PARENTERAL INFUSION PUMPS POLICY

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					                                                                 Policy No: RM58

                                                                 Version 1.0




Name of Policy:                      PARENTERAL INFUSION
                                        PUMPS POLICY


Effective From:
                                   December 2007



Approved by:                      Safe Care Council




Next Review Date:                             Reviewed by:
December 2009                                 SafeCare Council




This policy supersedes all previous issues.




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                                    CONTENTS
                                                                    Page No
    1. Summary                                                          3
    2. Introduction                                                     3
    3. Policy Statement                                                 4
    4. Roles & Responsibilities                                         4
       4.1 Management Responsibilities                                  4
       4.2 Directorate Responsibilities                                 5
       4.3 Infusion Device Users                                    5
       4.4 Medical Engineering Department                               5
       4.5 Medical Device Coordinator                                   6
    5. Application and Scope                                            6
       5.1 Availability of infusion equipment                           6
    6. Standardisation of infusion pumps                                7
       6.1 List of infusion types                                       7
       6.2 Selection for purchase                                       7
       6.3 Loan Equipment                                               8
             6.3.1 Equipment for trial or short term loan (<3 months)   8
             6.3.2 Equipment on long term loan (>3 months)          8
             6.3.3 Disposable items                                     8
    7. Labelling                                                        9
    8. Training & Competency                                            9
       8.1 Records of training and assessment                           9
             8.1.1 Competency based Training                            9
             8.1.2 Database                                             9
             8.1.3 Further / Top up training                            9
             8.1.4 Infrequent users                                     9
             8.1.5 Access to training                                   9
       8.2 Bank, agency and locum staff                                 9
       8.3 Introduction of parenteral infusion devices                  10
9.     Knowledge required to use infusion devices                       10
       9.1 Prior to using an infusion device                            10
       9.2 During the use of an infusion device                         10
       9.3 After the use of an infusion device                          10
10.    Documentation                                                    11
       10.1 Training records                                            11
       10.2 Central record keeping                                      11
       10.3 Operating manuals                                           11
       10.4 Ward/Department points of contact                           11
11.    Use, service and maintenance                                     11
       11.1User maintenance                                             11
       11.2 When things go wrong                                        12
       11.3Technical maintenance                                        12
11 Further information                                                  12
       12.1 Guidance on infusion pumps                                  12
APPENDIX A Infusion Devices held within                                 14
      Gateshead Health NHS Foundation Trust


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                          Parenteral Infusion Pumps Protocol

1. Summary
Any staff member required (see ‘local policy for authorised users of medical devices’ and ‘training policy
for medical devices’ RM46) to use a parenteral infusion pump to administer treatment to a patient must
be fully trained in its use, and deemed competent before using the device unsupervised. Staff are
accountable to their professional bodies in regard to their acts and omissions of practices stated in this
protocol. Nursing staff play a leading role in the delivery of IV therapy which incurs legal and
professional issues, however this protocol applies to all staff involved in the use of infusion devices.

All infusion pumps within the Trust should have a licence label attached. This informs staff of pending
maintenance schedules.
Unlabelled pumps or those past the service date must not be used, they should be returned to the
electronics department, complete with a request to repair form.

This protocol must be followed in conjunction with, competencies for the use of infusion devices and
with medical device policies.

2. Introduction
The Trust has a legal obligation under the Health & Safety at work etc Act 1974 and under various
regulations to provide training to its employees in the use of work equipment in cases where lack of
training will increase the risk of harm to the employees or other persons. Other persons include
patients.

Infusion devices are used to administer maintenance intravenous fluids, drugs required for rapid for
rapid action and drugs which are of a potent nature.
Up to 80% of patients admitted to hospital receive IV therapy. This totals approximately 15 million
patient infusions annually within the NHS.
There are 3 methods of operation to infusion devices these are gravity flow, syringe mechanism and
peristaltic mechanism. Staff must be aware of all operation methods.

