Rules and Regulations

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May 2024
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Nurse union survey: AI patient safety threats prove need for strict guardrails

Editor's Note Artificial intelligence (AI) threatens patient safety by undermining the judgment of human nurses, according to a survey by National Nurses United (NNU). “The findings, coupled with anecdotal reports from nurses at hospitals nationwide, underscore the urgent need for stricter regulation and greater input from nurses and health care…

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By: Matt Danford
May 24, 2024
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FDA announces Class 1 recall for Vyaire Medical’s Twin Tube CPX sample lines

Editor's Note A choking hazard prompted the US Food and Drug Administration (FDA) to designate Vyaire Medical’s recall of Twin Tube sample lines—critical components of the Vyntus CPX system—as Class 1, the most serious category of recall indicating a risk of serious injury or death. According to the agency’s May…

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By: Matt Danford
May 24, 2024
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Editorial: Nurse leaders, vendors must collaborate effectively

Is working with a healthcare vendor a necessary evil? For leaders in the perioperative space, where vendors abound, it may be tempting to answer “yes.” The relationship between vendors and nurse leaders is a delicate balance between give and take, but sometimes the take seems to outweigh the give. Nonetheless,…

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By: Jane E. Kuhn, RN, MSN, CNOR(e), NEA-BC (Retired)
May 24, 2024
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Built to grow: Key elements of planning a new ASC

Are you part of the ambulatory surgery center (ASC) construction boom? If so, you’re not alone. Approximately 116 new facilities opened in 2023, according to Becker’s ASC Review, and more are planned for and underway in 2024. This trend shows no signs of slowing. Fortune Business Insights projects the US…

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By: Brendan Dooley
May 24, 2024
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FDA announces class 1 recall for radiographic breast tissue marker

Editor's Note The US Food and Drug Administration (FDA) has designated the recall of Hologic Inc.’s BioZorb Marker a class 1, indicating a risk of serious injury or death. BioZorb is an implantable radiographic marker used to mark soft tissue (such as breast tissue) for future medical procedures. Provided sterile…

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By: Matt Danford
May 23, 2024
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Cyberattack-affected Providers seek clarity on stolen data reporting responsibility

Editor's Note A joint letter from the American Medical Association (AMA) and more than 100 medical organizations asks Health and Human Services (HHS) Secretary Xavier Becerra to confirm that providers do not bear responsibility for legal reporting requirements for information stolen in the Change Healthcare cyberattack, including personal patient data.…

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By: Matt Danford
May 22, 2024
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FDA announces class 1 recalls for heart devices, ventilators

Editor's Note The US Food and Drug Administration (FDA) has classified recalls of Abbot’s HeartMate 3 Left Ventricular Assist System (LVAS) implant kits and Phillips Respironics' Trilogy Evo ventilators as class 1, the most serious category indicating risk of serious injury or death. Used while waiting for recovery, a transplant,…

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By: Matt Danford
May 16, 2024
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FDA issues class 1 recall for medical catheters

Editor's Note The US Food and Drug Administration (FDA) has designated Route 92 Medical’s recall of products containing the Tenzing 7 delivery catheters as class 1, the most serious classification indicating risk of serious injury or death. The devices are used to deliver microcatheters to the blood vessels in the…

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By: Matt Danford
May 13, 2024
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Prolific ransomware group targets healthcare, prompts official warning

Editor's Note Black Basta, reportedly the second most prolific ransomware group in the world, has healthcare organizations firmly in its crosshairs, according to a May 13 article in the Hippa Journal. Citing a May 10 bulletin on the group from Health Information Sharing and Analysis Center Healht-ISAC, the article notes…

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By: Matt Danford
May 13, 2024
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Joint Commission identifies most cited certification performance requirements

Editor's Note Recognizing that complying with some standards is more difficult than complying with others, The Joint Commission regularly evaluates which areas are most difficult so it can tailor education accordingly. To that end, a May 7 report reveals the top 5 most frequently cited elements of performance (EPs) in…

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By: Matt Danford
May 10, 2024
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