Regulations/Legal

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September 2023
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The Joint Commission updates Health Care Equity resource centers

Editor's Note The Joint Commission, on August 2, announced that it had updated its Health Care Equity (HCE) Accreditation Standards & Resource Center and its HCE Certification Resource Center. A new resource available in the HCE Accreditation Standards & Resource Center is an On Demand Accelerate PI Webinar that provides…

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By: Judy Mathias
August 3, 2023
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FDA: Class I recall of Baxter SIGMA Spectrum, Spectrum IQ infusion pumps

Editor's Note The Food and Drug Administration (FDA), on August 1, identified the recall by Baxter Healthcare Corporation of its SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) and Spectrum IQ Infusion System with Dose IQ Safety Software (Version 9) as Class I, the most serious. The recall…

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By: Judy Mathias
August 1, 2023
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Update of strategies to prevent MRSA transmission, infection in acute care hospitals

Editor's Note This expert guidance document, sponsored by the Society for Healthcare Epidemiology of America (SHEA), updates the “Strategies to Prevent Methicillin-Resistant Staphylococcus aureus [MRSA] Transmission and Infection in Acute Care Hospitals” that were published in 2014. Among the updates: Recommendations are now categorized as Essential Practices that should be…

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By: Judy Mathias
July 31, 2023
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FDA: Class I recall of GE HealthCare’s TruSignal SpO2 sensors

Editor's Note The Food and Drug Administration (FDA), on July 28, identified the recall by GE HealthCare of its TruSignal SpO2 [arterial oxygen saturation] sensors as Class I, the most serious. The recall was initiated because of issues that may reduce the amount of energy sent to the heart during…

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By: Judy Mathias
July 31, 2023
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FDA: Class I recall of Abiomed Impella Left Sided Blood Pumps

Editor's Note The Food and Drug Administration (FDA), on July 27, identified the recall by Abiomed of all Impella Left Sided Blood Pumps as Class I, the most serious. Abiomed is recalling the pumps because the instructions for use do not adequately address precautions to take when treating transcatheter aortic…

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By: Judy Mathias
July 27, 2023
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FDA: Class I recall of Abbott Amplatzer Steerable Delivery Sheath

Editor's Note The Food and Drug Administration (FDA), on July 26, identified the recall by Abbott of its Amplatzer Steerable Delivery Sheath as Class I, the most serious. Abbott is recalling the sheath because of an increased risk for air emboli being introduced into patients who have cardiac catheterization procedures…

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By: Judy Mathias
July 27, 2023
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ACS: 19 surgical organizations oppose CMS code G2211

Editor's Note The American College of Surgeons (ACS) announced, on July 26, that it and 18 other surgical organizations sent a letter to the Centers for Medicare & Medicaid Services (CMS), strongly opposing implementation of its code G2211. The G2211 code is an effort by CMS to pay more for…

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By: Judy Mathias
July 26, 2023
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Pandemic experiences of infections preventionists resulted in moral distress

Editor's Note This study, led by nurse researchers at the College of Nursing, University of Wisconsin-Milwaukee, explores the experiences of infection preventionists (IPs) during the COVID-19 pandemic. Responses from 61 IPs surveyed were included in the analysis. Among the findings: The initial phases of COVID-19 was a time of clinical…

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By: Judy Mathias
July 25, 2023
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Military combat surgeon to lead new pandemic preparedness office

Editor's Note Paul Friedrichs, MD, a military combat surgeon and retired Air Force major general, will lead the new Office of Pandemic Preparedness and Response Policy, which will replace the current COVID-19 and monkeypox response teams, and prepare for future pandemics, the July 21 Reuters reports. Dr Friedrichs will be…

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By: Judy Mathias
July 25, 2023
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CDC data show COVID-19 indicators on the rise

Editor's Note Centers for Disease Control and Prevention (CDC) data is showing an uptick in COVID-19 positivity rates and emergency department visits after months of decline, according to the July 24 US News and World Report. Cases of the Omicron subvariant EG.5, which was recently added to the World Health…

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By: Judy Mathias
July 25, 2023
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