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									10        AMBULATORY SYRINGE DRIVERS: A BUYER’S GUIDE


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                                             AMBULATORY SYRINGE
                                             DRIVERS: A BUYER’S GUIDE
                                             E. Skryabina and J. Chan

                                             The UK National Health Service           This article is based on the
                                             (NHS) Purchasing and Supply              Ambulatory Syringe Drivers
                                             Agency (PASA) Centre for                 buyers’ guide [1]. Detailed
                                             Evidence-based Purchasing (CEP)          information relating to the technical
                                             has recently published a Buyers’         performance of ZiMed and CME
                                             Guide on Ambulatory Syringe              McKinley syringe drivers is also
                                             Drivers [1]. It is a comparative         available from the recently
                                             report on the specification, technical   published CEP evaluation reports
                                             performance and usability of             [2, 3]. Details of the Smiths Medical
                                             electronic ambulatory syringe            syringe drivers evaluation are
                                             drivers to help inform purchasing        available from the MHRA Pump
                                             decisions. Seven models of               Evaluation database [4]. A separate
                                             ambulatory electronic syringe            evaluation report of the Eden
                                             drivers, produced by ZiMed, Eden         Medical Micrel MPml/h was also
                                             Medical, Smiths Medical (formerly        published earlier by the UK
              Correspondence                 Graseby) and CME McKinley were           Medicines and Healthcare products
              Centre for Evidence-based      reviewed. These products can be          Regulatory Agency (MHRA) [5].
              Purchasing                     grouped according to the offered
                                             infusion delivery units; some
              152C Skipton House
                                             syringe drivers require the delivery     APPLICATIONS OF
              80 London Road
                                             rate to be set in millimetres of         AMBULATORY SYRINGE
              London
              SE1 6LH                        plunger travel per hour (mm·h-1) or      DRIVERS
              UK                             per day (mm·24 h-1) and, for some
                                             syringe drivers, the delivery rate       The reliability, safety, small size and
              E-mail: adseas@bath.ac.uk      has to be set up in volumetric units     ease of use of some modern drug-
              Website: www.pasa.nhs.uk/cep   (mL·h-1) (table 1).                      administration devices allow many




106     THE BUYERS’ GUIDE TO RESPIRATORY CARE PRODUCTS
                                                  AMBULATORY SYRINGE DRIVERS: A BUYER’S GUIDE                                 10




