FDA grants Stryker premarket approval for intracranial aneurysm stent
Editor's Note Stryker announced on May 20 that the Food & Drug Administration (FDA) granted premarket approval for its Neuroform Atlas stent system for intracranial aneurysms, the May 20 MassDevice reports. The self-expanding nitinol stent can now be used with neurovascular embolization coils to treat patients with saccular wide-necked…
FDA letter updates mortality risk in patients receiving Abiomed Impella RP System
Editor's Note The Food and Drug Administration (FDA) on May 21 released a letter to healthcare professionals about the most recent, interim post-approval study (PAS) results for the Abiomed Impella RP System, a percutaneous heart pump for right heart support. The latest interim results show a lower survival rate…
FDA issues warning on use of unauthorized devices for diabetes management
Editor's Note The Food & Drug Administration (FDA) on May 17 issued a warning to patients and healthcare professionals on the risks associated with the use of unapproved or unauthorized devices for diabetes management, including continuous glucose monitoring systems, insulin pumps, and automated insulin dosing systems. The use of these…
How will artificial intelligence impact surgical patient care? Part 2
As part of a special series on artificial intelligence (AI), OR Manager is taking a deep dive into the many facets of this new technology and its impact on patient care. Part 1 of this introduction to the series (OR Manager, May 2019, 1, 7-11) defined several different types of…
Artificial intelligence makes surgical 'black box' smarter
Perioperative services departments have been slow to adopt the black boxes used in the aviation industry, partly because it can take a large team of experts hours to analyze data collected by the box. However, the team behind a surgical black box is using artificial intelligence (AI) to significantly cut…
Cardiology services: The next wave in ASCs?
Many experts see cardiovascular (CV) care as the next wave in ambulatory surgery centers (ASCs), and a hybrid office-based lab (OBL)/ASC model is gaining momentum across the country. Robert J. Zasa, MSHHA, FACMPE, president and CEO of Ambulatory Systems Development, LLC, in Incline Village, Nevada, sees the hybrid arrangement as…
Patient, surgeon outcomes reporting app helps predict success of ventral hernia repair
Editor's Note Researchers have developed an online app that patients and surgeons can use to guide preoperative planning and provide predictive data for how a patient’s ventral hernia repair will turn out. The basis of the app is a tool named the “Outcomes Reporting App for CLinical and Patient Engagement”…
Use of TAVR in low-risk patients
Editor's Note In this study of low-risk patients with severe aortic stenosis, outcomes were significantly better at 1 year follow-up with transcatheter aortic-valve replacement (TAVR) than surgical aortic-valve replacement. In 1,000 patients at 71 centers who were randomized to undergo either TAVR or surgical aortic-valve replacement, the rate of the…
Off-label use of simethicone, lubricants, and tissue glue contributes to endoscope reprocessing failures
Editor's Note The off-label use of defoaming agents, lubricants, and tissue glue is common, and these insoluable substances are not removed during reprocessing, this study finds. Of 69 fully reprocessed endoscopes examined in four hospitals, microbial cultures were positive for 50% or more. The researchers, led by Cori Ofstead, MSPH,…
FDA announces new efforts to protect patients from risks associated with surgical staplers, implantable staples
Editor's Note The Food & Drug Administration on April 23 announced new steps it will be taking to help reduce risks associated with surgical staplers for internal use and implantable staples. The proposed steps include: Reclassifying surgical staplers from Class I (low risk) to Class II (moderate risk). Issuing guidance to…
Free Daily News
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- New studies, surgical feats advance organ transplant medicine
- Commentary: Cyberattacks threaten financial survival of surgical practices
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- Literature review: Endoscope disinfection failures highlight need for stronger sterilization practices
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- OAS CAHPS compliance soars to 96% among ASCs, vendor satisfaction also improves
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