Infusion
Systems

BULLETIN

MDA DB2003(02)
March 2003

Acknowledgements
We would like to thank the many organisations and individuals who gave their valuable
time in contributions to this revised document, including:
Teresa Dunn Bath Institute of Medical Engineering
Mark Roberts and Beth Louden NHS Purchasing and Supplies Agency
Mona Habib and Stephen Young Charing Cross Hospital, London
Justin McCarthy and Steve Keay University Hospital Wales
Chris Quinn Freeman Hospital, Newcastle
BSI CH115 Infusion Pump Standard Committee
National Patient Safety Agency
Health and Safety Executive
Scottish Healthcare Supplies
Health Estates DHSSPS, Northern Ireland
National Assembly for Wales

Note
Medicines and Healthcare products Regulatory Agency (MHRA)
The Medical Devices Agency (MDA) and the Medicines Control Agency (MCA) will merge
to form the Medicines and Healthcare products Regulatory Agency (MHRA) in April 2003.


The Medical Devices Agency helps safeguard public health by working with users, manufacturers and
lawmakers to ensure that medical devices meet appropriate standards of safety, quality and
performance and that they comply with the relevant Directives of the European Union.
Our primary responsibility is to ensure that medical devices achieve their fullest potential to help
healthcare professionals give patients and other users the high standard of care they have a right to
expect.
The Medical Devices Agency is an Executive Agency of the Department of Health

CONTENTS
EXECUTIVE SUMMARY ..............................................................................................5
Aim ............................................................................................................................5
Scope ........................................................................................................................5
INTRODUCTION...........................................................................................................6
What is an infusion system? ......................................................................................6
What are the problems? ............................................................................................6
1 ORGANISATIONAL RESPONSIBILITIES.................................................................9
1.1 Introduction..........................................................................................................9
1.2 Management recommendations...........................................................................9
1.2.1 Establish a clearly defined structure ............................................................9
1.2.2 Appoint a medical device co-ordinator .........................................................9
1.2.3 Medical device co-ordinator responsibilities...............................................10
1.2.4 Reporting adverse incidents ......................................................................11
1.2.5 Adequate staff numbers and skill levels.....................................................11
1.2.6 Regular systems audit ...............................................................................11
2 PROCUREMENT .....................................................................................................11
2.1 General guidelines .............................................................................................11
2.2 PASA procurement guide ..................................................................................12
2.2.1 Key points from PASA procurement guide.................................................12
2.3 Safety considerations ........................................................................................12
2.4 Rationalising makes and models .......................................................................13
2.5 Other methods of acquisition .............................................................................13
2.5.1 Donated devices........................................................................................13
2.5.2 Borrowing ..................................................................................................14
2.5.3 In-house manufacture................................................................................14
2.5.4 Modification and change of use .................................................................14
2.5.5 Full refurbishment......................................................................................14
2.5.6 Cannibalising.............................................................................................15
3 TRAINING................................................................................................................15
3.1 Why is training needed? ....................................................................................15
3.2 Who requires training and when is training needed?..........................................16
3.3 Organisation of training......................................................................................16
3.3.1 Training policy ...........................................................................................16
3.3.2 Training programmes ................................................................................17
3.3.3 Resources for training ...............................................................................18
3.3.4 Record keeping and assessment...............................................................19
3.4 Content of training..............................................................................................19
3.4.1 Training for hospital staff ...........................................................................19
3.4.2 Training for patients and carers .................................................................20
3.4.3 Healthcare professionals working in primary care and the community .......21
3.5 Discharge or transfer of patients ........................................................................21
3.6 Maintenance and repair .....................................................................................22
4 OPERATIONAL DOCUMENTATION.......................................................................24
4.1 Drug selection and dose calculation ..................................................................24
4.2 Prescription of drugs..........................................................................................24
4.3 Preparation of the drug in solution .....................................................................25
4.4 Administration....................................................................................................25

4.5 Discharge or transfer..........................................................................................26

5 GENERAL SAFETY RECOMMENDATIONS...........................................................28
5.1 Safe use of volumetric pumps ............................................................................28
5.1.1 Recommendations for using administration sets........................................28
5.1.2 Preventing free-flow (siphonage) ...............................................................28
5.1.3 Preventing air entrainment.........................................................................28
5.2 Safe use of syringe pumps.................................................................................29
5.2.1 Recommendations for using syringes in infusion pumps ...........................29
5.2.2 Preventing free-flow (siphonage) ...............................................................29
5.2.3 Preventing air entrainment.........................................................................30
5.3 Correct configuration/application of pumps ........................................................30
5.3.1 User-adjustable facilities............................................................................30
5.3.2 Blood sets and solution sets ......................................................................30
5.3.3 Battery powered pumps.............................................................................30
5.3.4 Ambulatory pumps.....................................................................................31
6 PRESSURE IN INFUSION SYSTEMS .....................................................................31
6.1 What pressures does the pump have to overcome in order to deliver the drug? 31
6.2 Why do simple gravity drips slow down when the patient sits up in bed? ...........32
6.3 When is a higher pumping pressure needed?....................................................33
6.4 Occlusion pressures and alarms........................................................................33
6.4.1 What triggers an occlusion alarm?.............................................................33
6.4.2 What are the hazards to the patient caused by occlusion? ........................33
6.4.3 Bolus at occlusion alarm and time to occlusion alarm................................34
6.4.4 Pressure at alarm ......................................................................................34
6.4.5 How can occlusion alarm time and bolus be reduced? ..............................35
6.5 Why are infusion pumps not configured to run at the lowest possible level? ......35
6.6 What are the implications for patient safety of configuring a high occlusion
pressure?...........................................................................................................36
6.7 How does raising or lowering an infusion pump relative to the infusion site
affect flow?.........................................................................................................37
6.8 Extravasation.....................................................................................................37
6.8.1 What is extravasation? ..............................................................................37
6.8.2 What causes extravasation?......................................................................38
6.8.3 Can an infusion pump detect extravasation? .............................................38
6.9 What are the risks of piggyback infusions? ........................................................39
7 ADVERSE INCIDENT REPORTS AND SAFETY WARNINGS................................39
7.1 What is an adverse incident?.............................................................................39
7.2 Reporting an adverse incident ...........................................................................40
8 PREPARATION FOR USE ......................................................................................41
8.1 Acceptance testing ............................................................................................41
8.1.1 Requirements of acceptance check...........................................................41
8.1.2 Type-testing and standards compliance ....................................................41
8.2 Medical device registers ....................................................................................42
8.2.1 Purpose.....................................................................................................42
8.2.2 Auditing and updating................................................................................42
8.2.3 Central and local registers .........................................................................42
8.2.4 Central medical device register .................................................................43
8.2.5 Local medical device register ....................................................................43
8.3 Manufacturers instructions ................................................................................44

9 MAINTENANCE AND REPAIR................................................................................44

9.1 Division of responsibility.....................................................................................44
9.2 Maintaining infusion systems in the community .................................................47
9.3 Routine maintenance.........................................................................................47
9.4 Breakdowns.......................................................................................................48
9.5 Record keeping .................................................................................................49
9.6 Replacement and obsolescence ........................................................................49
10 REFERENCES.......................................................................................................51
APPENDIX 1 Choosing infusion devices according to therapy category ..................53
1. Therapy categories, performance parameters and safety features .....................53
2. The performance parameters explained .............................................................56
3. Syringes and administration sets ........................................................................58
4. Training, standardisation and configuration ........................................................58
APPENDIX 2 Information for procurement of infusion devices ....................................60
1. MDA Device Evaluation Programme....................................................................60
2. Purchasing process criteria..................................................................................60
2.1 Proposed timescales......................................................................................60
2.2 Selection criteria.............................................................................................61
APPENDIX 3 Pressure in infusion systems.................................................................62
3.1 Pressure delivery methods ................................................................................62
3.2 Pressure at infusion site ....................................................................................62
3.3 Occlusion alarm mechanisms ............................................................................62
3.4 Bolus or cessation of flow due to raising or lowering of pump ............................64
3.5 Extravasation and in-line pressure monitoring ...................................................64
APPENDIX 4 Infusion devices: types, features and functions .....................................65
1 Gravity controllers ....................................................................................................65
1.1 Application.........................................................................................................65
1.2 Types of gravity controllers ................................................................................65
1.3 Usage considerations ........................................................................................65
1.4 Accuracy of drop controlled devices ..................................................................65
1.5 Gravity controllers and extravasation .................................................................66
2 Infusion Pumps ........................................................................................................66
2.1 Volumetric pumps..............................................................................................66
2.1.1 Application/usage considerations ..............................................................66
2.1.2 Features ....................................................................................................67
2.1.3 Types of mechanisms................................................................................67
2.1.4 Setting correct pressure levels...................................................................68
2.1.5 Correct use of administration sets .............................................................68
2.2 Syringe pumps...................................................................................................72
2.2.1 Application.................................................................................................72
2.2.2 Mechanism ................................................................................................72
2.2.3 Features ....................................................................................................72
2.2.4 Usage considerations ................................................................................72
2.3 PCA Pumps .......................................................................................................74
2.3.1 Application.................................................................................................74
2.3.2 Types of PCA Pumps ................................................................................74
2.3.3 Programming options ................................................................................74
2.4 Anaesthesia pumps ...........................................................................................75
2.4.1 Application.................................................................................................75
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2.4.2 Features ....................................................................................................75

