Regulations/Legal

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June 2019
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Joint Commission: Quick Safety addresses drug diversion

Editor's Note The Joint Commission announced on April 17 that the April issue of Quick Safety focuses on drug diversion and examines patterns and trends that could indicate drug diversion. It also offers safety actions organizations can take and describes how to take the mistakes other hospitals have made and…

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By: Judy Mathias
April 18, 2019
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FDA issues statement on trach tube shortages

Editor's Note The Food & Drug Administration on April 12 issued a statement about the agency’s efforts to mitigate the shortage of Smiths Medical’s Bivona tracheostomy tubes, especially the pediatric tubes. The shortage is a result of the closure of a large ethylene oxide sterilization facility in Willowbrook, Illinois, and there…

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By: Judy Mathias
April 17, 2019
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FDA: Class I recall of Brainlab Spine & Trauma 3D Navigation Software

Editor's Note The Food & Drug Administration (FDA) on April 15 identified the recall of Brainlab's Spine & Trauma 3D Navigation Software as Class I, the most serious. The Software is being recalled because of the potential for incorrect information to display during surgery, which may prevent the surgeon from…

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By: Judy Mathias
April 16, 2019
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FDA to require label changes on how to safely decrease opioids in physically dependent patients

Editor's Note The Food & Drug Administration (FDA) on April 9 issued a Drug Safety Announcement saying it has received reports of serious harm in patients who are physically dependent on opioid pain medications and suddenly have them discontinued or rapidly decreased. Because of these reports, the FDA is requiring…

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By: Judy Mathias
April 11, 2019
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FDA issues statement on review framework for AI-based devices

Editor's Note The Food & Drug Administration (FDA) on April 2 issued a statement announcing steps toward a new, tailored review framework for artificial intelligence (AI)-based medical devices. AI and machine learning have the potential to transform the delivery of healthcare, with earlier disease detection, more accurate diagnoses, more targeted…

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By: Judy Mathias
April 3, 2019
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Joint Commission, NQF name Eisenberg Award winners

Editor's Note The Joint Commission and National Quality Forum (NQF) on March 27 named the recipients of the 2018 John M. Eisenberg Patient Safety and Quality Awards. The Awards recognize innovative approaches to improve patient safety and quality of care. The winners are: Brent C. James, MD, MStat, clinical professor,…

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By: Judy Mathias
April 2, 2019
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Joint Commission posts ‘Top 5’ most challenging requirements for 2018

Editor's Note The Joint Commission on March 27 posted the “Top 5” requirements identified most frequently as “not compliant” during surveys and reviews in 2018. The Top 5 for hospital accreditation are: LS.02.01.35: The hospital provides and maintains systems for extinguishing fires (88.85%). EC.02.05.01: The hospital manages risks associated with…

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By: Judy Mathias
April 1, 2019
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FDA addresses potential medical device, product shortages amid shutdown of sterilization facility

Editor's Note The Food & Drug Administration on March 26 said it will take steps to address potential medical product and device shortages because of the recent closure of a large contract sterilization facility, Sterigenics (Willowbrook, Illinois). Earlier this year, the Illinois Environmental Protection Agency issued an order to stop…

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By: Judy Mathias
March 27, 2019
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CDC: Healthcare-associated infections declining

Editor's Note The Centers for Disease Control and Prevention on March 19 released its current progress report on healthcare-associated infections, which includes state and national level statistics for 2017. Among the findings for acute care hospitals: Clostridium difficile infections declined by 13%. Central line-associated bloodstream infections fell by 9%. Methicillin-resistant…

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By: Judy Mathias
March 26, 2019
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FDA issues Safety Communication on cybersecurity vulnerabilities in Medtronic cardiac devices

Editor's Note The Food & Drug Administration on March 21 issued a Safety Communication on cybersecurity vulnerabilities identified in wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers, and home monitors. Medtronic (Dublin, Ireland) is working on updates to address the vulnerabilities and recommends that healthcare…

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By: Judy Mathias
March 25, 2019
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