CEP08045 - Buyers' guide: Urodynamic assessment …ici-rs.info/PDFs/BuyersGuide.pdfUrodynamics is...

Buyers’ guide

Urodynamic systems CEP08045

December 2008

Contents 2

CEP08045: December 2008

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

Technical considerations......................................................................... 6

Operational considerations...................................................................... 8

Economic considerations ...................................................................... 12

Purchasing............................................................................................ 14

Market review........................................................................................ 17

Acknowledgements ............................................................................... 23

Glossary................................................................................................ 24

References............................................................................................ 25

Appendix 1: UK supplier contact details ................................................ 27

Appendix 2: Evaluation questionnaire ................................................... 28

Author and report information................................................................ 31

Introduction 3


Urodynamics is the term used to describe the investigation of bladder and urethral function by means of pressure and flow measurements. In the UK, urodynamic investigations are performed widely and several companies produce urodynamic equipment. There have been reviews of urodynamic equipment in the UK in the past [1], but none recently.

This buyers’ guide offers a comprehensive overview of urodynamic equipment available in the UK. It discusses the technical, operational, economic and purchasing considerations which might influence purchasing decisions, and provides comparative product specifications. Urine flow testing (uroflowmetry) is an integral part of urodynamic assessment, but ’stand-alone‘ flow meters, sold separately from urodynamic equipment, are beyond the scope of this guide.

Urodynamic investigations A number of different tests are included under the umbrella term of urodynamics:

• uroflowmetry (urine free flow tests) • filling and voiding cystometry (bladder pressure and urine flow measurement, with or

without X-ray imaging) • urethral pressure measurements (by withdrawing a catheter slowly through the urethra) • ambulatory monitoring (cystometry studies using portable equipment).

The range of urodynamic tests offered by any centre will vary according to referral patterns. A district general hospital will generally only offer flow studies and filling and voiding cystometry, whereas a regional centre receiving tertiary referrals may offer videocystometry and perhaps ambulatory monitoring in addition to the more routine tests.

Clinical background Lower urinary tract symptoms (LUTS) is the collective term for symptoms suggestive of bladder or urethral dysfunction. Symptoms include frequent urination, incontinence and difficulties in bladder emptying.

Men In men, difficulty in voiding is the most common symptom investigated using urodynamics. The first urodynamic test performed is usually a flow study (uroflowmetry). Flow studies are commonly used in isolation to investigate voiding problems. In addition voiding cystometry (pressure/flow study) is performed to differentiate between obstruction and detrusor underactivity as a cause for voiding difficulties [2;3]. The International Continence Society (ICS) uses pressure/flow study measurements to define whether urinary flow is obstructed [4].

Introduction 4


Women In women, incontinence is more common than voiding difficulties. Filling and voiding cystometry, and sometimes urethral pressure monitoring, are the main urodynamic investigations.

Children and patients with complex conditions It is often difficult to predict the underlying bladder pathology from knowledge of the disease alone, and symptoms are not always helpful when sensation may be impaired [5]. Urodynamic testing, usually by means of videocystometry, is recognised as having an important role in the management of children and adults with complex urological and neurological problems.

Development of urodynamics Historically, the diagnosis and management of women with LUTS has been based on careful history taking and physical examination. These methods are useful but not entirely accurate; studies have demonstrated an improvement in diagnostic accuracy when urodynamic testing is used in addition to history and examination [6;7].

Developments in electronics, allowing more accurate measurement of bladder pressure, and a greater awareness of the clinical and economic benefits of a reliable diagnosis prior to surgical intervention have led to the widespread uptake of urodynamics as a clinical investigation.

The need for standardisation was recognised early, and the International Continence Society (ICS) was founded in 1971 to encourage a uniform approach to urodynamic testing.

National guidance A Cochrane review has considered whether treatment based on urodynamic diagnosis was more likely to be successful than treatment based on presumptive diagnosis. This review recommended that a larger definitive trial was needed, as the numbers in published randomised controlled trials were too small to draw a conclusion [8].

The National Institute for Health and Clinical Excellence (NICE) recently published guidelines on the role of urodynamics in women with incontinence [9]. Cystometry is recommended before surgery to treat incontinence if:

• there is a suspicion of bladder muscle over-activity (spontaneous bladder contractions associated with urgency),

• there has been previous surgery for stress incontinence or prolapse, or • there are voiding difficulties.

Introduction 5


The guidelines recommend that cystometry is not necessary before starting conservative treatment (such as pelvic floor exercises) or before surgery for the “small group of women with a clearly defined clinical diagnosis of pure stress urinary incontinence” [9].

There have been no published Cochrane reviews or NICE guidelines concerning the role of urodynamic investigations in men.

Technical considerations 6


Urodynamic investigations Uroflowmetry Urodynamic equipment includes a flow meter so that pressure/flow studies can be performed. For urine free flow study (uroflowmetry) the patient voids into a machine that measures the rate and pattern of urinary flow. There are two types of urine flow meters: spinning disc and weight transducer. In addition, the perineal electromyographic (EMG) signal within muscles is sometimes measured during voiding.