patients with chronic conditions to        battery-powered medical infusion          accuracy. Smooth delivery might be
receive their treatment in the             devices which allow continuous            important for the administration of
comfort of their own homes and, as         fluid delivery from a syringe at a        some i.v. drugs, particularly
the therapies can be received              programmed rate. They are                 cardiovascular drugs, and
ambulatory, with minimum                   designed to deliver the therapy           ambulatory syringe drivers would
disruption to patients’ daily lives.       with minimal disruption to a              not be suitable for this type of
One of the key priorities of the           patient’s daily life and activities       application.
Department of Health for England           and, therefore, are of small size and
is to support people in managing           lightweight. Typical weight of a          Start up time of delivery
their care and treatment at home,          syringe driver with a battery is
wherever possible [6]. In addition to      around 200–250 g (~470 g when             Start-up time is defined as the time
enhancing the patient’s quality of         used with a lock box). Most syringe       required for an infusion device to
life and their independence,               drivers are designed to deliver           start delivering at a set rate. All
ambulatory infusion devices                infusions from any brand of syringe       modern syringe pumps have a
potentially help to reduce clinical        with a volume of 2–30 mL.                 delayed start of infusion and this is
staff time involved in administering       However, some devices require the         also the case with ambulatory
treatment and in shorter hospital          larger syringes (20–30 mL) to be          syringe drivers. The start up time is
stays. The latter of which could           under-filled to allow delivery,           affected by the design of the
help in limiting the risk of acquiring     which is due to the limited length        device’s driving mechanism and by
hospital-related infections [7].           of the mechanism that drives the          procedures carried out prior to
                                           syringe plunger. A variety of carry       starting the infusion. For a syringe
The main application area of               cases, both disposable and reusable,      pump, automatic purging of a
ambulatory syringe drivers is for          are typically offered to facilitate the   syringe reduces the start-up time, as
continuous subcutaneous drug               ambulatory applications.                  this helps to eliminate the
administration (infusion) (CSI).                                                     mechanical slack in the system.
Typically, CSI is less expensive than      Power supply                              Most modern syringe drivers offer
intravenous infusion and is                                                          the purge function as an option.
associated with a lower incidence of       Ambulatory devices need to be             The purge volume can be set up
injection site complications [8].          battery powered to allow mobility         when the pump is configured or it
Drugs given via CSI are usually            during the therapy provision. There       can be controlled by the user.
rapidly absorbed and have high             are syringe drivers offering use of
bioavailability (generally 100%) [9].      either a disposable or a                  Safety
                                           rechargeable battery. Only one
The main area of CSI application is        syringe driver, currently offered by      Alarms
seen to be in symptom management           the market, offers the use of both.
for cancer patients and palliative care.   An option to run on mains power is        Alarms alerting users to situations
However, there is a variety of drugs       offered by some syringe drivers as        that could compromise therapy
that can be administered via CSI; this     well, but this requires connection        delivery, such as power
includes heparin, insulin,                 either to a docking station or to a       interruption, a blocked line, a
chemotherapy, cytotoxic drugs and          special charger for a device running      displaced syringe, tampering with
bronchodilators [10].                      on an integral rechargeable battery.      the infusion and end of infusion,
                                                                                     are expected from all modern
Long-term CSI of terbutaline               Delivery patterns                         infusion devices. Ambulatory
(CSIT) is one of the ways of                                                         syringe drivers complying with IEC
treating adult patients with brittle       Typically, fluid is not delivered         60601-2-24 [14] offer these safety
asthma [11]. Continuous                    smoothly by ambulatory syringe            alarms. An alarm typically involves
subcutaneous salbutamol has been           drivers but as a series of small          an audible signal, sometimes
used to treat infants with acute           boluses. This is common for most          accompanied by a visual message
asthma [12] and a case study was           battery-operated ambulatory               on a driver’s display indicating the
reported on long-term use of CSIT          pumps and is a deliberate design to       reason for alarm and providing
in children with chronic severe            conserve battery power. Smooth            instructions on how to resolve the
asthma [13].                               and continuous delivery requires          problem.
                                           more battery power and reduces the
MAIN FEATURES OF                           overall battery life, thus resulting in   Syringe recognition system
AMBULATORY SYRINGE                         frequent battery replacement.
DRIVERS                                    However, CSI does not require very        A syringe recognition system,
                                           smooth flow patterns. The overall         offered by the syringe drivers
Ambulatory syringe drivers (also           hourly accuracy of delivery is more       complying with IEC 60601-2-24,
known as syringe pumps) are small,         important than minute-to-minute           performs two functions: it alerts




                                                                      THE BUYERS’ GUIDE TO RESPIRATORY CARE PRODUCTS         107
10     AMBULATORY SYRINGE DRIVERS: A BUYER’S GUIDE




          Table 1. Ambulatory syringe drivers

                                      ZiMed               Eden Medical            Smiths Medical          CME McKinley
                  -1
           mm·h



                                                          MP-101                  MS16A
                       -1
           mm·24 h



                                                          MPdaily                 MS26
           mL·h-1



                                      AD Syringe Driver   MPml/h                                          T34




          a user that syringe displacement          Carry cases                            Technical features
          has occurred during delivery and
          helps to prevent delivery error from      A variety of carry bags and pouches    Infusion delivery units
          the use of an incorrect syringe.          are typically offered for a syringe
          Syringe displacement can have             driver to facilitate its ambulatory    Infusion delivery units offered by
          serious consequences for a patient        applications. The offered carry bags   the currently available ambulatory
          as this may result in the syringe         can be disposable or reusable          syringe drivers are different, with
          emptying its content into the             (washable). Some carry bags can        some drivers offering delivery in
          patient (if a driver is raised relative   provide extra protection against       mm·h-1 or in mm·24 h-1 with the
          to infusion site) or syphoning, when      fluid ingress and claim compliance     others offering delivery in mL·h-1
          a driver is lower than the infusion       with the IPX4 standard for             (table 1). Using delivery in mm·h-1
          site. However, syphoning is               waterproofness.                        (or mm·24 h-1) is traditional and
          considered to be a less important                                                adapted in many practices. Syringe
          issue in a subcutaneous infusion                                                 drivers compliant with the safety
          than it is for an i.v. infusion.          KEY PURCHASING FACTORS                 requirements set up in the IEC
          Confirming incorrect syringe may          TO CONSIDER                            60601-2-24 deliver in mL·h-1; the
          result in serious delivery error for                                             delivered volume in mL is recorded
          devices delivering in mL·h-1 and, as      Clinical applications                  by the device and is available for
          an extra precaution, a syringe                                                   viewing at any time during delivery
          recognition system requires users to      The selection criteria for a new       from the display. Using dosing units
          confirm the volume and brand of           ambulatory syringe driver are          of mL·h-1 also facilitates drawing up
          the syringe used.                         dependent on the clinical              solutions and monitoring the
                                                    application(s). Compliance with IEC    delivery using the mL measurement
          Lock boxes                                60601-2-24 ensures that the driver     scale on the side of the syringe.
                                                    meets the key requirements for
          Lock boxes are offered for all            delivering therapies via both          Delivery options
          ambulatory syringe drivers but one,       subcutaneous and i.v. routes. This
          which offers an integral syringe          application diversity supports         Delivery options offered by a syringe
          cover as a part of the device,            standardisation of infusion            driver can differ depending on the
          providing excellent protection            equipment on a relatively small        model. An option to set up infusion
          against syringe displacement.             number of devices. The option to       over a fixed period, e.g. 24 h, can be
          Prevention of accidental changes to       set up a delivery in volume units      very convenient for some
          an infusion delivery can also be          (mL·h-1) allows consistency in         applications, e.g. for palliative care, as
          achieved using a keypad lock. This        training, as other infusion            drug dosage is typically prescribed
          feature is present on all modern          equipment are typically set up to      over 24 h. For devices offering a
          syringe drivers.                          deliver in the same way.               syringe recognition system, a user




