Tag: Patient Safety

FDA releases list of reusable devices requiring new validated IFU, validation data

Editor's Note The Food and Drug Administration (FDA) on June 9 released a list of reusable devices that will require new validated instructions for use (IFU) and validation data in premarket notifications regarding cleaning, disinfection, and sterilization. These actions are effective August 8, 2017. The list includes: Bronchoscopes (flexible or…

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By: Judy Mathias
June 12, 2017
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Racial disparities in surgical mortality narrowing

Editor's Note Despite concerns that quality improvement efforts may widen disparities, national racial disparities in surgical mortality are narrowing, this study finds. Using Medicare claims data from 2005 to 2014, Harvard researchers found that, overall, national mortality trends improved for both black and white patients by 0.10% and 0.07% per…

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By: Judy Mathias
June 12, 2017
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FDA extends UDI compliance dates for Class I, unclassified devices

Editor's Note The Food and Drug Administration (FDA) has notified medical device labelers that the compliance dates for unique device identifier (UDI) requirements for Class I and unclassified medical devices has been extended from September 24, 2018, to September 24, 2020, and for direct mark requirements from September 24, 2020,…

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By: Judy Mathias
June 12, 2017
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National Time Out Day is June 14

Editor's Note National Time Out Day, June 14, highlights the importance of taking a time out and increases awareness of safe practices that lead to optimal surgical patient outcomes. The Joint Commission is partnering with AORN on National Time Out Day to ask every perioperative team member to be a…

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By: Judy Mathias
June 7, 2017
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Safety of PACU discharge without motor function assessment after spinal anesthesia

Editor's Note Discharge from the postanesthesia care unit (PACU) without assessment of lower limb motor function after spinal anesthesia for total hip or knee arthroplasty did not increase length of hospital stay or readmissions but significantly reduced time in the PACU (0.40 vs 1.56 hours), this study finds. This multicenter…

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By: Judy Mathias
June 7, 2017
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Value-based reforms linked to readmission reduction

Editor's Note Hospital participation in value-based reforms was associated with greater reductions in 30-day readmissions, this study finds. In this analysis of 2,837 hospitals between 2008 and 2015, researchers found that participation in one or more voluntary Medicare value-based reforms, which included the Meaningful Use of Electronic Health Records program,…

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By: Judy Mathias
June 6, 2017
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Trauma centers with ACS verification have fewer complications

Editor's Note Trauma centers verified by the American College of Surgeons Committee on Trauma (ACS-COT) have fewer complications among pediatric, elderly, and severely injured patients, finds this study. The odds of experiencing any major complication were more than 3.0 times greater for elderly patients in trauma centers without ASC-COT verification…

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By: Judy Mathias
June 6, 2017
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Predicting transfusions in total joint patients

Editor's Note Using patient-specific preoperative variables, a validated logistic regression model predicted transfusions in total hip and knee patients in this study. The model identified preoperative hemoglobin, total hip arthroplasty, and females 65 years of age and older as predictors of perioperative transfusions. The model also may help identify those…

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By: Judy Mathias
June 5, 2017
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Study shows positive results for new AAA graft in women

Editor's Note Thirty-day data from the 225-patient LUCY (Evaluation of FemaLes who are Underrepresented Candidates for Abdominal Aortic AneurYsm Repair) Study showed that at least 28% more women became eligible for  minimally invasive endovascular abdominal aortic aneurysm (AAA) repair when using Endologix’s (Irvine, California) Ovation abdominal stent graft system, according…

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By: Judy Mathias
June 5, 2017
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Ketamine doesn’t affect postop delirium, pain

Editor's Note Ketamine does not decrease delirium or lower levels of pain in older adults after major surgery and might cause harm by inducing hallucinations and nightmares, this study finds. A total of 672 patients were randomly assigned to a placebo group (222 patients), a 0.5 mg/kg ketamine group (227),…

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By: Judy Mathias
June 2, 2017
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