Otolaryngologic clinics of North America
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Medical devices are essential in the diagnosis and treatment of otolaryngologic disease. The US Food and Drug Administration (FDA) is tasked with assuring the safety and effectiveness of these devices. ⋯ To best counsel patients, otolaryngologists should be aware of the strengths and limitations of device regulation by the FDA. This article reviews the FDA regulatory framework for medical devices, premarket evidentiary standards for marketing devices, and postmarket methods of safety surveillance.
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Otolaryngol. Clin. North Am. · Feb 2019
ReviewThe Impact of Cognitive and Implicit Bias on Patient Safety and Quality.
Humans use cognitive shortcuts, or heuristics, to quickly assess and respond to situations and data. When applied inappropriately, heuristics have the potential to redirect analysis of available information in consistent ways, creating systematic biases resulting in decision errors. Heuristics have greater effect in high-pressure, high-stakes decisions, particularly when dealing with incomplete information, in other words, daily medical and surgical practice. This article discusses 2 major categories: cognitive biases, which affect how we perceive and interpret clinical data; and implicit biases, which affect how we perceive and respond to other individuals, and also discusses approaches to recognize and alleviate bias effects.
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Otolaryngol. Clin. North Am. · Feb 2019
ReviewMultidisciplinary Tracheostomy Care: How Collaboratives Drive Quality Improvement.
There have been reports of successful quality-improvement initiatives surrounding tracheostomy care for more than a decade, but widespread adoption of best practices has not been universal. Five key drivers have been found to improve the quality of care for tracheostomy patients: multidisciplinary synchronous ward rounds, standardization of care protocols, appropriate interdisciplinary education and staff allocation, patient and family involvement, and use of data to drive improvement. The Global Tracheostomy Collaborative is a quality-improvement collaborative dedicated to improving the care of tracheostomy patients worldwide through communication, dissemination, and implementation of proven strategies based on these 5 key drivers.
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Otolaryngol. Clin. North Am. · Feb 2019
ReviewButton Battery Safety: Industry and Academic Partnerships to Drive Change.
The pediatric button battery (BB) hazard has been recognized for several decades. In 2012, the National Button Battery Task Force was established, and most manufacturers have improved warning labels, more secure packaging, and made BB compartments in products are more secure. ⋯ In absence of visible perforation, 0.25% sterile acetic acid esophageal tissue irrigation at time of BB removal is recommended as a neutralization strategy to mitigate injury progression. Future BB design changes could eliminate esophageal tissue injury.