Rules and Regulations

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November 2025
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FDA announces Class 1 recalls for upper airway stimulation system, MRI components

Editor's Note A manufacturing defect in a critical component of an upper airway stimulation (UAS) system and coils prone to overheating during magnetic resonance imaging scans (MRIs) prompted The US Food & Drug administration to issue two Class 1 recalls June 8. Class 1 is the most severe category, indicating…

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By: Matt Danford
July 10, 2024
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Healthcare industry groups criticize federal cybersecurity reporting rule

Editor's Note Healthcare industry groups are calling for the federal government to streamline and ease the recently proposed cybersecurity incident reporting rule by the Cybersecurity and Infrastructure Security Agency (CISA), Fierce Healthcare reported July 8. According to the report, CISA's proposal imposes enhanced reporting requirements for critical infrastructure entities, including…

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By: Matt Danford
July 9, 2024
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Supreme Court decision could lead to legal challenges to payments, risks to healthcare regulation

Editor's Note Food and Drug Administration (FDA) regulations are at risk, and legal challenges to Medicare payments are likely to rise following the Supreme Court’s overturning of the 40-year-old legal precedent Chevron deference, according to a June 28 report in Becker’s Hospital Review. "Chevron deference is the principle that when…

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By: Matt Danford
July 2, 2024
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FDA announces Class 1 recalls for ventilators, LVAS monitors

Editor's Note The US Food and Drug Administration has announced class 1 recalls—the most severe category indicating risk of serious injury or death—for Abbot Medical’s HeartMate System Monitor and Philips Respironics OmniLab Advanced+ (OLA+) ventilator. According to the agency’s June 28 report, the recall of the HeartMate System Monitor, part…

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By: Matt Danford
July 1, 2024
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Study: Federal antitrust action minimal relative to number of hospital mergers

Editor's Note Federal regulation of hospital mergers is inadequate, according to an April antitrust enforcement study scheduled to be published by the American Economic Association. According to a June 14 report in Modern Healthcare, researchers at universities including Harvard and Yale analyzed insurance claims data from Aetna, Humana, and UnitedHealthcare,…

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By: Matt Danford
June 27, 2024
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Change Healthcare issues notifications of patient data stolen in cyberattack

Editor's Note Change Healthcare has started to notify health care providers about patient data stolen in the February cyberattack and announced plans to mail affected individuals as well. A unit of UnitedHealth Group, the organization issued the update June 20. “CHC is providing this notice now to help individuals understand…

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By: Matt Danford
June 24, 2024
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Scaling standards from sterile processing department to clinic

Reforming instrument reprocessing practices does not always end with the main sterile processing department (SPD). Holding clinics to the same standard adds to the challenge, whether they are associated with hospitals or operate independently. Nonetheless, standardization is just as essential to maintaining efficiency and quality standards. Establishing and maintaining best…

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By: Angela Lewellyn, LPN, CRCST, CER, CHL and Vanessa Frank, CRCST, CHL, CER, CIS
June 24, 2024
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Ambulatory endoscopy management strategies keep patients, finances healthy

Gastrointestinal (GI) endoscopy is one of the most common procedures in the US. Performed more than 17.1 million times per year in inpatient and outpatient hospital settings as well as ambulatory surgery centers (ASCs), GI procedures account for 68% of all endoscopies, according to a May 2022 article in Digestive…

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By: Cynthia Saver, MS, RN
June 24, 2024
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Rural hospitals contend with challenging opportunities

Rural hospitals in the US have been facing a prolonged, multifaceted crisis. The literature presents several reasons for why healthcare facilities in rural areas struggle, including shrinking budgets, rising chronic illness and public health issues like addiction and obesity, poor telehealth and broadband access, aging populations, deteriorating mental health, and…

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By: David C. Walsh
June 24, 2024
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How competency assessment could extend beyond licensing

Competency assessment in perioperative nursing—and American healthcare in general—is a story of unrealized potential. Particularly in the wake of the pandemic, staffing shortfalls and financial pressures have made focusing on staff development difficult for nurse leaders. Nonetheless, the argument for investing more in professional development and competency has never been…

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By: James X Stobinski, PhD, RN, CNOR, CNAMB(E), CSSM(E)
June 24, 2024
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