The Medicines and Healthcare products Regulatory Agency (MHRA), UK, has recommended the healthcare staff to exercise caution while using paediatric Shiley tracheostomy tubes, due to the risk of device failure.
According to MHRA, based on the reports received between 2008 and 2010, there was an increase in failure rate of paediatric Shiley tracheostomy tubes.
In some instances, it may be difficult to insert obturator or suction catheter into the Shiley tracheostomy tubes.
A recall has not been initiated by the manufacturer, as Covidien considers the failure rate to be relatively low.
MHRA has recommended the staff, particularly those in supplies and paediatric departments, to check the tracheostomy tubes before use to ensure that obturator or suction catheter can be freely inserted into the tube.
If any fault is identified, the staff are recommended to report it to the MHRA and contact the manufacturer for replacement.