Pumps of the same type can be configured internally to behave in different ways. Thus two apparently
identical pumps can operate in different ways which can have serious safety implications. An example
of this is Arcomed pumps, which can be configured differently for adult performance compared to those
in our Special Care Baby Unit where the pumps require neonatal performance configurations, this risk
is addressed by visibly marking differently configured pumps and allocating them solely to certain
clinical areas.
          Configurations in the Trust
          Chemotherapy pumps have a white label stating chemotherapy use only
          Neonatal pumps have a yellow label stating neonatal use only

The Parenteral infusion pumps protocol for Gateshead Health NHS Foundation Trust is designed to
reduce risks associated with the use of infusion devices to patients .
The MHRA reports 59% of incidents involving infusion devices results or has the potential to result in a
patients death.
Experience in other Trusts has shown that users not trained in the proper use of specific infusion
devices can cause fatal harm to patients, (with an annual national average of 10 deaths a year.) Under
the same Act employees have a duty to co-operate with their employer by following H&S rules to
minimise risk.

The reduction of possible risks can be achieved by adhering to guidance described in this protocol,
which covers selection, training, lifetime management and use of equipment used for parenteral
infusions.
The NPSA advocates revision of purchasing decisions, implementation of a centralised equipment
library and agreement of configurations will also help reduce risks of patient safety incident involving
infusion devices


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NHSLA Risk Management Standards require evidence of systems in place for ensuring that all staff are
competent to use medical devices appropriate to their role. They will expect to see evidence of the
effectiveness of training, hence the need for training to be assessed and recorded.

Throughout this document the term “user” refers to Doctors, Registered Nurses, Registered Midwives,
Medical Technicians & Operating Department Practitioners.
In order to be effective, this protocol must be applied across the Trust.


3. Protocol Statements


1. All staff who use parenteral infusion pumps must be authorised
   and trained with evidence of competency prior to use – unless
   working under direct supervision of a competent user.

2. All parenteral pumps must be labelled in accordance with the
   trust licence scheme (Section 6).

3. Unlabelled pumps or those with an expired licence date must
   NOT be used (Sections 6).


4. Roles and Responsibilities

4.1 Management responsibilities
4.1.1 The Chief Executive:-
       Is responsible for ensuring that the trust complies with all health and safety regulations and
       approved guidance. In practice the tasks and responsibilities for ensuring compliance with
       regulations and guidance relating to medical equipment are delegated to senior managers but
       overall responsibility will remain with the Chief Executive.

4.1.2 The Trust Board:-
       Is overall responsible for formally reviewing the systems and processes for ensuring safe
       acquisition, storage, deployment and use of infusion devices.

4.1.3 Director of Estates and Risk Management:-
       Advises the Trust Board as to the level of funding required for equipment replacement as part of
       prioritising capital funds.
       The Director has the delegated responsibility for maintaining medical equipment and liaising
       with the Medical Devices Management Group. In practice this responsibility is delegated to the
       Specialist Service Manager.

4.1.4 Heads of Service and Service Managers:-
       Are responsible for ensuring adequate resources are available for Medical Device links to
       manage processes within their own area.

4.1.5 Supplies Manager:-
       Is to ensure compliance with Trust standing orders, legal obligations and European Legislation
       in respect of tendering and contract procedure, to ensure compliance with guidance, codes of
       conduct and good practice in respect of procurement and supply of medical equipment.

4.1.6 General Ward or Department Managers:-
       Responsible for designating staff from within their Directorates to act as Medical Device Leads,
       who with support of the manager, will have responsibility for representing all aspects of the use
       of infusion devices within their particular field of responsibility. The manager will also ensure
       staff are aware and adhere to this Trust policy in relation to Infusion devices.

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4.2 Directorate responsibilities
   Each service manager will ensure all clinical areas within the directorate have access to training
   programmes.
   Documentation is kept up to date relating to training.
   This policy is implemented.
   Local policies are completed indicating staff authorised to use infusion devices and training
   requirements.
   Service managers will be responsible for agreeing locally who are the authorised users of the
   equipment in the clinical areas, this will be forwarded to the medical devices coordinator.

