Regulations/Legal

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June 2019
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FDA issues Safety Communication for Stryker Wingspan Stent System

Editor's Note The Food and Drug Administration (FDA) on April 25 issued a Safety Communication on use of the Stryker Wingspan Stent System outside of approved indications. The Wingspan Stent System is used to open narrowed arteries in the brains of patients with intracranial stenosis who are experiencing repeated strokes.…

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By: Judy Mathias
April 29, 2019
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FDA issues draft guidance on initiating voluntary recalls

Editor's Note The Food and Drug Administration (FDA) on April 23 issued a new draft guidance to help manufacturers avoid delays in preparing, planning, and executing voluntary recalls. The guidance includes recommendations in three areas: proper training of personnel thorough and organized record keeping written recall initiation procedures. The guidance…

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By: Judy Mathias
April 25, 2019
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Joint Commission announces updates to E-dition

Editor's Note The Joint Commission on April 24 announced that it will be posting spring 2019 updates to the E-dition® of its accreditation and certification manuals in May. The changes, which can be viewed on an organization’s Joint Commission Connect® extranet site, will go into effect July 1 unless otherwise…

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By: Judy Mathias
April 25, 2019
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FDA considering additional regulatory actions to reduce duodenoscope risks

Editor's Note The Food & Drug Administration on April 16 announced it is considering additional regulatory actions, including consulting with federal health experts for guidance, to reduce the risks of contamination and infections associated with duodenoscopes. The FDA is also working with manufacturers of disposable duodenoscopes that would make reprocessing…

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By: Judy Mathias
April 23, 2019
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FDA announces new efforts to protect patients from risks associated with surgical staplers, implantable staples

Editor's Note The Food & Drug Administration on April 23 announced new steps it will be taking to help reduce risks associated with surgical staplers for internal use and implantable staples. The proposed steps include: Reclassifying surgical staplers from Class I (low risk) to Class II (moderate risk). Issuing guidance to…

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By: Judy Mathias
April 23, 2019
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Study: CMS policy changes cut readmission fines

Editor's Note The Centers for Medicare & Medicaid Services (CMS) recent changes to its Hospital Readmission Reduction Program resulted in a drop in readmission fines for academic, safety-net, and rural hospitals, this study finds. This analysis of 3,049 hospitals found that because of policy changes that now separate hospitals into…

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By: Judy Mathias
April 22, 2019
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FDA orders manufacturers to stop selling gynecologic mesh

Editor's Note The Food and Drug Administration (FDA) on April 16 announced that it had ordered manufacturers of surgical mesh products indicated for transvaginal repair of pelvic organ prolapse to stop selling and distributing their products in the US, immediately. The FDA has determined that manufacturers, Boston Scientific and Coloplast,…

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By: Judy Mathias
April 22, 2019
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Vigilance best protects ASCs from workplace violence

Violence is a fact of life in healthcare settings. The Occupational Safety and Health Administration estimates that, on average, healthcare workers are four times as likely to be victimized as those in private industry. Most types of violent incidents involve patients or visitors acting out against staff, accounting for 93%…

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By: Jennifer Lubell
April 22, 2019
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Accuracy of surgical procedure valuations in Medicare’s Fee Schedule

Editor's Note The Center’s for Medicare and Medicaid Services (CMS) is legally responsible for setting and updating the work element of its relative value units (RVUs), which form the Medicare Physician Fee Schedule used to determine physician payments. In practice, however, updating what is known as the “work RVU” is…

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By: Judy Mathias
April 18, 2019
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FDA continues efforts to assess duodenoscope contamination risk

Editor's Note The Food & Drug Administration (FDA) on April 12 announced that it is taking steps to implement additional regulatory actions, including consulting with federal health experts, on how to reduce the risks of contamination and infections linked to duodenoscopes. The agency is also collaborating with manufacturers of disposable…

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By: Judy Mathias
April 18, 2019
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