cep08048 buyers guide: laryngoscopes...laryngoscope construction laryngoscopes typically comprise:...

Buyers’ guide

Laryngoscopes CEP08048

July 2009

Contents 2

CEP08048: July 2009

Introduction ............................................................................................. 3

Technical considerations ......................................................................... 5

Operational considerations ...................................................................... 9

Economic considerations ...................................................................... 13

Purchasing ............................................................................................ 15

Market review ........................................................................................ 18

Acknowledgements ............................................................................... 40

Glossary ................................................................................................ 41

References............................................................................................ 42

Appendix 1: Supplier contact details ..................................................... 46

Appendix 2: EU procurement procedure ............................................... 48

Appendix 3: Evaluation protocol ............................................................ 50

Appendix 4: Supplier warranty information ............................................ 54

Appendix 5: Additional test results ........................................................ 56

Author and report information ................................................................ 57

Introduction 3

CEP08048: July 2009

Laryngoscopes are used during planned and emergency procedures to establish a secure airway for patient ventilation. Healthcare professionals, such as anaesthetists and paramedics, use the laryngoscope to move the tongue and epiglottis in the mouth and illuminate the back of the throat. A tracheal tube can then be passed through the vocal cords and into the trachea giving a secure route to deliver oxygen to the patient. Failure to provide adequate ventilation can result in permanent disability or death within a few minutes.

Typically, a laryngoscope consists of a handle containing a power source (A), a light source and a detachable blade (B), (figure 1). Both blade and handle may be single use or reusable.

Scope There are many types of laryngoscope blade available for different purposes. The Macintosh blade [1] is the most popular for use with adults in the United Kingdom and is normally available in four sizes: 1: small infant; 2: child; 3: adult; 4: large adult.

This buyers' guide examines currently available Macintosh blades, sizes 3 and 4, and appropriate handles. It is intended to assist procurement decisions by identifying products that meet local needs. The Market review provides comparative information on available products, including test data on light output, heating, and robustness, together with star ratings for ease of use. Technical, operational, economic and purchasing considerations are also discussed.

Evaluation protocol Product evaluation followed a protocol (appendix 3) based on previously published papers [2-6]. Sample products were provided by UK suppliers between April and June 2008 and were tested both in the laboratory and by user assessment with a manikin.

National guidance The Medicines and Healthcare products Regulatory Agency (MHRA) provides general guidance on the purchasing, deployment, maintenance, repair and disposal of medical devices [7] and specific guidance on sterilisation, disinfection and cleaning

A

B

Figure 1. Laryngoscope with Macintosh size 3 blade.

Introduction 4

CEP08048: July 2009

of reusable medical equipment [8], developed by the Microbiology Advisory Committee to the Department of Health.

The design of laryngoscopes is covered by International Standard ISO 7376:2003 [9], which is currently under review. A new standard is being developed [10].

Several professional organisations have provided guidance relevant to the use of laryngoscopes including:

• Association of Anaesthetists of Great Britain and Ireland (AAGBI) guidelines on infection control in anaesthesia [11]

• Royal College of Anaesthetists' (RCoA) guidance on variant Creutzfeldt-Jakob disease [12,13]

• Department of Health statement to RCoA on variant Creutzfeldt-Jakob disease [14]

• Difficult Airway Society (DAS) guidelines on the management of unanticipated difficult intubation [15]

• DAS guidelines for equipment to be kept available for routine airway management. Equipment should include two laryngoscope handles, which have been checked to be functional, and size 3 and 4 Macintosh blades [16].

Specific advice on the purchase, maintenance and replacement of anaesthetic-related equipment has been published by the Association of Anaesthetists of Great Britain and Ireland (AAGBI) [17]. (See also Purchasing).

Technical considerations 5

CEP08048: July 2009

Laryngoscope construction Laryngoscopes typically comprise:

• a handle containing disposable or rechargeable batteries

• a detachable blade, used to move the tongue and epiglottis out of the line of sight, allowing access to the larynx

• a light source illuminating the larynx allowing the user to see where to place the tracheal tube.

Depending on the location of the light source the laryngoscope is described as:

• bulb-in-blade (or ‘conventional’) – the light source is near the tip of the blade. A metal contact between the handle and the blade provides electrical power to the light source

• fibre-optic (or 'green standard’) – both the power and light source are in the handle and light is transmitted to near the blade tip by a fibre-optic bundle. The blade and handle should be marked in green to identify the product as a fibre-optic laryngoscope (figure 2).

Macintosh blade design The Macintosh blade (figure 2) is slightly curved with a small bulbous tip. In cross-section, it tends to be z-shaped with two grooves. It is inserted so that the blade tip reaches the base of the tongue. To obtain a good view of the larynx the tongue is swept to one side using one groove on the blade and the tongue and epiglottis lifted. The tracheal tube is then advanced along the second groove. In some blades the first groove is absent.

The blade should be smooth and without sharp edges to avoid patient trauma.

Figure 2. Macintosh size 3 blade (fibre-optic) with cross section view


CEP08048: July 2009

The shape of Macintosh blades varies considerably and there is no consensus on the optimum profile [5]. Although Macintosh considered shape to be relatively unimportant [18] the user assessment results indicate that blades with much deeper curves perform poorly (appendix 5).

Materials Blades may be made from metal or plastic, or a combination, as in figure 2. Where plastic connectors are used they may include metal reinforcement.

Handle compatibility Both handle and blade must be of the same type, either bulb-in-blade or fibre-optic. To ensure compatibility the international standard for laryngoscopes specifies the connector dimensions for blades and handles [9]. Any handle that complies with the standard should fit any blade that complies with the standard, provided that it is of the same type (bulb-in-blade or fibre-optic). It is essential that care is taken to check the type when ordering.

Light Laryngoscopes are used to provide direct vision of the larynx prior to intubation, enabling the user to insert a tube into the trachea, avoiding the oesophagus and minimising trauma to the vocal cords. The light needs to be sufficiently bright and in the correct location. This is achieved by a combination of light intensity, light distribution and blade shape.

Light intensity

Anaesthetists have a very wide range of preference for light levels in clinical use [19]. Low levels can make it hard to see important anatomical detail, however high light levels may cause glare. The Health and Safety Executive recommends a minimum illumination of 200 lux for general work and 500 lux for work requiring perception of fine detail [20]. The draft standard for laryngoscopes specifies a minimum illumination of 700 lux [10], however there is no evidence that higher levels are advantageous.

Light levels during use may be lower than results from tests performed with new batteries. For fibre-optic blades, repeated cleaning and autoclaving tends to damage the optical fibres and reduce the quality and level of the light output [21,22].

Light source

Bulbs may be incandescent (standard, xenon or halogen) or LED (light emitting diode). The choice of bulb determines the colour of the light output. Halogen and


CEP08048: July 2009

xenon bulbs are brighter and whiter than standard incandescent sources. LED lights typically give a blue-white light, but other colours may be available. There is no clear advantage of any one light colour.

All incandescent bulbs will emit infra-red radiation and become hot during use.

LED lights consume less energy than incandescent bulbs, giving a longer battery life. They also have a longer useable life and do not heat significantly during use.

Field of view

The shape and curvature of the blade should enable the user to see the larynx without the blade obstructing the view. The bulb or end of the fibre-optic bundle should be angled so that when the blade has been used to move the tongue to one side, the light still illuminates the glottis. The field of view may be poor where blades have low rigidity and this may also be influenced by other factors such as the curvature of the blade.

Strength and rigidity Laryngoscopes are used to sweep the tongue to one side and lift the epiglottis to obtain a view of the larynx. The blade and connector need to be strong to achieve this especially in very difficult intubations. There are reports of blades breaking during clinical use [23-24] which could put the patient at risk. Anaesthetists may use forces up to 100 N during difficult intubations [25] and a blade that withstood a force of 150 N would give a good margin of safety. This value has been used as the acceptance limit in the technical assessment (appendix 3).

The blade also needs to be rigid because if it flexes in either direction during use then the anaesthetist may not obtain the correct view of the larynx [2]. Deformation may occur in the blade, in the connector to the handle, or in both. Generally, plastic blades or blades with non-reinforced plastic connectors, are more flexible than other types. One-piece plastic laryngoscopes are likely to be more rigid than removable plastic blades.

Temperature of accessible surfaces during use The accessible surface temperatures of some bulb-in-blade laryngoscopes can be high [26] and the MHRA regularly receive reports of laryngoscopes getting very hot. Incidents have also been reported in literature where laryngoscopes have caused burns [27,28].


CEP08048: July 2009

LED bulbs generate less heat than incandescent bulbs and do not pose a thermal risk to patients. Fibre-optic type laryngoscope blades also reduce the risk of burns since the bulb is in the handle and does not come into contact with patient tissue.

There is no specific advice on a maximum acceptable temperature for instruments which are inserted into the throat. The general standard for medical electrical equipment, BS EN 60601-1:2006 [29], specifies limits for the temperature of accessible surfaces that could be in contact with healthy skin which depend on the material and the duration of contact. For metal surfaces in contact with skin for a minute or longer, the temperature limit is 48°C. For shorter contact times of between one and ten seconds the temperature limit is 56°C. A lower limit would be appropriate for delicate tissues within the mouth and throat.

Operational considerations 9

CEP08048: July 2009

Operation The laryngoscope blade is attached to the handle by pushing the connector onto the handle until it clicks into place. This allows the blade to swing freely. To activate the laryngoscope, the blade is moved away from the handle until it locks into position (figure 3). The user generally holds the laryngoscope in the left hand whilst holding a tracheal tube in the right hand. "Right-handed" versions are also available for left-handed users, if required.

Figure 3. Attachment of blade onto handle and activation of the laryngoscope.

Handle Various handle shapes are available for specific uses, including a short, stubby version, a thinner version for paediatric use and a handle which forms a larger angle with the blade. The latter was specifically designed for patients with polio in an iron lung and is used where access with a standard laryngoscope is difficult. Handles may be reusable or single use. In some laryngoscopes the handle is permanently attached to the blade.

