Supply Chain/Technology

Latest Issue of OR Manager
January 2019
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FDA: Class I recall of Endologix AFX Endovascular AAA System

Editor's Note The Food & Drug Administration on October 15 classified the recall by Endologix, Inc, of its AFX Endovascular AAA System as Class I, the most serious. The recall was initiated because of the risk of Type III endoleaks. When a Type III endoleak occurs, blood continues to flow…

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By: Judy Mathias
October 23, 2018
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Surgeons to monitor hip, knee patients using Apple Watches

Editor's Note Zimmer Biomet and Apple Inc have begun a multiyear study that will allow surgeons to use Apple Watches to monitor activities, including heart rate, steps taken, and standing hours of up to 100,000 patients before and after hip and knee replacement surgery, the October 15 Reuters reports. Providers…

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By: Judy Mathias
October 18, 2018
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FDA announces public workshop on management of cybersecurity in medical devices

Editor's Note The Food & Drug Administration (FDA) on October 17 announced a public workshop to discuss the newly released draft guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The need for effective cybersecurity to ensure medical device function and safety has become more important with…

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By: Judy Mathias
October 18, 2018
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FDA, DHS increase coordination for medical device cybersecurity

Editor's Note The Food and Drug Administration (FDA) on October 16 announced that as part of the Administration’s efforts to strengthen cybersecurity in healthcare, the FDA and Department of Homeland Security (DHS) have agreed to greater coordination and cooperation for addressing cybersecurity in medical devices. Under the agreement, DHS will…

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By: Judy Mathias
October 17, 2018
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FDA: Endo Pharmaceuticals recalls two lots of Robaxin

Editor's Note The Food & Drug Administration on September 28 announced the recall by Endo Pharmaceuticals Inc of two lots of Robaxin 750 mg tablets because of incorrect dosing information on the label. Robaxin contains methocarbamol, which is used as a muscle relaxant. Patients who follow the incorrect dosing information…

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By: Judy Mathias
October 4, 2018
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Trends, characteristics of health data breaches

Editor's Note Despite ethical and legal obligations to protect patient privacy and efforts to establish best practices for healthcare information security, breach rates have increased since 2010, this study finds. Of 2,149 breaches that involved 176.4 million records, the most common entities breached were healthcare providers, with 1,503 breaches that…

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By: Judy Mathias
October 2, 2018
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FDA announces framework for strengthening medical device cybersecurity

Editor's Note The Food & Drug Administration (FDA) on October 1 released a “Playbook,” developed by the Medical Device Cybersecurity Regional Incident Preparedness and Response (MITRE) Corp, to assist hospitals and other healthcare providers respond to cybersecurity incidents involving medical devices, the American Hospital Association reports.  The MITRE Playbook outlines…

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By: Judy Mathias
October 2, 2018
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ECRI Institute releases 2019 Top 10 Health Technology Hazards

Editor's Note The ECRI Institute on October 1 released its 2019 Top 10 Health Technology Hazards. Among the hazards: First is cybersecurity attacks Second is blood and body fluids on mattresses after cleaning Third is retained sponges Fifth is mishandling flexible endoscopes after disinfection Ninth is cleaning fluid seeping into…

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By: Judy Mathias
October 1, 2018
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FDA: Oscor Inc recalls TB-Temporary Bipolar Pacing Leads

Editor's Note The Food and Drug Administration (FDA) on September 27 announced the recall by Oscor Inc (Palm Harbor, Florida) of its TB-Temporary Bipolar Pacing Leads, with 2 mm unshrouded connectors. The recall was initiated because the connector cap housing may slide and expose the connection wire. This may cause…

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By: Judy Mathias
September 28, 2018
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FDA: Getinge recalls Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump

Editor's Note The Food and Drug Administration (FDA) on September 30 posted an announcement by Getinge that it is voluntarily initiating a worldwide recall involving a field correction of some 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp. The recall is because of the potential for interruption…

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By: Judy Mathias
September 25, 2018
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