Tag: compliance

FDA accelerates medical device safety alerts to reach public within days

Editor's Note The Food and Drug Administration (FDA) has expanded its early alert recall program to include all medical devices, speeding up how quickly the public learns about high-risk safety issues, Modern Healthcare October 9 reports. The initiative allows the FDA to post early alerts within days of manufacturers notifying…

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By: Tarsilla Moura
October 10, 2025
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AI is turning medical devices into learning systems, Google Cloud exec says

Editor's Note Artificial intelligence (AI) is driving medical technology from reactive tools to adaptive learning systems, Medical Device Network October 6 reports. Shweta Maniar, Google Cloud’s global director of healthcare and life sciences, said that advances in agentic AI are enabling medtech devices to anticipate patient needs, simplify operations, and…

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By: Tarsilla Moura
October 9, 2025
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FDA has begun requiring electronic De Novo submissions for new medical devices

Editor's Note Beginning October 1, the Food and Drug Administration (FDA) is mandating that all De Novo classification requests be submitted electronically using its eSTAR system, according to a final rule and guidance issued by the agency. As detailed in the September 30 release, the shift marks a procedural change…

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By: Tarsilla Moura
October 8, 2025
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Report warns sterile processing staffing crisis threatens surgical safety

Editor's Note Sterile processing departments (SPDs) face chronic staffing shortages and underinvestment that put surgical patients at risk, according to a Surgical Directions September 18 report. It emphasizes that sterile processing technicians, who decontaminate, inspect, and sterilize every surgical instrument, remain under-recognized despite their central role in surgical safety. Per…

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By: Tarsilla Moura
September 24, 2025
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Suicide Prevention Month: Hospitals prepare for new The Joint Commission suicide prevention goal, effective 2026

Editor's Note Hospitals will soon face stronger accountability for suicide prevention, as The Joint Commission prepares to implement “National Performance Goal (NPG) 8” on January 1, 2026, its September 3 news update reports. The goal, titled “The hospital reduces the risk for suicide,” replaces current requirements under “National Patient Safety…

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By: Tarsilla Moura
September 3, 2025
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Lessons for leadership: Navigating change in times of persistent uncertainty

Healthcare has never been static, but today’s perioperative leaders face a unique challenge: steering teams through volatility, complexity, and rapid disruption. In a recent OR Manager webinar, Phyllis Quinlan, PhD, RN, NPD-BC, executive coach, nurse entrepreneur, and longtime advocate for caregiver resilience, offered a candid roadmap for change management in…

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By: Tarsilla Moura
August 28, 2025
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AAAHC unveils v44 standards to sharpen focus on patient-centered ambulatory care

Editor's Note The Accreditation Association for Ambulatory Health Care (AAAHC) released its v44 Standards, introducing new guidance designed to strengthen patient-focused care, streamline compliance, and align with evolving state regulations, an August 18 AAAHC announcement reports. As detailed in the news release, the v44 Standards, effective December 16, 2025, were…

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By: Tarsilla Moura
August 26, 2025
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Study: Preoperative behavioral health evaluations improve orthopedic recovery

Editor's Note Meeting with a health behavior psychologist before orthopedic surgery can help patients identify and overcome barriers to recovery, leading to better surgical outcomes, according to a University of Missouri School of Medicine July 31 news article covering a study published in the Journal of Knee Surgery. The study…

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By: Tarsilla Moura
August 21, 2025
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2026 ICD-10 updates bring hundreds of new codes, new complexity

Editor's Note Healthcare providers, payers, and analytics teams face sweeping ICD-10 changes this fall, with the 2026 code updates taking effect October 1, 2025, Wolters Kluwer July 14 reports. The release includes 614 new codes, 12 invalidations, 642 billability changes, 88 terminology revisions, and the creation of an entirely new…

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By: Tarsilla Moura
August 21, 2025
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Standardized pathways cut costs, hospital days in pediatric surgery without raising complication rates

Editor's Note Standardized perioperative protocols can reduce hospital stays and costs for children undergoing surgery without affecting complication rates, JAMA Surgery August 20 reports. As detailed in this original investigation, the researchers evaluated the Minimizing Variance in Pediatric Surgery (MViPS) program, a fellow-led initiative launched in 2013 across two academic…

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By: Tarsilla Moura
August 20, 2025
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