Supply Chain/Technology

Latest Issue of OR Manager
April 2023
Home Supply Chain/Technology

FDA: Addition to Class I recall of LivaNova LifeSPARC System Controller

Editor's Note The Food and Drug Administration (FDA) on January 27 posted an addition to the Class I recall by LivaNova (TandemLife) of its LifeSPARC System Controller. The addition to the recall provides information about a software update now available to address the previous software malfunction and recall. The System…

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By: Judy Mathias
January 30, 2023
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Study: Fit test outcomes for N95 masks in HCWs

Editor's Note This study from the University of Florida College of Medicine, Gainesville, finds a large degree of variation in fit testing results for N95 masks in healthcare workers (HCWs). The researchers retrospectively analyzed 12,582 qualitative fit testing results for several models of N95 masks in 8,809 HCWs. Among the…

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By: Judy Mathias
January 23, 2023
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ECRI lists Top 10 Health Technology Hazards for 2023

Editor's Note ECRI on January18 published its Top 10 Health Technology Hazards report for 2023, which includes: Gaps in recalls for at-home medical devices Defective single-use medical devices Automated dispensing cabinet overrides Undetected venous needle dislodgement Cybersecurity risks associated with cloud-based clinical systems Inflatable pressure infusers Confusion about ventilator cleaning…

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By: Judy Mathias
January 19, 2023
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AAMI updates PPE standard

Editor's Note The Association for the Advancement of Medical Instrumentation (AAMI) on January 18 released a revised American National Standard that includes new information for manufacturers and users of personal protective equipment (PPE). The new edition of “ANSI/AAMI PB70:2022, Liquid barrier performance and classification of protective apparel and drapes intended…

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By: Judy Mathias
January 19, 2023
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Assessing options for post-warranty equipment maintenance

quality insurance

When making decisions about technology and equipment, there is a tendency to focus on immediate productivity increases—or perhaps, practical aspects such as carrying out an implementation or training staff. But here is another major issue: how to maintain OR equipment once the warranty runs out. This is more complex than…

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By: David Cotriss
January 19, 2023
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Digital transformation and its impact on OR utilization

Over my 40-year career—after starting at the bedside in surgical intensive care, moving to emergency medicine, and then to perioperative services—I have been fortunate to progress into executive leadership positions in academic medical center health systems and community hospitals, consult with a top global advisory firm, and now work in…

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By: Shawn Sefton, MBA, BSN, RN
January 19, 2023
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Other requirements for processing electrosurgical instruments

The use of electrosurgical instrumentation is common in minimally invasive surgery (MIS). However, while these instruments are common, processing them is complex and time-consuming. Insulated electrosurgical instrumentation can cause patient harm, including an electrical burn, if there is a breach in the insulation. These instruments are designed to have an…

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By: Susan Klacik, BS, FCS, ACE, CHL, CIS, CRCST, AAMIF
January 19, 2023
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ECRI launches new video series featuring insights from its experts

Editor's Note ECRI on January 11 announced that it is launching a new monthly video series featuring healthcare insights from its experts. Each episode will include topics of relevance to healthcare leaders, including physicians, nurses, pharmacists, patient safety and risk management professionals, supply chain leaders, and biomedical engineers. The first…

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By: Judy Mathias
January 18, 2023
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FDA issues warning letters to endoscope manufacturer

Editor's Note The Food and Drug Administration (FDA) on January 10 announced that it had recently issued two warning letters to Olympus Medical Systems Corporation and one of its subsidiaries, Aizu Olympus Co, Ltd, after facility inspections. The letters addressed violations related to medical device reporting (MDR) requirements and quality…

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By: Judy Mathias
January 12, 2023
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Allina Health and Qventus using AI tool for OR scheduling

Editor's Note Allina Health and software company Qventus partnered earlier this year to implement an artificial intelligence-based tool to help automate OR scheduling, according to a January 10 PR Newswire release, reports January 11 Becker’s Hospital Review. The tool has capabilities to integrate into electronic health record systems and uses…

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By: Bridget Brown
January 12, 2023
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