108   THE BUYERS’ GUIDE TO RESPIRATORY CARE PRODUCTS
                                                   AMBULATORY SYRINGE DRIVERS: A BUYER’S GUIDE                             10




would only need to check the              be clearly distinguishable from each     and lower limit, or configuring
parameters of the infusion and initiate   other, to minimise the risk of setting   the system for a single flow rate is
the delivery if the time of infusion is   up an incorrect delivery rate.           a good safety feature, as this
fixed. With an automatic syringe          Confusing a pump delivering in           would prevent the user from
volume recognition system, the rate is    mm·h-1 with a pump delivering in         setting rates outside the preset
calculated by the pump. Other             mm·24 h-1 can result in infusion rate    safety limits.
delivery options may be offered, such     24-times higher than required,
as setting up a different delivery rate   which can result in serious harm or      Monitoring
or setting up the time of delivery. The   even death to a patient.
choice of delivery options may be                                                  Visual indication of the battery
restricted by the manufacturer, at the    Alarms                                   status should be available to users.
purchaser’s request, to minimise the                                               Visual and audible alerts to warn a
risk of user error.                       The ability of a pump to indicate a      user of low battery status are
                                          malfunction or a dangerous               essential to ensure safe therapy
Bolus function                            condition, which can compromise          delivery. Option to check the
                                          the therapy, is an important safety      delivered volume, flow rate and
Bolus function is offered by some         feature. Users should check that the     time until the end of delivery
syringe drivers. This allows              alarm tone is sufficiently audible.      allows intermediate monitoring of
initiation of immediate delivery at       Clear messages on the device’s           infusion. A running infusion
maximum flow rate. A user can set         display to guide the user on the         indicator is another important
up a limit for the bolus volume.          cause of alarm and actions for           safety feature which must be
Bolus function is typically               resolving the problem are helpful.       offered.
configurable and can be disabled          Duration of standby alarm time is
from configuration, if clinical           important: a long standby alarm time     Event logging
practice does not advise using it.        could result in delayed feedback
                                          from the pump, if infusion is not        Event logging allows the driver’s
Power supply                              initiated immediately for any reason.    operation or any unauthorised
                                                                                   interference with its performance to
Power supply provision differs for        Syringe recognition system               be traced by storing the history of
different syringe drivers. Most of                                                 any key presses in the driver’s
them use a standard disposable            Pumps offering a syringe recognition     memory. This could help in
battery to run. There is one driver,      function require a user to confirm       identifying the cause of
however, which utilises an integral       the volume and brand of the syringe      performance issues.
dedicated lithium-ion rechargeable        used; this is an extra safety
battery, and another driver which         precaution which helps to prevent a      Ease of carrying
can run on both: a disposable or a        delivery error from an incorrect
standard rechargeable battery.            syringe. Any permitted syringe           The quality of the offered carry
Disposable batteries allow greater        brand and volume can be configured       cases is important and should be
flexibility for ambulatory                for use; the volume of the syringe       checked. Carry cases should be
applications as they typically run        content is estimated by the pump.        washable if for multiple use, or
for longer compared with a                                                         disposable if for single use. Users
rechargeable battery’s single charge,     Lock box                                 should refer to the manufacturer’s
they do not require regular                                                        instructions regarding cleaning of
recharging and can be purchased           Some clinical protocols may require      washable cases; however, it is an
from most retail outlets. However,        drugs to be locked in the infusion       advantage if reusable carry cases
the use of rechargeable batteries can     devices in order to prevent              can be washed at 60ºC [15].
reduce wastage significantly, and is      tampering with syringe content. This     Provision of carrying accessories to
more cost-effective. For integral         would require the use of a lockable      accommodate the lockable box
rechargeable batteries, management        box during delivery. The total           should be checked as well.
of the battery charger should be          weight of a driver and its lockable
taken into account and provision          box would need to be taken into          Cost
made for its storage.                     account, and provision for carry
                                          accessories to accommodate the           Capital outlay
Safety                                    lockable box should be offered.
                                                                                   List prices for the ambulatory
Pump appearance                           Limits on flow range                     syringe drivers are similar, being
                                                                                   £860–1000. Some level of service
Pumps offering delivery over              An option to restrict the flow rate      and on-site training is typically
different fixed time periods should       to a specific range with an upper        included in this price.




