Supply Chain/Technology

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August 2018
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Study: Medical device tax hurts investment in R&D

Editor's Note: This study from Iowa State University shows companies have cut funding for research and development (R&D) in response to the medical device tax imposed by the Affordable Care Act. Since 2013, the 2.3% excise tax has significantly reduced: R&D investment by $34 million Sales revenue by $188 million…

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By: Judy Mathias
June 6, 2018
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FDA: New labeling for liquid-filled intragastric balloons

Editor's Note The Food & Drug Administration on June 4 announced that it had approved new labeling on potential risks for liquid-filled intragastric balloons by Apollo Endosurgery and ReShape Lifesciences. The new labeling for the Orbera and ReShape balloon systems includes more information about possible deaths linked to the use…

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By: Judy Mathias
June 6, 2018
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FDA: Recall of STAT-Check and Medline manual resuscitator bags

Editor's Note The Food & Drug Administration on June 1 announced the recall by SunMed Holdings of 18,808 units of its STAT-Check and Medline manual resuscitator bags. The recall was initiated because the patient port retaining ring of the bags may not fully seat, which could allow the patient port…

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By: Judy Mathias
June 5, 2018
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FDA: Class I recall of HeartWare HVAD system by Medtronic

Editor's Note The Food & Drug Administration on June 1 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) system as Class I, the most serious. The recall was initiated because of the possibility for an interruption to occur in the electrical connection between the system’s power…

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By: Judy Mathias
June 4, 2018
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Report predicts spinal implant, surgical devices market growth

Editor's Note A Crystal Market Research report predicts the spinal implant and surgical devices market will top $15.7 billion by 2025, with a compound annual growth rate of 4.44%, according to the May 24 Becker’s Spine Review. The market will grow because of the rising geriatric population and enhanced technology.…

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By: Judy Mathias
June 1, 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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