The parameters for the uroflowmetry equipment are specified by the ICS and are recommended to be in the following range: flow rate 0 to 50 ml/s, volume up to 1000 ml, maximum time constant 0.75 s, and accuracy of ± 5% full scale [10].

Filling and voiding cystometry During filling cystometry, vesical (bladder) pressure (pves) and abdominal pressure (pabd) are measured. The detrusor is the muscle that is present in the bladder wall and detrusor pressure (pdet) is calculated by subtracting the abdominal pressure from the vesical pressure (pves-pabd = pdet). Abdominal pressure is recorded to allow for any changes, such as straining or talking, which might influence bladder pressure but not detrusor pressure. The calculated pdet thus reflects true changes in vesical / detrusor pressures caused by detrusor muscle activity

To conduct filling and voiding cystometry the bladder must first be filled actively by an infusion of normal saline or X-ray contrast medium. During filling cystometry, bladder and abdominal pressures are measured constantly using inserted catheters. After filling, voiding cystometry - also known as a pressure/flow study - is performed as the patient urinates, recording bladder and abdominal pressures, together with urine flow rate. Data are analysed and pressure/flow graphs are generated to determine whether or not a patient has an obstructed (high pressure/low flow) or underactive (low pressure/low flow) void. Videocystometry will require additional computer hardware to capture X-ray images from an image intensifier. EMG recording is also an option usually available, although the requirement for it varies between departments.

The ICS recommends the use of water-filled catheters, although air-filled and microtip catheters are also acceptable, provided precaution is taken with initial setting of zero pressure levels. The recommended accuracies are: ± 1cmH2O for pressure and ± 5% full scale for flow and volume. The recommended ranges for operational measurements are: 0 - 250 cmH2O, 0 - 25 ml/s (with 50 ml/s option), and 1000 ml for pressure, urine flow rate and volume respectively. The rate of data acquisition should be at least 10 Hz [10].

Technical considerations 7


Urethral pressure profile (UPP) measurement A special catheter is withdrawn slowly through the urethra while fluid is slowly infused through it, and urethral pressure at the catheter tip is recorded continuously. The resulting graph can give information on sphincter strength and prostate length and pressure. Machines normally use a small motorised arm (also called profilometer) to withdraw the catheter at a fixed rate. Many UK departments do not use UPPs on a regular basis.

Ambulatory monitoring During ambulatory monitoring bladder and abdominal pressures are recorded as for cystometry, but the bladder is allowed to fill naturally and a portable recording device is used. It is particularly useful if the patient’s symptoms were not reproduced (for whatever reason) during a standard urodynamic test. Ambulatory monitoring is normally carried out at specialist urodynamics centres using microtip rather than water-filled pressure measurement catheters.

Types of urodynamic systems Portable or pole-mounted systems These systems are designed for mobile clinic use or for easy portability within a department. They tend to use laptop computers and wireless links and occupy only a small floor area. They tend to have limited functionality as a result but are generally adequate for routine urodynamic testing.

Trolley mounted systems The majority of equipment sold in the UK is mounted on a dedicated trolley, which often holds the pump and pressure transducers as well as the desktop computer. They can be moved around a hospital fairly easily but occupy a little more floor space than a portable system and are best kept on the trolley once assembled.

Operational considerations 8


Specifications Transducers Bladder and abdominal pressure can be measured with several types of pressure sensor. The ICS recommends water-filled catheters connected to an external pressure sensor, but solid state (microtip) or air-filled catheters may also be used. Water-filled systems give more reliable resting pressures but are more susceptible to movement artefacts when for instance the tube is knocked. The reverse is true for other sensor types. In all cases, it is vital for good quality urodynamic traces that appropriate calibration and measurement protocols are followed [10]. It is possible to use different types of sensor for different pressure channels. The department should be clear before purchase which method is preferred as all manufacturers offer a choice of pressure transducers.

Other types of transducers will also need to be considered. Fluid infused is usually measured by a weight transducer holding the saline bag, although in practice a carefully calibrated pump will give a measure of infused fluid accurate enough for clinical purposes. Urine flow is measured by either a weight sensor measuring rate of change of urine weight, or a spinning disc flowmeter that calculates volume from direct measures of flow. There is no clinically significant difference in the accuracy of the flowmeter types [11], so considerations may only rest on, for example, compatibility with existing equipment or cleaning requirements.

Ergonomics and physical arrangements One of the most important considerations for the department will be the physical layout of the machine. A department that has a dedicated room will not need to move the equipment much, but one that shares space will need to consider issues such as how easy the unit is to take in and out of store, the presence of trailing wires, and whether the unit will restrict patient or staff access. A department that is either mobile or is very constrained for space will need to consider the smaller, portable models, all of which connect to laptop computers. In addition, if videocystometry is intended, it will be vital to check the range of movement of the fluoroscopy unit and how this matches the layout of the urodynamic machine and height of commode.