2.5 Ambulatory pumps.............................................................................................75
2.5.1 Application.................................................................................................75
2.5.2 Accuracy ...................................................................................................75
2.5.3 Electrical and non-electrical ambulatory pumps.........................................76
2.5.4 Reusable and disposable ambulatory pumps ............................................76
2.6 Drip rate pumps .................................................................................................76
Appendix 5 Contacts..................................................................................................77
List of figures
Figure 1
Figure 2:
Figure 3
Figure 4
Figure 5
Figure 6
Figure 7

Outcomes of adverse incident investigations involving infusion pumps

(1990 to 2000) .............................................................................................7
Decision tree for selecting the appropriate therapy category .....................55
Example of bolus and delivery delay due to raising and lowering of
a syringe pump..........................................................................................64
Linear peristaltic pump ..............................................................................69
Rotary peristaltic pump..............................................................................70
Dedicated cassette set ..............................................................................71
Syringe pump ............................................................................................73

List of tables
Table 1
Table 2
Table 3
Table 4a:
Table 4b:
Table 5
Table 6

Examples of types of incidents involving infusion pumps .............................8

Action required by infusion pump users .....................................................23
Division of responsibility ............................................................................46
Therapy categories and performance parameters .....................................53
Important safety features in descending order of importance.....................54
Proposed timescales for purchasing process.............................................60
Infusion system model selection criteria ....................................................61

EXECUTIVE SUMMARY
This publication replaces MDA DB9503 Infusion Systems, and MDA
DB9703 Selection and Use of Infusion Devices for Ambulatory
Applications and complements the Scottish Executive Health
Department publication The Management of Infusion Systems. It
takes into account changes in devices and practices, as well as
information gained from the investigation of adverse incidents and
current trends in the use of infusion systems, since the earlier
publications.

Aim
The purpose of this bulletin is to make recommendations on the
introduction of national operational and training standards, and
provide general guidelines for the purchase, management and use of
infusion systems used in healthcare organisations and the
community.
The use of powered infusion devices has grown enormously in the
last 20 years. The Medical Devices Agency (MDA) receives many
reports of incidents involving infusion pumps. These incidents are of
concern as many result in patient harm or death, primarily from overinfusions.
This document addresses problems in the use and selection of
infusion systems and the training of users. The bulletin is designed to
raise awareness of the nature of infusion systems, their advantages
and risks, management and training issues, with a view to reducing
the number of adverse incidents that arise from their use.
The advice is intended particularly for:

clinical managers;
hospital and community users of infusion devices;
medical engineering staff;
those in charge of procurement.

Scope
This document deals primarily with infusion pumps and infusion
devices for fixed and ambulatory applications. Gravity controllers are
addressed in less detail. The document does not cover implantable
infusion devices.

INTRODUCTION
What is an infusion system?
An infusion system is the process by which an infusion device and
any associated disposables are used to deliver fluids or drugs in
solution to the patient by the intravenous, subcutaneous, epidural,
parenteral or enteral route. The process comprises:

prescription of the fluid or drug;

preparation of the infusion solution;
selection of the appropriate infusion device;
calculation and setting of the rate of infusion;
administration of the fluid to the patient;
monitoring and recording of the actual delivery,
disposal.

The simplest devices, gravity controllers, employ a clamping action to

vary the flow of liquid under the force of gravity. More complex
systems use a positive pumping action for infusion. Infusion pumps
are powered items of equipment, which, together with an appropriate
administration set, provide an accurate flow of fluids over a
prescribed period. Volumetric pumps may employ a linear peristaltic
pumping mechanism or use a special cassette. Syringe pumps work
by pushing the plunger of a disposable syringe along at a
predetermined rate. The type of pump used will depend on the
required volume and speed of infusion. Appendix 4 gives more
detailed descriptions of the different types of pumps.

What are the problems?

Many thousands of infusion devices are now in use in hospitals and in
the community and there is an identifiable mortality and morbidity
associated with their use. In the 10 years between 1990 and 2000
there were 1495 incidents involving infusion pumps alone in the UK.
Figure 1 summarises the causes of these incidents as percentages of
the total number. In 53% of the reports no cause was established
(partly due to the reporter not providing enough information or
reporting the incident incorrectly) and 27% were attributed to user
error, including maintenance, damage and contamination problems.
The remaining 20% of incidents were due to device-related issues
such as performance, degradation, quality assurance and design and
labelling. Table 1 gives examples of types of adverse incidents
involving infusion pumps.

Figure 1

Outcomes of adverse incident investigations

involving infusion pumps (1990 to 2000)

20%
cause not established
user error

53%

device-related

27%

Although in theory any infusion system can be misused, in practice

syringe pumps have given rise to the most significant problems in
terms of patient morbidity and mortality. The majority of serious
problems relate to over-infusion of drugs. In most fatal incidents no
fault has been found with the infusion device, suggesting that user
error is the most significant contributing factor or that some form of
tampering has taken place.

Table 1

Examples of types of incidents involving infusion pumps

Category of incident

Examples of incidents

Storage / packaging

Flat battery due to not charging the pump.

Set packaging damaged set contaminated.

Maintenance

Pump not maintained correctly.

Contamination

Fluid ingress into infusion pump. Fluid ingress damaging

power cable.

Degradation

Set worn out inaccurate infusion.

Syringe restraining strap perished siphoning.

Damage

Damaged gearbox.
Damage to syringe size sensor.

Performance

Infusion pump not performing to specification.

Design and labelling

Incorrect instructions.

Quality assurance (QA)

Incorrect assembly not spotted at manufacturing plant.

User errors

Misloading administration set.

Misloading the syringe.
Setting the wrong rate.
Confusing primary and secondary rates.
Not confirming the set rate.
Not confirming the syringe size.
Confusing the pump type.
Not stopping the infusion correctly.
Not confirming the pump mode.
Configuration of the pump.

1 ORGANISATIONAL RESPONSIBILITIES
1.1 Introduction
This section outlines recommendations for the management of
infusion systems.
A management system is essential to ensure resources are used
efficiently and effectively. This helps a trust meet the goal of patient
care and safety.
The Department of Healths Controls Assurance Standard for Medical
Devices Management highlights the importance of establishing a
system that minimises the risks associated with procuring and using
medical devices. The organisational responsibilities involved in
managing medical devices are outlined in the Standard and in the
MDAs device bulletin DB 9801.
Since various groups of healthcare professionals (at different levels in
an organisation) use infusion systems, the responsibilities of each
group must be clearly defined. Distinct lines of accountability must
exist, ensuring that every member of staff using infusion systems fully
understands who is responsible for what, and to whom, within the
management system.

1.2 Management recommendations

1.2.1

Establish a clearly defined structure

A clearly defined structure for the management of infusion

systems must exist within a trust, down to unit level.
The ultimate responsibility for such management rests with the chief
executive of a trust. In practice, action may be delegated to other
staff.
The Controls Assurance Standard for Medical Devices Management
states that the responsibility for medical devices, including infusion
systems, is most effective when it is vested in a single director. A
broad-based medical devices group should be established, including
representatives of clinical, engineering or technical and purchasing
staff.
1.2.2

Appoint a medical device co-ordinator

A suitable medical device co-ordinator, or co-ordinators, should

take responsibility for the management of infusion systems and
operational matters among other devices.

In most hospitals, with the adoption of clinical directorates, the

medical device co-ordinator will usually be nominated from the
medical, nursing or paramedical staff in a directorate and be
accountable through the clinical director to the chief executive.
Alternatively, the local Drug and Therapeutics Committee could
nominate and co-ordinate medical device co-ordinators, particularly
for infusion devices.
Larger institutions should consider appointing an assistant medical
device co-ordinator, accountable to the departmental medical device
co-ordinator. The assistant would be responsible for geographical
areas, such as wards/theatres, or for certain types of medical
devices, such as infusion devices.
In smaller facilities only one co-ordinator may be required. This
should be an end user involved in clinical practice: for example, a
nurse, technician, doctor or pharmacist. The co-ordinator should be
responsible for supervising all devices, including infusion devices,
within the unit.
In the community or primary care setting senior managers or the
GP should appoint a designated individual with a clearly defined
territory.
1.2.3

Medical device co-ordinator responsibilities

The medical device co-ordinator, and/or the broad-based

medical device group, should be responsible for the following
aspects of infusion systems:

selection and procurement;

development of a unit policy to determine appropriate use;
risk assessment;
installation and commissioning;
maintenance;
staff training;
operational documentation;
development of policies that identify spare infusion devices,
control lending out, and facilitate recovery of devices both from
hospital departments and the community;
ensuring that safety warnings have been acted upon.

In smaller institutions, such as a GP practice, not all of these services

and facilities are available on site. In such cases, arrangements
should be put in place through a service level agreement with a local
medical physics department, or with another organisation, such as
the manufacturer or supplier.

10

1.2.4

Reporting adverse incidents

It is a management responsibility to ensure that adverse

incidents are reported to the MDA and that safety warnings are
circulated and acted upon in accordance with MDA guidance.
The MDA strongly recommends that the broad-based medical device
group should appoint a medical device liaison officer responsible for:

adverse incident reporting;

dissemination of safety warnings;
compliance with Health and Safety law; Reporting of Injuries
Diseases and Dangerous Occurrences Regulations (RIDDOR).

