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10 AMBULATORY SYRINGE DRIVERS: A BUYER’S GUIDE Main image: Rodho istockphoto 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 . 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 . 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 . 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) . 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: firstname.lastname@example.org 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 . 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 . 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 . 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%) . 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 . 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  offer these safety asthma . 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  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 . 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 . 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 email@example.com. 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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