An ADEPT Apology

An ADEPT Apology

The accidental omission of any authors’ competing interests and the subsequent corrigendum [1] made relating to the Difficult Airway Society ‘ADEPT’ guidance on selecting airway devices and the subsequent strategy for equipment evaluation [2] introduce several important questions.

Firstly, is it appropriate for anyone on the Airway Device Evaluation Project Team (ADEPT) to have any business associations with airway equipment manufacturers at all? Surely decisions regarding future airway equipment advances may be incorrectly perceived to be acting in the financial interests of the companies involved and, therefore, not be a true assessment of the device if it were in direct competition with a successful contemporary piece of equipment.

Secondly, how can the manufacturer of a new device be assured of the confidentiality of the committee and that new equipment details will not be given to current airway manufacturers from their medical advisers on this committee? Dr Shaikh writes from the relatively unique stand-point of being a doctor who is also an inventor and manufacturer of medical equipment (The Age of Aquarius Limited™) and, in particular, anaesthetic airway devices (the Tulip® airway). As matters stand the Tulip® supraglottic airway device may be the very first new development that is submitted to ADEPT for evaluation. If a submission occurs we expect and would like to be assured of total confidentiality comparatif achat viagra.

The Tulip® airway has been through the multiple processes of bench-testing to destruction (MeDEC, Wales School of Medicine, 2007), mannequin testing (TRUCORP AirSim Multi, TRUCORP AirSim Advance, AMBU, Laerdal) [3, 4] M.H.R.A. approval, component testing in-vivo, C.E. marking, and has been studied in-vivo for at least 24 months. The Tulip® airway is now undergoing a human pilot study and will undergo comparative clinical trials in 2012.  This airway has also been independently tested by consultant anaesthetists in Germany, Belgium, the U.S.A. and the United Kingdom yielding a body of knowledge about clinical efficacy that was never matched by older equipment when it was first introduced.

We are however pleased to see anaesthetic involvement, logic, discipline and method applied to the introduction of new medical devices because the current haphazard methodology of device introduction is undesirable. The guidance suggested by ADEPT to allow good new technology to be evaluated rapidly yet thoroughly, assisting its progress to introduction, whilst simultaneously screening and removing undesirable poor technology is commendable.

In any such process like ADEPT there must be benchmarks. That means all current technology on sale must also be subject to the ADEPT investigation and scrutiny process so that the benchmark statistical results established by current equipment within the ADEPT screening process can be improved upon in a measurable way, which includes bench-testing, mannequin simulation, pilot studies and comparative trials. For example, the new technology may score a 9/10 whilst the older device may score 8/10, giving a result of “9:8” which is easily understandable to the anaesthetic reader. Without such benchmarks we as anaesthetists have no landmarks of a successful new device. Older devices have had over twenty years to develop an evidence base and newer devices will never be able to achieve twenty years research in the three years suggested, irrespective of how well they work.

Any ADEPT assessment must do at least three things; screen out bad technology, assist the very best equipment and do both with total confidentiality. This confidentiality exists at present with the M.H.R.A. (Medical Healthcare Regulation Authority). Structures that last are built carefully. We recommend that once completed the worthy ADEPT methods be handed over to the M.H.R.A. as an adjunct to what they already currently do and do well. The gatekeepers for new anaesthetic technology must be beyond reproach, especially if the ADEPT process intends to formulate advice on ‘how products should be selected (i.e. purchased) at a potential cost of ’£25-50K’ to each manufacturer per submitted device to the financial advantage the Difficult Airway Society, as the ADEPT guidance recommends [2].

Yours Sincerely, 

Dr. A Shaikh,

St. Andrew’s Cottage,

3 North Burlingham,

Norwich, Norfolk, U.K.

NR13 4TA.

Dr P N Robinson,

Northwick Park Hospital,

North West London Hospitals NHS Trust

Middlesex, U.K.

Dr Shaikh is the inventor of the Tulip® airway. No external funding and no other competing interests are declared.

References;

1). Pandit JJ, Popat MT, Cook TM, et al.;“The Difficult Airway Society ‘ADEPT’ Guidance on selecting airway devices: the basis of a strategy for equipment evaluation”, Anaesthesia, October 2011; 66: 726–37.

2). Pandit JJ, Popat MT, Cook TM, et al; Corrigendum “The Difficult Airway Society ‘ADEPT’ Guidance on selecting airway devices: the basis of a strategy for equipment evaluation”, Anaesthesia, November 2011; 66 Page 1080.

3). Harrison S., Robinson N.P., Shaikh A., Yentis S.M.;“Manikin evaluation of the Tulip®, a new supraglottic airway”, Anaesthesia, June 2009; 64: Page 807, presented at the A.A.G.B.I. September 2008; Torquay.

4). Robinson N.P., Shaikh A.;“Manikin studies are essential in airway research”; Anaesthesia, September 2011, On-line correspondence.