All staff and device users should be regularly reminded of their

responsibility to report adverse incidents and to follow local
procedures, including isolating and retaining defective or suspect
items. This information should be given to new staff during induction
training (see section 7).
1.2.5 Adequate staff numbers and skill levels
Staff numbers and skill levels must at all times be adequate for
the management of any infusion systems in use, which in turn
reflect clinical need.
The decision to use an infusion device must be made on clinical
grounds. Management should not see it as a substitute for an
appropriate staff/patient ratio within a given area.
1.2.6

Regular systems audit

A regular audit should be carried out on all aspects of infusion

systems.

2 PROCUREMENT
2.1

General guidelines

All units responsible for buying infusion devices must have an agreed
and documented procurement policy. Clear specifications and
requirements should be prepared, based on the therapy categories in
Appendix 1.
Decisions on which infusion pumps should be purchased for each
individual unit should be made in close consultation with the medical
device co-ordinator and those responsible for their clinical use. In the

11

primary care setting, the medical device co-ordinator may also wish to
seek advice on procurement from a local broad-based medical device
group or other appropriate colleagues.
Advice given by the NHS Purchasing and Supply Agency (PASA) and
the guidance in the MDA publication DB 9801 and MDA evaluation
reports should be taken into account (see Appendix 2, table 6).

2.2 PASA Procurement guide

In England the NHS Purchasing and Supply Agency (PASA) was
formed from NHS Supplies in April 2000. Its role is to act as a centre
of expertise, knowledge and excellence in purchasing and supply
matters for the health service. In Scotland, Scottish Healthcare
Supplies (a Division of the Common Services Agency) carries out a
similar role.
As part of their work for the health service, the NHS Purchasing and
Supply Agency and Scottish Healthcare Supplies have produced
procurement guides for various goods and services to steer trusts
through the purchasing process.
The procurement guide for infusion pumps includes:

market information;
EU guidance;
procurement process information.

To obtain this guide, see Appendix 5.

2.2.1 Key points from PASA procurement guide
Strategy
A long-term procurement strategy should be developed, covering
both current and future clinical needs. The whole life costs of the
devices and their disposables should be considered.
Timetable
Ideally, allow a minimum of six months for the offer process. The key
stages and timescale for this process are outlined in Appendix 2.

2.3 Safety considerations

The following safety considerations should be taken into account
when buying an infusion device:

12

 compliance with the appropriate standard and that the device is

CE marked. The relevant standards for infusion devices are:

BS EN 60601-1 Part 1 Medical Electrical Equipment General

requirements for safety.
BS EN 60601-2-24 Part 2 Medical Electrical Equipment
Particular requirements for the safety of infusion pumps and
controllers.

history of reliability and safety;

security aspects/protection from tampering;
environment in which the device is to be used for example, is
immunity to electromagnetic interference required?

2.4 Rationalising makes and models

The number of different models used within a unit should be
rationalised. This will avoid confusion between makes and models
and reduce the amount of staff training required.
The following should be considered when rationalising the pumps
used within a trust:

training required (nursing and EBME staff);

optimum range of makes/models to be used;
clinical areas of use;
costs/availability of dedicated sets;
future pump requirements;
the risks associated with supply from a single manufacturer.

See Appendix 2, table 6 for some key criteria for model selection.

2.5 Other methods of acquisition

All devices, irrespective of method of acquisition, should be subject to
the same procurement policy (see MDA SN 2002(17)).
2.5.1 Donated devices
Individuals or organisations wishing to donate infusion systems must
be made aware of the local procurement policy. The trust should also
give advice on selecting appropriate devices.
Donated devices without CE marking must not be accepted. (See
DB 9801 Supplement 2).

13

2.5.2 Borrowing
Hospitals often lend each other infusion devices. Manufacturers may
also lend products for evaluation or as an incentive to purchase.
In both cases it is important to clearly establish where
responsibility lies for a borrowed device.
Borrowed devices must go through the same acceptance test
procedure as newly purchased pumps.
2.5.3 In-house manufacture
Many larger electrical and bio-medical engineering (EBME)
departments design and construct their own devices. These in-house
manufactured devices and devices custom-made for individual
patients must comply with the Medical Devices Regulations at the
design, manufacture and clinical evaluation stages.
See MDA Directive Bulletin 18.
2.5.4 Modification and change of use
Infusion systems should not be modified, nor used for purposes
not intended by the manufacturer.
When a device has been modified, the trust or hospital is considered
as the manufacturer under the Medical Devices Regulations, and
accordingly takes on the manufacturers responsibilities. There may
be safety implications and, if an adverse incident occurs, the original
manufacturers liability is limited and the organisation could be
exposed to legal action.
2.5.5 Full refurbishment
If an infusion device is fully refurbished, the Medical Devices
Regulations require a new CE marking to be affixed. This process is
usually carried out by the manufacturer, or following the
manufacturers recommendations. The infusion device will then be
put into use again as good as new.
Any establishment, including third party organisations, which carries
out full refurbishments must comply with the Medical Devices
Regulations. The MDA view is that these Regulations do not apply if
the refurbisher is a healthcare organisation that already owns the
device and intends to use it only for its own patients.

14

2.5.6 Cannibalising
Cannibalising means replacing parts that have failed in service with
those taken from other broken infusion devices. Cannibalising is not
recommended because:

using parts of unknown quality and suitability might be negligent;

manufacturers will not accept liability in these circumstances;
it is impossible to trace parts, if recalled by the manufacturer.

3 TRAINING
This section provides general guidelines for operational and training
standards required in the use of infusion systems

3.1 Why is training needed?

There is a high frequency of human error in using infusion systems,
particularly powered devices. This highlights the need for more
formalised and validated competence-based training and
assessment. Competence-based training is assessed on knowledge
and skills.
Historically, training has not always received the investment it
deserves in relation to its contribution to the safe use of medical
devices and effective risk management.
Current Health and Safety law places an obligation on trusts to
provide such training. Senior management must acknowledge the
need for training programmes and standards of practice. Resources
and time must be allocated to training in order to:

ensure patient safety and minimise adverse incidents;

ensure the appropriate device is used with each therapy;
improve staff competence;
report any adverse incidents;
keep up with technological developments.

Some current NHS human resources and quality assurance policies

refer to a blame culture, which encourages a covert approach if
anything goes wrong. A shift is required from a culture of blame, to
one of openness that encourages shared learning.
The Controls Assurance Standard for Medical Devices Management
requires that technical staff, clinical staff and, where relevant, end
users should be trained to use medical devices safely and effectively.

15

3.2 Who requires training and when is training needed?

The main users of infusion systems are nursing, medical and
pharmacy staff. However, all staff likely to use these systems should
receive training. Users should be given sufficient training, knowledge
and supervision to be competent when operating infusion devices.
Induction training should include practical instruction for all potential
users, regardless of their grade.
Anyone involved in the direct care of patients receiving parenteral
nutrition or medication via infusion devices must also receive practical
training, including the principles of operating infusion devices.
Additional training for any other devices used locally should also be
provided.
Organisations need to ensure that all professional staff, including
bank, agency and locums, are trained in the local procedures and any
pump configurations specific to a hospital or clinical area. Users who
are not familiar with an infusion system should not operate it unless
supervised or until they are considered competent in its use.
Users who feel they are not sufficiently trained, experienced or
confident to use a particular device or perform a particular procedure
must feel able to refuse to perform that task or procedure in the
interests of patient safety.
Users should also be made aware that they are accountable for their
own actions and may not be protected from the legal implications if
their actions are inappropriate.

3.3 Organisation of training

3.3.1 Training policy
All organisations must have a formal training policy but arrangements
will vary according to local circumstances. In a trust, the chief
executive often delegates authority for induction training and
subsequent updating to, for example, the medical device co-ordinator
and/or the broad-based medical device group or local equivalents.
The management system should ensure that:

responsibility for training is delegated to a suitable individual in

each unit;
adequate numbers of trainers are identified;
relevant skills are disseminated to other staff. Patient care should
only be handed over to appropriately skilled individuals;

16

operating instructions are available;

operating practices are periodically audited to ensure they adhere
to standards laid down by the trust.

3.3.2

Training programmes

When a new device is introduced, whether purchased, borrowed or

donated, training sessions should be arranged for all relevant staff
before it is used. The level of training required will depend on the
complexity of the system and on the training needs of individual
users.
Hospitals and primary care establishments should draw up formal
training programmes for those instructing new staff. Written training
plans are also required to ensure consistency among trainers.
When planning initial instruction in the use of a device, consideration
should be given to training provided by the manufacturer to clinical
engineering, medical, nursing and pharmacy staff, thereby developing
a core of local expertise. Such initial instruction should be included in
the contract conditions at the time of purchase.
Requirements of training programmes
Training programmes should be:

multi-disciplinary;
ongoing;
documented;
included in staff induction programmes;
form part of continuous professional development;
designed to include assessment of practical competence in
specific devices;
reviewed to reflect changes in equipment or software;
evaluated and updated as necessary.

