The Bair Hugger system is a convective temperature management system used in a hospital or surgery center to maintain a patient's core body temperature. The Bair Hugger system consists of a reusable warming unit and single-use disposable warming blankets for use before, during and after surgery. This medical device launched in 1987 and is currently manufactured by the 3M Company. [1]
The Bair Hugger system uses convective warming, also known as forced-air warming, to prevent and treat perioperative hypothermia.
The system includes two primary components: a warming unit and a disposable blanket. The warming unit is connected by a flexible hose to the single-use blanket. Warm air from the warming unit passes through the flexible hose and into the blanket. Once the warmed air reaches the blanket it exits through a series of micro-perforations on the underside of the blanket, warming the patient's skin in an area not involved in the surgical procedure. [2]
The Bair Hugger system warms effectively due to the properties of convection and radiation; heat transfer improves with the movement of warmed air across the surface of the patient's skin. Up to 64 percent of the patient's body surface may be recruited for heat transfer, depending on which Bair Hugger blanket is used. [3]
The Bair Hugger system was originally designed by Scott Augustine Bair, MD of Minnesota. [4] The Bair Hugger was produced by Arizant, previously known as Augustine Medicine. Augustine resigned from Arizant in 2002, and Arizant was bought by 3M in 2009. [5] Augustine later invented a different type of patient-warming device and formed a separate company to sell his competing device. [4]
Convection is single or multiphase fluid flow that occurs spontaneously through the combined effects of material property heterogeneity and body forces on a fluid, most commonly density and gravity. When the cause of the convection is unspecified, convection due to the effects of thermal expansion and buoyancy can be assumed. Convection may also take place in soft solids or mixtures where particles can flow.
Heat transfer is a discipline of thermal engineering that concerns the generation, use, conversion, and exchange of thermal energy (heat) between physical systems. Heat transfer is classified into various mechanisms, such as thermal conduction, thermal convection, thermal radiation, and transfer of energy by phase changes. Engineers also consider the transfer of mass of differing chemical species, either cold or hot, to achieve heat transfer. While these mechanisms have distinct characteristics, they often occur simultaneously in the same system.
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Endometrial ablation is a surgical procedure that is used to remove (ablate) or destroy the endometrial lining of the uterus. The goal of the procedure is to decrease the amount of blood loss during menstruation (periods). Endometrial ablation is most often employed in people with excessive menstrual bleeding following unsuccessful medical therapy. It is less effective than hysterectomy, but with a lower risk of adverse events.
Microshock refers to the risk that patients undergoing medical procedures involving externally protruding intracardiac electrical conductors, such as external pacemaker electrodes, or saline filled catheters, could suffer an electric shock causing ventricular fibrillation (VF) due to currents entering the body via these parts.
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The Center for Devices and Radiological Health (CDRH) is one of six product centers of the U.S. Food and Drug Administration (FDA), an agency that is part of the U.S. Department of Health and Human Services (HHS). CDRH is responsible for ensuring that patients and providers in the U.S. have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.
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Edwards Lifesciences is an American medical technology company headquartered in Irvine, California, specializing in artificial heart valves and hemodynamic monitoring. It developed the SAPIEN transcatheter aortic heart valve made of cow tissue within a balloon-expandable, cobalt-chromium frame, deployed via catheter. The company has manufacturing facilities at the Irvine headquarters, as well as in Draper, Utah; Costa Rica; the Dominican Republic; Puerto Rico; and Singapore; and is building a new facility due to be completed in 2021 in Limerick, Ireland.
Due to the many regulations in the industry, the design of medical devices presents significant challenges from both engineering and legal perspectives.
Ovine forestomach matrix (OFM), marketed as AROA ECM, is a layer of decellularized extracellular matrix (ECM) biomaterial isolated from the propria submucosa of the rumen of sheep. OFM is used in tissue engineering and as a tissue scaffold for wound healing and surgical applications.
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