4.3 Infusion Device Users
     Theoretical and Practical Training of all infusion devices used within the clinical area has been
     achieved, or declared if not achieved.
     Competency has been assessed and approved in the use of infusion devices (evidence must be
     available).
     If training or assessment has not taken place the user will not attempt to use the device, unless
     under direct supervision of a competent trainer/user.
     Equipment selected is suitable for the purpose required, awareness of other models and the
     differences.
     Correct, compatible supplies/ disposables/ attachments are selected for use with the device
     (expiry dates checked).
     Giving sets are changed every 24 hours when the device is in use.
     Single use attachments/ giving sets are not re-used. Ref MDA DB2000(04) discusses
     implications and consequences.
     Devices are cleaned in a way described by the manufacturer and Trust Decontamination Policy,
     users are able to assemble the devices following cleaning. See section 9.3.
     Incidents are reported and a datix form completed in accordance with Incident Reporting Policy
     RM 04.
     Malfunctioning devices are returned to the Electronics Department for Repair.
     Assessment of patients abilities e.g. physical/ sensory abilities, likelihood to tamper, ability to
     remember or understand are to be carried out prior to the device being left with the patient
     Monitoring patient and device for adverse effects, reactions etc.
     Checking devices for signs of wear and tear.
     Ensuring device alarms are used in compliance with recommendations of ‘Allitt Report’.
     Be aware of local policies and procedures appertaining to authorised level of use.
     They have full awareness of their responsibilities in the use of Infusion devices.

4.4 Medical Engineering Dept
     Maintain an equipment register of Infusion devices.
     Maintain records of device calibration, planned maintenance, inspection activities and expected
     replacement dates.
     Advise users on the technical nature and operation of equipment.
     Advise users of common faults and assists with defect and failure reports.
     Identify equipment beyond economic repair, following damage, ware & tear.
     Safely decommission or dispose of unusable infusion devices.
     Electronics department shall ensure maintenance and service requirements are considered prior
     to purchase, the following actions are to be taken into account and addressed within the Trust:-
              The repair and maintenance of a device is considered and reviewed at the purchase
              stage, a decision relating to In-house, manufacturer other maintenance service provider
              needs to be agreed and evaluated on a yearly basis.
              All information necessary to undertake a repair or to maintain a device safely is made
              available.
              Systems are in place between the manufacturer and Trust to bring any changes to repair
              and maintenance methods to the attention of the repairer.
              The repairers are appropriately trained and up-dated with their knowledge of repair and
              maintenance methods.
              The instruction used should be specified by the manufacturer.
              Replacement parts should match those specified by the manufacturer.
              The use of alternative instructions, methods and parts should be demonstrated to be
              equivalent and take into account all risks to patients and users, this process must be fully
              documented.
              Traceability of all replacement spare parts and critical components used in a repair or
              maintenance is required.

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              All associated repair and test equipment is suitable for its purpose and is appropriately
              maintained and calibrated.
              Repairer is made aware of any changes in circumstances which may effect the repair
              and maintenance and assess the impact of those changes to ensure that agreed
              specifications continue to be met.
              Repairers have a system in place to manage device repair and maintenance activities.
              The device itself remains identifiable.
              All records are accurate, detailed and accessible regarding the service and maintenance
              of medical devices.
              Audits are undertaken regularly to review maintenance processes, action is then taken as
              necessary.
              The manufacturer reports conditions of potential device failure or other factors likely to
              compromise the clinical outcome.
              Device failures are reported to the MHRA.
              A contract is drawn up to define responsibilities of the Manufacturer and the Trust in
              relation to service and maintenance.
              Legal responsibilities and liabilities are acknowledged.
              Devices intended for service or maintenance are not handled unless it is clear they are
              safe to touch i.e. contamination status is addressed.

4.5 Medical Devices Coordinator
              Ensuring there are appropriate systems in place to manage Infusion devices within the
              trust.
              The implementation of improvements, efficiency and quality of care in relation to Infusion
              devices.
              Directly managing the equipment library and the movement of infusion devices
              throughout the Trust
              The provision of technical and clinical expertise and advice to clinical staff within the
              trust.
              Participate in audit, monitoring, evaluation and practice developments.
              Advising and supporting risk assessment processes.
              Providing and supporting application of this protocol.
              Discover Training requirements for the use of infusion devices and assist in the
              development of appropriate training packages.
              Assisting in the investigation of clinical incidents involving the use of a infusion device.