Refresher training
Initial practical training must be supported by written instructions and
reinforced by refresher courses. Refresher training is needed to:

update the skills of regular users of infusion systems;

maintain levels of expertise amongst those who use the systems
less frequently.

17

3.3.3 Resources for training

Written operating instructions
Under the Medical Devices Regulations, manufacturers must provide
adequate operating and maintenance instructions. These instructions,
supplemented where appropriate by locally prepared material, should
be used when preparing teaching packages for staff training.
Instructions are usually contained in an operating manual. An
abbreviated form of the instructions often appears on, or attached to,
the device.
Copies of the instructions must be issued to all wards where the
equipment might be used. This is especially important where
abbreviated instructions do not appear on the device. If the
manufacturer does not provide summaries, the medical device coordinator should arrange for an experienced staff member to prepare
them, in consultation with the manufacturer. The summaries should
be issued before the device is used.
Example 1 Training to train
A large trust has appointed a medical device trainer who runs a training
programme for medical staff and nurses, involving many medical devices
from different manufacturers. The training focuses on the operation,
safety, maintenance and troubleshooting of medical devices. It also
emphasises common user errors specific to each ward. A training for
trainers course has also been set up for infusion systems. Its aim is to
appoint key trainers for each ward, responsible for cascading training to
their ward staff in a consistent, documented manner. In addition, to
measure competence, evaluation sheets are used to test each trainee.

Example 2 Finger on the Button

This is a proprietary based training system. It consists of around 8 hours
of open learning, a training and assessment day, skills training and
competence assessment. The open learning element reduces problems
for shift workers, and the training assessment day tests competence
against defined standards. Training is currently available for infusion
pumps. See Appendix 5 for contact details.

18

3.3.4 Record keeping and assessment

Training log
All users of infusion systems should be given a training log, as part of
their individual record of Continuing Professional Development.
The training log should be used to monitor staff training, and to
identify and remedy deficits. This process can be made easier by
holding the information on computer.
The log should detail, as a minimum:

dates of initial and refresher training;

system(s) covered;
trainers endorsement.

Assessing competence
An individuals competence to perform the required tasks should be
checked and verified. Certification and assessment by local training
procedures is an appropriate means of ascertaining whether
individuals have undergone current and relevant training and
achieved appropriate levels of competence.

3.4

Content of training

The areas covered in training should reflect local circumstances and

the specific needs of different staff and/or user groups.
3.4.1 Training for hospital staff
Training should demonstrate competence and seek learning
outcomes in the following areas:
Devices

the principles of the main types of devices, including the

advantages and disadvantages;
criteria for selecting and using infusion devices/associated
disposables for any given therapy or location;
setting up, priming, loading and checking procedures for devices;
monitoring of devices in use and observational skills in assessing
the observed flow rate compared with the rate displayed on the
device;
free-flow, including siphoning;
preventing air entrainment;
configuration of the devices used in their clinical area;

19

using battery powered pumps;

security against tampering;
maintenance, storage and cleaning.

Drugs and solutions

pharmacology of the most commonly used drugs/solutions and

associated hazards;
dose calculation and checking;
pharmaceutical information stability, incompatibilities,
interactions;
preparation of solutions.

Procedures

record-keeping, including training records, maintenance records,

reporting and recording of adverse incidents, device registers,
prescriptions and monitoring charts;
incident procedure;
rationale for regular maintenance;
reporting procedures for incidents and injuries, as well as
feedback on repeated errors (RIDDOR);
awareness of MDA publications (safety warnings, device alerts
and device bulletins), other relevant documentation, written
protocols and reporting of adverse incidents.

3.4.2 Training for patients and carers

Training instruction should be provided for patients/carers. Printed
guidance, which could combine the manufacturers instructions and
local guidelines, should be issued. This could include:

operation and control of the device, including known

environmental hazards;
details of settings;
regime of necessary checks required (type,
periodicity);
care of the device (cleaning and battery changes etc.);
recognition of a system failure;
what action to take in the event of system failure, extravasation or
adverse effects;
nature of the treatment and the drug(s) to be infused;
expected results and side effects;
reasons for the choice of infusion system;
preparation of the infusion and connection to the infusion device
(if required);
free-flow and siphonage;
individual(s) to be contacted in emergencies;

20

potential consequences of tampering;

care of the infusion site.

3.4.3 Healthcare professionals working in primary care and the

community
Healthcare professionals working in the community and primary care
setting face different challenges to their colleagues in hospitals,
where services, patients and clinicians share the same geographical
location.
Training for community nurses
Community nurses increasingly care for patients receiving drug
treatment via infusion devices. Examples include parenteral nutrition,
and drugs used in palliative care. Nurses may be faced with new
equipment or work for long periods of time without direct contact with
the hospital. In such situations, it can be difficult to maintain and
acquire skills related to the devices. Special consideration must be
given to the issues surrounding working in isolation, assessment and
maintenance of competence.
The most effective way of training community nurses might be to
provide training on specific equipment in the acute setting before
patients are discharged for care at home. Suitably trained nominated
staff could provide such training.
Training for nursing home staff
Patients in private sector nursing homes often receive treatment via
infusion devices. The nursing home may own infusion devices or
borrow them from the Macmillan service or hospice.
It is essential that nursing home owners ensure that nurses working in
this environment are adequately trained. Support for training is
available from local hospices and/or trusts. Under current Health and
Safety law trusts are obliged to provide training for the safe use of
medical devices and effective risk management.

3.5 Discharge or transfer of patients

With increasing numbers of day case treatments and earlier transfer
of patients to community or hospice care, many patients are
discharged or transferred whilst still requiring the use of an infusion
system.
In these circumstances, a written discharge plan is required (see
section 4.5) and, in some cases, training.

21

Training prior to discharge

If the district nurse and/or other carers are not familiar with the
infusion system, training will be required prior to discharge of the
patient. The training should cover understanding of the infusion
device (settings, alarms, assembly etc.), together with any special
precautions, safety or maintenance information.

3.6 Maintenance and repair

All users should be trained to:

ensure that devices are undamaged and functioning correctly;

make sure that devices are kept clean and, if necessary,
decontaminated;
carry out recommended inspection, functional and safety checks;
notify the appropriate people if a device malfunctions.

See Table 2 for a summary of actions.

Example 3

Infusion pump fails during patient transfer

Batteries on infusion devices often fail prematurely whilst critically ill

children are being transferred by ambulance between specialist units.
MDA investigated three infusion pumps that had failed. In each case, the
average battery capacity had been reduced by 85% as a result of poor
battery maintenance procedures. Users must be aware of the importance
of charging pumps when they are not in use.

Example 4

Over-infusion due to failure to close set roller clamp

A pump indicated 'misload' whilst a nurse was loading the set for a
synotocin infusion. The nurse went for assistance without closing the sets
roller clamp. The drug free-flowed into the pregnant patient and, as a
result, the baby had to be delivered by emergency caesarean section.
Users must take particular care to close the roller clamp before going for
help.

22

Table 2
When?

Action required by infusion pump users

Action

Before use

Check that leads, administration sets, bags and cassettes or syringes

are in good working order and properly assembled/loaded.
Carry out relevant functional and calibration checks (start up checks).
Note results.
Check control settings.
Check that correct flow rate has been set.

A problem occurs

Stop the infusion. Make sure that all clamps on the giving sets are
closed.
Seek technical advice.
Record problems and action taken.
If necessary, withdraw the device from service.

At specified intervals

Check that the observed flow rate corresponds to the rate displayed on
the infusion pump.
Inspect infusion site.
Note results.
If tests fail, withdraw the device from service.

After use

Clean.
Safely dispose of single-use devices and other accessories that cannot
be reused.

When sending an infusion

system to be repaired or
serviced

Include all the leads and accessories needed to operate the device.
Enclose a full account of any problems and faults.
Decontaminate.
Fill in decontamination form.

When an infusion device has

undergone service

Carry out all standard pre-use inspections.

Check the set-up of protocols and programs, as these may have been
altered during servicing.

When an adverse incident

has occurred

First take steps necessary for the well being of the patient and/or staff,
then:
Do not alter settings or remove administration sets.
Leave any fluids in the infusion system.
Note details of all medical equipment attached to the patient.
Note details of device: type, make, model and serial number.
Retain packaging for details of consumables.
Note setting of controls and limits of alarms.
Note the content volume remaining in the set or syringe.
If relevant, record the contents of computer memory logs of the
infusion pump. Seek the assistance of the Electrical Biomedical
engineering (EBME) department if necessary.
If possible, contact the MDA before moving or dismantling the
equipment.

23

4 OPERATIONAL DOCUMENTATION
Users must maintain careful documentation regarding all operational
aspects of infusion systems. This applies whether the infusion is
administered in a hospital or primary care setting.

4.1 Drug selection and dose calculation

Local drug and therapeutics committees at all levels should work
together to produce clinical guidelines for the safe prescribing and
administration of drugs using infusion systems in hospital and
community settings. The guidelines should be widely disseminated
and regularly reviewed and updated.
Users should seek additional advice from drug information
departments, ward pharmacists, local drug and therapeutics
committees and drug manufacturers, where appropriate.
Guidelines for safe prescribing and administration of drugs
The guidelines should include:

suitability of the infusion route;

choice of drug;
dosage calculations e.g. infusion rate;
standardised prescribing documentation;
standardised administration documentation.

