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January 2019
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FDA: Class I recall of CyPass Micro-Stent Systems

Editor's Note The Food & Drug Administration (FDA) on October 24 classified Alcon Research’s recall of its CyPass Micro-Stent Systems as Class I, the most serious. The recall was initiated because of the risk of corneal endothelial cell loss with the system, which is used in conjunction with cataract surgery…

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By: Judy Mathias
October 30, 2018
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Joint Commission: 2019 National Patient Safety Goals now available

Editor's Note The Joint Commission announced on October 24 that the 2019 National Patient Safety Goals (NPSGs) are now available on its website. Included is a new element of performance (EP) for NPSG.01.01.01, EP3, which is designed to improve the naming convention of newborns after delivery to prevent medical errors…

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By: Judy Mathias
October 26, 2018
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Joint Commission: Cardiac certifications available to all hospitals

Editor's Note The Joint Commission on October 24 announced that beginning January 1, 2019, any hospital wanting to pursue the Advanced Certification in Heart Failure or Comprehensive Cardiac Center Certification will no longer have to be accredited by the Joint Commission. The Joint Commission says it is making this change…

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By: Judy Mathias
October 26, 2018
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Joint Commission Resources offers new survey readiness guide for surgical settings

Editor's Note  Joint Commission Resources on October 24 announced the availability of a new accreditation prep guide specific for surgical settings. “Survey Readiness Guide for Surgical Settings: Standards, Tracers, and Tools” is a self-assessment tool that includes all relevant Joint Commission accreditation standards and provides an overview of the survey…

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By: Judy Mathias
October 25, 2018
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FDA: Safety Communication on Raindrop Near Vision Inlay

Editor's Note The Food & Drug Administration (FDA) on October 23 issued a Safety Communication on the increased risk of corneal haze associated with the Raindrop Near Vision Inlay, which is surgically implanted in the cornea of one eye to improve near vision. The notice is to alert eye care…

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By: Judy Mathias
October 25, 2018
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FDA: Promise Pharmacy recalls one lot of Prednisolone, Gatifloxacin Ophthalmic Solution

Editor's Note The Food & Drug Administration (FDA) on October 22 announced the recall by Promise Pharmacy (Palm Harbor, Florida) of one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3 mL vials (Lot Number 09042018@2, Exp 12/03/2018). The recall was issued because the product was found to have…

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By: Judy Mathias
October 24, 2018
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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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CMS gives states more Medicaid waiver power, and flexibility to lower premiums

Editor's Note The Centers for Medicare & Medicaid Services (CMS) on October 22 issued guidance that gives state governors more power and flexibility in overhauling the rules and regulations of their Medicaid programs imposed by the Affordable Care Act and changes the way waivers are evaluated. Under the new policy,…

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By: Judy Mathias
October 22, 2018
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APIC, CDC develop tools to help prevent HAIs

Editor's Note The Association for Professionals in Infection Control and Epidemiology (APIC) and Centers for Disease Control and Prevention (CDC) on October 18 announced the availability of free, downloadable Quick Observation Tools to help facilities prevent healthcare associated infections (HAIs). The Tools include 20 sets of quick assessment forms that…

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By: Judy Mathias
October 19, 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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