The handle finish should be comfortable for the user, avoiding sharp edges, and providing adequate grip. Many users hold the handle very close to the blade rather than on the main handle body, so this area should also be well rounded.

Power requirements The laryngoscope handle contains the batteries used to power the light source. Most handles contain two C size batteries or two AA batteries, providing about 3 V.

Rechargeable handles are available from some manufacturers. These usually provide higher voltages, typically 3.6 V, which can increase the light intensity. Rechargeable cells are usually recharged as a complete unit, either by placing the handle in a recharging station, or by plugging the handle into a power source. Some handles require the rechargeable battery to be removed from the handle for recharging. To ensure that a laryngoscope is always available for use, a second handle should remain on charge.


CEP08048: July 2009

Whichever sort of battery power is used, back up laryngoscopes should always be available.

Sterility There is no evidence to suggest that using clean rather than sterile single-use laryngoscope blades increases the risk of infection for a patient. The majority of blades are supplied clean. Reusable blades should always be cleaned and sterilised after use, to avoid cross-contamination.

Reusable or single-use Both blade and handle can be either single-use or reusable. Single-use laryngoscopes should allow several consecutive intubation attempts on the same patient, but they are not intended to be used repeatedly over several days.

Most single-use laryngoscopes are not designed to be activated repeatedly and the MHRA reports that frequent checking of single-use laryngoscopes can result in poor illumination, weakening or breakage during use, although this was not confirmed by the user assessment for this report. The MHRA recommends that they should only be checked immediately prior to use, but that two laryngoscopes of each size should always be available [30].

Laryngoscopes are also available where the blade is permanently attached to the handle and the whole unit is discarded after use. In one case, the unit cannot be switched off once activated.

Laryngoscopes can be difficult to clean effectively and commonly-used methods of sterilisation will not denature prions such as those linked to new variant Creutzfeldt-Jakob disease (vCJD). However, the Working Group of the AAGBI estimated that the risk of a laryngoscope becoming contaminated with vCJD is extremely small and that this risk is probably less than that arising from the use of a single-use laryngoscope for a difficult intubation [11]. Although the AAGBI states that the use of single-use laryngoscopes is to be encouraged [11], it also states that reusable blades should be available in case of difficulty.

Reprocessing reusable laryngoscopes Laryngoscope blades are known to become contaminated during use [31-35] and should be thoroughly cleaned and sterilised between patients. Cleaning and sterilisation advice is available from the MHRA [8]. Recommended cleaning methods include the use of an automated washer disinfector followed by steam sterilisation at 134°C for 3 minutes, although there are other acceptable methods. Not all blades


CEP08048: July 2009

state in their instructions for use that they can be processed in an automated washer disinfector.

Blade design can make cleaning easier by eliminating spaces that accumulate debris such as bulb fittings and screw threads. Blades with the fibre-optic bundle enclosed in the blade are usually very easy to clean. Some fibre-optic bundles can be removed for cleaning, although effort is required for disassembly. The best design for cleaning will depend on the local practices of the sterilising services department (SSD).

Laryngoscope handles can also become contaminated and the AAGBI recommends that they should be washed, decontaminated and if possible sterilised. Manufacturer recommendations should be followed carefully as they vary widely. All handles will require some disassembly for sterilisation to remove the batteries. Many require bulbs to be removed, or only allow an outer sleeve to be sterilised. The process also needs to include provision for the storage of batteries and non-sterilisable parts and for ensuring that parts from different handles cannot be confused.

Replacement parts When replacing a bulb in a reusable handle or blade, it is important to select the appropriate bulb for the voltage supply in the handle, as this varies between manufacturers. The manufacturer's instructions should always be followed.

Bulbs may become loose and a case has been reported where the bulb had fallen from the blade into the patients' airway [36]. Care must be taken when replacing bulbs to ensure that they are tightly screwed in. The MHRA has received reports of broken bulbs and fibre-optic bundles, usually due to poor handling.

Fibre-optic bundles are replaceable in some blades as these can become damaged and deteriorate due to repeated autoclaving. Care must be taken to position them correctly on replacement.

Where several types of laryngoscope are in use, different spares may be needed and users should be careful to select the appropriate item for each device. Standardising laryngoscopes will reduce the stock of spare parts needed and minimise error due to confusion.

Additional features Most laryngoscopes can be switched off by folding the blade against the handle. The connector on some blades is designed to prevent the blade touching the handle and contaminating it.


CEP08048: July 2009

Sheaths are available to cover blades and handles during use to prevent contamination of the laryngoscope during use. However, the use of a sheath reduces illumination [37] and may make intubation more difficult.

Marking and labelling The standard [9] requires that blades and handles are marked with the name or trademark of the manufacturer or supplier. This can facilitate tracking, maintenance and responding to relevant medical device alerts or other issues. Additionally, blades are required to be marked with their size and type, material information and, when appropriate, green colouring to identify that they employ fibre optic light transmission.

The draft standard [10] requires all single-use blades to be marked as such on the blade. There is no requirement for single-use marking on laryngoscope handles, either in the current or draft standard. However, a single-use metal handle is not easily distinguishable from a reusable once the packaging is removed. Absence of marking on the device itself might lead to accidental reuse of a single-use item.

The Medical Devices Directive requires that all devices are labelled with the name and address of the manufacturer (in addition to the name of the representative or importer into the EU) [38].

Disposal Contaminated single-use laryngoscope handles and blades should be disposed of as clinical waste for incineration. If laryngoscopes have been decontaminated then the metal and plastic can be recycled.

As there are now both single-use and reusable blades and handles in metal, it is possible that reusable items might be confused with single use versions. This can lead to unnecessary disposal of reusable devices, or reprocessing of single use ones. Ideally, the single-use symbol (figure 4) should be displayed on single use blades and handles. Any new purchases should be discussed with reprocessing staff to ensure that they are aware of changes.

Batteries must be removed prior to device disposal. They may not be placed in clinical or general waste, but must be disposed of according to local trust policy and national legislation [39].

Figure 4. Single-use symbol

Economic considerations 13

CEP08048: July 2009

Purchase costs

Single-use versus reusable

Given the wide variation in purchase prices and the different reprocessing facilities that are available in each trust, purchasers need to make their own local cost calculations. When evaluating the total cost of single-use and reusable laryngoscopes, broader resource use implications need to be considered.

For a single-use item, costs include purchase, storage of sufficient quantities, administration of re-ordering and stock control and disposal. Disposal will normally be by incineration as clinical waste, with a typical cost of approximately £367/tonne1.

Costs for a reusable item include the initial purchase, reprocessing, administration for return of reprocessed blades, repair and eventual disposal and replacement. Additional laryngoscopes will need to be purchased for use while others are being reprocessed. The cost of reprocessing a single item varies, however NHS PASA uses a figure of £1.05 [40] for similar items. A reusable laryngoscope can be expected to be in use for several years, although fibre-optic bundles may need replacing sooner.

Replacement light sources

The light source may need to be replaced during the life-time of the device. This forms part of the total life-cycle cost of a reusable device and should be considered as part of the purchasing decision. The bulb used must be appropriate for the device and the costs will vary.

LED light sources generally last much longer than incandescent bulbs leading to fewer replacements and lower maintenance costs.

Fibre-optic bundles are gradually damaged with successive autoclave cycles, causing a reduction in light transmission. The expected life of the fibre-optic differs between devices and may form part of the manufacturer warranty. Replacement fibre-optic bundles are available for some reusable blades, and can generally be installed by the user, increasing the useful life of the blade.

Batteries

Batteries in most handles were either standard C or AA size. Some handles are rechargeable, which eliminates the need for disposable batteries. 1Information sources: Cardiff and Vale NHS Trust

Economic considerations 14

CEP08048: July 2009

Batteries may no longer be placed in general waste destined for landfill, or incinerated [39], increasing costs to those using laryngoscopes with disposable batteries, particularly if single-use handles are employed and batteries discarded after one use.

Costs for rechargeable handles include the purchase cost of handles, batteries and a charger and electricity supply for charging. Costs for disposable battery handles include purchase costs for handles and purchase and disposal costs for batteries. Handle costs are very variable, and each trust will have different patterns of use, electricity and disposal costs. Purchasers need to make their own local calculation.

Table 1 takes an example using mid-range handle prices and compares the costs for rechargeable and disposable battery products. Costs of charging will vary according to electricity supplier and charging system. Battery disposal will depend on the supplier; it may be free of charge in some cases.

Table 1 Example of cost comparison for batteries1

Item Cost per unit

Number of units

Lifespan (years)

Rechargeable costs per year

Disposable costs per year

Non-rechargeable handle £75.00 2 5 n/a £30.00

Rechargeable handle & battery £121.00 2 5 £48.40 n/a

Charger £135.00 1 5 £27.00 n/a Cost of charging £0.083 per

KWh 7W for 12 hours, 5 days a week

n/a £1.88 n/a

Batteries (N changes per year) £0.392 2 x N n/a n/a £0.784 x N

Battery Disposal £0.185 2 x N n/a negligible £0.37 x N For the example in table 1 the rechargeable costs are £77.28 per year and the disposable costs are £30 per year plus £1.154 per battery change. In this case the costs break even when there are 41 battery changes in one year. If there are more frequent battery changes then the rechargeable option would be cheaper. 1Information sources: Rechargeable handle and charger used: Heine Non rechargeable handle used: Timesco Battery price: C Cell from NHS supply chain catalogue Energy price: SWALEC, as used at Cardiff and Vale NHS Trust. Battery disposal: Based on verbal estimation from Hagemeyer UK limited

Purchasing 15

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Purchasing procedures The Trust Operational Purchasing Procedures Manual provides details of the procurement process [41].

European Union procurement rules apply to public bodies, including the NHS. The purpose of these rules is to open up the public procurement market and ensure the free movement of goods and services within the EU. In the majority of cases, a competition is required and decisions should be based on best value. The EU procurement rules apply to contracts worth more than £90,319 (from 1 January 2008) [42]. Further details of the process are given in appendix 2.

NHS Supply Chain offers national contracts or framework agreements for some products, goods and services. Use of these agreements is not compulsory and NHS organisations may opt to follow local procedures.

