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…

Read More

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.…

Read More

Editor's Note A recent analysis by the RAND Corporation, a research and analysis nonprofit, revealed a disparity between hospital and ambulatory surgery center (ASC) prices paid by employers and private payers compared to Medicare prices, Revcycle Intelligence May 15 reports. The study, covering data from 2020 to 2022, showed private…

Read More

Editor's Note A $50 million initiative to develop cybersecurity tools for hospitals aims to protect providers and patients alike from ransomware, according to a May 20 report in Becker’s Health IT. The Universal PatchinG and Remediation for Autonomous DEfense, or UPGRADE, program was launched the same day by the Advanced Research…

Read More

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,…

Read More

Editor's Note According to the annual Sentinel Event Data Report, The Joint Commission received 1,411 reports of sentinel events—an event not related to the natural course of an illness or condition that causes severe harm, permanent harm or death—in 2023. Of that total, 96% of events were voluntary self-reported by…

Read More

Editor's Note With the goal of helping patients choose if outpatient care is right for them and identify the right ambulatory surgery center (ASC) for their needs, US News & World Report unveiled on May 14 its inaugural ranking of the best ASCs in the US. Reportedly, “fewer than 15%…

Read More

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…

Read More

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…

Read More

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…

Read More