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February 2025

FDA panel recommends reclassification of surgical staplers to Class II

Editor's Note The Food & Drug Administration’s General and Plastic Surgery Devices Advisory Committee on May 30 recommended that surgical staplers be reclassified from Class I to Class II devices. This would add premarket review and special controls to the devices. The Committee said Class II regulation would offer a…

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By: Judy Mathias
June 4, 2019
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Association of changes to Hospital Readmission Reduction Program with changes in penalties

Editor's Note Stratification of hospitals in Medicare’s Hospital Readmission Reduction Program (HRRP) was associated with a significant shift in hospital penalties for excess readmissions, this study finds. Beginning in FY 2019, Medicare is stratifying hospitals into five peer groups based on the proportions of each hospital’s patient population that is…

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By: Judy Mathias
June 4, 2019
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HHS releases final report on pain management

Editor's Note The Pain Management Best Practices Inter-Agency Task force, a Health and Human Services (HHA) federal advisory committee on May 30 released its final report. The report calls for a balanced, individualized, patient-centered approach to pain management and underscores the need to address stigma, risk assessment, access to care,…

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By: Judy Mathias
June 4, 2019
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Effect of opioid-sparing postop pathway on patient satisfaction, pain control

Editor's Note Patients on an opioid-sparing postoperative pain management pathway reported minimal or no opioid use and high satisfaction and pain control in this study. A total of 190 patients having one of six different procedures participated in the pathway and were advised to use acetaminophen and ibuprofen every 6…

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By: Judy Mathias
June 3, 2019
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FDA: Class I recall of SOLOPATH Balloon Expandable TransFemoral System, Re-Collapsible Balloon Access System

Editor's Note The Food & Drug Administration on May 30 identified the recall by Terumo Medical Corporation (Somerset, New Jersey) of its SOLOPATH Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System as Class I, the most serious. The recall was initiated because the tip could dislodge from the outer…

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By: Judy Mathias
June 3, 2019
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Association of step volume, intensity with mortality in older women

Editor's Note In this study, women who averaged approximately 4,400 steps per day had significantly lower mortality rates than women who took approximately 2,700 steps per day. Of 16,741 women with a mean age of 72 years analyzed, their mean step count was 5,499 per day. A step volume of approximately…

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By: Judy Mathias
May 30, 2019
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Joint Commission announces performance measures for heart attack certifications

Editor's Note The Joint Commission on May 29 announced performance measures for two newly developed advanced Disease-Specific Care Certification programs−Acute Heart Attack Ready and Primary Heart Attack Center. The measures will go into effect July 1, 2019, for critical access hospitals and hospitals (including freestanding emergency departments) pursuing these certifications.…

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By: Judy Mathias
May 30, 2019
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Survey: C-suite support needed to fully unleash nursing innovation

Editor's Note A new survey by the University of Pennsylvania School of Nursing and BDO Center for Healthcare Excellence & Innovation finds that clinical and business leaders value the innovation nurses bring to their organizations, just not at the C-suite level. Clinical and business leaders ranked skills, such as “the…

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By: Judy Mathias
May 30, 2019
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FDA: Heritage Pharmaceuticals recalls Amikacin Sufate Injection, Prochlorperazine Edisylate Injection

Editor's Note The Food & Drug Administration (FDA) on May 28 announced the recall by Heritage Pharmaceuticals Inc (East Brunswick, New Jersey) of Amikacin Sulfate Injection, USP 1 gm/4 mL (250 mg/mL), Lot: VEAC025, Expiry Date: October 2019; and Prochlorperazine Edisylate Injection, USP 10 mg/2 mL (5 mg/mL), Lot: VPCA172,…

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By: Judy Mathias
May 30, 2019
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Association between postop delirium, cognitive dysfunction

Editor's Note In this study, postoperative delirium significantly increased the risk of postoperative cognitive dysfunction in older adults at 1 month after surgery, but there was no association at 2 and 6 months. Of 560 patients analyzed, 24% developed delirium during hospitalization. At 1 month after surgery, 47% had not…

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By: Judy Mathias
May 29, 2019
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