As laryngoscopes are used in critical patient care scenarios it is important to follow the guidelines from the MHRA on procuring the most appropriate device [7]. There should always be a nominated consultant anaesthetist responsible for anaesthetic equipment purchasing decisions and the reasons for equipment choice should be recorded, as recommended by AAGBI [17]. AAGBI also states that "those purchasing laryngoscopes and other 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 alternative" [11].

MHRA [8] recommends that reprocessing instructions should be reviewed by relevant staff to ensure that they are compatible with their existing facilities. This will also limit misunderstandings about which devices are reusable, which parts should be dismantled, and how each component should be processed. This is particularly important since laryngoscopes which look similar may have very different cleaning and sterilisation instructions.

Warranty Warranties offered by the suppliers vary widely (appendix 4). For single-use blades, the warranty might cover one use, one patient episode or a number of activation/deactivation cycles. For reusable blades, the warranty might cover a length of time (typically between one and five years, or "lifetime") or a number of autoclave cycles (typically between 300 and 1000) or a combination of both. The warranty might be different for the fibre-optic component of the blade. Blades are not normally tracked in terms of time or autoclave cycles, and means of verifying these should be discussed with the supplier if required for the warranty.

Purchasing 16

CEP08048: July 2009

Sustainable procurement The UK Government launched its current strategy for sustainable development, Securing the Future [43] in March 2005. The strategy describes four priorities to progress sustainable development in the UK and in the world as a whole:

• sustainable production and consumption – working towards achieving more with less

• natural resource protection and environmental enhancement – protecting the natural resources and habitats upon which we depend

• sustainable communities – creating places where people want to live and work, now and in the future

• climate change and energy – confronting a significant threat to the global community.

The strategy also highlights the key role of public procurement in delivering sustainability.

There are sustainability issues throughout the lifecycle of any type of laryngoscope:

Production The environmental impact of production of a single disposable laryngoscope is probably comparable with that of a single reusable alternative. The impact of using disposable laryngoscopes is that many more items need to be produced. An in-depth comparison of the environmental footprint for production of the different devices is outside the scope of this report. Packaging This is generally not excessive. Single use devices will come in a plastic pocket, reusable devices may be individually packaged in a cardboard box. Since reusables are repackaged for sterilisation the impact of packaging is similar for single use or reusable devices. Transport Most products are produced in Asia and for the first use of any laryngoscope the transport impact is similar. Reprocessing a laryngoscope requires minimal transport and therefore transport impact of reusable devices is significantly less than for single-use devices. Use The environmental impact during use is largely from battery consumption. LED light sources give a longer battery life than incandescent bulbs. Lithium-ion rechargeable battery packs are available for some laryngoscopes, minimising battery consumption.

Purchasing 17

CEP08048: July 2009

Reprocessing Reusable laryngoscope blades must be decontaminated prior to reuse. The preferred treatment is a mechanical washing and disinfection process followed by steam sterilisation [8]. Environmental impact is from the chemicals in the washer, and the heat for both the washing, disinfection and sterilisation cycles. AAGBI recommends that handles are decontaminated after each use [11], although in many locations this is not routine. Reusable handles are frequently used in combination with single use blades, however there may be an increase in the use of disposable handles in the light of AAGBI recommendations. End of life disposal Where appropriate, suppliers of equipment placed on the market after the 13th August 2005 should be able to demonstrate compliance with the UK Waste Electrical and Electronic Equipment (WEEE) regulations (2006) [44]. The WEEE regulations place responsibility for financing the cost of collection and disposal on the producer.

Used, contaminated laryngoscopes are not covered by WEEE regulations, since contaminated items are exempt. Decontaminated handles and bulb-in-blade blades are covered by WEEE regulations. If laryngoscopes are reprocessed before disposal then much of the metal and plastic could be recycled and WEEE regulations would apply. Clinical risks of reprocessing devices due for disposal in the same facility as devices intended for reuse would have to be considered carefully and minimised.

At present contaminated devices are incinerated. This involves heating to over 1000°C and incurs a considerable energy cost. Plastic blades may be shredded and heat treated.

Where single-use laryngoscopes are used there will be much higher numbers of devices to dispose of, resulting in an increased environmental impact.

All batteries now need to be disposed of in accordance to the Batteries Directive that came into force in September 2008 [39]. Disposable batteries can no longer be sent to landfill and must never be left in laryngoscopes for incineration as clinical waste.

Market review 18

CEP08048: July 2009

Devices supplied for assessment This market review summarises product details and evaluation results for the majority of Macintosh size 3 and 4 laryngoscope blades, and the handles required for their use, available for purchase in the UK in June 2008. Technical testing was carried out on both blade sizes. Only Macintosh size 3 blades were evaluated by users. Contact details for the manufacturers and suppliers in the UK are provided in appendix 1.

Three manufacturers (Intersurgical, Marshall Products, Vygon) declined to participate. One, PROACT Medical, subsequently withdrew 1.Not all manufacturers supplied their full range of products.

Significant market developments occurred during production of this buyers' guide, and technical test data for these products were updated in April 2009. New user assessment data are not provided.

List prices for single-use and reusable blades ranged from £1.50 to £9.90 and £13 to £137, respectively. Discounts may be available for large volume purchases.

Evaluation summary

• Strength tests showed that all blades withstood 65N (the limit in the new draft standard [10]), but 3 blade types broke at 100N or below, and a further 5 blade types broke between 100 and 150N.

• All blades that broke were single-use; most were plastic. • The most flexible blades (both in primary and lateral axes) were linked to poor

field of view scores in user assessments, and increased intubation times. This was particularly apparent in difficult intubations.

• All blades that did not meet the draft standard [10] requirements for rigidity were either plastic or had a plastic connector.

• Higher user forces were linked to lower user scores for field of view and overall satisfaction.

• Light output varied widely, however very bright light sources (above 1500 lux) gave no increase in user scores for illumination (appendix 5).

• Some products were excessively hot after 3 minutes continuous activation. • One of the eight recommended blades is a single-use product, demonstrating

that single-use versions can offer performance similar to that of reusable products.

• Device marking was not consistent with the current laryngoscope standard [9] for many blades and some handles. Material marking was often omitted.

1 CEP was unable satisfactorily to resolve concerns raised by PROACT Medical, and decided to allow PROACT to withdraw from the project at a late stage. Consequently, CEP has modified its operating procedures to minimise the risk of such circumstances arising in future.

Market review 19

CEP08048: July 2009

Recommendations Blades are recommended if they meet the following criteria:

• all the user assessment scores are at least three stars

• light output is at least 700 lux (complying with the draft standard [10])

• rigidity complies with the draft standard

• temperature of the bulb is not more than 48°C when measured after three minutes.

The Consider category includes all blades that do not fully meet the criteria for Recommended, but are not considered unsafe. Devices are rated as Not recommended where they give rise to serious safety concerns. In each case the reason for the rating is given.

These recommendations are not prescriptive; they are intended solely as an aid to purchasing. Given that user preferences and local circumstances vary it may be more appropriate to use a laryngoscope that is rated Consider in some cases. Recently updated devices are also placed in the Consider category since user evaluation data are unavailable.

RECOMMENDED

Heine Classic+ F.00.22.103 Karl Storz 8541B Penlon Diamond Range 50532 Timesco Sirius 2955.150.20 Timesco Optima Clx 2970.150.20 Truphatek Shucman 5243 Vital Signs SteeLite 4603 Welch Allyn E-MAC 69213

CONSIDER

Albert Waeschle Guardian G.900.03 Falcon MAC103 Fannin Finesse FIBMAC33 Fannin Finesse CONMAC33 Flexicare Venticaire 040-112 Flexicare Venticaire 040-433 Flexicare BriteBlade Pro 040-713 Flexicare Venticaire 040-833 Meditech Greenline 226003MF Meditech 226003SS Multigate Yeescope Penlon Crystal 50553 Penlon Crystal 50674 Timesco Orion 2905.150.20 Timesco Freeway 2965.150.20 Timesco Europa DS.2940.150.20 Timesco Callisto DS.3940.150.20 Truphatek Greenspec 2 4233 Truphatek Trulite 4643 Truphatek Greenlite 4343T Truphatek Equiplite 4843T

NOT RECOMMENDED

Flexicare Venticaire 040-6131 Truphatek Lite-Blade Slims 404322

1 very long intubation times, very poor user evaluation scores 2 two blades cracked during user evaluations

3 These products are placed in the consider category since they have been recently updated and user evaluation data are unavailable.

Market review 20

CEP08048: July 2009

How to use the market review tables Table 1. Key to market review tables 2

Notation used

Feat

ures

Blade Normally metal or plastic Connector Normally metal or plastic. It can differ from the blade Blade length (a) Length of the blade (mm) (see appendix 3) Blade curve (b/a) Depth of the curve divided by blade length (see appendix 3) Bulb Type Conventional / Xenon / Halogen / LED ISO 7376:2003 - complies with the standard User replaceable fibre optic

- user can replace the fibre optic when it deteriorates

Machine wash - Instructions for use state that an automated wash/disinfect machine may be used

Handle used Handle that was used for all evaluations

Test

dat

a

Light output (lux) Measured light output with new / fully charged battery - complies with draft standard

Temperature (°C) Temperature at bulb or fibre-optic on blade tip after 3 mins Rigidity - complies with draft standard Strength - withstands applied force of 150N

Use

r eva

luat

ion

(Mac

3)

Manikin setting

User evaluation is based on subjective user opinion during a manikin simulation of intubation. Evaluation was of Mac 3 blades only (appendix 3) The manikin was set to easy or difficult intubation

Time to best view Time for user to achieve best view of larynx in seconds

Time to intubation Time for user to insert tracheal tube successfully

Blade smoothness

Very sharp/rough very smooth

Blade attachment Very difficult very easy

Illumination Unacceptable excellent

Field of view Unacceptable excellent

Overall opinion Unacceptable excellent

Intubation in less than 60 seconds

- all users were able to intubate within 60 seconds - some users were unable to intubate within 60 seconds

List price (£) List price per unit in GBP excluding VAT, July 2008. Minimum size orders will apply in most cases. Discounts may be available for large volume purchases

