FDA: Class I recall of Medfusion 4000 Syringe Pumps
Editor's Note The Food & Drug Administration (FDA) on December 19, 2019, identified the recall by Smiths Medical ASD, Inc of its Medfusion 4000 Syringe Pumps as Class I, the most serious. The recall was initiated because of malfunctioning low-battery alarms, which may lead to an interruption of therapy. The…
Laser-based imaging system, AI algorithm accurately identify brain tumors
Editor's Note Researchers at NYU Langone Health combined advanced optical imaging with an artificial intelligence (AI) algorithm to produce accurate, real-time intraoperative diagnosis of brain tumors in this study. Compared with the accuracy of pathologists’ interpretation of conventional histologic images, the results for both methods were comparable. The AI-based diagnosis…
First-year analysis of OR Black Box study
Editor's Note In this first-year analysis of a data capture system called the OR Black Box, frequent intraoperative errors, events, variation in surgeons’ technical skills, and a high amount of environmental distractions were identified. In 132 patients having elective laparoscopic general surgery: auditory distractions occurred a median of 138 times…
Can punctuality decrease OR costs?
Editor's Note In this study from Washington University School of Medicine, St Louis, a first case on-time starts (FCOTS) improvement initiative was linked to a higher frequency of FCOTS, which was independently associated with last case on-time ends (LCOTE) and decreased OR overtime costs. Of 12,073 cases (6,095 pre- vs…
Patients prefer checklists to be completed in front of them
Editor's Note Surgery patients overwhelmingly prefer pre-surgical safety checklists to be completed in front of them, contrary to what is thought by anesthesiologists, this Swiss study finds. In this trial, which included 110 anesthesiologists and 125 non-premedicated ear-nose-throat or maxillofacial surgery patients, the patients overwhelmingly agreed that anesthesiologists should use…
FDA: Class I recall of Cook Medical’s CrossCath Support Catheters
Editor's Note The Food and Drug Administration (FDA) on December 17 identified the recall by Cook Medical of its CrossCath Support Catheters as Class I, the most serious. The recall was initiated because of a manufacturing error that may cause the radiopaque marker bands on the catheters to dislodge or…
Development of surgery-specific second victim peer support program
Editor's Note In this study, researchers at the Massachusetts General Hospital, designed, implemented, and assessed the effect of the first surgery-specific peer support program in the US. The program uses five steps: creation of a conceptual framework choice of peer supporters training of peer supporters multifaceted identification of major adverse…
Boston Scientific receives FDA clearance for single-use duodenoscope
Editor's Note Boston Scientific announced December 13 that it had received Food & Drug Administration (FDA) 510(k) clearance for the EXALT Model D Single-Use Duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. The EXALT Model D, which was granted Breakthrough Device Designation from the FDA, eliminates the need for…
CMS expects greater scrutiny from Joint Commission surveyors
[This article from the January 2020 issue of OR Manager summarizes information presented at the 2019 OR Manager Conference. The presenter offered tips to help attendees comply with Joint Commission standards and achieve a successful Joint Commission survey. Readers are asked to note the following points of clarification: The presentation…
Is your staff ready to manage malignant hyperthermia?
Malignant hyperthermia (MH) is a rare but life-threatening surgical complication that seems to turn the effects of general anesthesia upside down. Instead of relaxing, muscles become rigid, releasing large amounts of acid and potassium into the blood. Instead of a normal slowing of breathing, respirations quicken, and end-tidal CO2 rises.…
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