Regulations/Legal

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June 2019
Home Regulations/Legal

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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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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You may also be interested in these sessions at the OR Manager Conference this September in Nashville, TN

The Road to Zero! Meeting Compliance After TJC Survey Using the SAFER Matrix

After this session you’ll be able to: Explain the SAFER Matrix used by The Joint Commission (TJC)., Discuss how to assess risk using mitigation strategies for compliance to the SAFER Matrix., Identify tools for creating and implementing required corrective action plans., Why this is important: The SAFER Matrix has been…

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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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CDC: No significant change in 2018 uninsured rate

Editor's Note The Centers for Disease Control and Prevention (CDC) on May 9 released a National Health Interview Survey that found an estimated 9.4% of US residents (30.4 million people) lacked health insurance in 2018, which is not significantly different than in 2017, but it is 18.2 million fewer than…

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By: Judy Mathias
May 13, 2019
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CDC: Hepatitis A infections up nearly 300%

Editor's Note In the May 10 Morbidity and Mortality Weekly Report, the Centers for Disease Control and Prevention reported that hepatitis A infections were up 294% in 2016-2018, compared with 2013-2015. The increases are related to outbreaks among homeless people, men who have sex with men, people who use drugs,…

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By: Judy Mathias
May 13, 2019
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CMS Physician Compare website lacks physician data

Editor's Note The Centers for Medicare & Medicaid Services (CMS) Physician Compare website contains quality information on just 23.3% of the more than 1 million physicians who care for Medicare patients, this study finds. A total of 76.6% of physician had no performance data, and almost none (99.7%) listed on…

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By: Judy Mathias
May 9, 2019
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You may also be interested in these sessions at the OR Manager Conference this September in Nashville, TN

2019 Update on Sterilization & Disinfection Standards

After this session you’ll be able to: Describe new changes to sterilization standards and guidelines., Discuss high non-compliance areas related to sterilization and disinfection., Identify how these changes can be incorporated into departmental procedures., Why this is important: With the increased complexity in medical devices that comes with advanced research,…

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