Supplier UK supplier of this product at publication date

User comments Comments from user evaluations (number of users who made this comment, from a total of 30)

Other comments

Market review 21

CEP08048: July 2009

Reusable bulb-in-blade laryngoscopes Table 2. Reusable bulb-in-blade laryngoscopes

Flexicare Timesco Venticaire Orion

MAC 3 MAC 4 MAC 3 MAC 4

040-112 040-113 2905.150.20 2905.150.25

Feat

ures

Blade Metal Metal Metal Metal Connector Metal Metal Metal Metal Blade length (a) 115mm 134mm 108mm 137mm Blade curve (b/a) 0.13 0.16 0.13 0.16 Bulb type Halogen Halogen Standard Standard ISO 7376:2003 Machine wash Handle used Flexicare 040-021 Timesco Orion 2905.300.10

Test

dat

a Light output (lux) 573 480 611 628 Temperature (°C) 47°C 50°C 37°C 49°C Rigidity Strength

Use

r eva

luat

ion

(Mac

3)

Manikin setting Easy Difficult Easy Difficult Time to best view 4s 4s 4s 5s Time to intubation 7s 8s 8s 9s Blade smoothness Blade attachment Illumination Field of view Overall opinion Intubation in less than 60 seconds

List price (£) £22.00 £22.00 £51.95 £51.95 Supplier Flexicare Flexicare Timesco Timesco

User comments

Other comments

Market review 22

CEP08048: July 2009

Table 2. Reusable bulb-in-blade laryngoscopes contd

Truphatek

Shucman 2

MAC 3 MAC 4

5243 5244

Feat

ures

Blade Metal Metal Connector Metal Metal Blade length (a) 109mm 137mm Blade curve (b/a) 0.13 0.13 Bulb Type Halogen Halogen ISO 7376:2003 Machine wash Handle used Truphatek Dolphin 5571

Test

dat

a Light output (lux) 3018 2570 Temperature (°C) 30°C 31°C Rigidity Strength

Use

r eva

luat

ion

(Mac

3) Manikin setting Easy Difficult

Time to best view 4s 5s Time to intubation 8s 12s Blade smoothness Blade attachment Illumination Field of view Overall opinion Intubation in less than 60 seconds 1 failed

List price (£) £53.50 £53.50 Supplier PAJUNK UK PAJUNK UK User comments

Other comments Blade has a bulb in its base and a fibre-optic bundle to deliver light to its tip. The fibre-optic bundle is replaceable by the user.

Market review 23

CEP08048: July 2009

Reusable fibre-optic laryngoscopes Table 3. Reusable fibre-optic laryngoscopes

Flexicare Heine

Venticaire Classic +


040-833 040-834 F.00.22.103 F.00.22.104

Feat

ures

Blade Metal Metal Metal Metal Connector Metal Metal Metal Metal Blade length (a) 113mm 131mm 109mm 132mm Blade curve (b/a) 0.13 0.16 0.12 0.15 ISO 7376:2003 User replaceable fibre optic Machine wash Handle used Flexicare 040-811 Heine F-02.22.863

Test

dat


Use

r eva

luat

ion

(Mac

3) Manikin setting Easy Difficult Easy Difficult

Time to best view 4s 4s 4s 4s Time to intubation 7s 8s 7s 7s Blade smoothness Blade attachment Illumination Field of view Overall opinion Intubation in less than 60 seconds

List price (£) £35.00 £35.00 £79.50 £84.00

Supplier Flexicare Flexicare Albert

Waeschle Albert

Waeschle

User comments

Other comments

Market review 24

CEP08048: July 2009

Table 3. Reusable fibre-optic laryngoscopes contd

Karl Storz Penlon

Diamond Range


8541B 8541A 50532 50533

Feat

ures

Blade Metal Metal Metal Metal Connector Metal Metal Metal Metal Blade length (a) 111mm 135mm 112mm 131mm Blade curve (b/a) 0.12 0.14 0.13 0.15 ISO 7376:2003 User replaceable fibre optic Machine wash limited limited Handle used Karl Storz 8546LD Penlon Crystal (Diamond Range)

Test

dat

a Light output (lux) 2622 1986 1132 (26081) 1132 (31641)Temperature (°C) 23°C 26°C 32°C 31°C Rigidity Strength

Use

r eva

luat

ion

(Mac



List price (£) £126.00 £126.00 £137.00 £137.00 Supplier Karl Storz Karl Storz Penlon Penlon

User comments Sharp corner on

handle (2)

Other comments

Device not marked with MAC

1Single-use handle was used for assessment. Light output is greater with reusable handle, as shown in figure in brackets

Market review 25

CEP08048: July 2009


Timesco Timesco

Optima CLX Sirius


2970.150.20 2905.150.25 2955.150.20 2955.150.25

Feat

ures

Blade Metal Metal Metal Metal Connector Metal Metal Metal Metal Blade length (a) 106mm 134mm 110mm 133mm Blade curve (b/a) 0.14 0.16 0.11 0.14 ISO 7376:2003 - in process - in process - in process - in process User replaceable fibre optic Machine wash Handle used Timesco Optima XL 3000.300.10 Timesco Optima XL 3000.300.10

Test

dat


Use

r eva

luat

ion

(Mac



List price (£) £81.00 £81.00 £81.00 £81.00 Supplier Timesco Timesco Timesco Timesco

User comments Sharp corner on handle (5)

Sharp corner on handle (1)

Other comments Device not marked green to indicate fibre-optic.

Market review 26

CEP08048: July 2009


Truphatek Welch Allyn

Green spec 2 E-MAC


4233 4234 69213 69214

Feat

ures

Blade Metal Metal Metal Metal Connector Metal Metal Mixed Mixed Blade length (a) 108mm 137mm 113mm 134mm Blade curve (b/a) 0.13 0.13 0.11 0.15 ISO 7376:2003 User replaceable fibre optic Machine wash Handle used Truphatek Tru-LED UL.E112595 Welch Allyn 60813

Test

dat


Use

r eva

luat

ion

(Mac



List price (£) £44.50 £44.50 £79.00 £79.00 Supplier PAJUNK UK PAJUNK UK Welch Allyn Welch Allyn

User comments Mixed views on

blue light (8)

Other comments Samples supplied by PROACT Light colour is determined by the handle used and not the blade for fibre optic devices.

Market review 27

CEP08048: July 2009

Single-use bulb-in-blade laryngoscopes

Table 4. Single-use bulb-in blade laryngoscopes

Falcon Fannin

Conventional


MAC103 MAC104 CONMAC3 CONMAC4

Feat

ures

Blade Metal Metal Metal Metal Connector Metal Metal Plastic Plastic Blade length (a) 111mm 139mm Blade curve (b/a) 0.14 0.14 Bulb Type Standard Standard LED LED ISO 7376:2003 Handle used Falcon BHC702

Test

dat

a Light output (lux) 474 1396 Temperature (°C) 42°C 50°C Rigidity Strength 1 broke,100N

Use

r eva

luat

ion

(Mac


Time to best view 4s 5s Time to intubation 9s 8s Blade smoothness Blade attachment Illumination Field of view Overall opinion Intubation in less than 60 seconds

List price (£) £4.52 £4.52 £2.95 £2.95 Supplier Falcon Falcon Fannin Fannin

User comments Light in wrong

direction (3)

Other comments Product launched since original testing was completed. The new product was not available in time for inclusion in this report.

Market review 28

CEP08048: July 2009

Table 4. Single-use bulb-in blade laryngoscopes contd

Flexicare Multigate

Venticaire Yeescope


040-433 040-434 AN010000 AN010001

Feat

ures

Blade Metal Metal Plastic Plastic Connector Metal Metal N/A N/A Blade length (a) 113mm 135mm 111mm 132mm Blade curve (b/a) 0.13 0.16 0.14 0.17 Bulb Type Halogen Halogen Xenon Xenon ISO 7376:2003 N/A N/A Handle used Flexicare 040-021 N/A

Test

dat


Use

r eva

luat

ion

(Mac


Time to best view 4s 5s 5s 5s Time to intubation 7s 9s 9s 12s Blade smoothness Blade attachment N/A N/A Illumination Field of view Overall opinion Intubation in less than 60 seconds 1 failed

List price (£) £4.50 £4.50 £9.90 £9.90 Supplier Flexicare Flexicare Fannin Fannin

User comments Hard to attach

blade (3)

Other comments One piece laryngoscope containing batteries that is activated by removing a plastic tab Once activated the light remains on until the battery is removed. The battery can be removed for disposal using the supplied adaptor.

Market review 29

CEP08048: July 2009


Meditech Timesco

Europa


226003SS 226004SS DS.2940.150.20 DS.2940.150.25

Feat

ures

Blade Metal Metal Metal Metal Connector Metal Metal Plastic Plastic Blade length (a) 113mm 131mm 107mm 131mm Blade curve (b/a) 0.12 0.15 0.13 0.16 Bulb Type Standard Standard Standard Standard ISO 7376:2003 (no-touch)1 (no-touch)1 Handle used Truphatek Dolphin 55711 Timesco Orion 2905.300.10

Test

dat

a Light output (lux) 1769 728 1266 1231 Temperature (°C) 55°C 61°C 72°C 72°C Rigidity Strength 1 deformed

Use

r eva

luat

ion

(Mac


Time to best view 5s 5s 5s 6s Time to intubation 8s 10s 8s 13s Blade smoothness Blade attachment Illumination Field of view Overall opinion Intubation in less than 60 seconds 1 failed

List price (£) £5.88 £5.88 £5.00 £5.00 Supplier Meditech Meditech Timesco Timesco

User comments Light flickers (2)

Sharp corner on

handle (3)

Other comments 1 Meditech handle was supplied late Device not marked with Manufacturer or MAC

1 ‘Connector prevents handle touching blade when folded to reduce cross infection risks. Complies except for connector dimensions. Blades generally fit all conventional handles.

Timesco comment: All our blades undergo inspection for any rough or sharp edges and we would agree with CEDAR that any comments made with regard to smoothness are subjective. We supply in excess of 600,000 SU blades into the UK market and have less than 0.005 % quality or finish issues.

