Patient Safety

Latest Issue of OR Manager
December 2017
Home Safety/Quality > Patient Safety > Patient Safety

FDA: Class I recall of Spectranetics’ Bridge Occlusion Balloon Catheter

Editor's Note The Food and Drug Administration (FDA) on September 25 categorized the recall by Spectranetics (Colorado Springs, Colorado) of its Bridge Occlusion Balloon Catheter (model 590-001) as Class I, the most serious. The Bridge Occlusion Balloon Catheter is used to temporarily block the superior vena cava when emergency control…

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By: Judy Mathias
September 26, 2017
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Mode of transport to hospital linked to mortality in penetrating trauma patients

Editor's Note Private vehicle transport was associated with a significantly lower likelihood of death compared with ground emergency medical services (EMS) transport for patients with gunshot and stab wounds in this study. In this analysis of 103,029 patients in the National Trauma Data Bank, 87.6% were male, 47.9% were black,…

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By: Judy Mathias
September 21, 2017
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Joint Commission: Top five most challenging requirements for 2017

Editor's Note The Joint Commission on September 20 announced the top five most challenging requirements for the first half of 2017. The top five requirements identified most frequently as “not compliant” during surveys and reviews for hospital accreditation were: 86%--LS.02.01.35: The hospital provides and maintains systems for extinguishing fires. 74%--LS.02.01.30:…

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By: Judy Mathias
September 21, 2017
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Gastric bypass found to be durable long term

Editor's Note This 12-year study showed long-term durability of weight loss and effective remission and prevention of type 2 diabetes, hypertension, and dyslipidemia after Roux-en-Y gastric bypass surgery. For the study, 1,156 severely obese patients were divided into three groups: 418 who sought and had Roux-en-Y gastric bypass (surgery group),…

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By: Judy Mathias
September 21, 2017
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FDA clears first duodenoscope with disposable end cap

Editor's Note The Food and Drug Administration (FDA) on September 20 cleared the first duodenoscope with a disposable end cap, which will improve access for cleaning and reprocessing. The new features of the Pentax ED34-i10T duodenoscope include a single-use detachable and disposable distal cap, simpler user interface, improved ergonomics, improved…

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By: Judy Mathias
September 21, 2017
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FDA updates Safety Alert for urogynecologic surgical mesh by Boston Scientific

Editor's Note The Food and Drug Administration (FDA) on September 19 updated its Safety Alert for urogynecologic surgical mesh manufactured by Boston Scientific. After an extensive review of data and testing, the FDA has determined that the change in supplier of the polypropylene used to manufacture the mesh currently on…

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By: Judy Mathias
September 19, 2017
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FDA: OriGen recalls two lots of dual lumen ECMO catheters

Editor's Note The Food and Drug Administration (FDA) on September 13 announced the recall by OriGen Biomedical (Austin, Texas) of two lots of its VV28F Reinforced Dual Lumen ECMO [extracorporeal membrane oxygenation] Catheters (Catalog number VV28F, Lots N18487 and V18487-1). The recall was initiated because the catheters have the potential…

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By: Judy Mathias
September 14, 2017
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Infection control practices linked to lower SSI rates

Editor's Note Infection control practices that focus on perioperative patient skin and wound hygiene and transparent display of surgical site infection (SSI) data, not OR attire policies, were associated with lower SSI rates in this multi-center study. A total of 20 American College of Surgeons National Surgical Quality Improvement Program…

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By: Judy Mathias
September 14, 2017
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Joint Commission issues Sentinel Event Alert on inadequate hand-offs

Editor's Note The Joint Commission on September 13 announced a new Sentinel Event Alert that focuses on inadequate hand-offs and tips to improve them. A common problem with hand-offs is communication, which is the focus of “Sentinel Event Alert, Issue 58: Inadequate hand-off communication.” The alert includes an infographic of…

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By: Judy Mathias
September 14, 2017
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Safety of transoral endoscopic thyroidectomy

Editor's Note The transoral endoscopic thyroidectomy vestibular approach can be safe for select patients, with outcomes similar to those of the open approach, this study finds. Of 425 patients analyzed, the operative time for the transoral approach was longer than the open approach (100.8 vs 79.4 minutes) but transoral patients…

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By: Judy Mathias
September 11, 2017
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