Another important parameter to consider is the location of the pump and volume transducer. Some machines have these rather low which hampers inspection of the drop chamber and increases difficulty of bag loading. During evaluation, staff should check the comfort of the access and ease of setting up the infusion set in the pump. The range of movement of keyboard and screen should also be noted during assessment, to ensure suitable ergonomics. If UPPs are used regularly, checks should also be made of the method used to deliver slow infusion. Roller pumps have the disadvantage of giving large pressure waves on the UPP trace, whereas machines that use compression bags wrapped around the saline have steady pressure but require careful attention to maintain the bag’s inflation.



Consumables The supply of consumables should also be investigated during purchase. In addition to a standard cost comparison, the number of supply sources available should also be considered. A greater choice will give better backup if one supplier fails. The configuration of consumables can also boost efficiency. For instance, the use of combined tube, tap and pressure dome set would result in lowering stock requirements and increasing clinic speed.

Infection control During equipment evaluations, the ease of cleaning according to department protocol between tests should be considered. Equipment that has cloth-covered or inaccessible surfaces should be shielded or modified. The MHRA recommends that water filled domes are disposed between tests to reduce the risk of cross infection [12], a practice that should be factored into the costing of consumables.

Software While the complexity of urodynamic equipment varies between systems, it does not always correlate with clinical usefulness. There may be a tendency for the operator to rely overly on automated results [13]. Since the acceptability of many software features is essentially subjective, purchasers should assess software suitability as part of their evaluations. Listed below are particular features that should be scrutinised before purchase:

Area Considerations

Urine flow • Is the signal filtered, smoothed or analysed excessively before display?

UPPs • What automatic features are available? • Are they necessary and helpful to us?

Cystometry

• What automatic analysis occurs at the end of the test? • Do we need it? • What points are taken for compliance measurements? • Are flow and pressure signals excessively processed before display? • Do volume calculations allow the user to incorporate leakage and residuals?

Calibration • Does the department prefer equipment calibration by their own personnel or by the supplier?

On-screen prompts and

information

• Are these helpful or do they reduce clarity? • Do they improve clinic operation?

Connectivity • Is a network connection required and if so will it affect system reliability?

Reporting • What formats are required for patient records? • Is recalling and printing a report straightforward? • Can reports and data analyses be manually edited?

Data Archiving • Are the data storage and transfer methods compatible with IT policies and hardware?



Other considerations The specifying department should consider carefully which tests are essential for their clinical use and which tests are merely desirable, as each option will add not just cost but also complexity to the machine. During the evaluation of equipment reported here, the following issues were highlighted as key to the acceptability and usability of a given device:

• size and layout of the machine • level of complexity relative to required functionality • training programme during the early days of use • availability of disposables (standard type or single source) • ease of printing and post-test analysis • personal, subjective acceptability of software interface, therefore trialling equipment

prior to purchase is essential. Staff requirements and training In order to operate a urodynamic clinic, it is necessary to have adequately trained staff. At present in the UK, there are no specific staff training or certification requirements to operate urodynamic equipment. Standards for training are currently being produced by the UK Continence Society in discussion with the Royal College of Obstetricians and Gynaecologists, Royal College of Surgeons and Royal College of Nursing. Certificate courses are available under the auspices of the ICS and it is probable that these will be incorporated into the training requirements. All manufacturers give user training upon purchase of the equipment. The department will find additional training of value once some experience on the equipment has been gained.

Levels of staffing for a particular clinic will vary depending on the range and type of tests that are offered. For example, a centre that sees mainly patients from one specialty for standard cystometry may be nurse led, whereas a centre that offers a wide range of tests will need levels of staffing that reflect that. The use of fluoroscopy in video urodynamics will necessitate input from medical physics and radiology.

Servicing and maintenance Service contracts, proximity for repair calls and technical staff support levels will also need to be considered. In-house biomedical or clinical engineering departments will be able to offer safety testing, regular maintenance and calibration checks. Specific training on particular equipment is not generally offered by suppliers as they have their own maintenance services available under contract, but such training is not essential for routine preventative maintenance. Detailed repair work and the purchase of parts will, of course, require supplier services. Monthly equipment calibration checks should be part of the in-house clinical routine.



Setting up clinics Clinics are most commonly run from a fixed location, such as a hospital. Not all urodynamic clinics have dedicated facilities, but this might be justified for those dealing with large numbers of patients. Mobile clinics providing more basic investigations are feasible.

Range of tests The range of tests offered will vary depending upon local requirements and clinical expertise. For example, a particular gynaecologist or urologist might run a clinic performing standard cystometry on their own patients prior to intervention. In contrast, regional centres, where referrals are often tertiary, might choose to offer a more comprehensive range of tests, including urethral pressure profilometry and videocystometry in addition to standard cystometry.

Choice of equipment The choice of equipment for any centre will be determined by the planned clinic location, as well as by the range of investigations that will be offered. For example, a mobile unit will require a more portable piece of equipment, even if that means giving up some functionality. A tertiary referral centre will need a piece of equipment with software capable of performing videocystometry.

All manufacturers offer a variety of options for each device, which results in a range of costs as listed in the market review table.

Options available will cover increased computer memory (RAM) for faster performance, extra software modules for automatic processing or reporting, backup hardware options for data storage, larger screen if required, etc. The purchasing department should consider carefully what performance features are clinical requirements in compiling the specification for potential suppliers. It should be noted that all machines currently available on the market have the option of network operation, include training packages with the supplier, and have acceptable parameter ranges for normal clinical use.

