A reply

We are grateful to Freeman and Cooke from Barema for their contribution to the debate on establishing a Device Evaluation Centre for anaesthetic equipment. The proposal we outlined [1] is only likely to succeed if there is support from industry as well as from the NHS and academia. However, we are concerned that Freeman and Cooke consider that a consequence of our proposal would be a ‘considerable slowdown in new product innovations’. Our aim is not to stifle true innovation in the medical industry. Wanless has already described how the UK is a ‘late and slow adopter of medical technology’ [2], a theme picked up the Healthcare Industries Task Force [3], and this was not our intention. Our concern is that, once innovation has taken place and a product has been well accepted and its efficacy well established, then other manufacturers can place similar, but not identical, products on the market. It is unfortunate, however, that there is generally little or no evidence of clinical efficacy of these newer products, and subtle differences in material or design can markedly alter their performance. The intention of our proposal is to ensure that evidence of comparative clinical efficacy is readily available for similar ‘me too’ products. Our proposal stemmed from an evaluation of an introducer [4], rather than laryngeal masks. Our concern with some of the newer introducers is that they have much poorer placement characteristics and potential for airway trauma than the device they are intended to replace, the Eschmann multiple-use introducer. Purchasers of anaesthetic equipment presented with a new introducer that looks and feels comparable to the Eschmann might be tempted to buy the newer one although this could then lead to serious harm when the introducer is actually used on a patient. Indeed, we have recently recommended, after careful analysis, that two introducers currently available on the market should no longer be used in clinical practice [5]. We consider that there is a similar problem with many other products. Since the editorial was published, Dr John Watt has suggested to us that anaesthetic face masks ‘which can pose a hazard though they may superficially seem similar to existing products’ should also be evaluated (J Watt, pers. comm., June, 2008); differences in the performance of some face masks have been demonstrated by our group previously [6]. We agree that it is for ‘medical practitioners to judge the efficacy of a given device’. We believe, however, that the judgements made by medical practitioners should be based on rigorous publicly-available peer-reviewed clinical trials of that device. We want to avoid the situation where products that can cause harm are only identified when practitioners use those products on their patients. We note that ‘the supplier has to record in the design file satisfactory clinical evidence’, but we also note that this evidence is, unfortunately, not available to those purchasers choosing between different devices. In addition, this evidence can be based on clinical evaluations of other similar, but not identical, products [7]. Freeman and Cooke ask how, at a practical level, our proposed Device Evaluation Centre would prevent anaesthetists having to use laryngeal masks they did not like. We assume this means how provision of expert advice will prevent purchasers from buying equipment with poor performance. This could be achieved by each Trust having a Purchasing Group with a named Consultant Anaesthetist responsible for anaesthetic equipment, as recommended by the Association of Anaesthetists of Great Britain and Ireland (AAGBI) [8]; the Purchasing Group would then only select equipment for which there is evidence of clinical efficacy provided by the Device Evaluation Centre. The Centre for Evidence-based Purchasing (CEP, part of the NHS Purchasing and Supply Agency) is currently preparing a buyers’ guide on laryngoscopes, which includes results from both technical and user assessments of 40 different Macintosh size 3 blades, all of which are available on the UK market. Choosing between 40 different blades would present a difficult task for a purchaser and the intention of the report is to help the purchaser make an informed decision. Some blades were demonstrably poorer than others, requiring more force to obtain the same view and a longer time to successful intubation in a manikin. Freeman and Cooke believe that the debate ‘should consider the implications of establishing an extensive and costly Evaluation Centre for medical devices’. We trust that the debate will also include the implications of not doing so. It is totally unacceptable to increase the risk to a patient by not securing an airway or by causing trauma during intubation when, by using another device, these complications could be reduced. Alternatively, identifying products that perform similarly to existing well established devices, but cost less, could potentially provide savings for the NHS. The proposed Device Evaluation Centre should therefore improve patient safety, clinical effectiveness and reduce costs. In addition, we note that the AAGBI has recently issued guidelines on infection control in anaesthesia [9]. In this guideline, the AAGBI states ‘Those purchasing laryngoscopes with single-use blades (and other single-use devices) have a responsibility to ensure that the performance of the instruments is at least as good as that of the standard reusable alternatives’. We would suggest taking the next logical step and encouraging those purchasing any new devices (single-use or reusable) to determine that they are at least as good as those devices they are intended to replace. We consider that the evidence on which to base these purchasing decisions is best provided by a national coordinated device evaluation centre along the lines we have described.