We have tested several different disposable Miller 1 blades with up to 150 N force applied to the tip to ascertain the flexibility and breaking points. We were concerned to find that all three Miller 1 Vital View blades (Vital Signs Ltd, Littlehampton, UK) that we tested broke, in a similar fashion, at a force of between 111 N and 130 N (Fig. 9). Broken disposable laryngoscope blades. There are no agreed standards for the forces that laryngoscope blades should withstand. We find this an unacceptable position. There has been a lot of interest in the anaesthetic literature regarding the forces that may be exerted during laryngoscopy, and, hence, the forces that these devices should be able to withstand [1, 2]. While we feel frustrated that these blades all broke at what we consider to be relatively low forces, we cannot categorically state that this blade is inadequate. Although some may well argue that one shouldn't exert this degree of force on a paediatric larynx, with no manufacturing standards in place this is merely conjecture. At present there is no independent testing of laryngoscope blades, nor indeed any anaesthetic equipment, as the Medicines and Healthcare products Regulatory Agency decided to withdraw funding for anaesthetic equipment testing in March 2004. We feel that an organisation should be set up to provide standards for anaesthetic equipment in order to prevent our anaesthetic rooms becoming awash with potentially substandard equipment. A. Wilkes was previously funded by the Medicines and Healthcare products Regulatory Agency. Thank you for allowing us to comment. Vital Signs has been manufacturing and distributing single use disposable laryngoscope blades of the Miller and Macintosh style since early 1994. A review of our records show we have shipped more than 1.8 million blades since 2001, and have had only four reported incidences of blade breakage. Specifically, there has been no ‘in-use’ failures of Miller 1 blades reported. Vital Signs, based on studies documented in the literature, established a break force criteria for its disposable blades. This issue is so important that we perform destructive testing on each batch of blades to ensure our specifications are met. We feel that a blade of strength capable of resisting a 100 N force has a large safety factor built in, especially for a Miller 1 or any of the smaller size blades used on individuals in the 3–11 kg weight range. Based on experience of use the Miller 1 blade this appears to be validated. Vital Signs would welcome the opportunity to participate in any efforts to develop standards. We believe most responsible manufacturers are not interested in producing ‘substandard equipment’. We also believe that there are organisations in place to develop standards for anaesthetic equipment such as Technical Committee ISO/TC 121. At this time there may not yet have been an overwhelming need to direct efforts towards developing a standard for ‘disposable’ laryngoscope blades. S. HillManaging Director Vital Signs Ltd. Thank you for the opportunity to reply to the letter from Dr Goodwin and colleagues. The current standard for laryngoscopes for tracheal intubation (EN ISO 7376 : 2003) contains a number of requirements for all types of laryngoscopes; however, it does not address the strength of the blade itself. I understand that the relevant BSI committee is currently preparing a first draft of a standard for single use laryngoscope blades. This will be progressed to either a European or an International standard. Progressing the debate in the European or wider arena will, no doubt, resolve the apparently different views held by manufacturers and the clinical community regarding an appropriate value, and methodology, for testing single use blades. It is disappointing, bearing in mind this letter and earlier Correspondence in Anaesthesia on the same subject, that the Medicines and Healthcare products Regulatory Agency (MHRA) has not received any adverse incident reports arising from breakage of single use laryngoscope blades during use. It is only through the reporting of adverse incidents that MHRA can investigate problems with medical devices and take appropriate action to resolve them. Such information could be used to inform the debate during standards development, to provide the basis for advice to the health service or allow the Agency to take appropriate action with the manufacturer to address an unacceptable level of failure with these devices. Reports can be made directly to the Agency using most communication means (please visit http://www.mhra.gov.uk for details) or, alternatively, they can be made via the local Trust Liaison Officer.
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