Economic considerations 12


Whole-life costing The purchaser should bear in mind that the capital cost of a device is only a fraction of the total cost of running a urodynamic machine. Other costs include equipment maintenance costs, staff time costs, consumables, laundry, room cleaning and facility depreciation. For a practical comparison, some of these costs are used below to demonstrate the use of the whole-life costing method in determining the total cost of a purchase. For simplicity, inflation affecting both costs and cash value has been ignored.

If we consider the consumables used over the average seven year lifetime of a machine, assume a two-year warranty followed by a five-year service contract, but ignore facility and staff costs as these are the same for each device, the following equation can be suggested to calculate the whole life cycle cost of a urodynamic machine:

Whole-life cost = P + (C x N x 7) + (M x 5)

where: P = initial purchase cost C = consumable cost per test N = number of tests carried out per year M = maintenance contract annual fee

The initial purchasing cost is based on the list price provided by a supplier, which is often given as a range of list prices. This range reflects the various hardware and software options available on a machine.

The typical cost for consumables per test is roughly the same for water-filled catheters on any machine, and is £30 (or £73 for video urodynamics). This includes the cost of a pump tube set, syringes and taps, 500ml bag of normal saline, sterile water, bladder and rectal catheters, disposable transducer domes, lignocaine and a catheter pack. For video urodynamics a more expensive contrast medium instead of saline fluid would be required. Many UDS machines use standard consumables available from multiple sources. As prices can vary significantly between suppliers, future price differences may be exploited. If a single supplier or proprietary consumable is used, the department should ensure there are clear benefits from choosing that route.

The average department might carry out 250 tests per year with typical duration of a test being 60 minutes with the cost per person per hour being £40 (North Bristol NHS Trust funding office).

Economic considerations 13


Maintenance cost is often based on a percentage of the machine capital cost and there is scope for variations. Typical maintenance arrangement may cover call-out charges, general support, annual service and calibration. Provision of spare parts can be offered at extra cost. Discounts for maintenance can be offered if the local hospital engineers or medical physics department can provide first line support, assuming appropriate training is provided by the supplier.

Purchasing 14


Decision guidance table Table 1 classifies all current models on the UK market according to two key features: their physical configuration, and their capacity for video urodynamics. Tables 1 - 3 are intended to help prospective purchasers to short-list suitable products.

Table 1: Decision guidance table

Portable or pole-mounted systems Trolley mounted systems

No option for video

connection

Andromeda Helix Dantec Brenna

Laborie Delphis / Delphis-IP Mediwatch Portable with Duet

SI.EM SensorQ

Laborie Delphis-KT

Option for video

connection

Andromeda Ellipse Life-Tech Mercury

Mediwatch Portable with Sensic

Albyn Phoenix Dantec Kallan / Acquanetta

Laborie Dorado KT / Triton / Aquarius Life-Tech Urolab

Mediwatch Encompass / Duet Logic G2 / G3 Sensic / Clinic with Duet or Sensic

MMS Solar Sedia SE6

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 [14], and an illustrative example is provided in the NHS PASA Operational Purchasing Procedures Manual, Procedure 1-01 [15].

The procurement panel A multidisciplinary team should be selected to guide the purchase. Representatives from clinical, operator, technical, estates and financial sections should be included.

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

Purchasing 15


Evaluation criteria Performance specifications should be derived from local operational requirements and agreed by the procurement panel. The performance specifications will form the basis for assessing the adequacy of suppliers’ technical specifications, provided in response to the technical specification questionnaire. Requests for features which are supplier-specific are not permitted under standard purchasing procedures. Very specific features, for instance colour schemes, which are not supported by operational requirements, are also not allowed as they may unfairly favour particular manufacturers.

Purchasing procedures The Trust Operational Purchasing Procedures Manual provides details of the procurement process [16]. 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 January 1st 2008) [17], an amount that is well in excess of the cost of a single urodynamic machine.

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.

Purchasing options Equipment may be purchased outright or leased. Local procurement departments should be consulted on the cost-effectiveness of lease arrangements, as the deals will be linked to consumable supply and maintenance contracts. Combinations of purchase and lease are also available, with a reduced price being payable after some lease time has elapsed.

Sustainable procurement The UK Government launched its current strategy for sustainable development, Securing the Future [18], in March 2005. The Strategy highlights the key role of public procurement in delivering sustainability and 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

Purchasing 16


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

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

For urodynamic equipment, the same consideration should be given as for general computing equipment, i.e. ensuring full use of equipment lifetime, avoidance of unnecessary features, energy efficient displays etc. Another consideration may be the amount of paper printed per test, as some systems have defaults for printing unused patient details and analysis figures. Reduction of the disposal of consumables, including administration sets, catheters and sterile equipment, is also an issue for comparison between systems or transducer types.

