Introducing new anaesthetic equipment into clinical practice

The Editorial by Wilkes et al. [1] proposes the formation of a Device Evaluation Centre to recommend which medical devices should be used in hospitals. Part of the need for the Centre is to counter the point that ‘manufacturers are allowed to market many medical devices without being required to provide evidence of their efficacy’. Efficacy is a key word, and according to a dictionary definition means there is a predetermined outcome. Obviously efficacy is used all the time when referring to pharmaceuticals, and new drug trials are about demonstrating efficacy. It is not the same with medical devices, which are designed for an ‘intended purpose’, and this is one of the major reasons for having different regulatory regimes between pharmaceuticals and medical devices. The CE mark for medical devices in Europe is to demonstrate that products are ‘fit for purpose’, and have met the requirements of the European Union Medical Device Directive. Suppliers design devices aimed at providing a defined performance to meet the ‘intended purpose’ for each device. Within the Directive, the procedure for introducing new innovative products normally includes the provision of clinical evidence, but this does not necessarily imply efficacy. It is for medical practitioners to judge the efficacy of a given device. With regard to similar (‘me-too’) devices of original designs, for instance laryngoscopes and, more recently, laryngeal masks, the supplier has to show that the product performs correctly in the prescribed clinical situation. This is mandated in the Directive, and before the new ‘me-too’ device can be placed on the market with a CE mark, the supplier has to record in the design file satisfactory clinical evidence. It is recognised that devices may always be subject to improvement, and this is also covered in the Directive. Suppliers must keep a record of all complaints and the subsequent continuous improvement actions that are taken. Many devices are therefore modified on a regular basis through design updates, both for equipment and consumables. From the Editorial, the case for a Device Evaluation Centre seems largely based on the single use laryngeal mask. A number of variants came on to the market at the expiry of the laryngeal mask patent, which happened to coincide with the publishing of new guidelines for the treatment of vCJD patients. Many anaesthetists found themselves having to use masks they did not like – therefore, at a practical level, how would the Device Evaluation Centre prevent this from happening? If the intention is that all new devices are additionally tested before general acceptance of use, then we believe a consequence would be a considerable slowdown in new product innovations. The British Anaesthetic and Respiratory Equipment Manufacturers Association (Barema) welcomes the debate put forward by Dr Wilkes and colleagues. We believe such a debate should consider the implications of establishing an extensive and costly Evaluation Centre for medical devices, taking into account that the European Union Medical Device Directive mandates for the control of devices introduced into use, and their removal if warranted.