Regulations/Legal

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March 2020
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CDC releases 2019 report on antibiotic resistance threats

Editor's Note More than 2.8 million antibiotic-resistant infections occur in the US each year, resulting in more than 35,000 deaths, according to a new “Antibiotic Resistance Threats in the United States 2019” report from the Centers for Disease Control & Prevention (CDC). The CDC also notes that 223,900 cases of…

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By: Judy Mathias
December 5, 2019
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FDA: B. Braun recalls blood administration sets

Editor's Note The Food & Drug Administration (FDA) on November 26 announced a voluntary recall by B. Braun Medical (Bethlehem, Pennsylvania) of 22 lots of blood administration sets. The recall was initiated because of the potential for leakage at the joint between the blood filters and tubing. This could force…

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By: Judy Mathias
December 3, 2019
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FDA approves first system for insertion of ear tubes with local anesthesia

Editor's Note The Food & Drug Administration (FDA) on November 25 approved a new system for the delivery of tympanostomy tubes into the eardrums of young children without using general anesthesia. The Tubes Under Local Anesthesia (Tula) System (Tusker Medical, Menlo Park, California) is the first ear tube delivery system…

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By: Judy Mathias
December 2, 2019
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Hospital-based care coordination strategies linked to CMS star ratings

Editor's Note Care coordination strategies were found to be associated with high overall hospital quality star ratings from the Centers for Medicare & Medicaid Services (CMS) in this study. A total of 710 general acute care noncritical access hospitals that received star ratings and responded to the 2015 American Hospital…

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By: Judy Mathias
November 21, 2019
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Joint Commission announces update of book on building new, updating facilities

Editor's Note The Joint Commission on November 20 announced an update to the book, “Planning, Design, and Construction of Health Care Facilities,” which was developed in partnership with the American Institute of Architects Academy of Architecture for Health (AIA/AAH). This 4th edition includes: Eight new case studies that highlight design challenges,…

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By: Judy Mathias
November 21, 2019
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FDA updates device failure linked to Getinge’s Maquet/Datascope Intra-aortic Balloon Pumps

Editor's Note The Food and Drug Administration (FDA) on November 19 updated the device failure associated with Getinge’s Maquet/Datascope Intra-aortic Balloon Pumps (IABPs) in a letter to health care providers. Since 2017, the FDA has received more than 75 reports of the IABPs shutting down while running on battery. Five…

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By: Judy Mathias
November 20, 2019
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FDA clears first duodenoscope with disposable elevator component

Editor's Note The Food & Drug Administration (FDA) on November 15 announced that it had cleared for marketing in the US the first duodenoscope with a sterile, disposable elevator component. The clearance of the Pentax Medical Video ED34-i10T2 duodenoscope represents a major step toward lowering the risk of infection in…

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By: Judy Mathias
November 18, 2019
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Sterilization trumps high-level disinfection for semicritical items

In the never-ending quest to improve patient care, we are always seeking better ways to process medical devices. Many leading experts now recommend transitioning from high-level disinfection (HLD) to sterilization for semicritical items. Semicritical items are instruments or objects that contact mucous membranes or nonintact skin of a patient, but…

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By: Susan Klacik, BS, CRCST, ACE, CIS, FCS
November 18, 2019
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A primer for starting a total joint replacement program

Ambulatory surgery centers (ASCs) have increasing incentives to offer total joint replacements (TJR) as Medicare expands the list of covered procedures. However, there’s a lot to consider in this particular service line. “There are many things to arrange that aren’t required with other service lines, particularly as home care of…

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By: OR Manager
November 18, 2019
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FDA: Class I recall of Zimmer Biomet’s ROSA Brain 3.0 Robotic Surgery System

Editor's Note The Food & Drug Administration on November 7 identified the recall by Zimmer Biomet of its ROSA Brain 3.0 Robotic Surgery System as Class I, the most serious. The recall was initiated because of a software issue that incorrectly positions the robotic arm. The company has received five…

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By: Judy Mathias
November 14, 2019
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