Tag: Technology

FDA announces Class 1 recall for Draeger breathing filters

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…

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By: Matt Danford
August 13, 2025
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5 costly mistakes to avoid when building an ASC

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,…

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By: Tarsilla Moura
August 12, 2025
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Healthcare providers express cash flow concerns under new 340B rebate model

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…

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By: Matt Danford
August 12, 2025
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Wearable tech predicts postoperative complications in pediatric patients

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,…

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By: Matt Danford
August 8, 2025
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FDA orders opioid label changes to highlight long-term risks

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…

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By: Matt Danford
August 6, 2025
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FDA safety alerts flag cardiac devices

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…

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By: Matt Danford
August 6, 2025
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How ASCs ace the AAAHC accreditation survey

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…

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By: Uyen Vo
August 6, 2025
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FDA issues Class I recall for Philips BiPAP ventilators

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…

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By: Matt Danford
August 5, 2025
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Study: Mixed reality system shows promise as alternative to optical neurosurgical navigation

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,…

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By: Matt Danford
August 5, 2025
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Nearly half of hospital patient harm events go unreported, OIG reveals

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…

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By: Matt Danford
August 4, 2025
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