Rules and Regulations
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…
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,…
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…
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…
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…
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…
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…
CMS to end Change Healthcare cyberattack assistance program
Editor's Note The Centers for Medicare & Medicaid Services (CMS) has announced assistance for providers affected by the Change Healthcare cyberattack ends next month. According to the June 17 announcement, payments under the Accelerated and Advance Payment (AAP) Program for the Change Healthcare/Optum Payment Disruption (CHOPD) will end July 12,…
Updated ethylene oxide sterilizer standard covers latest technology
Editor's Note The Association for the Advancement of Medical Instrumentation (AAMI) has updated its standard on ethylene oxide (EO) sterilizers for healthcare facilities, according to a June 12 press release. The first update in two decades, the fourth edition ANSI/AAMI ST24:2024 covers labeling, safety, performance, and testing requirements for general-purpose…
Endotracheal tube component failures prompt FDA Class I recall
Editor's Note The US Food & Drug Administration has designated Medline Industries’ recall of the Sub-G Endotracheal Tube with Subglottic Suction, which is used to keep a patients’ airway open, as a class 1, the most severe category indicating risk of serious injury or death. According to the agency’s June…
Free Daily News
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- AAMI updates sterilization materials compatibility guidance
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