Rules and Regulations
FDA designates Class 1 recalls for infusion pump software, ventilator software
Editor's Note The US Food and Drug Administration (FDA) designated software-related recalls for Fresenius Kabi USA’s Iveni Infusion Systems and Philips Respironics Triology Evo ventilators as class 1, the most severe category indicating serious risk of injury or death. According to FDA’s October 1 announcement, Fresenius recalled the Ivenix Infusion…
Deadline looms for CMS patient safety reporting requirements
Editor's Note Starting October 1, US hospitals participating in Medicare's Inpatient Quality Reporting Program will need to report adherence to 25 patient safety best practices, as mandated by the Centers for Medicare & Medicaid Services (CMS). According to a September 4 report from the Association of Health Care Journalists, the…
HHS announces $75 million investment in rural healthcare
Editor's Note The Health Resources and Services Administration (HRSA), part of the US Department of Health and Human Services (HHS), has announced nearly $75 million in funding to address critical challenges in rural health, including opioid treatment, maternal health care in the South, and supporting the financial stability of rural…
Why nurse travelers are more friends than foes
Many are quick to blame travelers for the poor state of hospital finances. However, isn’t there a difference between a traveler in the OR—an interim staff member in the hospital’s profit center—and an interim RN in an area financially supported by OR profits? What about the argument that travelers can…
Study: OR noise raises risk of surgical error
Editor's Note Often exceeding federal safety limits, OR noise contributes significantly to communication breakdowns, heightened cognitive load, and increased surgical errors, according to a review of literature published September 17 in Cureus. Identified noise sources include surgical instruments, alarms, and staff conversations, which can reach up to 120 decibels (dBA)—a…
California updates guidance on CRNA scope of practice
Editor's Note Confusion about the scope of practice for Certified Registered Nurse Anesthetists (CRNAs) prompted The California Department of Public Health to update guidelines for acute care hospitals, MedPage Today reported September 18. Issued after violations at two Modesto hospitals resulted in hundreds of cancelled surgeries, a letter from the…
FDA designates Class 1 recall for tracheostomy tubes
Editor's Note The US Food and Drug Administration (FDA) has designated the recall of Smiths Medical’s Bivona Neonatal/Pediatric and Adult Tracheostomy tubes as a Class 1, the most severe category indicating risk of serious injury or death. According to the agency’s September 18 report, the recall is due to a…
FDA: Class 1 infusion system recall expanded
Editor's Note B. Braun Medical Inc. has expanded last year’s recall of lnfusomat Space Infusion Pump systems to include more models. Designated by the US Food and Drug Administration (FDA) as Class 1—the most serious category indicating risk of severe injury or death—the recall was motivated by the risk of…
FDA designates Class 1 recall for infusion system components
Editor's Note The US Food and Drug Administration (FDA) has designated Fresenius Kabi’s recall of certain Ivenix infusion system components as Class 1, the most severe category indicating risk of serious injury or death. According to the agency’s September 16 announcement, the recalled items consist of a certain lot (3010538)…
WHO, Joint Commission mark World Patient Safety Day
Editor's Note In partnership with the World Health Organization (WHO), The Joint Commission and The Joint Commission and Joint Commission International (JCI) invite organizations, health professionals, patients, and their advocates to recognize World Patient Safety Day Tuesday, September 17. This year’s theme is “improving diagnosis for patient safety.” This theme…
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