The guidance on dosage calculations should draw particular attention

to the potential for error where the units of prescription differ from
units of administration. For example, a prescription might be written in
ml, mg or units per hour, whilst the device is set at mm per hour.

4.2 Prescription of drugs

Prescription details to be recorded by the prescriber should include:

the prescribed drug;

name and strength of diluent;
final concentration of drug e.g. mg per ml;
dose per unit of time;
route;
date and time (24 hour clock) to be started and completed;
signature of prescriber;
instructions for using bolus facilities or variable dose regimens.

24

4.3 Preparation of the drug in solution

Every time a solution is freshly prepared, the relevant details should
be recorded on the product label or appropriate unit document.
Whenever possible, drugs or fluids should be prepared aseptically in
the pharmacy.
Details recorded for prepared drug solutions should include:

date and time (24 hour clock);

total amount of drug used;
total volume of diluent used;
batch numbers of all ingredients;
names of persons preparing and checking solutions;
name of patient.

4.4 Administration
The following details should be recorded:
At start of infusion:

type of model, serial number etc. of device;

date;
route;
time infusion started (24 hour clock);
volume at start of infusion;
volume to be infused;
initial infusion rate setting;
expected completion time;
name(s) of person(s) setting and checking rates.

On each check:

date;
time (24 hour clock) actual time not a tick in a box;
volume remaining;
total volume infused;
infusion rate setting;
name of person carrying out the check.

25

In cases of variable prescribed dose regimens (e.g. heparin, insulin

sliding scale) where the concentration of the drug is not altered:

date;
time (24 hour clock);
rate setting;
name(s) of person(s) setting and checking rates;
indication for alteration;
appropriate notification if completion/replacement time altered.

With variable prescribed dose regimens it is important to consider the

need for replacement infusion solutions prior to the existing solution
running out.
Non-variable dose regimens
In the case of dose alteration with non-variable dose regimens (fixed
rate infusions), a new prescription is required as described in section
4.2. In instances where a new solution must be prepared, see section
4.3.
Rapid dose alterations in theatre and ICU
When alterations in doses are made in rapid succession, for example
in the operating theatre or intensive care unit, it may not be
practicable to document all changes. In such cases, procedures and
protocols should be prepared by clinical managers to ensure that safe
working practices are maintained.

4.5

Discharge or transfer

A discharge care plan is required for all patients who are discharged
from hospital to continuing care in the community. This should be
prepared in advance by hospital staff, together with the community
staff and GP.
If a patient is still undergoing treatment involving an infusion device,
the discharge care plan must detail all aspects of the therapy. This
should be given to the patient and carer, and to anyone else involved
in managing the patient.
Similar information must be given to hospital staff when patients are
transferred between units, whether within the hospital or from the
community or a hospice.

26

Discharge plan
The written discharge plan should include:

details of therapy (drug and dose);

details of settings;
regime of necessary checks to be made (type,
periodicity);
how to recognise an incident and what corrective
action to take;
details of clinical and technical support including a
contact telephone number.

Example 5

Good practice record keeping

A hospital has found an improved way of recording details of infusion

systems.
It designed a new form, which was monitored by a project team
representing several directorates and reviewed by the trusts drugs and
therapeutics committee.
The form is in two layers and is self-duplicating. The top layer has an
adhesive edge that is attached to the patients notes. The bottom layer is
sticky backed and wraps around the syringe barrel or infusion line. This
gives staff the extra security of a visible record of treatment, whilst
avoiding extra form filling (see DB9801 section B3).

27

5 GENERAL SAFETY RECOMMENDATIONS

Users should ensure that they are familiar with the manufacturer's
instructions and the organisation's practice policies. Appendix 4 gives
details of the different types of pumps.

5.1

Safe use of volumetric pumps

5.1.1

Recommendations for using administration sets

always use the administration set recommended by the

manufacturer;
check that the administration set is compatible with the infusion
pump. The correct pump should be listed specified on the
administration sets packaging;
always inspect the administration set for damage before priming
the line;
inspect the drop chamber, after loading the set and during
infusion, to ensure the drip rate is as anticipated;
consider using an administration set fitted with an anti free-flow
device;
always use the roller clamp to occlude the line when removing the
administration set, regardless of whether the set has an anti-free
flow device;
replace the administration set within the lifetime specified by the
manufacturer, in order to maintain accurate delivery.

5.1.2 Preventing free-flow (siphonage)

Free-flow will not occur if the set is loaded correctly and the door is
closed.
However, users should check that the roller clamp is closed before
removing the administration set from the pump, as a primary means
of occluding the line. If the administration set is fitted with a flow-stop
mechanism, this should not be relied upon and the roller clamp
should still be used.
5.1.3 Preventing air entrainment
The MDA recommends that all volumetric pumps whether mains
powered, battery powered or ambulatory be fitted with the means to
prevent air embolism.
Even if there appears to be no air in the line, the action of pumping
can often draw air out of solution and this can accumulate into

28

significant sized bubbles. Further, if there is a leak in the upstream

part of the line, the pumping action may draw air into the line.
Air entrainment can be prevented by the intrinsic design of the pump
or by using an air detector. Most air detectors can detect and stop the
passage of single bubbles of around 100I in volume. Some air
detectors are more sensitive and can detect champagne bubbles,
although this may give rise to nuisance alarms.
If an air detector is available as an optional extra, this should always
be purchased.

5.2

Safe use of syringe pumps

5.2.1

Recommendations for using syringes in infusion pumps

always check that the syringe is of the brand and size

recommended by the pump manufacturer;
check that the syringe barrel clamp is secured over the syringe;
do not place tape on the syringe barrel where the barrel clamp is
positioned;
make sure that the syringe plunger clamp is correctly secured;
check that the syringe finger grips are secure within the recess
located on the pump body;
inspect the syringe before use, checking in particular for signs of
damage around the syringe plunger. NEVER use a damaged or
defective syringe;
Use the prime or purge facility on the pump to reduce mechanical
backlash. NEVER prime or purge the line with the extension set
attached to the patient.

5.2.2

Preventing free-flow (siphonage)

Free-flow will not occur with syringe pumps if:

the syringe is loaded correctly and the plunger and barrel are
correctly secured;
the syringe and administration line are intact and correctly
connected.

The following safe practice should be followed:

ensure that the syringe (plunger and barrel) is correctly located

and secured;
position the syringe pump as close as possible to the infusion site
height;
consider using an anti free-flow valve.

29

5.2.3

Preventing air entrainment

There is minimal risk of air entrainment into the system when using a
syringe pump.

5.3

Correct configuration/application of pumps

It is essential that all pumps are configured correctly for their required
application. Configuring means selecting the appropriate mode for the
intended application. This is especially important since new
generation pumps have a variety of features, which allow them to be
used in more than one therapy category or application. (See
Appendix 1)
5.3.1

User-adjustable facilities

Pumps may have facilities including variable pressure, maximum flow

rate and flow rate increments.
When using such pumps, users must ensure that the level set is
consistent with the appropriate pump therapy category (see Appendix
1). Note that the manufacturer's default settings may be initiated on
start-up. Settings should therefore be checked or changed every time
the pump is used.
5.3.2

Blood sets and solution sets

Blood sets and solution sets are not usually interchangeable. Always
use the sets recommended by the manufacturer.
Hazards of using incorrect sets
The use of blood sets or solution sets with the incorrect pump has led
to the following hazards:

free-flow;
over/under infusion (inaccurate delivery);
malfunction of alarms.

In addition, incorrect use of blood sets can lead to air entrainment.

5.3.3

Battery powered pumps

Most mains powered pumps have an automatic backup. This gives a

few hours of extra use if the mains supply fails or the pump is used
during transportation. Batteries are generally rechargeable and are
charged by connecting the pump to the mains supply.

30

Users should follow the manufacturer's instructions regarding battery

type and frequency of charging. Rechargeable batteries should not be
used in pumps designed to use disposable batteries. This can result
in poor performance and a potential fire risk.
5.3.4

Ambulatory pumps

Ambulatory pumps are usually powered by rechargeable or

disposable batteries.
Users should follow the manufacturer's instructions regarding battery
type and frequency of charging. Some manufacturers have particular
recommendations regarding storage, for example removing the
batteries.

6 PRESSURE IN INFUSION SYSTEMS

The following background information aims to give users a better
understanding of pressure in infusion systems.

6.1 What pressures does the pump have to overcome in

order to deliver the drug?
A pump uses pressure to overcome resistance to flow. In an infusion
system, this resistance to flow is usually caused by:

small diameter cannula;

filters for air or particulates;
infusion administration set tubing ;
intravascular or intra-compartmental pressure at the infusion site,
at a level substantially higher than atmospheric pressure
length of the line.

See Appendix 3 for further details.

