Safety/Quality

Latest Issue of OR Manager
September 2019
Home Safety/Quality

FDA: Class I recall of Volumat MC Agilia Infusion System, Vigilant Drug Library

Editor's Note The Food & Drug Administration on August 12 identified the recall by Fresenius Kabi (Bad Homburg, Germany) of its Volumat MC Agilia Infusion System and Vigilant Drug Library as Class I, the most serious. The recall was initiated because of a “Low Priority,” “Keep Vein Open,” “End of…

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By: Judy Mathias
August 13, 2019
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Effect of BMI on SSI risk

Editor's Note This study found a trend of increasing risk of surgical site infections (SSIs) for almost all surgery types when body mass index (BMI) increased from normal to morbidly obese. Of 387,919 patients analyzed in the Dutch national surveillance network PREZIES, 1% were underweight, 30% had normal weight, 40%…

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By: Judy Mathias
August 8, 2019
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FDA: Class I recall of Teleflex/Sheridan Endotracheal Tubes

Editor's Note The Food & Drug Administration (FDA) on August 2 identified the recall by Centurion Medical Products of its Airway Kit containing Teleflex/Sheridan Endotracheal Tubes as Class I, the most serious. The recall was initiated because of the potential for the tube connector to dislodge from the endotracheal tube,…

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By: Judy Mathias
August 8, 2019
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Study links cancer center affiliation to lower postop mortality

Editor's Note Patients who had complex surgical procedures for cancer at community hospitals that were affiliated with top-ranked cancer hospitals were less likely to die within 90 days after surgery than patients treated at nonaffiliated hospitals, this study finds. Data for more than 14,000 Medicare patients showed 90-day mortality after…

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By: Judy Mathias
August 8, 2019
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Joint Commission clarifies survey process for telehealth organizations

Editor's Note The Joint Commission announced August 7 that the applicability of its Ambulatory Health Care Accreditation standards for telehealth organizations, which provide remote services, deploy in-person staff, and/or have equipment used between patients, is being evaluated. In the meantime, areas of noncompliance related to infection control, equipment and utility…

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By: Judy Mathias
August 8, 2019
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Patient factors tied to postop opioid consumption

Editor's Note In this study of opioid-naïve patients having major surgery, researchers found a number of patient characteristics associated with greater opioid use in the first month after surgery. Of 1,181 patients analyzed, the following were significantly associated with increased postoperative opioid consumption: younger age nonwhite race lack of college…

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By: Judy Mathias
August 7, 2019
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Deficiencies in human performance linked to surgical adverse events

Editor's Note In this study, human performance deficiencies were identified in more than half of surgical adverse events, and they were most commonly associated with cognitive errors. Of 5,365 surgical procedures analyzed, adverse events occurred in 188 patients. A total of 106 adverse events (56.4%) were because of human error,…

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By: Judy Mathias
August 6, 2019
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NYT: Experts call for single-use, sterilization or redesign of duodenoscopes, bronchoscopes

Editor's Note Contaminated duodenoscopes have transmitted drug-resistant infections to hundreds of patients, and now some experts are urging the Food & Drug Administration to force manufacturers to develop duodenoscopes that can be properly sterilized or single-use duodenoscopes or take duodenoscopes off the market, the August 6 New York Times Reports.…

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By: Judy Mathias
August 6, 2019
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Effect of oscillation and lung expansion on postop pulmonary complications

Editor's Note In this study, aggressive pulmonary treatment after surgery with oscillation and lung expansion (OLE) reduced the rate of postoperative pulmonary complications in high-risk patients having open thoracic, aortic, or upper abdominal surgery. A total of 419 patients (209 with OLE treatment and 210 without) were included in the…

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By: Judy Mathias
August 5, 2019
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FDA: Class I recall of Ellipse Implantable Cardioverter Defibrillators

Editor's Note The Food & Drug Administration on August 5 identified the recall by Abbott (formerly St Jude Medical Inc) of its Ellipse Implantable Cardioverter Defibrillators as Class I, the most serious. The recall was initiated because electrical failures have been identified that are due to a faulty manufacturing process…

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By: Judy Mathias
August 5, 2019
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