Supply Chain/Technology

Latest Issue of OR Manager
February 2020
Home Supply Chain/Technology

FDA updates device failure linked to Getinge’s Maquet/Datascope Intra-aortic Balloon Pumps

Editor's Note The Food and Drug Administration (FDA) on November 19 updated the device failure associated with Getinge’s Maquet/Datascope Intra-aortic Balloon Pumps (IABPs) in a letter to health care providers. Since 2017, the FDA has received more than 75 reports of the IABPs shutting down while running on battery. Five…

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By: Judy Mathias
November 20, 2019
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AI evaluation of ECGs predicts irregular heart rhythm, death risk

Editor's Note Artificial intelligence (AI) was able to predict which patients were likely to develop an irregular heart rhythm, even when physicians interpreted results as normal, and identified patients at increased risk of dying of any cause within 1 year, in this study presented November 16 at the American Heart…

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By: Judy Mathias
November 18, 2019
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FDA clears first duodenoscope with disposable elevator component

Editor's Note The Food & Drug Administration (FDA) on November 15 announced that it had cleared for marketing in the US the first duodenoscope with a sterile, disposable elevator component. The clearance of the Pentax Medical Video ED34-i10T2 duodenoscope represents a major step toward lowering the risk of infection in…

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By: Judy Mathias
November 18, 2019
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2020 OR Business Management Conference around the corner

Anyone seeking a break from the winter weather and a stimulating educational experience will find both at the 2020 OR Business Management Conference (ORBMC), which takes place January 27-30 in Weston, Florida. The highly relevant and timely presentations, along with networking events that connect OR business professionals with colleagues and…

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By: Elizabeth Wood
November 18, 2019
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FDA: Class I recall of Zimmer Biomet’s ROSA Brain 3.0 Robotic Surgery System

Editor's Note The Food & Drug Administration on November 7 identified the recall by Zimmer Biomet of its ROSA Brain 3.0 Robotic Surgery System as Class I, the most serious. The recall was initiated because of a software issue that incorrectly positions the robotic arm. The company has received five…

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By: Judy Mathias
November 14, 2019
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ECRI Institute opposes proposed ban of EtO sterilization

Editor's Note ECRI Institute on November 7 announced that it opposes a total ban of commercial ethylene oxide (EtO) sterilization operations because it could result in widespread shortages of sterile medical devices. Hospitals around the country reported device shortages after a large Illinois-based sterilization plant closed because of state environmental…

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By: Judy Mathias
November 12, 2019
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Improving prediction of adverse surgical outcomes with machine learning algorithm

Editor's Note In this study, a new machine learning Complexity Score algorithm outperformed three commonly used risk scores in predicting postoperative morbidity, 30-day readmission, 90-day readmission, and postoperative surper-use. Study patients underwent colectomy, abdominal aortic aneurysm repair, coronary artery bypass grafting, total hip or knee replacement, or lung resection. The…

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By: Judy Mathias
November 6, 2019
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FDA: Class I recall of Philips Medical System’s Forte Gamma Camera System

Editor's Note The Food & Drug Administration (FDA) on November 4 identified Philips Medical System’s (Cleveland) recall of its Forte Gamma Camera System as Class I, the most serious. The recall was initiated because of the potential for the detector, which weighs 660 pounds, to become detached from the device…

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By: Judy Mathias
November 6, 2019
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Use of medical scribes improves workflow of surgeons, residents in an outpatient setting

Editor's Note Incorporating medical scribes into surgical practices to reduce time surgeons spend on patient documentation and managing electronic health records increases the number of patients seen by surgeons and residents in outpatient clinics, finds this study presented October 29 at the American College of Surgeons Clinical Congress 2019 in…

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By: Judy Mathias
November 5, 2019
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FDA: Class I recall of Abbott CentriMag Circulatory Support System

Editor's Note The Food and Drug Administration on November 4 identified the recall by Abbott of its CentriMag Circulatory Support System as Class I, the most serious. The recall was initiated because of a calibration system error resulting from electromagnetic interference that may cause the pump to slow or stop,…

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By: Judy Mathias
November 5, 2019
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