Market review 30

CEP08048: July 2009


Truphatek Truphatek

Trulite Lite-Blade Slim


4643 4644 4043 4044

Feat

ures

Blade Metal Metal Plastic Plastic Connector n/a1 n/a1 Plastic Plastic Blade length (a) 108mm 136mm 109mm 132mm Blade curve (b/a) 0.13 0.13 0.12 0.14 Bulb Type LED LED Halogen Halogen ISO 7376:2003 n/a n/a Handle used N/A Truphatek Dolphin 5571

Test

dat

a Light output (lux) 1933 2013 2193 1924 Temperature (°C) 29°C 27°C 70°C 66°C Rigidity Strength all broke<100N all broke<100N

Use

r eva

luat

ion

(Mac


Time to best view 4s 6s 6s 7s Time to intubation 8s 11s 11s 18s Blade smoothness Blade attachment N/A N/A Illumination Field of view Overall opinion Intubation in less than 60 seconds 1 failed 3 failed

List price (£) £6.95 £6.95 £2.00 £2.00 Supplier PAJUNK UK PAJUNK UK

User comments Handle too short (6) light unreliable (3)

Poor view (6)

Other comments 1 Blade can be folded down, but not disconnected from handle. Samples supplied by PROACT

Two blades cracked during user evaluation Samples supplied by PROACT

Market review 31

CEP08048: July 2009


Truphatek

Equiplite

MAC 3 MAC 4

4843T 4844T

Feat

ures

Blade Metal Metal Connector Mixed Mixed Blade length (a) 106mm 133mm Blade curve (b/a) 0.13 0.14 Bulb Type LED LED ISO 7376:2003 Handle used Truphatek Dolphin 5571

Test

dat


Use

r eva

luat

ion

(Mac



List price (£) £3.95 £3.95 Supplier PAJUNK UK PAJUNK UK

User comments LED cover obscured view (4) Sharp corner on handle (3)

Other comments Samples supplied by PROACT

Market review 32

CEP08048: July 2009

Single-use fibre-optic laryngoscopes Table 5. Single-use fibre-optic laryngoscopes

Albert Waeschle Fannin

Guardian Finesse


G.900.03 G.900.04 FIBMAC3 FIBMAC4

Feat

ures

Blade Metal Metal Metal Metal Connector Metal Plastic Plastic Plastic Blade length (a) 111mm 136mm 110 138 Blade curve (b/a) 0.14 0.15 0.13 0.15 ISO 7376:2003 Handle used Heine F-02.22.863 Fannin Finesse FIBHAN2

Test

dat

a Light output (lux) 1107 1511 455 490 Temperature (°C) 29°C 33°C 28°C 27°C Rigidity Strength 1 deformed All broke > 100 N

Use

r eva

luat

ion

(Mac



List price (£) £4.95 £4.95 £2.95 £2.95

Supplier Albert

Waeschle Albert

Waeschle Fannin Fannin

User comments Fibre-optic obscures view (2)

Other comments Device not marked with manufacturer or MAC

Device not marked with manufacturer

Product has been updated since original testing was completed. New test data have been included.

Fannin comments: The green base connector has been significantly strengthened since CEDAR testing and will now withstand greater than150N. A new range of Fannin Finesse LED handles have been manufactured to have a significantly increased light output.

Market review 33

CEP08048: July 2009

Table 5. Single-use fibre-optic laryngoscopes contd

Flexicare Flexicare

BriteBlade Pro Venticaire


040-713 040-714 040-613 040-614

Feat

ures

Blade Metal Metal Plastic Plastic Connector Metal1 Metal1 Plastic1 Plastic1 Blade length (a) 112mm 134mm 109mm 139mm Blade curve (b/a) 0.13 0.16 0.20 0.16 ISO 7376:2003 Handle used Flexicare 040-811 Flexicare 040-811

Test

dat

a Light output (lux) 1522 1712 565 364 Temperature (°C) 25°C 26°C 27°C 29°C Rigidity Strength 2 broke <100N 2 deformed

Use

r eva

luat

ion

(Mac


Time to best view 4s 5s 11s 16s Time to intubation 7s 9s 20s 32s Blade smoothness Blade attachment Illumination Field of view Overall opinion Intubation in less than 60 seconds 1 failed 10 failed

List price (£) £5.50 £5.50 £2.00 £2.00 Supplier Flexicare Flexicare Flexicare Flexicare

User comments Blade hard to attach (3)

Poor view (8) Blade detached (1)

Other comments 1 Connector prevents handle touching blade when folded

View is poor due to curvature of blade 1 Connector prevents handle touching blade when folded Device not marked with single use

Flexicare comments: The BriteBlade requires a 45 degree angled insertion to create a secure and positive lock which is confirmed by an audible click. Flexicare offers training on blade attachment. All BriteBlade Pros undergo a unique specialist treatment of the entire surface metal to create a smooth finish and are supplied sterile.

Market review 34

CEP08048: July 2009


Meditech Penlon

Greenline/D Crystal


226003MF 226004MF 50674 50675

Feat

ures

Blade Metal Metal Metal Metal Connector Plastic1 Plastic1 Plastic Plastic Blade length (a) 106mm 132mm 113mm 132mm Blade curve (b/a) 0.12 0.14 0.14 0.16 ISO 7376:2003 Handle used Meditech 226000SSF Penlon Crystal (Diamond Range)

Test

dat

a Light output (lux) 284 153 257 (5081) 273 (4041) Temperature (°C) 28°C 27°C 27°C 26°C Rigidity Strength 1 deformed 1 broke>100N

Use

r eva

luat

ion

(Mac


Time to best view 5s 6s 4s 5s Time to intubation 9s 9s 7s 8s Blade smoothness Blade attachment Illumination 1 1 Field of view Overall opinion Intubation in less than 60 seconds

List price (£) £5.88 £5.88 £5.45 Supplier Meditech Meditech Penlon Penlon

User comments Poor fit to handle (5) Poor light (4) Sharp corner on handle (4)

Other comments 1 Connector prevents handle touching blade when folded

1 Single-use handle was used for assessment. Light output is greater with reusable handle, as shown in figure in brackets

Market review 35

CEP08048: July 2009


Penlon Timesco

Crystal Freeway


50553 50554 2965.150.20 2965.150.25

Feat

ures

Blade Plastic Plastic Plastic Plastic Connector Plastic Plastic Plastic Plastic Blade length (a) 111mm 137mm 107mm 132mm Blade curve (b/a) 0.14 0.16 0.10 0.14 ISO 7376:2003 - in process - in process Handle used Penlon Crystal (Diamond Range) Timesco Optima XL 3000.300.10

Test

dat

a Light output (lux) 792 (17642) 535 ( 14552) 1845 1121 Temperature (°C) 27°C 26°C 31°C 28°C

Rigidity Strength 2 broke>100N 1 broke>100N broke>100N

Use

r eva

luat

ion

(Mac


Time to best view 5s 6s 5s 7s Time to intubation 8s 16s 10s 16s Blade smoothness Blade attachment Illumination 2 2 Field of view Overall opinion Intubation in less than 60 seconds 2 failed 1 failed

List price (£) £2.50 £2.50 £3.00 £3.00 Supplier Penlon Penlon Timesco Timesco

User comments Poor view (3)

Light flickering (4)

Other comments 1 Connector prevents handle touching blade when folded 2 Single-use handle was used for assessment. Light output is greater with reusable handle, as shown in figure in brackets Device not marked with green to indicate fibre-optic

Fibre-optic bundle did not connect reliably with light source to activate light Device not marked with single use or MAC

Market review 36

CEP08048: July 2009


Timesco Truphatek

Callisto Greenlite


DS.3940.150.20 DS.3940.150.25 4343T 4344T

Feat

ures

Blade Metal Metal Metal Metal Connector Plastic Plastic Mixed Mixed Blade length (a) 107mm 131mm 105mm 133mm Blade curve (b/a) 0.12 0.15 0.14 0.14 ISO 7376:2003 no touch1 no touch1 Handle used Timesco Optima XL 3000.300.10 Truphatek Tru-LED UL.E112595 (TC)

Test

dat


Use

r eva

luat

ion

(Mac


Time to best view 5s 5s 5s 5s Time to intubation 8s 9s 9s 11s Blade smoothness Blade attachment Illumination Field of view Overall opinion Intubation in less than 60 seconds 1 failed

List price (£) £7.00 £7.00 £3.95 £3.95 Supplier Timesco Timesco PAJUNK UK PAJUNK UK

User comments Dim light (3) Mixed views on blue light (5)

Other comments 1 ‘Connector prevents handle touching blade when folded to reduce cross infection risks. Complies except for connector dimensions. Blades generally fit all conventional handles.

Samples supplied by PROACT Light colour is determined by the handle used, not the blade in this case.

Market review 37

CEP08048: July 2009


Vital Signs

SteeLite

MAC 3 MAC 4

4603 4604

Feat

ures

Blade Metal Metal Connector Plastic Plastic Blade length (a) 110mm 134mm Blade curve (b/a) 0.14 0.13 ISO 7376:2003 Handle used Vital Signs Greenlight II 4558GSP

Test

dat


Use

r eva

luat

ion

(Mac



List price (£) £3.00 £3.00 Supplier

User comments

Other comments

Market review 38

CEP08048: July 2009

Handles Table 6. Reusable handles

Name / Code Power source Bulb Machine Wash Cost

Reu

sabl

e

Bulb-in-blade

Soon to be available Fannin CONHAN2 n/a £14.00

Flexicare 040-021 2 × C batteries n/a £25.00

Timesco Orion 2905.300.10 2 × C batteries n/a £45.95

Truphatek Dolphin 5571 2 × C batteries n/a 1 £19.95

Fibre-optic

Fannin FIBHAN2 2 × C batteries Xenon £14.00

Fannin FIBHAN2-LED 2 × C batteries LED £20.00

Flexicare 040-811 2 × C batteries Halogen remove bulb £25.00

Karl Storz 8546LD Rechargeable LED £296.002

Heine F-02.22.863 Rechargeable Xenon

outer sleeve only

£121.003

Penlon Diamond 50525 2 × C batteries Xenon

outer sleeve

only £137.00

Timesco Optima XL 3000.300.10 2 × C batteries Standard £75.00

Truphatek Tru-LEDUL.E112595 (TC)

Rechargeable LED

outer sleeve only

£89.004

Vital Signs Greenlight II 4558GSP

2 × AA batteries LED £74.00

Welch Allyn 60813 2 × C batteries Halogen £67.00

Notes: All manufacturers/suppliers confirmed that their handles complied with ISO 7376:2003 All handles can be steam sterilised, disassembly requirement for sterilisation are as for machine wash. Batteries must be removed in all cases. 1 Handle can be soaked without battery removal 2 Price includes battery. Induction charger base unit for two handles is £411 3 Price includes battery. Charger base unit for two handles is £135 4 Price includes battery and charger.