End of life disposal Consideration should be given to the likely financial and environmental costs of disposal at the end of the product’s life. 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) [19]. The WEEE regulations place responsibility for financing the cost of collection and disposal on the producer. Electrical and electronic equipment is exempt from the WEEE regulations where it is deemed to be contaminated at the point at which the equipment is scheduled for disposal by the final user. However, if it is subsequently decontaminated such that it no longer poses an infection risk, it is again covered by the WEEE regulations, and there may be potential to dispose of the unit through the normal WEEE recovery channels.

Market review 17


Evaluation methods and protocol A representative sample of each manufacturer’s models on the UK market was selected. The study covered most permutations of devices available, excluding the very top-end models of each range.

The aim was to have each machine evaluated by five users, all of whom routinely carry out urodynamics but who have differing levels of experience and backgrounds. The team comprised one doctor who regularly practices urodynamics, three nurses and one clinical engineer. The evaluation was carried out according to the protocol detailed in figure 1. A urodynamic simulator built at Southern General Hospital, Glasgow was used to generate pressures that replicate patient test recordings.

Figure 1: The evaluation protocol

The market review tables that follow list the main specifications for each machine currently available on the market. Table 2 summarises the features of trolley-mounted systems and table 3 provides a summary for more portable devices. The tables group together some devices in a single column. The differences between such devices are in features that are not listed in the market review tables. For these cases, the picture shown is of the models which differ greatly in their appearance, otherwise the picture is of the first model listed.

Those systems that were evaluated have ‘star’ ratings showing the assessment of usability. These star ratings are derived from completed laboratory questionnaires, using the median of the team’s assessment for a given area of operation. The 37-point questionnaire used for assessment (included at appendix 2) was divided into three areas for this analysis. The star ratings are relative and subjective, but reflect the average assessment of a team of experienced users. Three stars means ‘acceptable’ and five stars ‘very good’. Where stars are not given, it indicates that the particular model was not included in the evaluation but is available on the UK market.

In the tables that follow, whole-life costs for the urodynamic systems are estimated using the guidelines provided in the Economic considerations section, based on a throughput of 250 tests per year with consumable costs of £30 per test. The ranges

Protocol

Supplier installation & induction

Individual assessment using questionnaire

Telephone survey of current users Editing of report

with PASA and manufacturers

PASA website publication www.pasa. nhs.uk/cep Analyse, report

Market review 18


of purchase list prices and maintenance contract prices reflect the various available hardware / software options and levels of maintenance cover.

The ECRI report on urodynamic measurement systems, published in 2005 [20], includes devices in this buyers’ guide, as well as those available only on the US market. Some of the devices covered in this buyers’ guide are not available in the US.

Market review 19


Table 2: Trolley mounted systems

Model Albyn

Phoenix Plus Dantec

Kallan / Acquanetta Laborie

Delphis-KT Laborie

Dorado KT / Triton / Aquarius

Picture

or

Normal Configuration Trolley Trolley Trolley Trolley

Uroflowmeter type Weight sensor Weight sensor Weight sensor Weight sensor Wireless flowmeter

option

Profilometer option Max no. of pressure

channels 9 8 4 8

Calibration by user EMG amplifier

option

Monitor size (cm) Optional (up to 55) 48 35 48 Video Capture

option

Report formats Word & PDF PDF, Word Proprietary, PDF Proprietary, PDF

Spec

ifica

tion

Data export formats CSV Text, ICS Text, ICS Text, ICS

Supplier name Albyn Dantec Dynamics Sigmacon Sigmacon

List price range, £ 16k to 25k 18k to 20k 14k to 17k 20k to 48k Warranty period,

years 2 2 2 2

Year first sold 2001 2008 in UK 2007 2004 Number sold to date

in UK (up to 2008) >75 2 1 28

Maintenance contract price (£/yr) 1750 650 to 1700 650 to 1600 650 to 4120

Purc

hasi

ng in

form

atio

n

Lifecycle cost (£) 77k to 86k 68k to 73k 70k to 78k 76k to 121k

Physical setting-up and checking

Flow, UPP and Pressure/flow tests

Report, analysis & data management

Usa

bilit

y

Summary of user comments

Screen and printout can be complex, but user interface is good. Solid and safe construction – monitor is fixed.

Not evaluated – new to UK market

Not evaluated – portable model was evaluated (table 3)

Dorado KT evaluated Laid out very tightly

on single trolley. Software and data

can be complex without careful setting

up. Clear screen displays.

= very poor = poor = acceptable = good = very good

Market review 20


Table 2: Trolley mounted systems continued

Model Life-Tech Urolab

Mediwatch Duet Logic G2 / Clinic with Duet /

Clinic with Sensic / Encompass

MMS Solar

Sedia SE6

Picture

Normal Configuration Various Trolley Trolley or pole mounted Trolley

Uroflowmeter type Weight sensor User choice Weight sensor Weight sensor Wireless flowmeter

option (02 2009) ( Sensic )


channels 8 4 (10 Encompass) 5 - 15 31

Calibration by user

EMG amplifier option

Monitor size (cm) User choice 38-43-53 48 42 or any

Video Capture option

Report formats Numerous PDF, Word PDF, proprietary PDF & proprietary

Spec

ifica

tion

Data export formats Text, ICS, Excel Proprietary, ICS, CSV, HL7

ICS, ASCII, CSV, XML, RTF, XLS

Supplier name Genesis Medical Mediwatch Lewis Medical Digitimer

List price range, £ 15k to 34k 14k to 40k 14k to 25k 21.6K

Warranty period, years 1 2 2 1

Year first sold Early 1980s 2003 2001 2004 Number sold to date in

UK(up to 2008) N/A 52 40+ 63

Maintenance contract price (£/yr) 1600 to 2400 600 to 2500 1000 to 2500 1648 (min)

