Regulations/Legal

Latest Issue of OR Manager
October 2023
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ACS addresses opioid prescription misuse with new QI project

Editor's Note The American College of Surgeons (ACS), on September 12, announced a new quality improvement (QI) project that will evaluate the most effective ways to help patients safely manage postoperative pain and reduce the risk of opioid dependence. The project will be conducted in collaboration with Health Care Service…

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By: Judy Mathias
September 13, 2023
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FDA: Class I recall of Mallinckrodt One-Way Valve, 22F x 22M

Editor's Note The Food and Drug Administration (FDA), on September 12, identified the recall by Mallinckrodt Manufacturing of its One-Way Valve, 22F x 22M, as Class I, the most serious. The recall was issued because the devices are not opening properly, which prevents or reduces the flow of ventilated air…

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By: Judy Mathias
September 13, 2023
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FDA approves updated COVID-19 boosters

Editor's Note The Food and Drug Administration (FDA), on September 11, approved the Moderna and Pfizer/BioNTech updated COVID-19 boosters that target the Omicron subvariant XBB.1.5, the September 11 Reuters reports. The boosters, which were approved for those 12 years and older and authorized for emergency use for children ages 6…

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By: Judy Mathias
September 12, 2023
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New CMS rule focuses on postop opioids in outpatient settings

Editor's Note The Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act, which is set to take effect in 2025, will set up a separate Centers for Medicare and Medicaid Services (CMS) payment for certain nonopioid pain management techniques in outpatient and ambulatory surgery center (ASC) settings, the September 12 Becker’s…

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By: Judy Mathias
September 12, 2023
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COVID-19 hospitalizations, deaths increasing

Editor's Note The COVID-19 hospital admission rate in the US rose some 16% to more than 17,400 for the week ending August 26, and deaths increased by nearly 18% from the prior week, the September 7 New York Times reports. This marks the seventh consecutive week of increases. The Omicron…

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By: Judy Mathias
September 11, 2023
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University of Miami School of Nursing and Health Studies awarded $23.57M NIH grant

Editor's Note The University of Miami School of Nursing and Health Studies, on September 5, announced that it had been awarded a $23.57 million grant from the National Institutes of Health (NIH). The grant will be used to fund a project to investigate how stress experienced by parents, and fueled…

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By: Judy Mathias
September 11, 2023
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US and UK sanction Russian cybercrime group targeting hospitals, providers

Editor's Note The United States, in coordination with the United Kingdom, has imposed sanctions on 11 individuals linked to the Russia-based cybercrime group known as Trickbot, a US Department of the Treasury September 7 press release reports. These sanctions were issued by the US Department of the Treasury's Office of…

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By: Tarsilla Moura
September 8, 2023
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Healthcare employment up in August

Editor's Notes Overall healthcare employment in the US was up in August to a seasonally adjusted 17,014,300 workers, the Bureau of Labor Statistics reported on September 1. That’s up 70,900 since July. Hospital employment also was up by 14,500 jobs. The overall unemployment rate rose in August to 3.8%, for…

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By: Judy Mathias
September 5, 2023
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FDA: Class I recall of Cardiosave Hybrid, Rescue IABPs

Editor's Note The Food and Drug Administration (FDA), on August 31, identified the recall by Getinge/Maquet/Datasocpe of its Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious. The FDA posted four recalls for four separate reasons: Because they may overheat when the device’s internal temperature…

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By: Judy Mathias
September 5, 2023
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FDA: Class I recall of certain Hamilton ventilators

Editor's Note The Food and Drug Administration (FDA), on August 30, identified the recall by Hamilton Medical of its HAMILTON-C1, C2, C3, and T1 ventilators as Class I, the most serious. The recall was initiated because of software issues that may cause the ventilators to stop without notice. There have…

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By: Judy Mathias
August 31, 2023
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