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.

Medical devices; gastroenterology-urology devices; classification of pancreatic drainage stent and delivery system. Final order.

The Food and Drug Administration (FDA) is classifying the pancreatic drainage stent and delivery system 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 pancreatic drainage stent and delivery system 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.

Drenos abdominais: indicações e utilização na prática cirúrgica / Abdominal drains: indications and uses in surgical practice

O uso de drenos abdominais é cercado de controvérsias. Historicamente, sua indicação era empírica, conforme a experiência do cirurgião. Hoje, sabe-se das suas complicações e contraindicações, orientando seu uso de forma racional. Além disso, o tipo de dreno preferencial, ativo e fechado é o priorizado atualmente. O presente estudo visa discutir estes aspectos e analisar características dos diferentes tipos de drenos e sua aplicação prática.

The use of abdominal drainage is controversial. Formerly, the indications were empiric, depending on surgeon experience. Nowadays, considering the risk of complications, there is a shift to a rational use. There is increasing interest for active, closed tubular drains in the field of abdominal surgeries. This study will discuss theses aspects and analyse characteristics of different types of drains and it's appliance.