Regulations/Legal

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March 2020
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House passes year-end bill that repeals ACA taxes including medical device tax

Editor's Note The US House of Representatives on December 17 passed a year-end spending bill that repeals several Affordable Care Act (ACA) taxes, including the 40% tax on generous health insurance plans and the 2.3% tax on the sale of medical devices, the December 17 Reuters reports. The bill also…

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By: Judy Mathias
December 18, 2019
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FDA: Class I recall of Cook Medical’s CrossCath Support Catheters

Editor's Note The Food and Drug Administration (FDA) on December 17 identified the recall by Cook Medical of its CrossCath Support Catheters as Class I, the most serious. The recall was initiated because of a manufacturing error that may cause the radiopaque marker bands on the catheters to dislodge or…

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By: Judy Mathias
December 18, 2019
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Development of surgery-specific second victim peer support program

Editor's Note In this study, researchers at the Massachusetts General Hospital, designed, implemented, and assessed the effect of the first surgery-specific peer support program in the US. The program uses five steps: creation of a conceptual framework choice of peer supporters training of peer supporters multifaceted identification of major adverse…

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By: Judy Mathias
December 17, 2019
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Boston Scientific receives FDA clearance for single-use duodenoscope

Editor's Note Boston Scientific announced December 13 that it had received Food & Drug Administration (FDA) 510(k) clearance for the EXALT Model D Single-Use Duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. The EXALT Model D, which was granted Breakthrough Device Designation from the FDA, eliminates the need for…

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By: Judy Mathias
December 17, 2019
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CMS expects greater scrutiny from Joint Commission surveyors

The start of a new year includes OR Manager’s annual updates on Joint Commission standards—an effort to help OR leaders ensure their facilities are in compliance. With increasingly stringent expectations from the Centers for Medicare & Medicaid Services (CMS), the Joint Commission and other accreditation organizations are under pressure to…

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By: OR Manager
December 17, 2019
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To avoid penalties, know the rules for quality reporting

Keeping up with Medicare’s regulatory and reporting requirements for ambulatory surgery centers (ASCs) can be as difficult as ensuring physicians arrive to start their cases on time. “Regulations can change frequently,” says Gina Throneberry, MBA, RN, CASC, CNOR, director of education and clinical affairs for the Ambulatory Surgery Center Association…

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By: OR Manager
December 17, 2019
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FDA: Medtronic recalls SynchroMed II implantable drug infusion pump

Editor's Note The Food and Drug Administration (FDA) on December 16 announced that Medtronic has recalled its SynchroMed II implantable infusion pump. The pump is being recalled because of the potential presence of foreign particles inside the pump motor assembly that may lead to a pump motor stall. Medtronic has…

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By: Judy Mathias
December 16, 2019
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Joint Commission transitioning to CMIP data submission app

Editor's Note The Joint Commission announced December 11 that starting January 1, 2020, it will no longer have contracts with ORYX chart-based vendors for accreditation or certification purposes. Hospitals with advanced certification programs must manually enter their performance measure data into the Certification Measure Information Process (CMIP) app on their…

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By: Judy Mathias
December 12, 2019
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Joint Commission surveys based on version of USP 797 chapter adopted

Editor's Note The Joint Commission announced December 11 that during the appeals process of he United States Pharmacopeia (USP) 797 chapter revisions, it will evaluate organizations based on the version they have adopted−either 2008 or the 2019 revised chapter. Organizations may not independently choose specific components from both versions, but…

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By: Judy Mathias
December 12, 2019
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Joint Commission: Password reset coming for single sign-on access to website

Editor's Note: The Joint Commission announced on December 4 that it will soon unveil a new website design with a single sign-on for multiple sites, including Joint Commission Connect, Targeted Solutions tool, and the Joint Commission Resources webstore. When the new website launches, users will be prompted to reset their…

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By: Judy Mathias
December 5, 2019
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