Market review 39

CEP08048: July 2009

Table 7. Disposable handles

Sing

le u

se

Bulb-in-blade

Falcon BHC702 2 × C batteries n/a n/a £4.52

Fibre-optic

Meditech 226000SSF1 2 × C batteries Standard n/a £5.50

Penlon Crystal2(Diamond range)

2 × C batteries Halogen n/a £8.25

Notes: All manufacturers/suppliers confirmed that their handles complied with ISO 7376:2003 1 Device not marked with manufacturer name 2 Handle is not marked as single use, although packaging is. This may lead to unintentional reuse.

Acknowledgements 40

CEP08048: July 2009

We should like to thank the following for their contribution to this evidence review.

Harrie Cooke, Secretary, Barema Rebekah Day, Foundation Year 1 Doctor, Cardiff and Vale NHS Trust John Duggan1, Consultant Anaesthetist, The Newcastle upon Tyne Hospitals NHS Foundation Trust Esther Flavell, Specialist Registrar in Anaesthesia, Cardiff and Vale NHS Trust Les Gemmell2, Consultant Anaesthetist, North Wales NHS Trust Naomi Goodwin, Consultant Anaesthetist, Cardiff and Vale NHS Trust Shelley Gussin, Medical Device Trainer, Barts and the Royal London NHS Trust3 Judith Hall, Chair, Anaesthetics and Intensive Care Medicine, Cardiff University Mark Hampson, Technician, Anaesthetics and Intensive Care Medicine, Cardiff University John Henderson1, Consultant Anaesthetist, NHS Greater Glasgow and Clyde David Jessop, Waste Compliance Manager, Cardiff & Vale NHS Trust Howard Lawrence, Operations Manager, IH Sterile Services, Cardiff Gareth Lewis, Hospital Sterilisation and Disinfection Unit Quality Manager, Abertawe Bro Morgannwg University NHS Trust Kay Lewis, Manager, Sterile Services Unit, Llandough, Cardiff and Vale NHS Trust Douglas McIvor, Senior Medical Device Specialist, MHRA Louise Mulroy, Medical Device Specialist, MHRA Sahir Rassam, Consultant Anaesthetist, Cardiff and Vale NHS Trust Harry Stevens, Head of Resuscitation Services, Cwm Taff NHS Trust Gwyn Thomas, National Equipment Manager, Welsh Ambulances Services NHS Trust Adrian Woollard, Specialist Registrar in Anaesthesia, Cardiff and Vale NHS Trust Tahsin Zatman, Consultant Anaesthetist, Cardiff and Vale NHS Trust Media Resources, School of Medicine, Cardiff University

Manufacturers and suppliers of listed products

1 Nominated by the Difficult Airway Society (DAS) 2 Nominated by the Association of Anaesthetists of Great Britain and Ireland (AAGBI) 3 Nominated by the College of Operating Department Practitioners (CODP)

Glossary 41

CEP08048: July 2009

Disinfection A process to reduce the number of viable infectious agents, but which may not inactivate some microbial agents [8].

Epiglottis The flap-like cartilage attached to the base of the tongue that protects the glottis and prevents food passing into the trachea during swallowing

Glottis The glottis is the space between, and including, the vocal cords.

Incandescent bulb Bulb containing a filament that is heated by electric current and thus produces light. Includes conventional, xenon and halogen bulbs.

Larynx The larynx is the organ that protects the trachea and produces sound; it is situated at the base of the pharynx just below where it splits into the trachea and the oesophagus.

Macintosh Blade shape originally designed by Sir Robert Reynolds Macintosh (1897-1989). Macintosh's laryngoscope, first described in the Lancet in 1941, was just one of many very important developments in anaesthesia for which he was responsible.

Reusable Pertaining to an item that can be used on a patient, then cleaned and sterilised, and reused for a subsequent procedure on a different patient.

Decontamination A process which removes or destroys contamination so that infectious agents or other contaminants cannot reach a susceptible site in sufficient quantities to initiate infection or other harmful response [8].

Single-use Pertaining to an item intended to be used on an individual patient during a single procedure and then discarded. In the context of laryngoscopes this may involve several intubation attempts.

Sterilisation A process used to render an object free from viable infectious agents including viruses and bacterial spores [8].

Trachea Also known as the windpipe, the trachea is the tube connecting the larynx and the bronchi.

Tracheal tube Tube placed into the trachea for ventilation.

VAS Visual analogue scale. Used to record questionnaire responses on a continuous line between two fixed points.

References 42

CEP08048: July 2009

1. Macintosh RR. A new laryngoscope. Lancet 1943; i: 205.

2. Evans A, et al. A comparison of the forces exerted during laryngoscopy using disposable and non-disposable laryngoscope blades. Anaesthesia 2003; 58: 869-73.

3. Wilkes AR, et al. Illumination provided by single-use laryngoscopes. Anaesthesia 2005; 60: 302-3.

4. Wilkes AR, et al. Distortion of laryngoscope blades under applied force. Anaesthesia 2005; 60: 303-4.

5. Rassam S, et al. A comparison of 20 laryngoscope blades using an intubating manikin: visual analogue scores and forces exerted during laryngoscopy. Anaesthesia 2005; 60: 384-94.

6. Goodwin N, et al. Flexibility and light emission of disposable paediatric Miller 1 laryngoscope blades. Anaesthesia 2006; 61: 792-9.

7. MHRA. Managing medical devices (DB2006(05)). London: Medicines and Healthcare products Regulatory Agency, November, 2006.

8. MHRA. Sterilisation, disinfection and cleaning of medical equipment. Guidance on decontamination from the Microbiology Advisory Committee to Medicines and Healthcare products Regulatory Agency (MHRA). London: MHRA, Part 1 Principles (revised 2002); Part 2 Protocols (revised 2005); Part 3 Procedures (revised 2006). www.mhra.gov.uk

9. British Standards Institute. Anaesthetic and respiratory equipment - laryngoscopes for tracheal intubation (BS EN ISO 7376:2003). London: British Standards Institution, 2003.

10. International Organization for Standardization (ISO). Anaesthetic and Respiratory Equipment – Laryngoscopes for Tracheal Intubation. ISO 7376 TC 121 ⁄ SC 2, N. Geneva: ISO, 2007.

11. Association of Anaesthetists of Great Britain and Ireland. Infection control in anaesthesia. Anaesthesia 2008; 63: 1027-36.

12. Smith G. Variant vCJD: what you need to know at present. Bulletin of the Royal College of Anaesthetists 2001; 7: 302-3.

References 43

CEP08048: July 2009

13. Royal College of Anaesthetists. FAQ archive: Question 6. What is the latest College position with regard to the use of non-disposable equipment (including LMAs) for tonsillectomy? Accessed from: www.rcoa.ac.uk/index.asp?PageID=146. Accessed 12 May, 2008.

14. Statement issued by the Department of Health in March 2001. Advice for anaesthetists on publication of risk assessment on vCJD and surgery. Bulletin of the Royal College of Anaesthetists 2001; 7: 305.

15. Henderson JJ, et al. Difficult Airway Society guidelines for management of the unanticipated difficult intubation. Anaesthesia 2004; 59: 675-94.

16. Difficult Airway Society. Recommended equipment for management of unanticipated difficult intubation. Accessed at www.das.uk.com/equipmentlistjuly2005.htm.

17. AAGBI. Anaesthetic-related equipment. Purchase, maintenance and replacement. London: Association of Anaesthetists of Great Britain and Ireland, 1994.

18. Macintosh RR. Laryngoscope blades. Lancet 1944; i: 485.

19. Scholz A, et al. Minimal and optimal light output of Macintosh size 3 laryngoscopy blades: a manikin study. Anaesthesia 2007; 62: 163-8.

20. Health and Safety Executive. Lighting at Work, HSG 38 HSE books. 1998 (available from http://www.hsebooks.com).

21. Bucx MJL, et al. The effect of steam sterilisation at 134°C on light intensity provided by fibrelight Macintosh laryngoscopes. Anaesthesia 1999; 54: 875-8.

22. Bucx MJL, et al. The effect of mechanical cleaning and thermal disinfection on light intensity provided by fibrelight Macintosh laryngoscopes. Anaesthesia 2003; 58: 461-5.

23. Babb S, Mann S. Disposable laryngoscope blades. Anaesthesia 2002; 57: 286-7.

24. Jefferson P, et al. Problems with disposable laryngoscope blades. Anaesthesia 2003; 58: 385-6.

References 44

CEP08048: July 2009

25. Rocco M,et al. Laryngoscope handle malfunction. Anesthesiology 1986; 65: 107.

26. Lewis E, et al. The temperature of laryngoscope light bulbs compared to light emitting diodes. European Journal of Anaesthesiology 2007; 24 (Supplement 39): 19AP1-9.

27. Koh, THHG, Coleman R. Oropharyngeal burn in a newborn baby: new complication of light-bulb laryngoscopes. Anesthesiology 2000; 92: 277-9.

28. Toung TJ, et al. Thermal burn caused by a laryngoscope. Anesthesiology 1981; 55: 184-5.

29. British Standards Institute. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (BS EN60601-1:2006). London: British Standards Institution, 2006.