5. Application and Scope
This protocol applies to the Gateshead Health NHS Foundation Trust with effect from Dec 07

The Protocol covers the management and use of all parenteral infusion pumps as defined by MDA DB
9503 (May 1995), namely: (see appendix A)

Syringe pumps
Volumetric Pumps
Patient Control Analgesia pumps (PCA)
Epidural pumps
Anaesthetic pumps
Ambulatory pumps (syringe drivers)

The protocol relates to all infusion pumps used within the Trust, and is therefore inclusive of those
infusion devices which are department/ward owned, library owned, patient owned or on loan from
another organisations . The protocol is designed to meet the requirements of legislation and guidance
and shall be monitored by periodic audits carried out by the Trust’s Medical Devices Coordinator to
monitor clinical effectiveness on behalf of the Clinical Risk Team.

5.1 Availability of Infusion Equipment
Should a general ward require an infusion device, the equipment library should be contacted to satisfy
the request. Equipment library hours are 08:30 – 17.00 hours. The Equipment Library aims to deliver
the device to the requesting ward within a 30 minutes from the request time.

Each infusion device loaned from the Equipment Library is for individual patient use. Once a patients
treatment no longer requires administration via an infusion device the infusion device should be
returned to the equipment library where it will be prepared for its next loan.

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Should a patient require transfer from one clinical area to another while connected to an infusion device,
the device is to be transferred with the patient.

Out of hours, i.e. between the hours of 17.00- 08.30, weekends and bank holidays, general ward areas
should bleep the portering staff who have access to the library.
Should equipment be unavailable in the library the requesting ward should
     inform 1200 bleep,
     contact MAU to request a clean device from their supply,
     if MAU is unable to assist in the loan, the requesting ward should complete a Datix incident form
     then reprocess/ decontaminate any devices they may have waiting on their ward for return to the
     library
     If no devices are waiting for return, the requesting area should then try to commandeer a device
     from another clinical area which is awaiting return to the equipment library
 Also see Equipment Library Operational Policy

6. Standardisation of infusion pumps
The National Patient Safety Agency helped confirm the root cause of several incidents involving infusion
devices where no fault of the equipment was identified they found
    Trusts had a wider range of infusion devices than needed and too many with a higher specification
    than necessary
    Staff training is not a priority or competency based
    Devices of the same type have multiple configurations and react differently under the same
    circumstances
The Trust is therefore working towards standardisation of infusion devices so fewer makes are in
circulation.
Standardisation of infusion pump is currently underway within the trust we are phasing out Graseby,
Alaris, Imed and Gemini pumps, this is expected to be complete by mid of 2008.

6.1 List of Pump types
There is a list of pumps for use in the Trust for the following categories: (see appendix A)

                 Syringe pumps
                 Volumetric Pumps
                 PCA pumps
                 Epidural pumps
                 Anaesthetic pumps
                 Ambulatory pumps (syringe drivers)

This list will be updated subject to clinical, safety, training and technical considerations.

Gravity devices - depend entirely on gravity to drive the infusion, the pressure for the infusion depends
on the height of the liquid above the infusion site. Flow is measured by counting the drops.
A gravity device should be considered due to its simplicity and low cost for low risk infusions such as
Sodium chloride, dextrose saline and dextrose infusions.
A gravity device should not be used for infusions containing potassium, or drug therapies requiring
accurate monitoring or delivery of accurate volumes.
Infusions, even low risk, should not be delivered to volume sensitive patients via a gravity line but must
be given via an infusion pump

Syringe pumps – used to administer drugs/ infusions in small or medium volumes, rates 0.1 - 500.0
mls/hr.
Syringe pumps have a better short term accuracy than volumetric pumps and are therefore typically
more superior when delivering drugs at rates below 5ml/hr. Syringe pumps are used extensively where
small volumes of highly concentrated drugs are required at low flow rates.
Staff must be aware of the disadvantage of start up delay/ mechanical backlash when using a syringe
pump and take actions to overcome this.

