Patient Safety

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February 2018
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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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FDA: Class I recall of Datascope/MAQUET intra-aortic balloon pumps

Editor's Note The Food and Drug Administration (FDA) on September 6 categorized the recall by Datascope/MAQUET of its CS100i, CS100, and CS300 intra-aortic balloon pumps as Class I, the most serious. The recall was initiated because of a false blood detection alarm and ingress of fluid into the balloon pump.…

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By: Judy Mathias
September 11, 2017
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Preadmission frailty predicts adverse outcomes in geriatric trauma patients

Editor's Note In this study, preadmission clinical frailty independently predicted adverse discharge destination (ie, death or discharge to a long-term, chronic or acute care facility) in geriatric trauma patients. The analysis of 266 trauma patients 65 years and older using the Clinical Frailty Scale (CFS) and the laboratory Frailty Index…

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By: Judy Mathias
September 11, 2017
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FDA: Genetech recalls three lots of Activase

Editor's Note The Food and Drug Administration (FDA) on September 7 announced the recall by Genetech (South San Francisco, California) of three lots of Activase (alteplase) 100 mg vials that were co-packaged with sterile water for injection. The vials of water, manufactured by Hospira Inc (Lake Forest, Illinois), may be…

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By: Judy Mathias
September 11, 2017
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FDA: Recall of Hydromorphone HCL and Levophed Injection by Hospira

Editor's Note The Food and Drug Administration (FDA) on September 5 announced the recall by Hospira Inc (Lake Forest, Illinois) of one lot of Hydromorphone HCL injection, USP, CII 2 mg/mL and four lots of Levophed (norepinephrine bitartrate) injection because of a lack of sterility assurance resulting from a damaged…

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By: Judy Mathias
September 6, 2017
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Causes of malpractice lawsuits against surgical residents

Editor's Note This database review of malpractice lawsuits against surgical residents highlights the importance of perioperative management, particularly among junior residents, and the importance of appropriate supervision by attending physicians as targets for education on litigation prevention. During a 10-year period, 87 malpractice cases involving surgical residents were identified. Results…

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By: Judy Mathias
September 6, 2017
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