three handheld robotic devices: the HandX powered laparoscopic instrument from…

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By: Matt Danford
August 26, 2024
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FDA announces Class 1 recall for chest compression devices

Editor's Note The US Food and Drug Administration (FDA) has designated Defibtech, LLC’s recall of RMU-2000 ARM XR Chest Compression Devices as Class 1, the most severe category indicating serious risk of injury or death. A motor issue could stop  compressions in adults whose hearts suddenly stop, according to the…

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By: Matt Danford
August 23, 2024
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Studies highlight success strategies for combatting handoff communication failure, care inequity

Editor's Note Recent research sheds new light on addressing two of the most pressing problems for surgical care: handoff communication failures and care bias and inequities leading to adverse—and preventable—events.   These problems are the subjects of two separate success stories in the August issue of The Joint Commission Journal…

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By: Matt Danford
August 23, 2024
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Immunotherapy’s FDA approval expected to improve lung cancer treatment

Editor's Note The US Food & Drug Administration (FDA) has approved immunotherapy durvalumab for perioperative treatment of resectable non-small cell lung cancer (NSCLC), according to an August 15 announcement. The approval is for durvalumab (Imfinzi, AstraZeneca) in combination with platinum-based chemotherapy as a neoadjuvant treatment, followed by durvalumab alone as…

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By: Matt Danford
August 22, 2024
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