Volumetric pumps – used to administer drugs/ infusions in small, medium or large volumes, rates 0.1
– 999 mls/ hr
Volumetric pumps should be used for large volume/ high risk infusions and or infusions requiring
accurate monitoring.
These pumps should not be used where short term accuracy is required (syringe pumps should be
used instead)
Delivery of low risk infusions should be considered via a gravity device rather than a volumetric pump,
                                                                                                          7
unless accurate monitoring is required, or the patient is at risk of fluid over load.

Epidural pumps – used to administer anaesthetic or analgesic drugs via the epidural space. The
pumps used to deliver this type of treatment need to be easily identifiable from those giving drugs/
infusions intravenously. Within the Trust a number of Hospira Gemstar Epidural pumps. These pumps
are configured specifically for epidural use. Attempts to administer Intravenous infusions through these
epidural pumps must be avoided.
Only yellow giving sets should be used with these devices, this serves as an additional visible check to
IV or epidural route.
All epidurals should be administered via epidural pumps and not through standard VP7000 or Graseby
500 pumps.

PCA – Patient controlled Analgesia – used to administer analgesia in one of the following modes
   Patient bolus only – the pump only delivers after pressing the patient bolus key with no respect for
  lockout time. If the patient bolus key is pressed during the lock out time, no bolus is delivered.
   Patient bolus and continuous basal rate. A continuous basal rate is delivered during the whole
  administration. Additional patient bolus can be requested by pressing the patient bolus button
   Patient bolus and limited continuous basal rate. After each bolus the pump continues to deliver a
  continuous basal rate for a limited time
   Initial charge bolus. The administration is started with an initial charge bolus. After the initial charge
  bolus, further patient bolus can be requested by pressing the patient bolus key with respect to the
  lockout time
   Physician bolus. The physician bolus can be requested at any time using the access password.

Anaesthetic pumps – Are syringe pumps specifically designed for the administration of anaesthetic
agents and are unsuitable for any other use.

Ambulatory pumps – Miniature versions of syringe pumps which are battery driven. They deliver their
dose in bursts, not in an even flow rate, almost like a continual sequence of micro boluses.
Ambulatory pumps can be carried around by patients whether they are in hospital or at home. Within
the Trust we are planning to move from MS16 & MS26 pumps to McKinley T34 pumps during
2008/2009


6.2 Selection for purchase
All bids for new models of pumps need to be considered to ensure compliance with the Medical Devices
Procurement Policy and standardisation programmes
The Procurement of new design/ updated / different makes or models of infusion devices must involve
input from the Trust Supplies Department and the Medical Devices Management Group to provide
advice on purchases/contracts which meet with the Trust's Standing Orders / Standing Financial
Instructions, European Community Supplies & Services Directives, all relevant legislation including
Standards. All purchases should demonstrate value for money and include provision of training by the
manufacturing/ providing company. Full life costings including disposable items and maintenance must
be considered.


6.3 Loan equipment / Equipment on trial
It is important that new equipment being considered for purchase is properly tried out in the Trust.
However this has risks and in order to reduce this risk the trial process needs to be controlled.
Manufacturers are willing to provide a degree of indemnity and national agreements are in place dealing
with this.


6.3.1 Equipment on trial or short term loan (<3 months)
An infusion pump(s) on trial must be checked by Medical Engineering & Electronics department and the
appropriate indemnity forms completed before use. Any infusion pump used in the Trust without being
checked formally by Medical Engineering will be the personal responsibility of the organiser for which
the Trust will have no liability. For unfamiliar pumps on trial in the Trust special labelling of the device
and training of the users is essential.

Medical Engineering will also ensure that the equipment is covered by master indemnity agreements or
a signed indemnity form as recommended by the MRHA (DB 9801).
Medical Engineering will inform the Trust Supplies Department and Medical Devices Management
Group of all trials involving infusion pumps.


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6.3.2 Equipment on long term loan (>3 months)
Infusion pumps on long term loan will be managed and used in the same way as Trust owned
equipment.
Equipment on long term loan such as lease or those associated with consumables deals have to be
treated as if the Trust owned them because in regard to Health and Safety their use is in the control of
the Trust.