Examples
To deliver simple electrolytes into an adult intravenous site through a
16G, 9cm long cannula at 100 ml/h the pressures caused by
resistance are:
Maximum adult venous pressure
Filter
Cannula
Administration set
Total

31

30mmHg
10mmHg
100mmHg
1mmHg
141mmHg

However, an infusion pump with an occlusion alarm configured to

140mmHg or less could not administer the fluid at this rate. An
occlusion alarm would result, even without any blockage in the fluid
pathway. Therefore, to administer this infusion the occlusion alarm
pressure should be configured above 140mmHg.
Note: using a positive pressure device for this infusion does not raise
the pressure in the vein to 140mmHg or more. A pressure of
111mmHg plus venous pressure will occur in the pumping chamber of
the device. There will be a pressure gradient between the pumping
chamber and the vein. Pressure in the vein will remain at normal
physiological levels. In this example 141 mmHg is the pressure drop
over the whole administration set plus cannula.
Neonatal infusions
Resistance is lower in neonatal infusions, leading to lower driving
pressures being required.
For a neonatal infusion the rate selected is rarely greater than 10ml/h.
Any catheter used would not be very long, although it would probably
be narrow.
A typical example:
Maximum neonatal venous pressure
Filter
Cannula
Administration set
Total

10mmHg
1mmHg
10mmHg
<1mmHg
22mmHg

Therefore the pressure required to sustain an infusion at typical

neonatal rates is far less than that required for adult infusions. The
occlusion alarm pressure can therefore be configured lower (see
section 6.4 below). The advantage of configuring the lowest feasible
occlusion pressure is that it minimises time to alarm and postocclusion bolus.

6.2 Why do simple gravity drips slow down when the

patient sits up in bed?
Pressure generated within a gravity system is limited by the height of
the fluid container above the infusion site. The bag can be hung up to
1.5 metres above the infusion site. This height provides a hydrostatic
pressure of around 110mmHg (see Appendix 3). If the bag is hung
lower, or the patient moves upwards, the available driving pressure is
decreased. This is why simple gravity drips slow down if the patient
sits up in bed.

32

6.3 When is a higher pumping pressure needed?

In a horizontal tube in which flow is occurring, a higher pressure
appears at the tubing inlet than at the outlet. The pressure drops
over the length of the tubing. For example, 100mmHg pressure within
the pumping chamber does not appear as a pressure of 100mmHg at
the infusion site.
Higher pumping pressures are also needed for:
narrower cannulae;
higher flow rates;
longer cannula, such as a PICC;
more viscous fluids e.g. 50% dextrose.

6.4 Occlusion pressures and alarms

An infusion pump attempts to maintain sufficient pressure on the fluid
to cause it to flow through all restrictions, such as the cannula or filter,
at the set rate. The pump detects any resistance to flow and
increases the pumping pressure to maintain the set flow rate.
The same effect is achieved in gravity devices by opening the clamp
to allow freer flow.
The occlusion pressure of a pump is the pressure in the tubing,
registered at the pump, when the pump is still operating but cannot
sustain the flow rate. The resultant build up of pressure sets off the
occlusion alarm.
6.4.1 What triggers an occlusion alarm?
An occlusion alarm can be set off by:

a blockage in the delivery tubing often inadvertently caused by

leaving a roller clamp or three-way tap closed;
a clotted-off cannula;
a partially occluded cannula, if it causes the required driving
pressure to rise above the occlusion alarm level;
a very narrow or very long cannula.

6.4.2 What are the hazards to the patient caused by occlusion?

Occlusion causes two main hazards to the patient:

interruption to therapy;
a potential sudden injection of an unwanted bolus, on release of
the occlusion.

33

The parameters that most affect the patients safety are:

time to alarm from occlusion (rate dependant);

stored bolus.

Both these parameters should be minimised for optimum safety. The

recommended actions in Appendix 1 will ensure that pumps with the
shortest time to alarm and bolus are used for critical applications
where continuity and consistency of flow are most important.
6.4.3 Bolus at occlusion alarm and time to occlusion alarm
If an occlusion occurs, the feedback circuits of the pump cause the
pumping mechanism to work harder to overcome the additional
resistance. Although fluid is incompressible, the administration set
and other components of the system have some give (compliance).
The tubing expands under the increasing pressure. Other
components of the system, such as the bung of the syringe, become
compressed. This expansion and compression takes some time to
occur. If a high occlusion pressure limit is set, it may take some time
for the occlusion pressure limit to be reached and the alarm to sound.
In the case of a complete occlusion, there is no flow to the patient
whilst pressure in the system is increasing. When the occlusion is
released, the build up of fluid in the tubing results in a large bolus
being delivered to the patient. The lower the occlusion alarm pressure
level is set, the more quickly the alarm will sound and the smaller the
bolus will be on release of the occlusion.
6.4.4 Pressure at alarm
The presence of large pressures in the pumping chamber of an
infusion device has not been shown to present a direct hazard to the
patient. The venous system is a highly compliant reservoir and, in
ordinary circumstances, the pump cannot cause the pressure in the
venous or arterial system to rise to a higher level. The pump only
develops enough pressure to deliver fluid from the end of the cannula
at the set flow rate. The pressure usually drops before the vein is
reached. As fluid is pumped into the vascular system, the vascular
reservoir expands to accommodate it. As a result, local increases in
pressure are negligible.
There are only two exceptions to this:

when a vein is thrombosed and is therefore not connected to the

rest of the venous system;
when flow rates far greater than the ordinary physiological flow
rates in veins are delivered.

34

6.4.5

How can occlusion alarm time and bolus be reduced?

use the highest flow rate clinically acceptable. This reduces the
time to alarm;
use a smaller syringe size. This reduces both bolus and time to
alarm;
use better quality syringes. This minimises stiction and normal
variability in driving force;
use a current generation syringe pump with a backoff feature.
The pumping mechanism briefly runs backwards upon occlusion
alarm, thereby reducing the potential bolus.

6.5 Why are infusion pumps not configured to run at the

lowest possible level?
It would seem sensible to configure all infusion pump occlusion
alarms at the lowest possible level. This would give rapid alarm and a
tiny occlusion bolus.
Reasons why this is not done are:

infusions need pressure to drive the fluid through components of

the system which present resistance to flow;
pressure is needed to overcome the normal physiological
pressure at the infusion site;
less sophisticated occlusion mechanisms, which estimate rather
than measure the pressure in the fluid, are prone to error and
require some leeway to allow for inaccurate estimates.

To ensure the system is as safe as possible, the following should be

taken into account:

the occlusion alarm pressure should be configured at the

minimum level above the normal running pressure of the required
infusion;
the configured pressure at alarm should allow for any
miscalculation of pressure by the device;
lower alarm pressure should be configured for low flow rates, and
higher alarm pressures for narrow cannulae.

It should be noted that the normal running pressure of every infusion

is determined by many different factors. Optimal occlusion alarm
levels can only be achieved if the alarm level is set for each infusion.

35

6.6 What are the implications for patient safety of

configuring a high occlusion pressure?
It is sometimes necessary to configure a relatively high occlusion
pressure. An example is when epidural infusions are given, as
epidural cannulae are comparatively narrow. If a high alarm pressure
has to be configured to sustain a high running pressure, there will be
unavoidable consequences for patient safety, which must be
understood.
a) For the alarm time

If the occlusion occurs after the pump has stabilised at its set flow
rate, the alarm time will not be unusually long. The pressure in the
pumping chamber increases from the already high running
pressure up to the alarm level. This occurs relatively quickly.

If the occlusion is present from the beginning of the infusion, the

time to alarm will be increased. The pressure in the pumping
chamber increases from zero at the start of the infusion up to the
alarm level. This is the most likely situation, as leaving stopcocks
closed is the most usual cause of occlusions. The patients
therapy will therefore be interrupted for a lengthy period.

b) For the occlusion bolus

The occlusion bolus will be greater for a higher configured

pressure at alarm. This increases the potential hazard to the
patient.

Summary
If the occlusion alarm pressure is configured higher than the standard
test levels, the usual result is slower alarms and larger post-occlusion
boluses.
The safest system is a pump that allows the user to assess the
baseline infusion pressure early in the infusion. The user can then set
an alarm pressure that exceeds this baseline pressure by a minimum
amount.
Pumps with highly configurable pressure alarms are the most
clinically flexible. This may be particularly useful when very lowpressure infusions are required, for instance the very low flow rates
appropriate to neonates. Here the alarm pressure can be configured
to very low values (10-50mmHg) so that alarm is reasonably rapid
even at the lowest flow rates.

36

The correct configuring of alarm pressure is vital to optimise patient

safety.

6.7 How does raising or lowering an infusion pump relative

to the infusion site affect flow?
Users should be aware that unplanned boluses or delays to therapy
might occur if the infusion device is moved in relation to the level of
the infusion site. It is good practice to minimise disturbance to the
pumps and to maintain the pump at the same level throughout an
infusion, so far as possible. Manufacturers usually design positive
pressure infusion devices to operate optimally when positioned at the
same level as the infusion site. This position should be adopted
where possible.
Infusion devices are usually mounted on a pole at or just above the
infusion site. If the pump is raised from this level whilst connected to
the infusion site, a bolus will be delivered to the patient.
This occurs because, when the pump is raised, the infusion tubing
collapses slightly under the negative pressure developed. Similarly,
as the pump is lowered, the infusion tubing acts like an elastic
reservoir and fluid flows back into it, thus momentarily reducing the
flow to the patient.
Syringe pumps are more vulnerable to this phenomenon than other
types of pump. Not only does the elastic tubing flatten or expand in
response to the sudden change in pressure, but the syringe can slide
backwards in its mounting. Pushing the syringe body back to its
normal position can cause a delay of several minutes before fluid
delivery is resumed (see Appendix 3; Krauskopf 1996, Lonnqvist
1997, Lonnqvist 2000).

