Rules and Regulations
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…
Class 1 recall announced for ambulatory infusion pump
Editor's Note The US Food and Drug Administration (FDA) has designated OptumHealth Care Solutions’ recall of the Nimbus II ambulatory infusion pumps a class 1, the most severe category indicating risk of serious injury or death. According to the agency’s May 30 announcement, the company recalled the pumps in direct…
Colorado passes first state-level AI regulations
Editor's Note Colorado is the first state in naton to pass legislation regulating the use of artificial intelligence (AI) in pivotal decision-making, including in healthcare, according to a May 22 report in Politico. The new law has sparked significant debate, according to the report, with some viewing it as a…
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…
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…
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,…
Built to grow: Key elements of planning a new ASC
Are you part of the ambulatory surgery center (ASC) construction boom? Approximately 116 new facilities opened in 2023, according to Becker’s ASC Review, and more are planned for and underway in 2024. The upward trend shows no signs of slowing. Fortune Business Insights projects the US ambulatory surgery center market…
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…
Free Daily News
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