Purc

hasi

ng in

form

atio

n

Lifecycle cost (£) 76k to 99k 70k to 102k 72k to 90k 82k




Usa

bilit

y


Large number of options may

confuse if displayed unnecessarily by user. However,

software is versatile and expandable –

three levels to choose from.

Duet Logic G2 evaluated. Upgrade of former Medtronic

Duet. Layout requires care with

infection prevention. Pressure

transducers are very close together.

Has many useful options, printouts can be busy as a

result. Needs careful setting up. Good pump and infusion holder

design. ‘Silver’ / ‘gold’ models

available.

Cable management can be awkward, but normally all

hidden on trolley. Software navigation needs practice but displays are clear.


Market review 21


Table 2: Portable / pole mounted systems Model Andromeda

Helix Andromeda

Ellipse Dantec Brenna

Laborie Delphis

Picture

or

Normal Configuration Mini trolley Mini trolley Pole mounted Pole (IP) / mini trolley

Uroflowmeter type Weight sensor Weight sensor Weight sensor Weight sensor Wireless flowmeter

option


channels 3 8 5 4

Calibration by user


Monitor size (cm) 3.8 3.8 user choice 35

Video Capture option

Report formats PDF, Word PDF, Word PDF, Word Proprietary, PDF

Spec

ifica

tion

Data export formats Text, ICS Text, ICS Text, ICS Text, ICS

Supplier name Mediplus Mediplus Dantec Dynamics Sigmacon

List price range, £ 11k+ 12k+ c12K 12k to 16k

Warranty period, years 2 2 2 2

Year first sold 1996 2006 2008 in UK 2002 Number sold to date in

UK (up to 2008) 3 1 0 17

Maintenance contract price (£/yr) 550 to 1400 650 to 1600 650 to 1700 650 to 1600

Purc

hasi

ng in

form

atio

n

Lifecycle cost (£) 66k to 71k 68k to 73k 68k to 73k 68k to 77k




Usa

bilit

y


Compact and portable, but

transducer height is not adjustable. PC used only for real time display and

post-test analysis.

Transducer mounting can be difficult. PC used only for real time display and post-

test analysis. Dealer needs to set

up test protocol.

Not evaluated – new to UK market

Excellent portability and infection control features. Laptop and

printer wirelessly connected.


Market review 22


Table 3: Portable / pole mounted systems

Model Life-Tech Mercury

Mediwatch Portable with Sensic /

Portable with Duet SI.EM

SensorQ

Picture

Normal Configuration Portable Portable Portable

Uroflowmeter type Weight sensor User choice Weight sensor Wireless flowmeter

option (02/2009) (Sensic)


channels 8 4 2

Calibration by user


Monitor size (cm) Laptop 38-43-53 8

Video Capture option (Sensic)

Report formats Numerous Word Proprietary

Spec

ifica

tions

Data export formats Text, ICS, Excel Custom, HL7

Supplier name Genesis Medical Mediwatch Mediplus

List price range, £ 15k to 24k 9k to 14k 5k to 8k

Warranty period, years 1 2 2

Year first sold 2007 2009 2006 Number sold to date in

UK (up to 2008) N/A 0 0

Maintenance contract price (£/yr) 1600 to 2400 600 to 1700 500 to 1000

Purc

hasi

ng in

form

atio

n

Lifecycle cost (£) 76k to 99k 65k to 75k 60k to 66k




Usa

bilit

y


Very compact system. Many software options

available, thus user experience needed for full

utility. Three levels of software to choose from.

Portable with Sensic evaluated. Software is easy

to use and quite fail-safe, with many automatic

features. For full versatility it requires an extra software

key.

Unique urethral angle and leak sensors. Designed to

be stand-alone / simple, therefore limited in

application. Controls require practice as they have multiple functions.

Small screen very limiting for conventional

urodynamics = very poor = poor = acceptable = good = very good

Acknowledgements 23


We should like to thank the following for their contribution to this buyers’ guide:

Connie Chew, Debbie Delgado, and Julie Ellis-Jones, Urodynamics Department, Southmead Hospital, Bristol. Samih Al-Hayek, Specialty Registrar, Royal United Hospital, Bath. Fadi Al-Housami, Specialty Registrar, Musgrove Park Hospital, Taunton Jon McFarlane, Consultant Urologist, Royal United Hospital, Bath. Aled Evans, Donald Smith and Doug Small, Medical Physics Department, Southern General Hospital, Glasgow.