                                                                       THE BUYERS’ GUIDE TO RESPIRATORY CARE PRODUCTS     109
10     AMBULATORY SYRINGE DRIVERS: A BUYER’S GUIDE



          Table 2. Ambulatory syringe drivers: features

           Pump                        AD Syringe Driver          MPdaily / MP-101/           MS26 / MS16A                McKinley T34
                                                                  MPml/h

                                       Picture




           List price                  960                        875*                        852.5                       995
           (excl. VAT) £

           Manufacturer                ZiMed                      Eden Medical                Smiths Medical              CME McKinley

           Meets IEC                   ✓                                                                                  ✓
           60601-2-24

           Size (HxWxD) mm 230x87x43                              165x40x23                   166x53x23                   169x53x23

           Weight with                 470                        200                         185                         260
           battery g

           Lock box                    Integral lockable          290                         183                         188
           weight g                    cover

           Water resistance            IPX1                       IPX4                        IPX1                        IPX1

           Power supply                Battery, mains             Battery                     Battery                     Battery, mains

           Battery options             Rechargeable               Disposable                  Disposable                  Disposable or
                                       (integral)                                                                         rechargeable
                                                                                                                          (standard)

           Battery life# days          3¶                         70                          50                          7+

           Battery replacements 0§                                6                           8                           53+
           per year

           Stated flow rate            ±2%                        ±4%                         ±5%                         ±2%
           accuracy

           Overall summary             New to the market.          Compact, lightweight       Compact, lightweight         Complies with IEC
                                       Complies with IEC           and small size driver.     and small size driver.       60601-2-24. Runs on
                                       60601-2-24. Runs on an      Users found it easy to     Users found it robust,       both: a disposable or a
                                       integrated                  use and set up. Similar    easy to use and set up,      standard rechargeable
                                       rechargeable battery,       to the Smiths Medical      however the lack of          battery. 30-50 ml
                                       requires an external        MS drivers, but offers     essential safety             syringes should be
                                       charger. Accepts fully-     extra safety features:     features makes it            significantly under-
                                       filled 30 mL syringes.      key press start and        vulnerable to user           filled to fit the driver,
                                       Offers limits for flow      stop of infusion, limits   error. Good quality          and some 30 ml and 50
                                       rate, good syringe          for flow rate, low         lock box is offered.         ml syringes do not fit
                                       protection by a             battery alarm, event                                    into the lock box.
                                       lockable syringe cover.     log, brief instructions                                 Offers limits for flow
                                       Does not require            on the pump body.                                       rate, good font size,
                                       additional lock box.                                                                ease to maintain and
                                       Infusion monitoring                                                                 repair. Logical menu
                                       and syringe                                                                         and easy monitoring
                                       displacement                                                                        were praised by users,
                                       protection were                                                                     as well as good
                                       praised by users, as                                                                manufacture support.
                                       well as good
                                       manufacturer support.
          #
            : for a typical 24-h infusion in palliative care; * MPml/h price list is £912; ¶: battery needs to be recharged regularly, at least every
          3 days, using a provided charger. Estimated battery life is 3 yrs; +: for disposable battery; §: this driver uses an integrated
          rechargeable battery which, on average, needs to be changed once in three years. Initial cost of the battery is included into the
          driver’s list price.


