Supply Chain/Technology

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February 2019
Home Supply Chain/Technology

FDA: Class I recall of Edwards Lifesciences Swan-Ganz Thermodilution Catheter

Editor's Note The Food and Drug Administration (FDA) on February 5 identified the recall by Edwards Lifesciences (Irvine, California) of its Swan-Ganz Thermodilution Catheter as Class I, the most serious. The recall was initiated because of incorrect assembly and reversal of catheter lumens that can expose the patient to serious…

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By: Judy Mathias
February 14, 2019
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Medtronic recalls nearly 157,000 dual-chamber pacemakers

Editor's Note Medtronic published an urgent recall on January 7 for a subset of its dual-chamber pacemakers because some may temporarily lose their ability to pace the heart. The recall affects 156,957 devices distributed worldwide between March 10, 2017, and January 7, 2019, under the brand names Adapta, Versa, and…

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By: Judy Mathias
January 23, 2019
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Automated text messages improve joint replacement outcomes

Editor's Note An automated text messaging system increased patient engagement with home-based exercise and promoted faster recovery after knee and hip replacements, this study finds. In this analysis of 159 patients (83 controls, 76 intervention) having total knee or hip replacement surgery, those receiving timely texts showed improvement in the…

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By: Judy Mathias
January 22, 2019
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Robotics expanding rapidly in orthopedics, spine

Editor's Note The Healthcare Quarterly report by Moody’s Investors Service shows the orthopedics and spine sectors increasingly performing robotic-assisted procedures, the January 18 Becker’s Spine Review reports. This is resulting in strong growth for device firms with major investments in these specialties, particularly Medtronic with its Mazor robotics platform for…

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By: Judy Mathias
January 22, 2019
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FDA: Sun Pharmaceutical recalls four lots of Vecuronium Bromide

Editor's Note The Food & Drug Administration (FDA) on January 8 announced the recall by Sun Pharmaceutical Industries, Inc (Cranbury, New Jersey) of three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder) (Lots: JKS0443A, JKS0444A, JKS0477A), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder)…

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By: Judy Mathias
January 16, 2019
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Disruptive innovation in supply chain: Impact of Amazon Business and technology, Part 1

Supply chain is the lifeblood of the OR, so any disruption in the flow of that lifeblood can lead to outcomes ranging from dissatisfaction with backorders to chaos if a new implant doesn’t arrive on time. But disruption also can be a positive force, especially if it supports flow. When…

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By: Cynthia Saver, MS, RN
January 14, 2019
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Comprehensive ROI pitch helps to procure OR equipment

Multiple requests for new equipment and technology—usually from surgeons but also sometimes from staff—are not uncommon. As part of their due diligence, OR leaders must determine whether the return on investment (ROI) justifies the purchase. Doing ROI calculations systematically—and involving key stakeholders—can help ensure that the organization makes the best…

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By: Cynthia Saver, MS, RN
January 14, 2019
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Surgical VAC mines new software for deeper look at products

After transitioning from a paper-based data and operations management system to one that uses relational database software, Lahey Hospital and Medical Center (LHMC) in Burlington, Massachusetts, saved more than $1 million in product purchases in 2017. The surgical value analysis committee (VAC) evaluated 150 product requests and managed the conversion…

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By: Robert Dolan, MD,, Kristen Murphy, MBA, and Edward Aiello
January 14, 2019
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FDA: Class I recall of Medtronic’s Synergy, Stealth Station S7 Cranial Software

Editor's Note The Food & Drug Administration (FDA) on January 8 identified the recall of Medtronic’s Synergy Cranial Software and Stealth Station S7 Cranial Software as Class I, the most serious. The Software is used with the Stealth Station Surgical Navigation System to provide detailed 3D images of a patient’s…

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By: Judy Mathias
January 10, 2019
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FDA Pre-Cert Pilot Program to promote more efficient review of digital health innovations

Editor's Note The Food and Drug Administration (FDA) on January 7 issued a statement from Commissioner Scott Gottlieb, MD, on the agency’s new actions under the Digital Health Pre-Certification (Pre-Cert) Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations. Because digital…

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By: Judy Mathias
January 8, 2019
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