Medical devices; gastroenterology-urology devices; classification of the urethral insert with pump for bladder drainage. Final order.

The Food and Drug Administration (FDA) is classifying the urethral insert with pump for bladder drainage into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the urethral insert with pump for bladder drainage's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Critical classification of craniostomy for chronic subdural hematoma; safer technique for hematoma aspiration.

Chronic subdural hematoma (CSDH) is generally treated by twist drill, and one and two burr-hole craniostomy. We proposed new classification of the intraoperative condition of CSDH, and present a safer technique for aspiration of CSDH in one burr-hole surgery. The intraoperative condition of CSDH was classified according to the connections between the hematoma cavity and the extracranial space as follows. The "closed condition" represents only a single route consisting of a tube inserted intraoperatively connecting the extracranial space to the hematoma cavity. The "open condition" includes another route or space, which can freely pass air, saline, or old hematoma fluid, in addition to the tube inserted intraoperatively. Twist drill craniostomy and two burr-hole craniostomy clearly involve the intraoperative closed and open conditions, respectively. One burr-hole craniostomy may involve either condition due to the operative procedure. Aspiration and irrigation of the hematoma is basically free and safe in the open condition, but risky in the closed condition. All of the hematoma can be aspirated through one burr hole under certain open conditions with temporary replacement of the hematoma cavity with air followed by replacement of air with saline. Twenty-seven patients with symptomatic CSDH underwent one burr-hole craniostomy by the above mentioned aspiration technique. There were no special complications. The recurrence rate was average. The substitution of saline after complete aspiration of hematoma carries little risk only under the "open condition," shortens the operation time, and achieves good irrigation of the hematoma.

Surgical vacuum drains: types, uses, and complications.

High- and low-pressure vacuum drains are commonly used after surgical procedures. High-pressure vacuum drains (ie, sealed, closed-circuit systems) are efficient and allow for easy monitoring and safe disposal of the drainage. Low-pressure vacuum drains use gentle pressure to evacuate excess fluid and air, and are easy for patients to manage at home because it is easy to reinstate the vacuum pressure. Perioperative nurses should be able to identify the various types of commonly used drains and their surgical applications. Nurses should know how to care for drains, how to reinstate the vacuum pressure when necessary, and the potential complications that could result from surgical drain use.

Influência do aleitamento sobre a frequência dis hábitos de sucçäo / Lactation's influence on sucking habits frequency

Os benefícios do aleitamento materno, tanto para a mäe quanto para o bebê säo amplamente discutidos nas pesquisas científicas, entretanto algumas questöes ainda apresentam controvérsias. Entre elas, estäo a relaçäo entre o aleitamento e a presença de hábitos viciosos, assim como suas consequências para o desenvolvimento das arcadas dentárias e das funçöes orofaciais. Este trabalho teve como objetivo estudar o aleitamento (natural e artificial), dentro de um padräo sócio-econômico menos favorecido, e sua influência sobre a presença dos hábitos de sucçäo

Guía para el drenaje y succión pleural / Guide for suction and pleural drainage

Se establece las bases racionales, fisiopatológicas y biofísicas, de la succión pleural continua en el manejo de los pacientes sometidos a cirugía de tórax, o que la requieran como consecuencia de un neumotórax o un hemotórax traumático, lesiones cada día más frecuentes debido a los accidentes y al incremento de las heridas por arma de fuego y por arma blanca. Se describe en detalle el ensamblaje de los diferentes sistemas de succión torácica con uno, dos o tres frascos reesterilizables, o con la unidad desechable de plástico.