FDA designates Class 1 recall for infusion pumps due to air bubble risk
Editor's Note The US Food and Drug Administration (FDA) has deemed Zyno Medical’s recall of Z-800, Z-800F, Z-800W, and Z-800WF infusion pumps a Class 1, the most severe designation indicating serious risk of injury or death. According to FDA’s October 11 announcement, the recall was due to a defect in…
CMS proposes $2 Drug List Model to reduce out-of-pocket costs for Medicare recipients
Editor's Note CMS has taken the next steps in making prescription drugs more affordable for Medicare recipients, according to an October 9 report from The US Department of Health and Human Services (HHS). The proposed Medicare $2 Drug List Model, developed in line with President Biden’s Executive Order 14087, aims…
FDA announces Class 1 recall for pediatric resuscitator
Editor's Note The US Food and Drug Administration (FDA) has deemed Mercury Medical’s recall of Neo-Tee Resuscitators a Class 1, the most severe category indicating serious risk of injury or death. According to the agency’s October 7 announcement, the recall was motivated by potential for the inline controller to come…
AAMI, CTA partners to develop healthcare AI standards
Editor's Note The Association for the Advancement of Medical Instrumentation (AAMI) has entered into a partnership with the Consumer Technology Association (CTA) to develop new standards for the integration of artificial intelligence and machine learning in healthcare, according to an October 1 report in DOTmed. Formalized through a memorandum of…
Hurricane disrupts IV fluid manufacturing as hospitals cope with chaos
Editor's Note The shuttering of a critical Baxter International manufacturing plant in North Carolina due to Hurricane Helene could put significant stress on already strained healthcare supply chain, according to an October 1 report in Axios. According to the article, the facility is a critical production center for produces intravenous…
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…
How perioperative staff can combat human trafficking—Part 2
Human trafficking (HT) is a hidden-in-plain-sight crime—victims walk among the public at large, yet they remain essentially invisible. Lack of education and knowledge on HT and anti-trafficking measures is particularly egregious in healthcare. In fact, the literature shows the majority of people being trafficked access the system without being identified…
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 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)…
Joint Commission International launches healthcare sustainability certification for global organizations
Editor's Note Joint Commission International (JCI) and the International Hospital Federation's Geneva Sustainability Centre (GSC) have introduced a new Healthcare Sustainability Certification (HSC) for healthcare organizations outside the U.S., according to a September 11 report from The Joint Commission. The goal of the new initiative is to address the nearly…
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