Introduction and evaluation of new airway devices: Current issues
Cook TM., Pandit JP., Wilkes AR.
There is a clear potential benefit from developing new technology and devices to improve the breadth and safety of medical care. Clinicians and patients largely rely on manufacturers to develop such technology and on regulatory processes to ensure it is safe to use. For all parties (especially all responsible manufacturers) clinical safety and efficacy are paramount. Previous government-funded evaluation of such devices to determine technical and clinical safety has waned in the last decades. In the European Union the Medical Devices Directives and the CE mark are central to ensuring devices are reliably produced, technically safe and to allowing the device to be marketed. However clinical evaluation is likely needed to ensure clinical utility and safety and the present regulations often fail to require such testing before devices are brought to market, or even afterwards. There are examples in the field of anaesthetic airway management devices where such omissions have led to product withdrawal, product redesign or even patient harm. A number of proposals have been advanced to improve the processes of clinical evaluation before (or after) devices are brought to market and to aid purchasers and users in their decision-making regarding whether to adopt new technology. This article explores this topic. © 2012 Elsevier Ltd.