Stuart Taylor, Product Manager, Albyn Medical

Carl Loveluck, Medical Engineer, Dantec Dynamics Ltd Paul Scarborough, Digitimer Ltd Jo Wilkinson, Product Specialist, Genesis Medical Ltd Adrian Smart, Customer Support, Laborie Medical Technologies Roger Lewis, Managing Director, Lewis Medical James Urie, Product Manager, & Tim Ward, Project Engineer, Mediplus Ltd Nick Darker, Product Manager, & Howard Brobin, Urodynamics Specialist, Mediwatch UK Ltd

Glossary 24


BUI Bristol Urological Institute (www.bui.ac.uk)

BIME Bath Institute of Medical Engineering (www.bime.org.uk)

Cystometry the study of bladder pressure and volume

Detrusor the muscle found in the bladder wall

EMG electromyographic signal, the electrical signal within muscles

ICS International Continence Society (www.icsoffice.org)

LUTS lower urinary tract symptoms

MHRA Medicines and Healthcare products Regulatory Agency

NICE National Institute for Health and Clinical Excellence

N/A Not Available - the data not provided by the supplier

pabd abdominal pressure, measured usually rectally or vaginally

pdet detrusor pressure (= pves - pabd)

pves vesical pressure, the pressure inside the bladder lumen

Pressure/flow or voiding cystometry, the study of bladder pressure and urine flow

UPP urethral pressure profile

Vesical within the bladder

References 25


[1] Barnes DG, Ralph D, Hill PD, et al. A consumer's guide to commercially

available urodynamic equipment. British Journal of Urology 1991 Aug;68(2):138-43.

[2] Abrams PH, Farrar DJ, Turner-Warwick RT, et al. The results of prostatectomy: a symptomatic and urodynamic analysis of 152 patients. Journal of Urology 1979;121(5):640-2.

[3] Abrams P. Objective evaluation of bladder outlet obstruction. British Journal of Urology 1995;76(Suppl 1):11-5.

[4] Abrams P. Bladder outlet obstruction index, bladder contractility index and bladder voiding efficiency: three simple indices to define bladder voiding function. BJU International 1999 Jul;84(1):14-5.

[5] McGuire EJ, Woodside JR, Borden TA, et al. Prognostic value of urodynamic testing in myelodysplastic patients. Journal of Urology 1981;126(2):205-9.

[6] Clarke B. The role of urodynamic assessment in the diagnosis of lower urinary tract disorders. Int Urogynecol J Pelvic Floor Dysfunct 1997;8(4):196-9.

[7] Fitzgerald MP, Brubaker L. Urinary incontinence symptom scores and urodynamic diagnoses. Neurourology and Urodynamics 2002;21(1):30-5.

[8] Glazener CMA, Lapitan MC. Urodynamic investigations for management of urinary incontinence in children and adults. 2002. Report No.: Issue 3. Art. No: CD003195.

[9] National Institute for Health and Clinical Excellence. Urinary incontinence: the management of urinary incontinence in women. 2006 Oct.

[10] Schäfer W, Abrams P, Liao LM, et al. Good Urodynamic Practices: Uroflowmetry, Filling Cystometry and Pressure-Flow Studies. Neurourology and Urodynamics 2002;21(3):261-74.

[11] Gammie et al. UKCS ASM 2007, Birmingham. 2007.

[12] Medical Devices Agency. MDA Safety notice: SN 2000(09) Pressure transducer cover (SensoNor Pressure Dome) for urodynamic system of bladder pressure measurement. 11-5-2000. Ref Type: Generic

[13] Lewis P, Howell S, Shepherd A, et al. Computerised urodynamics: help or hindrance? Neurourology and Urodynamics 1997;16(5):508-9.

References 26


[14] website 2008Available from: URL: http://www.ogc.gov.uk/documentation_and_templates_business_case.asp

[15] website 2008Available from: URL: http://home.pasa.nhs.uk/PASAWeb/Guidance/OPPM/LandingPage.htm

[16] website 2008Available from: URL: http://home.pasa.nhs.uk/PASAWeb/Guidance/TOPPM/LandingPage.htm

[17] website 2008Available from: URL: http://www.ogc.gov.uk/procurement_policy_and_application_of_eu_rules_eu_procurement_thresholds_.asp

[18] UK Government Strategy for Sustainable Development; Securing the Future. website 2008Available from: URL: http://www.defra.gov.uk/sustainable/government/publications/index.htm

[19] EC Directive on Waste Electrical and Electronic Equipment. website 2008Available from: URL: http://www.berr.gov.uk/files/file35992.pdf

[20] ECRI Product Comparison Urodynamic Measurement System. ECRI (USA) 2005Available from: URL: www.ecri.org

Appendix 1: Supplier contact details 27


UK Supplier Address Telephone / Fax /

Website Manufacturer

Albyn Bridgend Road Industrial Estate Dingwall Ross-shire IV15 9QF Scotland, UK

01349 862388 01349 864146 www.albynmedical.com

Albyn www.albynmedical.com

Dantec Garonor Way Royal Portbury Bristol BS20 7XE

01275 375333 01275 375336 www.dantecdynamics.com

Dantec www.dantecdynamics.com

Digitimer 37 Hydeway Welwyn Garden City AL7 3BE

01707 328347 01707 373153 www.digitimer.com

Sedia www.sedia.ch

Genesis Medical

7 Trojan Business Park Cobbold Road London NW10 9ST

0208 451 4100 020 8451 4115 www.genmedhealth.com

Life-Tech www.life-tech.com

Lewis Medical

826 Green Lanes London N21 2RT

0208 360 7273 0208 360 9176 www.lewismedical.uk.com

MMS www.mmsinternational.com

Mediplus Unit 7 The Gateway Centre, Cressex Business Park Coronation Road High Wycombe HP12 3SU

