Abstract

A 55 year-old female patient was admitted to ICU with pneumonia and sepsis requiring ventilation. A decision was made to perform an early tracheostomy because of anticipated prolonged ventilator dependence. Due to the absence of clear anatomical landmarks, the patient was unsuitable for a percutaneous tracheostomy and an ENT surgeon performed a surgical tracheostomy instead. A size 8.0 Portex® (Smiths Medical, Hythe, UK) adjustable flange profile cuff tracheostomy tube (Ref. 100/523/080) was inserted in the operating theatre. On return to the ICU, it was discovered that the flange was positioned upside down with the ends of the flange stitched on the upper chest instead of on the neck. In this position, the flange could not have held the tube securely. Traction is directed outwards on to the tracheostomy tube due to the pulling of the ventilator connecting tubes, particularly in the head-up position. The ENT surgeon was called to re-adjust the position of the flange. During the procedure, ventilation became difficult and on inspection it was found that the tracheostomy tube had migrated outwards. Attempts to re-insert the tube were unsuccessful due to a combination of difficult neck anatomy, bleeding and oedema and orotracheal intubation was required. A new tracheostomy tube was re-inserted the following day in theatre through the same tracheotomy site without complications. In our view, this near fatal incident occurred because of the way these tracheostomy tubes are packaged with the curved flange orientated downwards (Fig. 7). Even though the package insert indicates the need to rotate the flange through 180 degrees prior to insertion (Fig. 8), presenting the tracheostomy tube with the flange rotated the correct way could reduce the risk of accidental decannulation. Position of the flange as tube is packaged. Position of the flange after rotation. Thank you for the opportunity to respond to Drs Rauf and Zwaal's letter. Smiths Medical (Portex Ltd) has noted these comments and as a result we are reviewing the packaging of the Adjustable Flange Tracheostomy tubes (100/523 and 100/526). We consider that the product, as it is currently presented, is safe to use as both the inner and outer packaging highlights the need to refer to the Instructions for Use, which tells users to rotate the flange by 180 degrees before insertion. We would like to thank Drs Rauf and Zwaal for bringing this matter to our attention. T. MorrisProduct Manager – Smiths Medical Hythe CT21 6JL, UK

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