Tag: Patient Safety

FDA: Bella Pharmaceuticals recalls all sterile drug products

Editor's Note The Food and Drug Administration on August 18 announced the recall by Bella Pharmaceuticals (Chicago, Illinois) of all lots of unexpired sterile drug products because of a lack of sterility assurance. Affected products include all lots distributed April 17, 2017, to August 10, 2017, nationwide. Products are packaged in…

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By: Judy Mathias
August 21, 2017
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Few outcome measures meet criteria for accuracy, validity assessment

Editor's Note This study from the Joint Commission finds that criteria for assessing whether outcome measures are accurate and valid enough to use for public reporting, payment, and accreditation are not well-defined. The authors propose four criteria to assess outcome measures: Strong evidence should exist that good medical care leads…

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By: Judy Mathias
August 17, 2017
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FDA: Class I recall of Zenith Alpha Thoracic Endovascular Graft by Cook Medical

Editor's Note The Food and Drug Administration (FDA) on August 16 classified the recall by Cook Medical Inc (Bloomington, Indiana) of its Zenith Alpha Thoracic Endovascular Graft as Class I, the most serious. Cook Medical is aware of reported cases where the graft became blocked or closed with blood clots…

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By: Judy Mathias
August 17, 2017
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Five-year outcomes of on-pump vs off-pump CABG

Editor's Note In this multicenter study, on-pump coronary artery bypass grafting (CABG) led to significantly higher rates of 5-year survival and event-free survival than off-pump CABG. From 2002 to 2007, a total of 2,203 patients at 18 medical centers were randomly assigned to undergo either on-pump (1,099 patients) or off-…

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By: Judy Mathias
August 17, 2017
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Joint Commission: Quick Safety on noises, distractions in ORs

Editor's Note The Joint Commission on August 16 announced a new Quick Safety that focuses on noise and distractions in the OR and how they can make it difficult to hear and discern information or communicate effectively. ORs are prone to high levels of noise, which can be distracting and…

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By: Judy Mathias
August 17, 2017
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Effect of antibiotic duration on colorectal SSIs

Editor's Note When colorectal surgical patients, who were given a single dose of antibiotic before surgery and re-dosing if the procedure lasted longer, were compared to patients given additional antibiotics for 24 hours postoperatively, infection rates were identical, this study finds. A total of 965 patients were included in this…

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By: Judy Mathias
August 14, 2017
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FDA: Safety Alert on liquid-filled intragastric balloon systems

Editor's Note The Food and Drug Administration (FDA) on August 10 issued a Safety Alert to update healthcare providers on five reports of unanticipated deaths that have occurred from 2016 to the present in patients with liquid-filled intragastric balloon systems used to treat obesity. Four reports involve the Orbera Intragastric…

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By: Judy Mathias
August 14, 2017
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Outcomes in patients diagnosed with OSA during preop screening vs previously diagnosed

Editor's Note In this study, patients diagnosed on the day of surgery as moderate to high risk for obstructive sleep apnea (OSA) had similar rates of adverse respiratory events (ie, perioperative hypoxemia and difficult airway management) as patients who had been diagnosed with OSA previously. However, those diagnosed with OSA…

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By: Judy Mathias
August 14, 2017
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Cognitive assessment helps predict survival in frail surgical patients

Editor's Note Adding cognitive assessment to frailty assessment predicted poor postoperative outcomes and survival in frail patients better than either measurement alone, this study finds. The study included 330 patients having major surgery who were assessed with a four-level composite frailty scoring system, which was created by combining the Fried…

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By: Judy Mathias
August 10, 2017
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Obese cardiac surgery patients use more ICU resources

Editor's Note After cardiac surgery, obese patients required significantly more ICU resources and longer recovery times, resulting in more expensive, labor-intensive care, this study finds. Of 5,365 patients included in the analysis, 1,948 were classified as obese. Patients with greater obesity were: four times more likely to have longer time…

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By: Judy Mathias
August 10, 2017
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