Standards/Regulations

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December 2017
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FDA: Increased rate of major adverse events with Absorb GT1 Bioresorbable Vascular Scaffold

Editor's Note The Food and Drug Administration (FDA) on October 31 issued a Safety Alert saying that interim study results continue to show an increased rate of major adverse cardiac events and Bioresorbable Vascular Scaffold (BVS) thrombosis in patients receiving the Absorb GT1 BVS by Abbott Vascular (Abbott Park, Illinois),…

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By: Judy Mathias
October 31, 2017
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Joint Commission: New Sentinel Event Alert video on RSIs

Editor's Note The Joint Commission on October 25 announced a new Sentinel Event Alert video on Preventing Unintended Retained Foreign Objects, also known as retained surgical items (RSIs). The new video with Erin Lawler, a human factors engineer from the Joint Commission, explains how to maximize safety in the OR…

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By: Judy Mathias
October 25, 2017
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FDA: SCA pharmaceuticals recalls certain lots of injectable products

Editor's Note The Food and Drug Administration (FDA) on October 21 announced the recall by SCA Pharmaceuticals (Little Rock, Arkansas) of various lots of injectable products.  The recall was initiated because of the potential for the products to contain microbial contamination.  Many of the recalled products are used in anesthesia,…

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By: Judy Mathias
October 24, 2017
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FDA updates Safety Alert for St Jude defibrillators

Editor's Note The Food and Drug Administration (FDA) on October 19 issued an updated Safety Alert for implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators by St Jude Medical. Because batteries for the devices may fail earlier than expected, St Jude has made available a new battery performance management tool,…

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By: Judy Mathias
October 23, 2017
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FDA clears new surgical robot

  Editor's Note The Food and Drug Administration (FDA) on October 13 cleared the Senhance System (TransEnterix Surgical Inc, Morrisville, North Carolina), a new robotically-assisted surgical device. The design of the Senhance System allows surgeons to sit at a console unit that provides a 3-D high-definition view of the surgical…

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By: Judy Mathias
October 18, 2017
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Joint Commission abandons proposed telehealth standards

Editor's Note The Joint Commission has abandoned proposed amendments to its accreditation standards that would have required healthcare systems to obtain patient consent, confirm patient location, and predict a patient’s financial responsibility before providing telehealth services, the October 11 mHealth Intelligence reports. The changes, which would have amended two existing…

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By: Judy Mathias
October 16, 2017
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CMS moving MU attestation to QualityNet Secure Portal

Editor's Note The Centers for Medicare & Medicaid Services (CMS) is moving submission of 2017 meaningful use (MU) data from the Electronic Health Record (EHR) Incentive Program Registration and Attestation System to the QualityNet Secure Portal (QNet), effective January 2, 2018, the October 4 EHR Intelligence reports. QNet is currently…

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By: Judy Mathias
October 9, 2017
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Joint Commission begins Phase 4 revisions of EP Review Project

Editor's Note The Joint Commission on October 4 announced that Phase 4 of the EP [elements of performance] Review Project has begun, with EPs across all accreditation programs being evaluated for streamlining and consolidation. Revisions from the first part of Phase 4 will take effect January 1, 2018. Consolidation is…

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By: Judy Mathias
October 9, 2017
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Joint Commission deletes Medication Management EP

Editor's Note The Joint Commission announced on October 4 that it is deleting element of performance (EP) 3 for Medication Management 09.01.01 for hospitals and critical access hospitals, effective October 1. The standard states: “The [critical access] hospital educates patients, and their families as needed, regarding the appropriate use of…

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By: Judy Mathias
October 5, 2017
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FDA issues Safety Alert for intraocular TMV injections

Editor's Note The Food & Drug Administration (FDA) on October 3 issued a Safety Alert saying the agency had received an adverse event report on a patient who was diagnosed with bilateral hemorrhagic occlusive retinal vasculitis after being administered injections of a compounded triamcinolone, moxifloxacin, vancomycin (TMV) formulation in each…

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By: Judy Mathias
October 5, 2017
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