6.3.3 Disposable items
A Trust policy requirement (policy for the use management and procurement of medical devices) is that
single use items should not be reused.
It is the responsibility of all infusion device users to ensure they use the correct consumables or
disposable with the device. Infusion device users must ensure they are aware of disposables which are
model specific or treatment specific e.g. using blood sets for administration of blood, using Arcomed
sets in Arcomed infusion devices, opaque sets for light sensitive drugs etc
Specific disposables required for infusion device use will be covered in training

7. Labelling
1 All infusion devices are labelled to indicate the date of the next maintenance/calibration check.
2 Each device also has a label which specifies its unique asset ID number, this is to aid identification
  and location.
3 Following risk assessment all infusion devices were given a high risk category and therefore a
  high risk label is attached




1                            2                          Gateshead Health NHS Trust       3

                                                                                                      High risk
                                                                                                       device!
                                                                                                     Competency
                                                                                                      must be
                                                                                                      assessed

                                                             I.D 021242
                                  MEDICAL EQUIPMENT LIBRARY Q.E.H
                                  VOL INFUSION PUMP              Value; £2500
                                  Model; VOLUMED UVP 7000        Serial No;
                                  1440508
                                  For service Contact Electronics Department Ext; 2116




8. Training & competence

8.1 Records of training and assessment

8.1.1 All staff, including bank, locum, agency and those in training, who use parenteral infusion
devices shall receive competency-based training. Following assessment, the individual user is
responsible for their continued competence in the use of the device and shall have these skills reviewed
annually.

8.1.2 The Medical Devices Coordinator will keep and maintain a database of all users from
information provided by each clinical area devices link. Staff are required to follow the re-training matrix
on completion of competency training to establish their future training schedule (see medical devices
training policy)
If staff feel that they need re-training, over and above the requirements in 7.1.2, it is their own
responsibility to arrange this with their department devices link, manager or through the Medical
Devices Coordinator direct.

8.1.3 If after assessment, it is agreed between the user and the assessor that further training would
be advisable this should be agreed with the user, their manager and the Medical Devices coordinator.

8.1.4 Staff who use infusion pumps infrequently will require updates more often than regular users
(see retraining matrix – medical devices Training Policy), a staff member should never operate an
infusion device unless they are competent to do so.


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8.1.5 Training and assessment is available through the following routes: -
                Medical Devices Coordinator direct
                Specific workshops
                Ward Educational Lads
                Ward cascade trainers
                Manufacturing representatives

8.2 Bank and agency and locum staff
All bank staff will receive training via cascade trainers, or accessing the medical devices coordinator.
Agency and locum staff required to use infusion pumps will be provided with information on how to
receive their training and advised not to use any unfamiliar equipment for which they have had no
previous training.
Once a bank, agency or locum member of staff has been assessed and has demonstrated competency
in the use of infusion devices, they are to hold a personal record which should be taken to each clinical
area they work for, as proof of competency

8.3 Introduction of parenteral infusion devices
New types of infusion pumps will be phased into clinical areas to ensure staff have received training and
deemed competent prior to use


9 Knowledge required to use infusion devices

9.1 Prior to using an infusion device ask yourself &/or carry out the following
Following training do I have knowledge of:-
     How the infusion pump is to be used
     The limitations and contra-indications for use
     Has the device been well maintained – any signs of wear & tear
     How to set up the device – ideal height of device, height of hanging fluids, how to prevent start up
     delay, how to prevent free flow syphonage,
     How the device should perform and the monitoring required to check its performance
     The correct additional equipment, e.g. disposables
     How to recognise a failure in the device
     How to report a fault or failure
Have I read or do I have access to the instruction manual?
How is my competency in relation to this device?
Do I need refresher training?
Inform the patient of the need to administer treatment via a device
Assess the patients ability to understand what you are telling them
Assess the patients level of risks while attached to an infusion device e.g. ability to mobilise etc
On selection of the most appropriate infusion device to fit the patients needs
i.e. epidural pump, volumetric pump, syringe pump etc ensure the correct consumables/ disposables
are selected
Complete section 2 of the equipment library loan form
Ensure your actions at the set up stage of the equipment/ infusion are witnessed by another qualified
nurse who can verify the infusion is set up correctly. This second nurse will also witness the infusion is
being administered to the correct patient.
The set up of Arcomed infusion pumps should incorporate use of the devices built in calculator which
allows drug rates to be calculated. This process will check manual calculations are correct

