UK regulatory authority the MHRA has issued a medical device alert(MDA) relating to certain products and lot numbers of the Shiley™ reusable cannula, cuffed tracheostomy tubes supplied by Covidien. There have been reports of leakage and disconnection between the inner and outer cannulae, which may compromise patient ventilation.
The MHRA has issued its alert following an earlier field safety notice from Covidien which related to reported problems with certain of its size 8 Shiley reusable cannula, cuffed tracheostomy tubes that had reportedly suffered volume leakage and/or disconnection between inner and outer cannulae. Concerns that under these circumstances ventilation might be adversely affected prompted the company to issue its notice, following which the MHRA has stepped in to ensure compliance with the required measures which involve a recall of affected product codes and lot numbers.
The full MDA can be found here and includes the original field safety notice and details of all affected products.
The MDA notes that patients already fitted with affected products should have the tube replaced when clinically appropriate and the company says monitoring should be increased in the interim.