Rules and Regulations

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September 2024
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FDA designates Class 1 recall for infusion system components

Editor's Note The US Food and Drug Administration (FDA) has designated Fresenius Kabi’s recall of certain Ivenix infusion system components as Class 1, the most severe category indicating risk of serious injury or death. According to the agency’s September 16 announcement, the recalled items consist of a certain lot (3010538)…

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By: Matt Danford
September 16, 2024
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WHO, Joint Commission mark World Patient Safety Day

Editor's Note In partnership with the World Health Organization (WHO), The Joint Commission and The Joint Commission and Joint Commission International (JCI) invite organizations, health professionals, patients, and their advocates to recognize World Patient Safety Day Tuesday, September 17. This year’s theme is “improving diagnosis for patient safety.” This theme…

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By: Matt Danford
September 16, 2024
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Joint Commission International launches healthcare sustainability certification for global organizations

Editor's Note Joint Commission International (JCI) and the International Hospital Federation's Geneva Sustainability Centre (GSC) have introduced a new Healthcare Sustainability Certification (HSC) for healthcare organizations outside the U.S., according to a September 11 report from The Joint Commission. The goal of the new initiative is to address the nearly…

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By: Matt Danford
September 13, 2024
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Study: Tubal ligation surgeries surged after abortion restrictions

Editor's Note Tubal ligation procedures increased after the 2022 overturn of Roe v. Wade and were particularly concentrated in states with abortion bans, according to a September 11 Associated Press (AP) report on a study published in JAMA. Researchers analyzed insurance claims for approximately 4.8 million women across 36 states…

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By: Matt Danford
September 12, 2024
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FDA announces Class 1 recall for ventilator adapter assemblies

Editor's Note The US Food and Drug Administration (FDA) designated Baxter’s recall of certain Single Patient Use Circuits and Blue Ventilator Adapter Assemblies as Class 1, the most severe recall category indicating significant risk of injury or death. The Single Patient Use Circuit and Blue Adapter Assembly are patient circuit…

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By: Matt Danford
September 5, 2024
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Water quality: 5 Ws and an H for sterile processing pros

Asking who, what, why, when, where, and how—otherwise known as the “5 Ws and an H”— is a time-tested way for writers and researchers to ensure comprehensive coverage of any topic. Here, we apply this framework from the perspective of sterile processing department (SPD) professionals seeking to start a water…

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By: Angela Lewellyn, LPN, CRCST, CER, CHL
August 28, 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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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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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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California bill seeks stricter oversight of private equity in healthcare

Editor's Note A bill in California that aims to increase oversight of private equity healthcare investments is receiving support from consumer advocates, labor unions, and the California Medical Association and opposition from hospitals worried about losing funding sources, the Los Angeles Times reported August 9. Sponsored by Attorney General Rob…

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By: Matt Danford
August 20, 2024
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