Standards Development
This document specifies general and functional requirements on tracheostoma valves (T-VAL) including relevant test methods as well as requirements on marking and labelling and information to be provided by the manufacturer.
Tracheostoma valves are frequently and worldwide used medical products. There are many different types of tracheostoma valves from different companies available. As there is no existing standard for tracheostoma valves there are no common rules on marking, symbols and the intended use of these products. Users have to have very specific knowledge about products to use them correctly. In the recent months several incident reports on life threatening and even mortal injuries with the use of tracheostoma valves have been published. The analysis of these incidents showed that tracheostoma valves got mixed up with HME filters or were used in wrong clinical situations or product combinations. The proposed standard is intended to reduce risks associated with tracheostoma valves by defining all aspects for product safety. To help users in hospitals and homecare, special attention is payed to clear marking, symbols and instructions for use.
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