Regulations/Legal

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June 2019
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FDA: Class I recall of Integra LifeSciences CSF drainage, ICP monitoring systems

Editor's Note The Food & Drug Administration on May 24 identified the recall by Integra LifeSciences of its LimiTorr Volume Limiting Cerebrospinal Fluid (CSF) Drainage System and the MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring System as Class I, the most serious. The recall was initiated because of…

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By: Judy Mathias
May 28, 2019
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Joint Commission issues Quick Safety on disinfection of tonometers, other ophthalmology devices

Editor's Note The Joint Commission on May 21 issued Quick Safety 49: Disinfection of tonometers and other ophthalmology devices. The Joint Commission noted that the American Academy of Ophthalmology has reported that transmission of adenovirus and herpes simplex virus HIV, hepatitis C virus, enterovirus 70, Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus,…

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By: Judy Mathias
May 23, 2019
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FDA grants Stryker premarket approval for intracranial aneurysm stent

Editor's Note Stryker announced on May 20 that the Food & Drug Administration (FDA) granted premarket approval for its Neuroform Atlas stent system for intracranial aneurysms, the May 20 MassDevice reports.   The self-expanding nitinol stent can now be used with neurovascular embolization coils to treat patients with saccular wide-necked…

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By: Judy Mathias
May 23, 2019
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FDA letter updates mortality risk in patients receiving Abiomed Impella RP System

Editor's Note The Food and Drug Administration (FDA) on May 21 released a letter to healthcare professionals about the most recent, interim post-approval study (PAS) results for the Abiomed Impella RP System, a percutaneous heart pump for right heart support.   The latest interim results show a lower survival rate…

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By: Judy Mathias
May 22, 2019
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IV bags of normal saline, D5W do not support bacterial growth 24 hours after spiking

Editor's Note No bacterial growth was found in any of 257 samples of normal saline and dextrose 5% in water (D5W) 24 hours after using standard sterile techniques to spike them in the perioperative area. Two 1000 mL bags of IV normal saline and D5W were spiked and hung in…

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By: Judy Mathias
May 20, 2019
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You may also be interested in these sessions at the OR Manager Conference this September in Nashville, TN

Ace the Test: Strategies for a Successful Joint Commission Survey

After this session you'll be able to: Summarize 2019 Joint Commission (TJC) standards and Centers for Medicare & Medicaid Services (CMS) regulations pertinent to Surgical Services. Develop strategies to ensure ongoing compliance and survey readiness. Understand methodologies surveyors use to assess compliance. Why this is important: Is your team prepared…

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FDA issues warning on use of unauthorized devices for diabetes management

Editor's Note The Food & Drug Administration (FDA) on May 17 issued a warning to patients and healthcare professionals on the risks associated with the use of unapproved or unauthorized devices for diabetes management, including continuous glucose monitoring systems, insulin pumps, and automated insulin dosing systems. The use of these…

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By: Judy Mathias
May 20, 2019
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Editorial

Nearly 40 “awareness” or prevention and education wellness initiatives are listed for the month of May—among them, National Nurses Week, World Hand Hygiene Day, and Mental Health Month. Mental health caught my eye because it was a featured topic at the World Healthcare Congress in Washington, DC, where a panel…

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By: Elizabeth Wood
May 17, 2019
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FDA: Class I recall of Ethicon circular staplers

Editor's Note The Food and Drug Administration (FDA) on May 16 identified the recall by Ethicon of its Endo-Surgery and Endo-Surgery Endoscopic Curved Intraluminal Staplers with adjustable height staples as Class I, the most serious. The recall was initiated because Ethicon confirmed that uncut washers in the staplers and malformed…

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By: Judy Mathias
May 16, 2019
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Performance on patient safety measures linked to hospital financial performance

Editor's Note Hospitals that perform better on measures to prevent postoperative complications also have better performance on measures of profitability, this study finds. Improved patient safety performance was associated with higher net patient revenue for five of seven Surgical Care Improvement Project (SCIP) measures, including starting and stopping preventive antibiotics…

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By: Judy Mathias
May 16, 2019
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Joint Commission offers accredited hospitals real-time quality metrics

Editor's Note The Joint Commission on May 14 announced that it is expanding its quality measure program to provide accredited hospitals with year-round, real-time access to quality measures without additional outside vendors. The Joint Commission can now use a single environment to specify, develop, test, and distribute clinical quality language…

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By: Judy Mathias
May 15, 2019
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You may also be interested in these sessions at the OR Manager Conference this September in Nashville, TN

2019 Regulatory and Quality Measure Reporting Update for ASCs

After this session you'll be able to: Discuss the most current updates to federal regulations and what to expect in 2020. Identify quality reporting for ambulatory surgery centers (ASCs) required by the Centers for Medicaid & Medicare Services (CMS). State the recent changes to the ASC quality reporting program. Why…

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