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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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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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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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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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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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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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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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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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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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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