Tag: Patient Safety

FDA issues Safety Communication on cybersecurity vulnerabilities in Medtronic cardiac devices

Editor's Note The Food & Drug Administration on March 21 issued a Safety Communication on cybersecurity vulnerabilities identified in wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers, and home monitors. Medtronic (Dublin, Ireland) is working on updates to address the vulnerabilities and recommends that healthcare…

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By: Judy Mathias
March 25, 2019
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Effect of care bundle on emergency laparotomy outcomes

Editor's Note Hospitals should consider adopting a care bundle approach to improve outcomes for emergency laparotomy patients, this study finds. In this analysis of 14,809 patients in 28 hospitals in the UK, reduction in unadjusted mortality (from 9.8% to 8.3%) and length of stay (from 20.1 days to 18.9 days)…

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By: Judy Mathias
March 21, 2019
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Joint Commission: eCQM Proven Practices must be submitted by April 5

Editor's Note The Joint Commission on March 20 announced that time is running out for organizations to submit applications for the 2019 Pioneers in Quality Proven Practices Collection. Applications must be submitted online by April 5. Among topics of interest: Demonstrating improvements in clinical performance or outcomes using electronic clinical…

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By: Judy Mathias
March 21, 2019
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Inhaled anesthetics vs total IV anesthesia for CABG surgery

Editor's Note In this study, having elective coronary artery bypass grafting (CABG) surgery under inhaled (ie, desflurane, isoflurane, or sevoflurane) anesthesia did not result in significantly fewer deaths than total intravenous (IV) anesthesia, though inhaled agents have cardioprotective effects. A total of 5,400 patients at 36 centers in 13 countries…

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By: Judy Mathias
March 21, 2019
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FDA issues warning letters to two breast implant manufacturers

Editor's Note The Food & Drug Administration (FDA) on March 19 issued warning letters to two breast implant manufacturers (Mentor Worldwide LLC of Irvine, California, and Sientra, Inc of Santa Barbara, California) for failing to comply with post-approval study requirements. All manufacturers of approved silicone gel-filled implants are required to…

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By: Judy Mathias
March 21, 2019
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Cleveland Clinic launches new artificial intelligence center

Editor's Note The Cleveland Clinic has launched a new Center for Clinical Artificial Intelligence, which will focus on applying machine learning to healthcare diagnostics, predictive analytics, and treatment planning, the March 13 Health IT Analytics reports. As part of the Cleveland Clinic Enterprise Analytics division, the new center will analyze…

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By: Judy Mathias
March 20, 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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Effect of hospital intervention, state legislation on postop opioid prescribing practices

Editor's Note After a hospital-wide intervention and state-wide legislation, this community hospital in Michigan achieved a 60%-70% decrease in postoperative opioid prescriptions and less variation in opioid prescription practices. This retrospective study of opioid naïve adult patients who had one of five general surgical procedures between 2015 and 2017 found…

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By: Judy Mathias
March 18, 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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