Rules and Regulations
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…
Prolific ransomware group targets healthcare, prompts official warning
Editor's Note Black Basta, reportedly the second most prolific ransomware group in the world, has healthcare organizations firmly in its crosshairs, according to a May 13 article in the Hippa Journal. Citing a May 10 bulletin on the group from Health Information Sharing and Analysis Center Healht-ISAC, the article notes…
Joint Commission identifies most cited certification performance requirements
Editor's Note Recognizing that complying with some standards is more difficult than complying with others, The Joint Commission regularly evaluates which areas are most difficult so it can tailor education accordingly. To that end, a May 7 report reveals the top 5 most frequently cited elements of performance (EPs) in…
Kaiser Permanente data breach affects 13.4 million
Editor's Note A recent data breach at Kaiser Permanente could impact as many as 13.4 million people who are part of the healthcare conglomerate’s Kaiser Foundation Health Plan, according to the Department of Health and Human Services (HHS). Fox Business reported the news April 29. The breach was first reported…
FDA medical device Class 1 recalls trend upward
Editor's Note The number of US Food and Drug Administration (FDA) Class 1 recalls—the most serious classification—for medical devices has been trending upwards. Regulatory News, a publication of the Regulatory Affairs Professional Society (RAPS), reported the news April 25. According to the report, Anne Reid, program director of the Office…
Free Daily News
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