Editor's Note The FDA has issued a Class 1 recall—the most severe category indicating risk of serious injury or death—for Draeger Filter SafeStar 90 Plus (MP05785), Filter SafeStar 55 Plus (MP05790), Filter SafeStar 60A Plus (MP05795), and Filter/HME TwinStar HEPA Plus (MP05801) breathing system filters, affecting all lot numbers. Draeger…
Editor's Note Poor planning and rushed decisions derail too many ambulatory surgery centers (ASCs) before they open their doors. In a recent blog post, ASC consultant Emily Spooner outlined the top five errors commonly made during ASC development, offering targeted guidance on how to avoid them. According to the post,…
Editor's Note Healthcare providers could experience significant cash flow and operational changes under a new voluntary pilot program that fundamentally alters how the nation's second-largest drug payment program operates, according to an August 11 article in Modern Healthcare. As detailed in the article, The Health Resources and Services Administration announced…
Editor's Note Consumer wearables can help detect surgical complications in children days before formal diagnosis, according to a July 9 article from the Feinberg School of Medicine at Northwestern Medicine. The article focuses on a study published in Science Advances and led by researchers at Northwestern University, Shirley Ryan AbilityLab,…
Editor's Note The US Food and Drug Administration (FDA) is requiring safety labeling changes for all opioid pain medications to better emphasize and explain the risks associated with long-term use, according to a July 31 announcement. These changes follow a May advisory committee meeting where the agency reviewed data on…
Editor's Note The US Food and Drug Administration (FDA) issued early alerts August 6 for three medical devices due to safety concerns: Medline ReNewal’s reprocessed St. Jude Medical electrophysiology catheters, Boston Scientific’s ENDOTAK RELIANCE defibrillation leads with ePTFE-coated coils, and Boston Scientific's WATCHMAN Access Systems. The Medline alert involves specific lots…
For an ambulatory surgery center (ASC), earning accreditation can be more than a mark of excellence. The Accreditation Association for Ambulatory Health Care (AAAHC) offers Medicare Deemed Status Accreditation, eliminating the need for separate surveys to certify compliance with the Conditions of Participation (CoPs) required by the Centers for Medicare…
Editor's Note Philips Respironics BiPAP A30, A40, and V30 Auto ventilators are subject to a Class 1 recall—the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or death—due to the risk for a failure in the Ventilator Inoperative alarm, which can cause therapy interruption…
Editor's Note A mixed reality navigation (MRN) system for neurosurgery achieved performance comparable to traditional optical navigation (TON) in certain clinical scenarios, while significantly reducing equipment costs, according to an August 1 study published in BMC Surgery. The MRN system, built around a Microsoft HoloLens headset and infrared tracking tools,…
Editor's Note Nearly half of hospital harm events—particularly surgical events—were not captured by reporting systems, according to a July 30 TechTarget report on new findings from the Office of Inspector General (OIG). The OIG report examined 299 harm events experienced by a nationally representative sample of 770 Medicare patients discharged…