110   THE BUYERS’ GUIDE TO RESPIRATORY CARE PRODUCTS
                                                  AMBULATORY SYRINGE DRIVERS: A BUYER’S GUIDE                                      10




Manufacturers sometimes include           extended warranty or
                                                                                         SUPPLIER DETAILS
accessories in the overall bundle of      comprehensive warranty at extra
costs, but these can vary and it          cost.
                                                                                        ZiMed Ltd
would be recommended to check
                                                                                        Unit 34, Llys Edmund Prys.
which accessories are included.           Training                                      St Asaph Business Park,
                                                                                        St Asaph
Accessories usually include a carry       Manufacturers typically conduct               Denbighshire
bag, a user manual and training           initial training programmes for               LL17 OJA
material. The lockbox is provided         clinical and technical staff at no            01745 585770
by some manufacturers free of             extra charge. Any further upgrade             www.zi-medical.com
charge with any new purchased             training would generally be the
pump, whilst others supply it as a        purchaser’s responsibility.
cost option.                              However, some manufacturers offer             Eden Medical Limited
                                                                                        1 Dryden Loan
                                          extra training if required over the
                                                                                        Bilston Glen Industrial Estate,
Although syringe drivers do not           life-time of the device, at no                Loanhead
require use of dedicated infusion         additional cost. ■                            Midlothian, EH20 9HR
sets, some manufacturers offer                                                          0131 4406500
proprietary infusion sets for their                                                     www.edenmedical.co.uk
products.                                  The NHS Purchasing and Supply
                                           Agency’s Centre for Evidence-based
Maintenance                                                                             Smiths Medical
                                           Purchasing (CEP) provides
                                                                                        International Limited
                                           independent, objective evidence-based        Colonial Way, Watford
The warranty period for a syringe          information on medical technologies          Herts, WD24 4LG
driver is typically either 1 or 2 yrs,     to underpin purchasing decisions             01923 246434
depending on the manufacturer,             and to drive the uptake of innovative        www.smiths-medical.com/uk
with the typical recommended               devices by the NHS in England. All
servicing interval being 12 months.        CEP reports published since 2002 are
In the UK, most purchasers carry           available to freely download from            CME McKinley UK Limited
out their own servicing and                www.pasa.nhs.uk/cep . An email               Kincraig Business Park
maintenance of syringe drivers,            alert service is also available, by          Kincraig Road
with the hospital technical                                                             Blackpool
                                           contacting cep@pasa.nhs.uk. Further
departments typically servicing                                                         Lancashire, FY2 0PJ
                                           details about CEP service are                01253 894646
local community devices as well.           available from the organisation’s            www.mckinleymed.co.uk
Some manufacturers may offer a             website www.pasa.nhs.uk/cep.
preventative maintenance contract,




  REFERENCES
1. NHS Purchasing and Supply Agency,        Department of Health; January 2006.        11. Ayres JG, Miles JF, Barnes PJ.
   CEP08046 Buyers’ guide: Ambulatory     7. Department of Health. Winning ways:           Brittle asthma. Thorax 1998; 53:
   syringe drivers. December 2008.           working together to reduce healthcare         315–321.
2. NHS Purchasing and Supply Agency.         associated infection in England.          12. Bremont F, Moisan V, Dutau G.
   Report 05076 McKinley T34 syringe         Department of Health; December                Continuous subcutaneous infusion
   pump. March 2006.                         2003.                                         of -2 agonists in infantile asthma.
3. NHS Purchasing and Supply Agency.      8. Storey P, Hill HH, Jr., St Louis RH, et       Pediatr Pulmonol 1992; 12: 81–83.
   Report CEP08047 AD Ambulatory             al. Subcutaneous infusions for control    13. Payne DNR, Balfour-Lynn IM,
   Syringe Driver. March 2009.               of cancer symptoms. J Pain Symptom            Biggart A, et al. Subcutaneous
4. MHRA Infusion Device Evaluation           Manage 1990; 5: 33–41.                        terbutaline in children with chronic
   Database; Ambulatory Pumps.            9. Hanks G. Principles of drug use in            severe asthma. Pediatr Pulmonol
   www.bath.ac.uk/bime/evalcentre/onlin      palliative medicine. In: Doyle D,             2002; 33: 356–361.
   ereview/pump/index.htm . 2009.            Hanks G, Cherny N, et al, eds.            14. Medical electrical equipment – Part
5. MHRA. Evaluation Report 03117             Oxford Textbook of Palliative                 2: Particular requirements for the
   Micrel Medical Devices Micropump          Medicine. 3rd edn. Oxford, OUP,               safety of infusion pumps and
   ml/h. November 2003.                      2005; p. 219.                                 controllers. 1998. Report No.: IEC
                                          10. Wilson V. Guidelines for use of the          60601-2-24.
6. Department of Health. White Paper:
   Our health, our care, our say: a new       MS26 daily rate syringe driver in the    15. Lawrence J, Dee M. Infection control
   direction for community services.          community. Br J Community Nurs               in the community. Illustrated edn.
                                              2000; 5: 162–168.                            2003. p. 59.




                                                                      THE BUYERS’ GUIDE TO RESPIRATORY CARE PRODUCTS              111

								
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