Otological Ventilation Tubes


Otological Ventilation Tubes are available in the following designs:


 

General Information


 

Description

Otological Ventilation tubes are designed for easy placement through the tympanic membrane to ventilate the middle ear space, and, if present, drain accumulations of fluid from the middle ear.

These tubes act as ventilation devices allowing a free exchange of air between the outer ear and middle ear space, equalizing the air pressure on both sides. When fluid is present, the ventilation tubes can also act as drain devices allowing fluid to drain from the middle ear space to the external auditory canal.

These tubes are available in a variety of designs, sizes and materials to best suit the doctor's preference and need.

Materials used

The materials used to manufacture Tecfen Ventilation Tubes are Silicone, Fluoroplastic, and Polyethylene. These materials have long histories of use as implanted medical devices. They are known for their smoothness of texture, inertness, biocompatibility, and effectiveness for both short- and long-term middle ear drainage and ventilation.

The color of Tecfen Silicone and Polyethylene Tubes are blue, and Tecfen Fluoroplastic Tubes are white.

Sterility

Sterilization of these tubes is by ethylene oxide gas under a tested, controlled cycle. Each lot is tested for sterility in accordance with United States Pharmacopeia guidelines.

Packaging

Sterilized Products:
Tecfen Tubes are normally supplied sterile one each in an inner gelatin capsule. The secondary package is a Tyvek/Polymylar peel open pouch, multilingual and with lot number.
An outer box is used to store 10 individually packed sterile tubes.
Non-Sterile Products:
Non-Sterile Tubes are available in bulk, in small polyethylene bags.

Sterilization/Resterilization

All Fluoroplastic and Silicone Tubes may be sterilized or resterilized by any commonly accepted method. Polyethylene tubes should be sterilized or resterilized by gas or cold sterilization solutions only.