Regulations/Legal
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…
Florida allows C-sections outside hospitals amid controversy over safety, cost
Editor's Note Florida became the first US state to permit doctors to perform cesarean sections (C-sections) outside hospitals, siding with a private equity-owned physicians group advocating for cost reduction and a homier birthing environment, KFF Health News and HealthLeaders May 28 reports. However, the hospital industry and the American College…
Study: Quality for nonsurgical care declined for non-COVID patients during 2020 COVID-19 surges
Editor's Note A recent analysis from the Agency for Healthcare Research and Quality (AHRQ) of over 19 million hospital discharges in the US showed a significant decline in the quality of nonsurgical care for non-COVID-19 patients during the 2020 COVID-19 surges, Healthcare Purchasing News May 28 reports. Specifically, the study…
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,…
Supply chain stress fractures demand rock-solid continuity planning
More than 4 years after personal protective equipment production and inventories crashed amid the global COVID-19 pandemic, the “new normal” in healthcare supply chains seems to be “uncertainty.” Although hospital margins are improving and patient volumes are trending upward, “stress fractures continue to remain in place,” says Michael Schiller, CMRP,…
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…
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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