Regulations/Legal

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October 2019
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HHS forms group to streamline quality programs

Editor's Note The Department of Health and Human Services (HHS) announced on July 9 that it has formed a summit of key industry stakeholders and government leaders to provide insight as the Trump administration seeks to streamline, improve, and align measures used across federal healthcare quality programs. The Quality Summit,…

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By: Judy Mathias
July 11, 2019
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FDA: Class I recall of Edwards Lifesciences’ IntraClude Intra-Aortic Occlusion Device

Editor's Note The Food and Drug Administration on July 1 identified the recall by Edwards Lifesciences (Irvine, California) of its IntraClude Intra-Aortic Occlusion Device as Class I, the most serious. The recall was initiated because of a risk of balloon rupture during use in patients undergoing cardiopulmonary bypass. The company…

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By: Judy Mathias
July 9, 2019
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Joint Commission deletes annual training requirement for fluoroscopy equipment

Editor's Note The Joint Commission on June 26 announced that, effective immediately, Human Resources (HR) standard HR.01.05.03, element of performance (EP) 15, has been deleted from the Hospital, Critical Access Hospital, Ambulatory Care, and Office-Based Surgery accreditation programs. The deleted EP is: “The [organization] verifies and documents that individuals (including…

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By: Judy Mathias
June 27, 2019
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CMS finalizes coverage policy for TAVR

Editor's Note The Centers for Medicare & Medicaid Services (CMS) on June 21 issued final updates to its national coverage policy for Transcatheter Aortic Valve Replacement (TAVR). The update provides more flexibility in how centers meet volume requirements for performing TAVR, while emphasizing the importance of the heart team for…

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By: Judy Mathias
June 26, 2019
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FDA: Class I recall of Hudson RCI Sheridan, Sheridan Endotracheal Tubes

Editor's Note The Food & Drug Administration on June 21 identified the recall by Teleflex Medical (Wayne, Pennsylvania) of the Hudson RCI Sheridan and Sheridan Endotracheal Tubes as Class I, the most serious. The recall was initiated because of the risk of the Sheridan connector disconnecting from the breathing circuit.…

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By: Judy Mathias
June 25, 2019
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CMS selects ECRI Institute for NQIIC designation

Editor's Note The ECRI Institute on June 20 announced that the Centers for Medicare & Medicaid Services (CMS) had awarded it with the Network of Quality Improvement and Innovation Contractors (NQIIC) designation. With this designation and partnering with other quality improvement contractors under the new CMS Indefinite Delivery/Indefinite Quanity (IDIQ)…

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By: Judy Mathias
June 24, 2019
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Joint Commission announces new NAHQ report on quality competencies

Editor's Note The Joint Commission on June 19 announced that the National Association for Healthcare Quality (NAHQ) has issued a new report−“Key Workforce Competencies for Quality-Driven Healthcare”− that focuses on creating a new framework for competencies needed by healthcare organizations to meet new goals for quality-driven healthcare. Among the competencies:…

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By: Judy Mathias
June 19, 2019
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FDA: Class I recall of Cook Advance Enforcer 35 Focal-Force PTA Balloon Catheter

Editor's Note The Food & Drug Administration on June 18 identified the recall by Cook Incorporated (Bloomington, Indiana) of its Advance Enforcer 35 Focal-Force PTA Balloon Catheter 6 mm x 4 cm as Class I, the most serious. The recall was initiated because of multiple complaints of balloons bursting below…

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By: Judy Mathias
June 18, 2019
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Legal and ethical questions temper excitement about AI--Part 1

As part of a special series on artificial intelligence (AI), OR Manager is taking a deep dive into the many facets of this new technology and its impact on patient care. Part 1 and Part 2 of the introduction to AI (May 2019 and June 2019) defined types of AI…

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By: Cynthia Saver, MS, RN
June 18, 2019
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CDC investigating sepsis cases after platelet transfusions

Editor's Note The Centers for Disease Control and Prevention (CDC) announced June 14 in its Morbidity and Mortality Weekly Report that four hospital patients developed sepsis after receiving platelet transfusions contaminated with bacteria. The CDC found that the platelets contained Acinetobacter calcoaceticus-baumannii complex and Staphylococcus saprophyticus. The agency is still…

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By: Judy Mathias
June 17, 2019
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