Regulations/Legal

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October 2024
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Staffing solutions depend on collaborative, innovative culture

There is no shortage of advice, opinions, and proposed solutions when it comes to staff shortages, but the issue continues to plague healthcare systems nonetheless. For a couple of years now, speakers at the OR Business Management Conference and OR Manager Conference have been asking attendees, “Who still struggles to…

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By: Tarsilla Moura
August 28, 2024
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How perioperative staff can combat human trafficking—Part 1

Human trafficking (HT) is a global public health crisis and one of the fastest growing criminal enterprises that grosses hundreds of billions of dollars annually, all of which are tax-free profits made off the sale of human cargo. And yet, research shows the problem is poorly understood or recognized among…

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By: Francine Bono-Neri, PhD, RN, APRN, PNP
August 28, 2024
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UnitedHealth Group explores acquisition of Surgery Partners amidst antitrust scrutiny

Editor's Note UnitedHealth Group (UHG) is in early talks to potentially acquire Surgery Partners, the third-largest operator of ambulatory surgical centers (ASCs) in the US, according to Bloomberg, Healthcare Finance August 26 reports. Surgery Partners has also attracted interest from private equity firms, including TPG Inc. While no deal is…

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By: Tarsilla Moura
August 28, 2024
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Some FDA-recalled medical devices remain in use while manufacturers implement corrections

Editor's Note A 2016 recall issued for the Abbott MitraClip cardiac device highlighted potential safety concerns, but instead of removing the product from the market, Abbott and the Food and Drug Administration (FDA) allowed continued use with revised instructions and additional training for doctors. This approach reflects a broader trend…

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By: Tarsilla Moura
August 27, 2024
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International study highlights OR waste management strategies, barriers

Editor's Note Effective waste segregation and adopting a circular economy approach can significantly reduce environmental impact of incinerating hospital waste incorrectly classified as hazardous, according to a narrative review published August 19 in the Medical Journal of Australia. However, surgeons' concerns about patient safety and insufficient systemic policies can hinder…

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By: Matt Danford
August 27, 2024
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FDA announces Class 1 recall for chest compression devices

Editor's Note The US Food and Drug Administration (FDA) has designated Defibtech, LLC’s recall of RMU-2000 ARM XR Chest Compression Devices as Class 1, the most severe category indicating serious risk of injury or death. A motor issue could stop  compressions in adults whose hearts suddenly stop, according to the…

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By: Matt Danford
August 23, 2024
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Studies highlight success strategies for combatting handoff communication failure, care inequity

Editor's Note Recent research sheds new light on addressing two of the most pressing problems for surgical care: handoff communication failures and care bias and inequities leading to adverse—and preventable—events.   These problems are the subjects of two separate success stories in the August issue of The Joint Commission Journal…

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By: Matt Danford
August 23, 2024
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Immunotherapy’s FDA approval expected to improve lung cancer treatment

Editor's Note The US Food & Drug Administration (FDA) has approved immunotherapy durvalumab for perioperative treatment of resectable non-small cell lung cancer (NSCLC), according to an August 15 announcement. The approval is for durvalumab (Imfinzi, AstraZeneca) in combination with platinum-based chemotherapy as a neoadjuvant treatment, followed by durvalumab alone as…

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By: Matt Danford
August 22, 2024
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Health systems accelerate ASC partnerships amid shift to outpatient care

Editor's Note As healthcare continues to transition from inpatient to outpatient settings, large health systems are increasingly forming partnerships and joint ventures to develop and manage ambulatory surgery centers (ASCs), Becker’s ASC Review August 16 reports. Per the outlet, health systems have historically been hesitant to embrace ASCs due to…

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By: Tarsilla Moura
August 21, 2024
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Battery problem prompts FDA Class 1 recall for infusion pumps

Editor's Note The US Food and Drug Adminstration (FDA) has classified a recall of ICU Medical’s Plum 360, Plum A+ and Plum A+3 infusion pumps as Class 1, the most severe category indicating risk of serious injury or death. According to he agency’s August 20 announcement, the company is updating…

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By: Matt Danford
August 21, 2024
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