9.2 During the use of the infusion device carry out the following
Check the device to ensure it is functioning correctly, and to the manufacturers specifications.
Action required if the infusion device does not function properly – see section 11.2
Document the infusion device details in the patient notes, i.e. type/model, Asset I.D number.
Should a patients treatment / circumstances change, check the type of device in use still appropriate
e.g. a patients treatment is administrated via a syringe pump while in hospital, if the patient is
discharged in to the community, should the syringe pump be changed to an ambulatory pump
Monitor the patient in addition to the device, monitor the patients cannula site for signs of phlebitis,
extravasation, observe for an adverse reaction related to the infused substances
The volume of fluid/drug delivered to the patient should be checked and documented hourly on the
patients fluid chart, to ensure the infusion and infusion pump is running to time, any unexpected
discrepancies should be investigated and reported via datix


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Where possible an infusion devices in use should be connected to a the mains power (with the
exception of e.g. ambulatory pumps)
If changes to the infusion are required e.g. increasing or decreasing the rate then this should be
preformed by one qualified nurse with another qualified nurse witnessing the process. This is aimed to
reduce the number of incidents involving the incorrect setting up of infusion devices.
Ensure giving/ administration sets are changed at time intervals recommended by the manufacturer

9.3 After use
Unless otherwise stated in the manufacturers guidelines, Follow the decontamination guidelines – All
infusion devices require decontamination following each patient use, this includes electrical flex.

Gloves and apron are to be worn as a protective barrier during manual decontamination. Eye protection
should be used if the device has visual contaminants i.e. blood or is heavily soiled.

Ensure the device is disconnected from the electrical supply prior to decontamination.
For general cleaning use white roll soaked in hot water (60ºF / 16ºC) and general purpose detergent,
ensuring excess water is squeezed out.

Rinse with clean water and dry.

Devices used on a patient with or suspected to have MRSA or a risk of cross infection should;
     a) Clean the device as above.
     b) Wipe device with a 70% disposable disinfecting wipe, Or alternatively Haz Tab Chlorine solution
      as per Cleaning and Disinfection Policy No.15.


Consumables used in the decontamination of a device are to be discarded in an orange clinical waste
bag.
If the infusion device is on loan from the equipment library it must now be placed in the collection bag
and returned to the library. This is done by contacting the library direct during opening hours. There is
no out of hours collection service. A message may be left on the library answer phone and the devices
will be collected the following working day
Complete section 3 of the equipment library loan form indicating the decontamination status of the
infusion device.

10. Documentation

10.1 Training records
Individuals shall maintain their own records of training and or assessment in the use of infusion pumps

The Medical Devices Coordinator will maintain records of training. These records are accessed from
either ward/department device links - for cascade training occurring within the ward, or training session
provided by rep’s or medical devices coordinator. Training records are entered into a data base housed
in the equipment library.
Each ward/ department should hold a record of staff training for reference
The ward manager should ensure that staff are made available to attend training sessions.
The ward manager has a responsibility of ensuring device training is discussed during staff PDP’s


10.2 Central record keeping
The Trust, through the database will keep records of: -

         Name of staff member, grade and location details
         Infusion pumps trained on
         Date of training
         Dates of subsequent training and assessment
         If that person has not attended


10.3 Operators manuals
All wards/departments will have a copy of operators’ manuals for all the infusion pump equipment they
use. The manuals will be made available to ALL appropriate staff. This is available via the Intranet & or

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as a hard copy at ward level. The equipment library / medical engineering department may also keep
copies of manuals.


10.4 Ward / Department points of contact
Each Ward / Department should appoint a suitably trained devices link to aid training coordination within
their own clinical area, the Medical Devices Coordinator will fill for areas where this is not possible.


11. Use, Service & Maintenance

11.1 User maintenance
All mains operated infusion pumps should be returned to the equipment library in a clean condition. In
the library infusion devices are further decontaminated and connected to a mains electrical point to
keep the battery charged.

