Introduction We report the first prospective analysis of human factors elements contributing to invasive procedural never events using a validated Human Factors Analysis and Classification System (HFACS). Methods From 8/2009 - 8/2014 surgical and invasive procedural “Never Events” (retained foreign object, wrong site/side procedure, wrong implant, wrong procedure) underwent systematic causation analysis promptly after the event. Contributing human factors were categorized using Reason's 4 levels of error causation and 161 HFACS subcategories (nano-codes). Results During the study approximately 1.5 million procedures were performed and 69 never events were identified. A total of 628 contributing human factors nano-codes were identified. Action-based errors (n=260) and preconditions to actions (n=296) accounted for the majority of the nano-codes across all four types of events, with individual cognitive factors contributing half of the nano-codes. The most common action nano-codes were confirmation bias (n=36) and failed to understand (n=36). The most common pre-condition nano-codes were channeled attention on a single issue (n=33) and inadequate communication (n=30). Conclusion Targeting quality and system improvement interventions addressing cognitive factors and team resource management as well as perceptual biases may reduce errors and further improve patient safety. These results delineate targets to further reduce never events from our healthcare system.
Introduction Current Advanced Trauma Life Support guidelines recommend decompression for thoracic tension physiology using a 5-cm angiocatheter at the second intercostal space (ICS) on the midclavicular line (MCL). High failure rates occur. Through systematic review and meta-analysis, we aimed to determine the chest wall thickness (CWT) of the 2nd ICS-MCL, the 4th/5th ICS at the anterior axillary line (AAL), the 4th/5th ICS mid axillary line (MAL) and needle thoracostomy failure rates using the currently recommended 5-cm angiocatheter. Methods A comprehensive search of several databases from their inception to July 24, 2014 was conducted. The search was limited to the English language, and all study populations were included. Studies were appraised by two independent reviewers according to a priori defined PRISMA inclusion and exclusion criteria. Continuous outcomes (CWT) were evaluated using weighted mean difference and binary outcomes (failure with 5-cm needle) were assessed using incidence rate. Outcomes were pooled using the random-effects model. Results The search resulted in 34,652 studies of which 15 were included for CWT analysis, 13 for NT effectiveness. Mean CWT was 42.79 mm (95% CI, 38.78–46.81) at 2nd ICS-MCL, 39.85 mm (95% CI, 28.70–51.00) at MAL, and 34.33 mm (95% CI, 28.20–40.47) at AAL (P=0.08). Mean failure rate was 38% (95% CI, 24–54) at 2nd ICS-MCL, 31% (95% CI, 10–64) at MAL, and 13% (95% CI, 8–22) at AAL (P=0.01). Conclusion Evidence from observational studies suggests that the 4th/5th ICS-AAL has the lowest predicted failure rate of needle decompression in multiple populations.
Treatment of esophageal disease can necessitate resection and reconstruction of the esophagus. Current reconstruction approaches are limited to utilization of an autologous conduit such as stomach, small bowel, or colon. A tissue engineered construct providing an alternative for esophageal replacement in circumferential, full thickness resection would have significant clinical applications. In the current study, we demonstrate that regeneration of esophageal tissue is feasible and reproducible in a large animal model using synthetic polyurethane electro-spun grafts seeded with autologous adipose-derived mesenchymal stem cells (aMSCs) and a disposable bioreactor. The scaffolds were not incorporated into the regrown esophageal tissue and were retrieved endoscopically. Animals underwent adipose tissue biopsy to harvest and expand autologous aMSCs for seeding on electro-spun polyurethane conduits in a bioreactor. Anesthetized pigs underwent full thickness circumferential resection of the mid-lower thoracic esophagus followed by implantation of the cell seeded scaffold. Results from these animals showed gradual structural regrowth of endogenous esophageal tissue, including squamous esophageal mucosa, submucosa, and smooth muscle layers with blood vessel formation. Scaffolds carrying autologous adipose-derived mesenchymal stem cells may provide an alternative to the use of a gastro-intestinal conduit for some patients following resection of the esophagus.
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