01494 551200 01494 536333 www.mediplus.co.uk

Andromeda and SI.EM www.andromeda-ms.de www.siemonline.com

Mediwatch Swift House Cosford Lane Rugby CV21 1QN

01788 547888 01788 536434 www.mediwatch.com

Mediwatch www.mediwatch.com

Sigmacon Heriots Wood The Common Stanmore Middlesex HA7 3HT

020 8950 9501 020 8950 9199 www.sigmacon.co.uk

Laborie www.laborie.com

Appendix 2: Evaluation questionnaire 28


Area of evaluation / Task Ve

ry p

oor

Less

than

ac

cept

able

Acce

ptab

le

Goo

d

Very

goo

d

Any comments?

Training

1. Initial induction Rate the ease of first learning during induction

Physical

2. The arrangement of transducers Rate the ease of access in a clinical setting

3. The layout of computer and printer Rate the ease of handling and use

4. Portability Rate the ease of movement about the room

5. Wires and cables Rate the safety of wire arrangement

6. Infection control / cleaning Rate the ease of cleaning

Setting up

7. Mount transducer domes Rate the ease of mounting domes

8. Access for flushing transducers. Rate the ease of access for the flushing procedure

9. Flush transducers Rate the style of dome for ease of flushing out air

10. Load bag & pump, draining fluid into free jug Rate the ease of loading bag and giving set

11. Adjust height of transducers. Rate the ease of adjusting transducer height

Accuracy checking and zeroing 12. Checking of flow reading Rate the ease of checking flow rate

13. Checking of pressure reading Rate the ease of checking both pressure lines

14. Zeroing transducers to atmosphere Rate the ease of zeroing transducers



Area of evaluation / Task

Very

poo

r

Less

than

ac

cept

able

Acce

ptab

le

Goo

d

Very

goo

d

Any comments?

Data entry and flow test 15. Enter patient data (use machine name and your initials) Rate the ease of patient data entry, noting any unique features

16. Record a flow test using constant flow bottle Rate the ease of recording the flow test, noting any automatic features

UPP test

17. Record the UPP test Rate the ease of carrying out the UPP test

18. UPP analysis Rate the ease of analysing the trace, noting any automatic features

Dummy test (using urodynamic simulator) 19. Starting software for test run Rate ease of starting to record the urodynamic test

20. Attempt real time annotation Rate the ease of making annotations during the test

21. Change pump speed up and down Rate the ease of changing pump speed, noting any helpful features

22. Video frame acquisition Rate the ease of capturing video images from the camera, noting positive and negative features

23. EMG signal acquisition Holding all of the electrodes in one hand, rate the ease of EMG signal display and volume control

24. Change infusion bag Rate ability of software to adjust volume during change of bag

25. Display of signals Rate the clarity of display on the pressure lines of cough, detrusor overactivity and tube movements

26. Screen layout and quality Rate the clarity of displays and layout of screens

27. Flush lines. Rate the response of the software to the flush



Area of evaluation / Task

Very

poo

r

Less

than

ac

cept

able

Acce

ptab

le

Goo

d

Very

goo

d

Any comments?

Report printing and analysis 28. Print out the whole test Rate ease of setting up print out of single and multiple tests

29. Quality of printout Rate quality of trace printout

30. Review the numeric data of the test screen Rate ease of reading off figures from screen

31. Review the numeric data of the test printout Rate clarity of printed out figures

32. Summarised data printout Rate usefulness of summarised data printout, note any automated analysis

33. Play back the filling and voiding test on the screen Rate ease of test playback / review

Data management 34. Review some old traces on the machine and edit the test just carried out Rate ease of retrieval of previous tests

35. Data storage system Rate clarity of data storage system, noting any features that assist data management

36. Data saving process Rate clarity of data saving process, noting any potential errors for overwriting

37. Exit the software and power down the urodynamic PC Rate the ease of shutdown

Additional comments 38. Note here any other general comments and impressions concerning the machine

39. Note any features which should be added (or removed) to improve the performance and/or ease of use of the system

Author and report information 31


Buyers’ guide: Urodynamic systems Lucy Swithinbank, Andrew Gammie, Elena Skryabina*, Jennifer Chan*, Steven Wilson*, Craig Davey* Bristol Urological Institute, Southmead Hospital, Bristol BS10 5NB Tel: 0117 959 5690 Email: [email protected] www.bui.ac.uk *Bath Institute of Medical Engineering, Wolfson Centre, Royal United Hospital, Bath BA1 3NG Tel: 01225 824103 Email: [email protected] www.bime.org.uk 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 2008

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