Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom issued a Medical Device Alert concerning silicone tracheostomy tubes.

The MHRA is aware of several incidents where the eyelets of tracheostomy tubes appear to have been damaged by the holder. This led to dislodgement of the tube with the subsequent risk of airway loss.

Therefore, the MHRA advised all staff responsible for the care of patients with tracheostomy tubes to:-

• Check the instructions for use for both the tracheostomy tube and the holder to ensure that they are compatible.
• Be aware that some manufacturers have recently updated their instructions for use to include a warning to users not to use their tracheostomy tubes with sharp-edged holders, for example some types of Velcro or metal edged holders.
• Ensure that the instructions for use are followed for both the tracheostomy tube and the holder.

For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON184707

Posted on 12 September 2012