6.8 Extravasation
6.8.1 What is extravasation?
Extravasation occurs when fluid that should be delivered
intravenously is inadvertently delivered into a tissue space. It can be
caused by misplaced cannulae. The cannulae migrate and puncture
the vessel wall or thrombosed veins.

37

6.8.2 What causes extravasation?

There are various theories as to why extravasations occur.
Extravasations have been associated with:

the occurrence of phlebitis;

the use of drugs that cause a local vasoconstrictive effect (Phelps
1987);
the use of steel cannulae e.g. butterfly.

The actual mechanics of extravasation are still the subject of

hypothesis. Suggested causes include

a blocked vein;
a misplaced cannula;
a fibrin sheath that develops around a long line, such as a
peripherally inserted central catheter (PICC). The sheath prevents
flow from the tip of the cannula into the vascular system, and can
channel it backward between the sheath and the outside surface
of the catheter. This can result in fluid leaking into the tissues
where the cannula is inserted into the vein.

There is no published evidence to suggest that extravasation

correlates with the use of positive pressure devices. On the contrary,
there are reports that suggest no significant difference in the rate of
occurrence of extravasations when positive pressure devices are
used rather than gravity controllers (Chen 1998). A gravity controller
can provide sufficient pressure to deliver fluid into the tissue spaces.
6.8.3 Can an infusion pump detect extravasation?
Studies monitoring pressure during infusions show that there is no
significant rise in pressure at the infusion site when an extravasation
occurs. Fluid continues to be delivered to the tissue space without
alarm, since most tissue spaces present very little resistance to the
flow of fluid. Occlusion alarm mechanisms on most current infusion
devices cannot detect the small change in baseline pressure that may
arise when an extravasation occurs.
This does not mean that pressure will never rise during an
extravasation. In rare cases, extravasations may cause a rise in
pressure the fibrin sheath that forms around a PICC is one such
case. In general, however, the body of evidence suggests that
occlusion alarm mechanisms are unlikely to sense when
extravasations occur.
The most effective safeguard against extravasation is to visually
inspect the infusion site regularly.
See Appendix 3 for more information on extravasation.

38

6.9 What are the risks of piggyback infusions?

Piggyback infusions, also known as secondary infusions, (using a
single volumetric pump) allow delivery from a second source
container at a rate and volume independent of the primary infusion. In
order to successfully deliver two drugs/fluids through the same IV line
by piggyback infusion, users need a firm understanding of the
principles of pressure in infusion systems.
Pressure, not the pump, determines which bag is administered. The
change over from piggyback to primary rate occurs after a set volume
has been delivered. However the change over from piggyback to
primary bag occurs only when the piggyback bag is exhausted.
The pump cannot determine which bag the flow is coming from. The
volume of fluid in bags can only be estimated. There are risks
associated with this procedure:

the end of the piggyback infusion may be administered at the

primary rate;
or, if the volume of the piggyback bag is overestimated, the
primary fluid may be delivered for a limited period at the
secondary rate. The volume should therefore be estimated
carefully to avoid any hazard to the patient.

7 ADVERSE INCIDENT REPORTS AND

SAFETY WARNINGS
7.1 What is an adverse incident?
An adverse incident is an event which gives rise to, or has the
potential to produce, unexpected or unwanted effects involving the
safety of patients, users or other persons.
Adverse incidents can be caused by:

shortcomings in the device itself;

inadequate instructions for use;
insufficient servicing and maintenance;
locally initiated modifications or adjustments;
inappropriate user practices, including inadequate training;
inappropriate management procedures;
the environment in which pumps are used or stored;
incorrect prescription;
conditions e.g. environment and location.

39

7.2 Reporting an adverse incident

It is essential that users know how to report an adverse incident.
Adverse incidents should be reported to the MDA immediately, either
direct or via a medical device liaison officer who is responsible for
prompt action in:

reporting adverse incidents through agreed channels;

disseminating safety warnings for equipment.

Serious incidents should be reported by the fastest means available,

for example via the MDAs website, email or fax. Telephone reports
should be followed up by a written report as soon as possible.
Content of adverse incident report
The initial written report of the incident must include all relevant
details immediately available. These include:

make and model of pump and consumables;

serial number;
batch number of sets;
flow rate;
drug/feed;
syringe or bag size;
amount of drug/feed left in bag or syringe;
details of the incident, including times;
names of staff on duty.

Further details can be found in Medical Device Alert MDA/2003/001,

available on our website: http://www.medical-devices.gov.uk
Note:
From 1st April 2003:
The Medical Devices Agency (MDA) and the Medicines Control
Agency (MCA) will merge to form the Medicines and Healthcare
products Regulatory Agency (MHRA).

40

8 PREPARATION FOR USE

8.1 Acceptance testing
When a new infusion system is delivered, the user organisation must
check that it operates safely in accordance with MDA DB 9801
Supplement 1 Checks and Tests for Newly Delivered Medical
Devices. An organisation could be found negligent if harm occurs
which could have been prevented by acceptance testing.
This check must be carried out prior to use and applies to all new
infusion systems, whether purchased or on loan. Nominating a central
delivery point for all products makes it easier to ensure that checks
have been carried out.
8.1.1 Requirements of acceptance check
The acceptance check must confirm that:

the correct product has been supplied;

all manuals and accessories are included;
the product has been delivered in good condition and in working
order;
any risks associated with using a device for the first time have
been minimised;
the product has been recorded on a medical device register (see
section 8.2). This will initiate the required maintenance and, if
there is an adverse incident when the product is first used,
provide evidence of good practice;
there is compliance with safety legislation.

It should also identify:

any training needs (see section 3). Training should be

implemented before or at the same time as the device is
introduced;
appropriate planned preventative maintenance (see section 9);
technical support needs of the users;
software configuration, if applicable, such as the occlusion alarm
level;
any requirement to mark the device with therapy classification
(see Appendix 1).

8.1.2 Type-testing and standards compliance

It is important to distinguish between acceptance checks for newly
delivered devices and type testing or tests to prove compliance with
standards.

41

Type testing is not recommended for newly purchased products

which are to be put into service. This is because such testing could
damage the device and is outside the scope of most EBME
departments.

8.2 Medical device registers

All units should develop and maintain comprehensive device registers
and resource information as soon as possible.
All medical devices, including those on loan or donated, must be
entered into a medical device register. All staff using infusion systems
must have access to this register.
8.2.1 Purpose
These registers provide up-to-date information on the availability of
devices and on important practical aspects of each infusion system,
especially those related to patient safety. Such aspects include
training requirements, maintenance records and safety warnings.
Note: Medical device registers should not be confused with asset
registers, which are a simple list of equipment purchased, without the
additional details included in the medical device register.
8.2.2 Auditing and updating
The broad-based medical device group and/or the medical device coordinator should establish standards for regular auditing of the
register(s).
Holding the registers on computer will facilitate their updating.
Information on an infusion device must be retained on a register for a
minimum period of 11 years (Department of Health HSC 1999/053)
after the device has been removed from use.
8.2.3 Central and local registers
A large unit, such as a trust hospital, may require two types of
register:

a central register for the directorate or department;

separate local registers for each area or ward, allowing day-today supervision.

42

Smaller units, such as nursing homes and primary care practices,

may only require one register, which combines the functions of both
registers (described below).
8.2.4 Central medical device register
The central register is the responsibility of the medical device coordinator(s). For every infusion device it should record:

date of receipt;
date placed into service;
location of operating instructions (master copy);
training requirements;
calibration details/records;
maintenance carried out;
official location;
history of damage, malfunction, modification or repair;
procedures for recall;
action taken in response to safety warnings;
software configuration.

It is recommended that the master copy of the manufacturers

instructions be kept with the central device register.
8.2.5 Local medical device register
The individual responsible for device management in that unit should
maintain the local device register.
For every infusion device it should record:

normal location or new location, if it has been moved;

calibration requirements;
maintenance requirements;
malfunctions and action taken;
software configuration;
procedures for recall;
copies of relevant safety warnings;
reference to central medical device register

Particular difficulties arise in the case of devices loaned between

units. As noted above, details of any movement from the original
location should be documented in the appropriate register.
Arrangements must also be made to ensure that the device is
returned when it is no longer required.

43

8.3 Manufacturers instructions

Manufacturers are required to provide operating and maintenance
instructions. These instructions, supplemented by local material as
required, should be used when preparing teaching packages for staff
training.
Providing instruction summaries
Operating instructions are normally contained in a manual. They may
also appear in an abbreviated form on, or attached to, the device
itself. Where this is not possible, copies of the instructions should be
issued to all wards where the equipment might be used.
If the manufacturer does not provide instruction summaries, the
medical device co-ordinator should ensure that they are prepared by
an experienced member of staff and approved by the manufacturer
before use. If possible, they should also be attached to the device.