Manufacturers guidelines should be followed for cleaning/decontaminating, the user is responsible for
ensuring infusion devices are processed through the equipment library between each patient use. If an
infusion device is not processed through the library (on rare occasions only) it is the responsibility of the
user to ensure it is thoroughly cleaned between patients and an Incident form completed. All infusion
pumps shall be checked by the user to confirm serviceability.

If, during the user checks, the equipment is, or is thought to be faulty, it must be withdrawn from use,
sent to electronics together with a request to repair form.

If, during operation, the equipment is (or is thought to be) faulty, it must be withdrawn from operation,
and with a completed request for repair from sent to electronics. Should a patient suffer actual or
potential harm due to the failure of equipment, adherence to the to the Trust Incident Reporting Policy
must be followed.

If any infusion pump is dropped it must be checked by the Electronics department before further use.

11.2 When things go wrong
The following have been found to be the cause of infusion device failures/incidents
Mechanical failure
Electrical Failure
Software Failure
Use error including
    mis-loading disposables
    Incorrect setting of rates
    Inadequate training
    Unsuitable environment
    Incorrect prescribing
    Medication errors – wrong patient ,wrong route, under or overdose

 Actions required following an incident/ near miss
Attend to patient clinical needs
Quarantine the infusion device, the giving set and any fluid containers
Do not alter the settings on the equipment
Label the equipment as hazardous
Complete an incident form
Inform devices coordinator, risk team or electronics department of the incident

11.3 Technical maintenance

All infusion pumps shall be safety tested and maintained by the electronics department in accordance
with formal work instructions based on the specific device model and are upon manufacturers guidance
and the Medical Electrical Equipment. General Requirements for Safety (British Standard BS 5724-1:
1989, IEC 60601-1:1998).

12. Further information

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Any enquiries regarding this information should be directed to: -
Jacqui Edwards – Medical Devices Coordinator – extension 3871 bleep 2757
Or e-mail – jacqui.edwards@ghnt.nhs.uk

12.1 References and Guidance on infusion pumps includes : -

Medical Devices Agency (1998) Medical Device and Equipment Management for Hospital and
Community-based Organisations. MDA Device Bulletin 9801.

Medical Devices Agency (2003) Infusion Systems MDA Devices Bulletin 9503.

UKCC (1992) Standards for the Administration of Medicines.

Department of Health (1981) Health Equipment Information 95 – Code of Practice for Acceptance
Testing of Medical Electrical Equipment.

IEC 930: 1988 Guidelines for Administrative, Medical and Nursing Staff Concerned with the Safe Use of
Medical Electrical Equipment.

Medical Electrical Equipment. General Requirements for Safety (British Standard BS 5724-1: 1989, IEC
60601-1:1998).

Medical Devices Agency (1995) Report on the Expert Working Group on alarms on Clinical Monitors.

Relevant Copies of Medical Devices Agency publication “Evaluation”.

Harrogate District Foundation Trust




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Appendix A Infusion devices held within Gateshead Health NHS
Foundation Trust (5 & 6.1)


     SYRINGE PUMPS -
           Graseby 3100
           Graseby 3200
           Graseby 3150
           Graseby 3400
           Graseby 3500
           Arcomed SP 6000
                                                Graseby & Imed devices
     VOLUMETRIC PUMPS –                         are being phased out in
          Arcomed VP 7000
                                                2007/8 and Arcomed will
          Graseby 500
          Imed Gemini PC1                       become the standard
          Imed Gemini PC2                       infusion device used in the
          Imed 950                              Trust with the exception of
                                                epidural and ambulatory
     PATIENT CONTROLLED ANALGESIA PUMPS –
                                                pumps
           Graseby 3300 PCA
           Arcomed SP600 PCA

     EPIDURAL PUMPS -
           Arcomed VP7000
           Gemstar

     ANAESTHETIC PUMPS –
          Base Primea IS
          Module DPS IS 3


     AMBULATORY PUMPS (SYRINGE DRIVERS) –
          Graseby MS 16 A
          Graseby MS 26
          McKinley T34




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