LAUSR

We would like to thank Dr. Stacey and Dr. Chaggar for their letter reporting and reviewing two cases where a manufacturing fault with the Solus Flexible laryngeal mask compromised the patency of the airway channel and also for highlighting the importance of ensuring all airway equipment is checked appropriately before use. We are also pleased to note from separate correspondence that, in both the cases discussed in their report, due to the prompt action taken by the anaesthetists concerned, no patient harm occurred. The issue described by Dr. Stacey and Dr. Chaggar was caused by a defect in the reinforced tube, which led to the formation of small air bubbles or voids. Due to their location, the air bubbles expanded when the cuff was inflated, compromising the patency of the airway channel. As this represented a serious risk to patient safety, and we could not be certain the problem did not exist in Solus Flexible laryngeal masks, Intersurgical initiated a Field Safety Corrective Action (FSCA Identifier: 164826) and issued a Field Safety Notice for the device. This requires all Solus Flexible to be immediately quarantined and destroyed. The Medicines and Healthcare products Regulatory Agency (MHRA) have been informed. All other Solus products are unaffected. As Dr. Stacey and Dr. Chaggar noted, the Association of Anaesthetists of Great Britain and Ireland (AAGBI) safety guidelines [1] confirm that all airway equipment must be ‘checked for patency’. In addition, the instructions for use for Solus Flexible [2] confirm that before use, the interior of the airway tube should be checked for occlusion or the presence of foreign objects and the patency of the cuff section checked by fully deflating and then reflating to the maximum cuff inflation value. The cuff should then be fully deflated again before insertion. We do agree this problem may not always be identified by visual inspection alone and this highlights the importance of vigilance when inspecting and testing all airway devices during pre-use checks and continuing to monitor them throughout their use to ensure optimal performance and the early detection of any problems. We would like to apologise for this manufacturing fault. We do understand the considerable inconvenience and additional work this product issue and the subsequent corrective action in the Field Safety Notice has caused, but our absolute priority is patient safety, and therefore to protect patients from harm we have taken the action indicated. We are currently reviewing all manufacturing processes and quality assurance procedures related to Solus Flexible. We will only resume supply when all improvements identified from this process have been validated, implemented and we are satisfied the device is safe to use and fit for purpose. Once again, we would like to thank Dr. Stacey and Dr. Chaggar for sharing their experience of this issue and bringing it to the attention of the wider anaesthetic community.