Supply Chain/Technology

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June 2018
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FDA: Class I recall of HeartMate 3TM Left Ventricular Assist System

Editor's Note The Food and Drug Administration on May 22 identified the recall by Abbott of all lots of its HeartMate 3TM Left Ventricular Assist System as Class I, the most serious. The recall was issued because of a malfunction in the device’s outflow graft assembly that may cause the…

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By: Judy Mathias
May 22, 2018
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ECRI Institute research helped guide FDA report on medical device servicing

Editor's Note The ECRI Institute on May 21 announced that it had provided conclusive research to help guide the Food and Drug Administration’s (FDA) new “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices.” The FDA report, which addresses concerns about the quality of service provided…

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By: Judy Mathias
May 22, 2018
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FDA: Class I recall of Medtronic’s MindFrame Capture LP revascularization device

Editor's Note The Food and Drug Administration (FDA) on May 18 identified the recall of Medtronic’s MindFrame Capture LP revascularization device as Class I, the most serious. Medtronic is recalling the device because there is a risk of the delivery wire breaking or separating during use. The clot retriever, which…

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By: Judy Mathias
May 21, 2018
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ECRI Institute: Boston Medical Center wins 2018 Health Devices Achievement Award

Editor's Note The ECRI Institute on May 17 announced that Boston Medical Center had won the 2018 Health Devices Achievement Award for its patient-centric mobile pulmonary care app. The ICOUGH Recovery app guides patients through the hospitals postoperative pulmonary care protocol, which focuses on: Incentive spirometry Coughing and deep breathing…

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By: Judy Mathias
May 18, 2018
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Surgical Council facilitates service line moves between hospitals

To improve healthcare delivery and eliminate duplication, hospitals are banding together into systems in which specialties such as labor and delivery and smaller surgical cases are performed at satellite hospitals, and larger, more complex procedures are done at the main campus. This is the approach taken at the Cleveland Clinic,…

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By: Judith M. Mathias, MA, RN
May 18, 2018
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Determining if an Orthopedic Robotic Program Is Right for Your Surgical Suite

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FDA: Class I recall of Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit

Editor's Note The Food and Drug Administration (FDA) on May 11 announced the Class I recall, the most serious, of Vyaire Medical Inc's (Lake Forest, Illinois) AirLife Resuscitation Device & Broselow Convenience Kit. The recall was initiated because of an error in product design that may result in difficulty or…

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By: Judy Mathias
May 14, 2018
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FDA: AuroMedics Pharma recalls two lots of Piperacillin and Tazobactam for Injection

Editor's Note The Food and Drug Administration (FDA) on May 8 announced the recall by AuroMedics Pharma (Windsor, New Jersey) of two lots of Piperacillin and Tazobactam for Injection, USP 3.375 g in a single-dose vial. The vials were found to contain particulate matter after reconstitution that was confirmed to…

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By: Judy Mathias
May 14, 2018
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FDA: Class I recall of Fabius Anesthesia Machines by Dräger Medical

Editor's Note The Food and Drug Administration (FDA) on May 9 announced a Class I recall, the most serious, of Fabius Anesthesia Machines by Dräger Medical. The recall was initiated because of excessive oil that was not removed at the time of production. Excess oil may interfere with the position…

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By: Judy Mathias
May 11, 2018
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FDA sends letter to healthcare providers on neurovascular stents

Editor's Note The Food and Drug Administration (FDA) on May 8 sent a letter to healthcare providers that included recommendations on the use of neurovascular stents for stent-assisted coiling in the treatment of unruptured brain aneurysms. The FDA has received reports associated with these devices that suggest events of peri-procedural…

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By: Judy Mathias
May 9, 2018
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FDA: AuroMedics recalls two lots of Ampicillin and Sulbactam for Injection

Editor's Note The Food and Drug Administration (FDA) on May 8 announced the recall by AuroMedics Pharma (Windsor, New Jersey) of two lots of Ampicillin and Sulbactam for Injection USP, 3 g single-dose vials. The recall was issued because of customer complaints of the presence of red particulate matter in…

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By: Judy Mathias
May 9, 2018
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