Tag: Patient Safety

FDA: Class I recall of Cardiosave Hybrid, Rescue IABPs

Editor's Note The Food and Drug Administration (FDA), on August 31, identified the recall by Getinge/Maquet/Datasocpe of its Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious. The FDA posted four recalls for four separate reasons: Because they may overheat when the device’s internal temperature…

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By: Judy Mathias
September 5, 2023
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Cosmetic surgery, facial procedures rising trend among young adults, teens

Editor's Note The rise of the "selfie boom" and social media usage, often referred to as "snapchat dysmorphia" or the "instaface effect," has led to an increase in young adults and teens seeking cosmetic surgeries, particularly non-invasive procedures like Botox and dermal fillers, News Center Maine August 28 reports. According…

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By: Tarsilla Moura
September 1, 2023
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Study: Bacterial transmission in anesthesia work area increases SSI risk

Editor's Note Recent research delved into the connection between the transmission of antibiotic-resistant bacteria in the anesthesia work area and the occurrence of surgical site infections (SSIs), Anesthesiology News July 19 reports. While it was previously recognized that reducing microbial transmission through the anesthesia work area is crucial for preventing…

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By: Tarsilla Moura
September 1, 2023
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FDA: Class I recall of certain Hamilton ventilators

Editor's Note The Food and Drug Administration (FDA), on August 30, identified the recall by Hamilton Medical of its HAMILTON-C1, C2, C3, and T1 ventilators as Class I, the most serious. The recall was initiated because of software issues that may cause the ventilators to stop without notice. There have…

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By: Judy Mathias
August 31, 2023
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Effect of surgeon gender on postop outcomes

Editor's Note This Canadian study examines whether surgeon gender is associated with long-term postoperative patient outcomes. A total of 1,165,711 patients (151,054 treated by female surgeons and 1,014,657 treated by male surgeons) were included in the analysis. Multivariate adjusted rates of adverse postoperative events (ie, death, readmission, or complication) showed…

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By: Judy Mathias
August 30, 2023
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FDA: Class I recall of Draeger Carina Sub-Acute Care Ventilators

Editor's Note The Food and Drug Administration (FDA), on August 23, identified the recall by Draeger Medical of its Carina Sub-Acute Care Ventilators as Class I, the most serious. The recall was initiated because of the presence of contaminants in the device’s airpath. The contaminants exceed acceptable levels if the…

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By: Judy Mathias
August 24, 2023
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FDA: Class I recall of labeling for Impella RP Flex with SmartAssist

Editor's Note The Food and Drug Administration (FDA), on August 17, identified the recall by Abiomed of the labeling for its Impella RP Flex with Smart Assist System Catheter as Class I, the most serious. The recall was initiated because the catheters’ instructions for use did not appropriately address precautions…

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By: Judy Mathias
August 21, 2023
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Effect of augmented reality on perioperative anxiety

Editor's Note This study from the University of Miami examines the effect of a preoperative walkthrough of a patient’s day of surgery using augmented reality (AR) on perioperative anxiety levels. A total of 95 patients undergoing elective orthopedic surgery at an outpatient surgery center were randomized to an AR intervention…

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By: Judy Mathias
August 17, 2023
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FDA: Class I recall of certain Philips Respironics ventilators

Editor's Note The Food and Drug Administration (FDA), on August 14, identified the recall by Philips Respironics of its Trilogy Evo, Evo 02, EV300, and Evo Universal Ventilators as Class I, the most serious. The recall was initiated after detecting dust and dirt from the environment in the air path…

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By: Judy Mathias
August 15, 2023
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FDA: Class I recall of Cardiosave Hybrid, Rescue IABPs

Editor's Note The Food and Drug Administration (FDA), on August 10, identified the recall by Datascope/Maquet/Getinge of its Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious. The recall was initiated because the pumps may shut down unexpectedly due to electrical failures in the Power…

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By: Judy Mathias
August 11, 2023
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