Rules and Regulations
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…
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.…
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,…
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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