30. MHRA. One Liners. Issue 60. London: Medicines and Healthcare products Regulatory Agency, July, 2008.

31. Beamer JER, Cox RA. MRSA contamination of a laryngoscope blade: a potential vector for cross infection. Anaesthesia 1999; 54: 1010-11.

32. Ballin MS,et al. Contamination of laryngoscopes. Anaesthesia 1999; 54: 1115-6.

33. Miller DM,et al. Presence of protein deposits on 'cleaned' re-usable anaesthetic equipment. Anaesthesia 2001; 56: 1069-72.

34. Foweraker JE. The laryngoscope as a potential source of cross-infection. Journal of Hospital Infection 1995; 29: 315-6.

35. Morell RC, Crews DA. A survey of laryngoscope contamination at a university and a community hospital. Anesthesiology 1994; 80: 960.

36. Perel A,et al. Fiberbronchoscopic retrieval of an aspirated laryngoscope bulb. Intensive Care Medicine 1981; 7: 143-3.

37. Anderson KJ, Bhandal N. The effect of single use laryngoscopy equipment on illumination for tracheal intubation. Anaesthesia 2002; 57: 773-7.

References 45

CEP08048: July 2009

38. European Economic Community. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Official Journal of the European Communities 1993; 36 (L169): 1-43.

39. The Batteries and Accumulators (Placing on the Market) Regulations 2008. http://www.opsi.gov.uk/si/si2008/pdf/uksi_20082164_en.pdf

40. Purchasing and Supply Agency. Main principles to be considered when setting up a decontamination service for PCTs, Appendix B. 2005 (NB This information is only available on the NHSnet PASA website. Non-NHS personnel wishing to access this data should contact PASA.) nww.pasa.nhs.uk/PASAWeb/Guidance/Decontamination/Guidancedocuments.htm

41. http://home.pasa.nhs.uk/PASAWeb/Guidance/TOPPM/LandingPage.htm

42. http://www.ogc.gov.uk/procurement_policy_and_application_of_eu_rules_eu_procurement_thresholds_.asp

43. UK Government Strategy for Sustainable Development; Securing the Future. http://www.sustainable-development.gov.uk/publications/uk-strategy/index.htm

44. EC Directive on Waste Electrical and Electronic Equipment. http://www.berr.gov.uk/files/file35992.pdf

45. http://www.pasa.nhs.uk/pasaweb/productsandservices/leasing

46. http://www.ogc.gov.uk/stdtoolkit/reference/documentation/p13_buscase.html

47. http://home.pasa.nhs.uk/PASAWeb/Guidance/OPPM/LandingPage.htm

48. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsProcurement/DH_4070620

49. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsProcurement/DH_4109316

http://www.pasa.nhs.uk/PASAWeb/Guidance/Decontamination/

http://www.ogc.gov.uk/procurement_policy_and_application_of_eu_rules_eu_procurement_thresholds_.asp

http://www.defra.gov.uk/sustainable/government/

http://www.ogc.gov.uk/documentation_and_templates_business_case.asp

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsProcurement/DH_4109316

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsProcurement/DH_4070620

Appendix 1: Supplier contact details 46

CEP08048: July 2009

Supplier Albert Waeschle Drager Medical Fannin UK Limited

Address 11 Balena Close Creekmoor Industrial Estate Creekmoor Poole Dorset BH17 7DX

The Willows Mark Road Hemel Hempstead Hertfordshire HP2 7BW

42-46 Booth Drive Park Farm South Wellingborough Northamptonshire NN8 6GT

Telephone 01202 601 177 01442 213 542 0118 930 5333

Fax 01202 650 022 01442 240 327 0118 930 5111

Website www.aw-online.com www.draeger.co.uk www.fanninuk.com

Supplier Flexicare Medical Limited Intersurgical Limited Marshall Products Limited

Address Cynon Valley Business Park Mountain Ash CF45 4ER

Molly Millars Lane Wokingham RG41 2RZ

1 The Maltings Brassmill Lane Bath BA1 3JL

Telephone 01443 474 647 0118 9656 300 0845 612 8888

Fax 01443 474 222 0118 9656 356 0845 612 8889

Website www.flexicare.com www.intersurgical.com www.marshallproducts.co.uk

Karl Storz Endoscopy UK Meditech Systems Limited PAJUNK UK Medical Products Ltd

Address 392 Edinburgh Avenue Slough Berkshire SL1 4UF

Unit 3 Richmar Butt's End Industrial Estate Sturminster Newton Dorset DT10 1AZ

PAJUNK UK Medical Products Ltd Rotterdam House 116 Quayside Newcastle upon Tyne NE1 3DY

Telephone 01753503500 01258 471 770 0191 206 4101

Fax 01753578124 01258 471 772 0191 206 4001

Website www.karlstorz.com www.electrosurgery.co.uk www.pajunk.co.uk

Supplier Penlon Limited PROACT Medical Limited Timesco

Address Abingdon Science Park Barton Lane Abingdon OX14 3PH

9 - 13 Oakley Hay Lodge Great Folds Road Oakley Hay Business Park Northants

NN18 9AS

Timesco House 3 Carnival Park Carnival Close Basildon Essex SS14 3WN

Telephone 01235 547 000 0870 909 7400 01268 297 700

Fax 01235 547 041 0870 909 7500 01268 297 800

Website www.penlon.com www.proactmedical.co.uk www.timesco.com

Appendix 1: Supplier contact details 47

CEP08048: July 2009

Supplier Vital Signs Limited Vygon UK Ltd Welch Allyn (UK) Limited

Address 13 - 14 Eldon Way Lineside Industrial Estate Littlehampton West Sussex BN17 7HE

Bridge Road Cirencester Gloucestershire GL7 1PT.

Cublington Road Aston Abbotts Buckinghamshire HP22 4ND

Telephone 08456 444 955 01285 657 051 020 7365 6780

Fax 08456 444 966 01285 650 293 020 7365 9694

Website www.vital-signs.co.uk www.vygon.com www.welchallyn.co.uk

Appendix 2: EU procurement procedure 48

CEP08048: July 2009

EU procurement procedure Lease options National frameworks are in place for operating leases to help the NHS procure leases more cost efficiently and effectively. The framework came into place on 1st April 2007 and runs for two years. Further details are available from NHS PASA [45].

EU procedures The Public Sector Directive (2004/18/EC) has been transposed into UK law. This has been achieved by means of the following statutory instruments:

• the Public Contracts Regulations SI 2006 No.5 (the regulations) • the Utilities Contracts Regulations SI 2006 No. 6 (not relevant to this guide).

The regulations apply to contracts worth more than £90,319 (from January 1st 2008) [42] over their whole life, and specify the procedures to be followed for public sector contracting, including adherence to strict timetables, requirements for advertising, invitation to tender and the award of contract. Organisations undertaking a procurement exercise covered by the regulations must give all suppliers an equal opportunity to express an interest in tendering for the contract by placing a contract notice in the Official Journal of the European Union (OJEU).

At all stages of the procurement process, the purchaser must be demonstrably fair, as any decision made can be challenged by the unsuccessful suppliers.

Establishing a procurement strategy To achieve a successful outcome, decisions need to be made on:

• whether an existing contract/agreement can be used • the need to consider sustainable development issues • whether EU directives apply • the type and form of contract • sourcing potential suppliers • duration of contract and opportunity to review/extend • payment schedules • how to minimise any risks with the chosen strategy, including supplier appraisal

and evaluation/clarification of suppliers’ bids. Preparing a business case A business case should be drafted and approved before conducting any procurement exercise. Further guidance on preparing business cases is available from the Office of Government Commerce [46] and an illustrative example is provided in the NHS PASA Operational Purchasing Procedures Manual, Procedure 1-01 [47].

Appendix 2: EU procurement procedure 49

CEP08048: July 2009

The EU tendering exercise EU procurements usually take between 4 and 6 months to complete. This needs to be taken into account in the planning stages. The length of the exercise depends on the chosen procedure (open or restricted). Further information is available from the Department of Health [48].

The procurement panel A multidisciplinary team should be selected to guide the purchase. Representatives from clinical, user, technical, estates and financial areas should be considered.

Identifying potential suppliers Criteria for supplier selection must be established. A supplier pre-qualification questionnaire may be employed as an initial screen to exclude unsuitable suppliers which asks for details such as skills and experience of the service engineers.

Evaluation criteria Performance specifications should be derived from local operational requirements, and agreed by the procurement panel. They will form the basis for assessing the adequacy of suppliers’ technical specifications, provided in response to the technical specification questionnaire.

It is important to have agreed on the performance specifications of the product as they will be used in the adjudication against company specifications.

Requests for features which are supplier-specific are not permitted under the regulations. Very specific features which are not supported by operational requirements are also not allowed.

Award of contract Following award of the contract to the successful supplier; unsuccessful suppliers may need to be debriefed. This is at the supplier’s request.

Buyers must be aware of the ‘Alcatel’ procedure (see the Trust Operational Purchasing Procedures Manual [41], Procedure No.T-08, section 6 - ‘Mandatory Standstill Period’).

For more information on procurement please refer to the Department of Health Website [49].

Appendix 3: Evaluation protocol 50

CEP08048: July 2009

The evaluation process followed stakeholder consultation and is based on previously published papers [2-6]. Technical testing was carried out on Macintosh blade sizes 3 and 4; user evaluation was on Mac 3 blades only.

User evaluation The laryngoscopes were assessed by 30 anaesthetists (16 consultants and 14 specialist registrars; 17 were male) who each had more than five years' experience in anaesthetics. The user assessment was based on previously published studies [2,5] and addresses the following issues:

• ease of use, time taken for intubation and force used during laryngoscopy

• visibility of the vocal cords during insertion of tube

• light output and direction

• reduction of trauma – blade smoothness (particularly on tips and edges)

• connecting and activating laryngoscopes (effect of repeated activating on performance).

