Supply Chain/Technology

Latest Issue of OR Manager
April 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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After 10 years, EHRs don’t live up to promise

Editor's Note The US government claimed that digitization of healthcare records would improve the quality and value of healthcare; however, 10 years after legislation fast-tracked the move to electronic healthcare records (EHRs), even the architects of the effort agree that the $36 billion investment has not delivered as expected, the…

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

Episode of Care: Managing the Unique Supply Chain Needs of the ASC

After this session you'll be able to: 1. Compare and contrast the traditional ambulatory surgery center with a multi-licensed facility. 2. Describe the unique supply chain needs of a multi-licensed ASC. 3. Identify supply chain models that can be implemented in both a multi-licensed ASC and a traditional ASC. Why…

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

Communication is Key: Using Technology to Eliminate Barriers presented by Owens & Minor

After this session you'll be able to: Identify strategies to maximize the management of vendor-owned inventory. Discuss actions for better communication and efficiency without additional operational or capital expenditures. Understand the tools and technology available to improve perioperative forecasting. Why this is important: A successful relationship between the operating room…

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