Safety/Quality

Latest Issue of OR Manager
February 2020
Home Safety/Quality

FDA: Class I recall of LivaNova VNS Therapy SenTiva Generator

Editor's Note The Food & Drug Administration (FDA) on January 2 identified the recall by LivaNova of its VNS Therapy SenTiva Generator System as Class I, the most serious. The recall was initiated because of an unintended reset error that causes the system to stop delivering vagus nerve stimulation therapy…

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By: Judy Mathias
January 7, 2020
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Bacterial contamination of surgical scrubs worn outside the OR

Editor's Note In this study from Israel, researchers found that surgical scrubs worn outside the OR were contaminated with a low bacterial load and only a small number of pathogenic bacteria. For the study, specimens were collected at the entrance to the OR from surgical scrubs worn by 133 surgeons.…

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By: Judy Mathias
January 6, 2020
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Depuy, Zebra Medical partner on AI algorithm development

Editor's Note Johnson & Johnson’s Depuy Synthes and Israel-based Zebra Medical Vision have partnered to develop artificial intelligence (AI)-based algorithms for use in preoperative orthopedic surgical planning, the January 2 BioWorld reports. The algorithms would enable the creation of 3D models from x-ray images so that radiation risks and costs…

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By: Judy Mathias
January 6, 2020
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First-year analysis of OR Black Box study

Editor's Note In this first-year analysis of a data capture system called the OR Black Box, frequent intraoperative errors, events, variation in surgeons’ technical skills, and a high amount of environmental distractions were identified. In 132 patients having elective laparoscopic general surgery: auditory distractions occurred a median of 138 times…

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By: Judy Mathias
January 2, 2020
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FDA workshop: Role of AI in radiological imaging

Editor's Note The Food & Drug Administration (FDA) on December 30 announced a public workshop on the “Evolving Role of Artificial Intelligence [AI] in Radiological Imaging, which will take place February 25-26, 2020, at the Natcher Conference Center, National Institutes of Health, Bethesda, Maryland. The workshop will include discussions on…

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By: Judy Mathias
January 2, 2020
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Can punctuality decrease OR costs?

Editor's Note In this study from Washington University School of Medicine, St Louis, a first case on-time starts (FCOTS) improvement initiative was linked to a higher frequency of FCOTS, which was independently associated with last case on-time ends (LCOTE) and decreased OR overtime costs. Of 12,073 cases (6,095 pre- vs…

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By: Judy Mathias
December 18, 2019
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House passes year-end bill that repeals ACA taxes including medical device tax

Editor's Note The US House of Representatives on December 17 passed a year-end spending bill that repeals several Affordable Care Act (ACA) taxes, including the 40% tax on generous health insurance plans and the 2.3% tax on the sale of medical devices, the December 17 Reuters reports. The bill also…

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By: Judy Mathias
December 18, 2019
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Patients prefer checklists to be completed in front of them

Editor's Note Surgery patients overwhelmingly prefer pre-surgical safety checklists to be completed in front of them, contrary to what is thought by anesthesiologists, this Swiss study finds. In this trial, which included 110 anesthesiologists and 125 non-premedicated ear-nose-throat or maxillofacial surgery patients, the patients overwhelmingly agreed that anesthesiologists should use…

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By: Judy Mathias
December 18, 2019
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FDA: Class I recall of Cook Medical’s CrossCath Support Catheters

Editor's Note The Food and Drug Administration (FDA) on December 17 identified the recall by Cook Medical of its CrossCath Support Catheters as Class I, the most serious. The recall was initiated because of a manufacturing error that may cause the radiopaque marker bands on the catheters to dislodge or…

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By: Judy Mathias
December 18, 2019
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Development of surgery-specific second victim peer support program

Editor's Note In this study, researchers at the Massachusetts General Hospital, designed, implemented, and assessed the effect of the first surgery-specific peer support program in the US. The program uses five steps: creation of a conceptual framework choice of peer supporters training of peer supporters multifaceted identification of major adverse…

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By: Judy Mathias
December 17, 2019
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