The size 3 blades were presented to each anaesthetist in random order and the user completed an evaluation form, as summarised in table 8. The anaesthetist first provided a visual analogue score (VAS) for Q1 and Q2 and then carried out laryngoscopy in a manikin (Laerdal Airway Management Trainer). The manikin was set so that an end point of a Cormack and Lehane grade 1 view was achieved. An appropriate spray was used to simulate moist tissue. The time required to achieve this view was recorded as the duration of laryngoscopy. The anaesthetist was then asked to place a tracheal tube through the vocal cords. The time was recorded as the duration of intubation. Each anaesthetist was asked to answer Q3, Q4 and Q5. Anaesthetists were asked to indicate all the scores on a 100mm line with the ends labelled for each question as shown below.

Table 8. Summary of user evaluation form

Question on user assessment form 0mm 100mm

Q1 How did you find the tip and sides of the blade? Very sharp / rough very smooth

Q2 How did you find attaching the blade to the handle? Very difficult very easy

Q3 How was the illumination provided by the laryngoscope? Unacceptable excellent

Q4 How was the field of view provided by the laryngoscope? Unacceptable excellent

Q5 Overall, thinking about the use of the laryngoscope in the clinical setting, what was your opinion of the laryngoscope?

Unacceptable excellent


CEP08048: July 2009

During each laryngoscopy, the force applied by the anaesthetist to the manikin was measured. Force in the horizontal direction was measured using a force transducer. Force in the vertical direction was measured using a balance (the manikin was placed on the balance). The overall peak force was obtained from the horizontal and vertical forces.

Each anaesthetist repeated the assessment of the laryngoscope using a second manikin set to provide a more difficult laryngoscopy. This was done by fixing the neck of the manikin using a hard cervical collar (Laerdal stifneck® collar) so that only the posterior part of the vocal cords was visible.

A panel of experts re-assessed the blade activation and illumination (Q2 and Q3) after the blades had been activated and de-activated 30 times, using the normal airway manikin only.

Summary of star rating boundaries for user assessment scores

The mean VAS score for each blade and each question was given the following ratings:

Stars

VAS score (mm) 0-19 20-39 40-59 60-79 80-100

Technical assessment The technical assessment was based on studies by Wilkes et al and Goodwin et al [3-5]. It was designed to address user concerns about blade flexibility and strength, light output, and reported incidents of burns due to blade heating.

Rigidity and strength

The current standard [9] does not specify values for strength or rigidity. The draft standard [10] specifies that the tip of the blade should not move more than 10mm when a force of 65N (6.4 kg) is applied vertically.

The draft standard implies that withstanding 65N without significant flexing is an acceptable blade performance. This was felt to be low for the strength test, there are several studies of anaesthetists using forces of this magnitude and one records forces up to 100N for a difficult intubation [25]. A blade that withstood a force of 150N would give a reasonable margin of safety.


CEP08048: July 2009

The rigidity for the blades that did not deform or break was the same at 65N or 150N. Where blades deformed or broke the rigidity was measured prior to the deformation.

Laryngoscopes are also used to move the tongue sideways out of the field of view, so the user will exert a lateral force on the blade. This is not addressed specifically in the current or draft standard [9,10], but too much lateral flexibility may cause the user difficulty in obtaining a clear view of the larynx.

Each blade was attached to an appropriate handle. The handle was clamped to a rigid base (figure 5). A sling was placed around the blade 10 mm from the tip. The other end of the sling was attached to a pneumatically-operated piston. The piston was slowly pulled at right-angles to the blade. A force transducer, rigidly attached to the piston, measured the force applied to the blade. The extension of the blade was measured by a displacement transducer. The force and extension data were recorded. The flexibility (slope of extension against force) was calculated over the range from 0 to 150N. Any breakages or other adverse effects of the applied force on the blade were noted. The test was repeated on three samples of each blade.

Figure 5. Laryngoscope and test rig for measurement of flexibility and strength

The flexibility and strength of the blade was also measured by applying force in the lateral direction (figure 6). The same test rig was used and the force was increased up to a maximum of 50N. This measures the flexibility of the blade during simulation of the movement of the tongue away from the field of view by the user.


CEP08048: July 2009

Figure 6. Laryngoscope and test rig for measurement of flexibility and strength in the lateral direction.

Illumination

The laryngoscope handle was held in a retort stand. The tip of the blade was positioned at right angles to a light sensor positioned at the centre of target and at 20 mm from the surface of the light sensor. The test was repeated three times for each sample of each blade and on three samples of each blade.

The illumination was also measured after 30 activation/de-activation cycles.

Temperature of accessible surfaces

Laryngoscopes may be activated before use on a patient and may remain on for a while before use. Laryngoscopy might take up to a minute or more before an airway is established. We considered that a laryngoscope could remain activated for three minutes and contact made with the patient at some point during this time.

A thermocouple was attached to the exposed light source or end of the fibre-optic bundle on each blade, as appropriate, and the temperature measured for 3 minutes with the laryngoscope activated.

Dimensions of blades

The length (a) and depth (b) were measured for each blade (Figure 7). The blade curvature was calculated as length divided by depth (b/a).

Figure 7. Dimensions of blade

Appendix 4: Supplier warranty information 54

CEP08048: July 2009

Blades Length of warranty Type of cover

Reu

sabl

e

Flexicare 5 years defects in materials and workmanship Heine 5 years or 4000 autoclaves blade and fibre-optic

Karl Storz 2 years defects in manufacture and failure of materials

Penlon blade: normal lifetime lightguide: 5 Years

all - materials, workmanship, design. lightguide - Total failure.

Timesco working lifetime

Should any of our reusable instruments crack, break, bend, deform, corrode or fail whilst being used for the intended purpose, we will simply replace it with a new one or repair it free of charge. Our guarantee does not cover fair wear and tear.

Truphatek stainless steel parts: 5 years fibre clips: 15 Months from date of Manufacture

stainless steel parts and fibre clips

Welch Allyn Blade: 10 years fibre optic light pipe: 5 years

Manufacturing Defects for reasons other than misuse, neglect, damage during shipment, or normal wear and tear use.

Sing

le u

se

Falcon single use n/a

Fannin single use (5 years if unopened and undamaged) faulty materials and workmanship

Flexicare single use device defects in materials and workmanship Heine single use n/a Meditech single use n/a Multigate, Yeescope

until expiry date - single use only faulty materials and workmanship

Penlon 1 year from purchase materials and workmanship

Timesco single patient episode

Should the instrument crack, break, bend, deform, corrode or fail whilst being used for the intended purpose, we will replace it with a new one or repair it free of charge.

Truphatek out of box blade and handle Vital Signs single use n/a

Appendix 4: Supplier warranty information 55

CEP08048: July 2009

Handles Length of

warranty Type of cover

Reu

sabl

e

Fannin

12 months (5 year warranty if packaged un opened & not damaged)

faulty materials and workmanship

Flexicare 5 years defects in materials and workmanship

Heine 5 years

Karl Storz 2 years defects in manufacture and failure of materials

Meditech 3 years

Penlon normal lifetime materials, workmanship and design, excludes lamp

Timesco lifetime

Should any of our reusable instruments crack, break, bend, deform, corrode or fail whilst being used for the intended purpose, we will simply replace it with a new one or repair it free of charge.Our guarantee does not cover fair wear and tear.

Truphatek 5 years from manufacture handle

Vital Signs 5 years from manufacture

repair or replacement of any parts, including the LED light source that fail other than through loss, misuse, neglect, damage in shipment or normal wear and tear.

Welch Allyn 10 years manufacturing defects for reasons other than misuse, neglect, damage during shipment, or normal wear and tear use.

Sing

le

use

Falcon single use n/a

Meditech single use n/a

Penlon 1 year from purchase materials and workmanship, excludes lamp

Years of use and number of autoclaves are not normally recorded for laryngoscopes. The supplier should be asked what verification may be required to claim under the warranty.

Different terms are used for length of warranty for single-use devices; clarification should be sought from suppliers, as necessary.

Appendix 5: Additional test results 56

CEP08048: July 2009

Optimum illumination There is no consensus among anaesthetists on what constitutes optimum illumination [19]. From the present study, user evaluation for light output did not improve with illumination over about 1500 lux (figure 8). However, the average score was over 50 for all blades tested. Figure 8. Mean user score against measured illumination for all blades

Blade curvature Two of the 40 blades included in the user assessment had a more pronounced curvature than the others and achieved markedly lower user evaluation scores (figure 9). One of these has now been withdrawn from the market. Figure 9. Mean user score for view obtained against dimension b/a for all blades

Unacceptable 0

20

40

60

80

Excellent 100

0.05 0.1 0.15 0.2 0.25 Blade depth curvature (dimension b/a)

Use

r ass

essm

ent

of fi

eld

of v

iew

(V

AS)

metal

plastic

TruLite

0 1000 2000 3000 4000Measured illumination (lux)

Use

r ass

essm

ent

of il

lum

inat

ion

(VA

S)

Unacceptable 0

20

40

60

80

Excellent 100

Author and report information 57

CEP08048: July 2009

Buyers’ guide: Laryngoscopes Megan Dale1, Tony Wilkes2, Diane Crawford1 1. Clinical Engineering Device

Assessment and Reporting (CEDAR) Cardiff Medicentre Cardiff CF14 4UJ Tel: 029 2068 2120 Fax: 029 2075 0239 Email: [email protected]

www.cedar.wales.nhs.uk 2. Anaesthetics and Intensive Care

Medicine School of Medicine Cardiff University Heath Park Cardiff CF14 4XN Tel: 029 2074 4852 Fax: 029 2074 3412 Email: [email protected]

About CEP The Centre for Evidence-based Purchasing (CEP) is part of the Policy and Innovation Directorate of the NHS Purchasing and Supply Agency. We underpin purchasing decisions by providing objective evidence to support the uptake of useful, safe and innovative products and related procedures in health and social care.

We are here to help you make informed purchasing decisions by gathering evidence globally to support the use of innovative technologies, assess value and cost effectiveness of products, and develop nationally agreed protocols.

Sign up to our email alert service All our publications since 2002 are available in full colour to download from our website. To sign up to our email alert service and receive new publications straight to your mailbox contact:

Centre for Evidence-based Purchasing Room 152C Skipton House 80 London Road SE1 6HL Tel: 020 7972 6080 Fax: 020 7975 5795 Email: [email protected] www.pasa.nhs.uk/cep © Crown Copyright 2009

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