Tag: Safety

FDA issues final guidance for drug-device combo products

Editor's Note The Food & Drug Administration (FDA) on July 22 issued a final guidance for makers of products that combine devices and drugs or biologics. The guidance clarifies how manufacturers should comply with recordkeeping requirements and how they should submit safety reports and avoid duplication.

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By: Judy Mathias
July 25, 2019
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Effectiveness of ACS bleeding control training in laypeople

Editor's Note Laypeople currently trained in the American College of Surgeons (ACS) Bleeding Control Basic (B-Con) course may not be prepared to care for bleeding individuals because the principles for correct Combat Application Tourniquet (CAT) application taught in the course are not fully translatable to other commercial or improvised tourniquets,…

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By: Judy Mathias
July 25, 2019
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Legal and ethical questions temper excitement about AI--Part 2

As part of a special series on artificial intelligence (AI), OR Manager is taking a deep dive into the many facets of this new technology and its impact on patient care. In this issue we continue our examination of the challenges related to AI, which began in last month’s issue…

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By: Cynthia Saver, MS, RN
July 24, 2019
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Research raises concerns about lubricants used in endoscopes

Current endoscope reprocessing methods are not consistently effective in eliminating organic soil or microbes, and the off-label use of products for defoaming, lubrication, and bleeding control may be contributing to reprocessing failures. Though endoscope manufacturers have cautioned against the use of these products, endoscopists still commonly use them, and many…

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By: Judith M. Mathias, MA, RN
July 24, 2019
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Are you prepared for the OR of the Future?

Innovative technology and surgical procedures, including artificial intelligence, will be explored in depth during the OR Manager Conference, September 18-20 in New Orleans. The new OR of the Future gives attendees a unique opportunity to learn through interactive experiences, educational sessions, and discussions with leading experts: product manufacturers as well…

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By: Cynthia Saver, MS, RN
July 24, 2019
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Consider all angles when choosing AI technology

This article concludes OR Manager’s special series on artificial intelligence (AI). Parts 1 and 2 (May 2019 and June 2019) introduced AI, defining the different types of technology and describing its many current and potential applications for surgery. The series also presented examples of AI (June and July 2019). We…

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By: Cynthia Saver, MS, RN
July 24, 2019
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Tackling the opioid crisis through community teamwork

The opioid epidemic has risen to alarming proportions in the United States, claiming 46,000 lives in 2018. Studies and federal reports documenting evidence of narcotics overuse and addiction in patients have built momentum to curb prescribing habits. Responding to these trends, a Midwestern orthopedic practice launched a multiphase project to…

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By: Jennifer Lubell
July 24, 2019
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Effect of incentive spirometer patient reminder after CABG

Editor's Note An incentive spirometer reminder after coronary artery bypass grafting (CABG) improved patient adherence and, in turn, improved the atelectasis severity score and multiple subsequent clinical outcomes, this study finds. In this study of 212 patients who had CABG surgery, 145 were randomized by hourly reminder SpiroTimer “bell on”…

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By: Judy Mathias
July 18, 2019
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Duration, type of surgical prophylaxis linked to adverse events

Editor's Note The risk of adverse events increases with each additional day of surgical antimicrobial prophylaxis, and extended duration does not lead to additional surgical site infection (SSI) reductions, finds this study. In this study of 79,058 patients having surgical procedures in the VA healthcare system, increasing the duration of…

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By: Judy Mathias
July 18, 2019
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CDC: Drug overdose mortality drops for the first time in 20 years

Editor's Note The US drug overdose mortality rate dropped 5.1% to 68,557 deaths last year, compared with 72,224 in 2017, the Centers for Disease Control & Prevention (CDC) reported on July 17. It’s the first time overdose mortality has declined since 1999. The CDC noted that the death counts are…

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By: Judy Mathias
July 18, 2019
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