Supply Chain/Technology

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December 2017
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Lumbar spine fusion market set for growth

Editor's Note Analysis by 360 Market Updates estimates that the lumbar spine fusion market will see a compound annual growth rate of 4.9% through 2021, the September 15 Becker’s Spine Review reports. A key driver of growth is the increasing popularity of physician-owned ambulatory surgery centers. DePuy Synthes, Medtronic, Stryker,…

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By: Judy Mathias
September 18, 2017
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FDA: OriGen recalls two lots of dual lumen ECMO catheters

Editor's Note The Food and Drug Administration (FDA) on September 13 announced the recall by OriGen Biomedical (Austin, Texas) of two lots of its VV28F Reinforced Dual Lumen ECMO [extracorporeal membrane oxygenation] Catheters (Catalog number VV28F, Lots N18487 and V18487-1). The recall was initiated because the catheters have the potential…

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By: Judy Mathias
September 14, 2017
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Children’s Hospital Colorado alerts patients of data breach

Editor's Note Officials at Children’s Hospital Colorado in Aurora are sending notifications to nearly 3,400 patient families about a data breach that may have compromised their health information, according to the September 11 Becker’s Health IT & CIO Review. On July 11, investigators found an unauthorized person may have accessed…

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By: Judy Mathias
September 13, 2017
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FDA to staff new digital health unit

Editor's Note The Food and Drug Administration (FDA) is filling 13 positions in a new digital health unit that was created as part of the FDA Reauthorization Act of 2017, the September 11 FierceHealthcare reports. The FDA intends to build a group of experts who are experienced with software lifecycle…

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By: Judy Mathias
September 13, 2017
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FDA: Class I recall of Datascope/MAQUET intra-aortic balloon pumps

Editor's Note The Food and Drug Administration (FDA) on September 6 categorized the recall by Datascope/MAQUET of its CS100i, CS100, and CS300 intra-aortic balloon pumps as Class I, the most serious. The recall was initiated because of a false blood detection alarm and ingress of fluid into the balloon pump.…

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By: Judy Mathias
September 11, 2017
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FDA: Genetech recalls three lots of Activase

Editor's Note The Food and Drug Administration (FDA) on September 7 announced the recall by Genetech (South San Francisco, California) of three lots of Activase (alteplase) 100 mg vials that were co-packaged with sterile water for injection. The vials of water, manufactured by Hospira Inc (Lake Forest, Illinois), may be…

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By: Judy Mathias
September 11, 2017
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FDA: Recall of Hydromorphone HCL and Levophed Injection by Hospira

Editor's Note The Food and Drug Administration (FDA) on September 5 announced the recall by Hospira Inc (Lake Forest, Illinois) of one lot of Hydromorphone HCL injection, USP, CII 2 mg/mL and four lots of Levophed (norepinephrine bitartrate) injection because of a lack of sterility assurance resulting from a damaged…

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By: Judy Mathias
September 6, 2017
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FDA issues alert for alcohol pads, benzalkonium chloride antiseptic towelettes by Foshan Flying Medical Products

Editor's Note The Food and Drug Administration (FDA) on September 1 issued a Safety Alert notifying healthcare professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products Co Ltd (China) because of lack of sterility and other quality issues. Use of…

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By: Judy Mathias
September 6, 2017
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FDA: Hospira recalls one lot of vancomycin hydrochloride

Editor's Note The Food and Drug Administration (FDA) on August 31 announced the recall by Hospira Inc (Lake Forest, Illinois) of one lot of vancomycin hydrochloride for injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A. The recall was initiated because of a customer report of the presence of particulate matter,…

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By: Judy Mathias
September 5, 2017
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Effect of mandatory reporting system on prevalence of intraop adverse events

Editor's Note After implementation of an anesthesia information management system (AIMS)-based mandatory quality assurance process for reporting of intraoperative adverse events at two academic medical centers, documented adverse events decreased significantly, this study finds. Over a 2-year period after implementation of mandatory reporting, the adverse event rate at Thomas Jefferson…

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By: Judy Mathias
September 1, 2017
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