Supply Chain/Technology

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June 2019
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Study: TAVR equal to or better than surgery

Editor's Note This study comparing transcatheter aortic valve replacement (TAVR) with standard open-heart surgery found no difference in stroke or death from any cause at 2 years follow-up. The findings were presented March 17 at the American College of Cardiology’s Annual Scientific Session in New Orleans. A total of 1,468…

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By: Judy Mathias
March 19, 2019
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FDA: Class I recall of Cook Medical’s Transseptal Needle

Editor's Note The Food and Drug Administration on March 18 identified the recall by Cook Medical Inc (Bloomington, Indiana) of one lot of its Transseptal Needles as Class I, the most serious. The recall was initiated because of a manufacturing error that resulted in some needle tips missing the back…

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By: Judy Mathias
March 19, 2019
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FDA: Hospira recalls 8.4% Sodium Bicarbonate Injection

Editor's Note The Food and Drug Administration (FDA) on March 15 announced the recall by Hospira, Inc (a Pfizer company) of three lots of its 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL). The recall was initiated because of the presence of particulate matter, confirmed as glass. The…

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By: Judy Mathias
March 18, 2019
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FDA: Guardian Pharmacy ordered to stop producing sterile compounded drugs

Editor's Note The Food & Drug Administration on March 12 announced that a federal judge entered a consent decree against Guardian Pharmacy Services (Dallas, Texas) to stop the company from producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic (FD&C)…

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By: Judy Mathias
March 14, 2019
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Levels of innovativeness in nurse executives, managers, clinical directors

Editor's Note Understanding the levels and components of innovativeness can help nurse leaders affect change in themselves and their organizations, this study concludes. A total of 137 nurse leaders in executive and management positions were surveyed on their levels of innovativeness using the Scales for Measurement of Innovativeness. Of 137…

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By: Judy Mathias
March 7, 2019
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FDA: Class I recall of RVO 2.0 Raindrop near vision inlay

Editor's Note The Food & Drug Administration (FDA) on March 5 identified the recall by RVO 2.0, Inc (Aliso Viejo, California) of its Raindrop near vision inlay as Class I, the most serious. All lots of the inlay are being recalled because data from the post-approval study showed an increased…

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By: Judy Mathias
March 6, 2019
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FDA issues Safety Communication on using surgical robots in women’s health

Editor's Note The Food and Drug Administration (FDA) on February 28 issued a Safety Communication on the safety and effectiveness of using robotically-assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer in women. The FDA cited limited, preliminary evidence that the use of robotically-assisted surgical…

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By: Judy Mathias
March 5, 2019
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FDA: Class I recall of Physio-Control LIFEPAK 15 Monitor/Defibrillator

Editor's Note The Food & Drug Administration (FDA) on February 27 identified the recall by Physio-Control, Inc (Redmond, Washington) of its LIFEPAK 15 Monitor/Defibrillator as Class I, the most serious. The recall was initiated because the device may “lockup” (freeze) after a shock is delivered. Once it freezes, it cannot…

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By: Judy Mathias
February 28, 2019
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Joint Commission accepting applications for leaders in eCQM proven practices

Editor's Note The Joint Commission announced on February 27 that in support of organizations adopting electronic clinical quality measures (eCQMs), it is accepting applications from accredited hospitals and health systems for the “2019 Pioneers in Quality Proven Practices Collection.” The organizations’ success stories can be used as learning tools to…

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By: Judy Mathias
February 28, 2019
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Unnecessary UTI testing cut by 45%

Editor's Note Making a simple change to the electronic system used by physicians to order urine tests can cut by 45% the number of bacterial cultures ordered without compromising the identification of patients who need treatment for urinary tract infections (UTIs), this study finds. In this analysis of 18,954 patients…

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By: Judy Mathias
February 25, 2019
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