Supply Chain/Technology

Latest Issue of OR Manager
August 2019
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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…

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By: Judy Mathias
May 23, 2019
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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…

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By: Judy Mathias
May 22, 2019
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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…

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By: Judy Mathias
May 20, 2019
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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…

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By: Cynthia Saver, MS, RN
May 17, 2019
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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…

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By: Cynthia Saver, MS, RN
May 17, 2019
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What should you do if your sterilizer fails?

A sterilization failure is a significant event. Receiving a positive biological indicator (BI) result from a sterilizer can be devastating and presents a patient safety concern because it could result in infection. This article addresses the proper action to take in the event of a positive BI result and biological…

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By: Susan Klacik, BS, CRCST, CHL, CIS, ACE, FCS
May 17, 2019
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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…

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By: Jennifer Lubell
May 17, 2019
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FDA: Class I recall of Ethicon circular staplers

Editor's Note The Food and Drug Administration (FDA) on May 16 identified the recall by Ethicon of its Endo-Surgery and Endo-Surgery Endoscopic Curved Intraluminal Staplers with adjustable height staples as Class I, the most serious. The recall was initiated because Ethicon confirmed that uncut washers in the staplers and malformed…

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By: Judy Mathias
May 16, 2019
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FDA issues alert on premature battery depletion in certain Medtronic pacemakers

Editor's Note The Food & Drug Administration (FDA) on May 7 issued a Safety Alert on the risk for premature battery depletion in nearly 132,000 biventricular and conventional cardiac resynchronization therapy implantable pacemakers by Medtronic. The FDA is aware of three patients in which a battery fully drained because of…

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By: Judy Mathias
May 9, 2019
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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”…

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By: Judy Mathias
May 8, 2019
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