9 MAINTENANCE AND REPAIR

9.1 Division of responsibility
A clearly defined division of responsibilities between hospital/facility
management, the technical supervisor and clinical supervisor is
essential, to ensure infusion pumps keep operating reliably and
safely.
Planned preventative maintenance
A broad-based medical device group and/or the medical device coordinator(s) must decide the most appropriate strategy for planned
preventative maintenance and repairs, based on the original
manufacturers recommendations.
They should ensure that satisfactory arrangements are in place to
ensure that:

servicing is carried out at appropriate intervals;

servicing is carried out promptly in the event of malfunction;
devices are handed over for repair and servicing;
devices are returned to the unit after repair and servicing;
safety warning advice is assessed and acted upon accordingly;
provision of alternative devices.

See Table 3.

44

Responsibilities of the technical supervisor

A technical supervisor should be appointed, usually from the electrical
and bio-medical engineering (EBME) or medical physics department.
The responsibilities of the technical supervisor include:

establishing and operating a servicing system;

overall technical management of scheduled and unscheduled
servicing;
determining the suitability of contractors;
determining, in conjunction with the medical device co-ordinator,
the capability of in-house facilities, ensuring they meet quality
assurance standards.

In smaller organisations, which do not have a technical supervisor,

the medical device co-ordinator is responsible for ensuring that
appropriate technical assistance is available from outside agencies.
Note: An EBME department that carries out servicing for a primary
care unit is considered a third party organisation. See MDA DB
2000(02).

45

Table 3

Person

Hospital/facility
management

Responsibility

Technical
supervisor

Clinical supervisor

Division of responsibility

Set procedures for placing maintenance contracts.

Ensure calls and safety-related modifications take place
Decide when to use in-house, manufacturer, or third party
maintenance organisations.
Set training budgets that give adequate training in infusion
system use, safety and maintenance.
Authorise staff to carry out jobs based on their training and
experience.
Organise manuals and ensure spare tools and test equipment is
available.
Monitor the quality control of infusion devices following
maintenance and repair work.
Supervise contracted staff.
Oversee record keeping and scheduling services.
Keep in touch with professional users.
Take overall responsibility for safety.
Advise management on technical content of repair and
maintenance agreements, as well as required action in a major
crisis.
Supervise routine maintenance.
Attend commissioning of new infusion systems.
Organise staff training for new and existing infusion systems.
Oversee planned maintenance: negotiate schedules and
manage necessary interruptions to maintenance schedules.
Oversee handing over and returning of infusion systems,
ensuring pumps are decontaminated before release.
Check records to ensure that maintenance intervals are not
exceeded.
Ensure maintenance engineers have suitable working conditions.
Plan fallbacks in case of equipment failure.
Provide advice on user interests in maintenance and repair.

46

9.2 Maintaining infusion systems in the community

In the community, patients and carers are responsible for the safe
operation and day to day care of infusion systems. (See SN 2002
(17))
It is important that an appropriately trained health professional makes
sure that carers and patients are able to:

check that devices are undamaged and functioning correctly;

carry out recommended inspection, functional and safety checks;
ensure devices are kept clean and, if necessary, decontaminated;
notify the appropriate people of device malfunctions.

In some cases, appropriate training may be required.

End users in the community should be assigned a named contact, by
the healthcare supplier, who can provide technical and clinical
support. An out-of-hours contact service should be arranged to offer
clinical support and, if required, to replace faulty devices.

9.3 Routine maintenance

Requirements of the maintenance system
All devices should be maintained to the manufacturers
recommendations. A formal maintenance system is essential to
ensure that devices remain safe and reliable. The system should
include:

regular checks and maintenance by users;

scheduled servicing;
defect reporting and correction.

All scheduled servicing and emergency repairs must be carried out by

trained technicians.
The technical supervisor, in consultation with the medical device coordinator, should specify the frequency of servicing. This is
particularly important in the case of heavy use, greater than usual
wear and tear, or when pumps are returned from community or
domiciliary use.

47

All servicing organisations, whether an EBME department or third

party, must have:

properly trained staff;

up-to-date manuals;
updates and tools;
access to manufacturer-approved spare parts;
adequate quality control;
systems to ensure that recalls, updates and modifications are
carried out.

Avoiding unauthorised modifications

It is dangerous to modify an infusion pump without authorisation. All
modifications must be authorised by the technical supervisor and
medical device co-ordinator, together with the manufacturer, to
ensure that safety is not compromised.
Example 6 Over-infusion incident following maintenance
A patient suffered an over-infusion whilst using an infusion pump at
home.
The infusion pump came from a special stock maintained for home
applications. All pumps were set to a single, standard infusion rate.
Following maintenance, the pump in question had been returned, set to
its highest rate. The rate had not been checked and reset before issue.

9.4 Breakdowns
In the case of breakdowns, the pump should be replaced with an
equivalent device or rapidly repaired. Planning is required to ensure
that suitable replacement devices are available and that maintenance
contracts specify acceptable response times.
If an infusion pump has been accidentally damaged, perhaps dropped
or subject to fluid spillage, it must be withdrawn from service
immediately. The usual service department EBME, manufacturer or
supplier should be contacted for advice.
Each unit should establish a clear system for notifying damage or
malfunction to any device during use. This can be verbal or written.
The medical device co-ordinator should notify the technical
supervisor, to ensure prompt repair.

48

Example 7

Unmodified pumps incompatible with giving sets

A pump manufacturer offered, free of charge, to modify users pumps to

accept new giving sets, in order to standardise the sets. A trust had all its
pumps modified, except in one hospital. When that hospital received new
sets from the trust, it reported under-infusions. Furthermore, sets
purchased from a third party manufacturer for these pumps were only
compatible with the unmodified pumps. When these sets were used with
modified pumps it resulted in over-infusions.
Service records must be kept and pumps should be labelled after
servicing.

9.5 Record keeping

Within larger trusts, each unit should keep a service record of every
device it holds, including infusion devices. This record is in addition to
the central device register. The record should specify:

servicing, repair and modification work carried out;

date of next service;
movements of devices to other units, including those outside the
hospital.

9.6 Replacement and obsolescence

A system is required, in both hospital and community settings, to
determine when an infusion pump needs replacing.
Criteria for replacement include:

levels of wear and damage beyond economic repair;

chronic unreliability;
obsolescence;
spare parts no longer available;
availability of more cost-effective or clinically effective pumps.

Informed purchasing decisions estimate how long each pump will last.
This estimate should be held in the servicing record. When the
estimated time of life has elapsed, the pump should be inspected
against the criteria above.

49

If a pump passes its inspection, a date should be set for re-testing, for
example in a years time. If a pump fails this test, it should be
decommissioned immediately (see DB 9801 Supplement 2).

Example 8: Equipment libraries

Some trusts have centralised infusion pumps and other medical devices
by setting up an equipment library. The concept of an equipment library is
to provide an efficient service to clinical areas of commonly used
equipment and to facilitate the safe and optimal usage of equipment for
the benefits of patients and staff.
Equipment libraries have many benefits:

Equipment is cleaned and charged in the library, and devices are

easily retrieved for repair and planned maintenance.

Trusts are easily able to identify supply needs and replace old, unsafe
and inappropriate devices.

Training needs can be identified.

Quality of service can be improved by:

reducing time wasted on finding equipment;
reducing the number of incidents due to poor maintenance and
improving the tracking of devices.

50

10 REFERENCES
British Standards Institution. Medical electrical equipment - general
requirements for safety. BS EN 60601-1, 1990, with subsequent
amendments.
British Standards Institution. Medical electrical equipment - particular
requirements for the safety of infusion pumps and controllers. BS EN
60601-2-24:1998, BS 5724-2.124:1998, IEC 60601-2-24:1998
Chen JL and O'Shea M. Extravasation injury associated with lowdose dopamine. Annals of Pharmacotherapy 32(5), 1998, p. 545-548.
Department of Health (Controls Assurance Support Unit). Controls
assurance standards. Available online:
http://www.casu.org.uk/standards/index.php
[Last checked 4 February 2003].
Department of Health. For the record: managing records in NHS
trusts and health authorities. Health Service Circular HSC 1999/053,
1999.
Great Britain. Health and Safety at Work Act 1974. London: HMSO,
1974.
Great Britain. The Medical Devices Regulations 2002. SI 2002 No.
618. London: HMSO, 2002. ISBN 0110423178.
Great Britain. The Reporting of Injuries, Diseases and Dangerous
Occurrences Regulations 1995. SI 1995 No. 3163. London: HMSO,
1995. ISBN 0110537513.
Krauskopf KH, Rauscher J and Brandt L. [Disturbance of continuous,
pump administration of cardiovascular drugs by hydrostatic pressure.]
Der Anaesthesist 45(5), 1996, p. 449-452. [Article in German]
Lonnqvist PA and Lofqvist B. Design flaw can convert commercially
available continuous syringe pumps to intermittent bolus injectors.
Intensive Care Medicine 23(9), 1997, p. 998-1001.
Lonnqvist PA. How continuous are continuous drug infusions?
Intensive Care Medicine 26(6), 2000, p. 660-661.
Phelps SJ and Helms RA. Risk factors affecting infiltration of
peripheral venous lines in infants. Journal of Pediatrics 111(3), 1987,
p. 384-389.

51

Phelps SJ, Tolley EA and Cochran EB. Inability of inline pressure

monitoring to predict or detect infiltration of peripheral intravenous
catheters in infants. Clinical Pharmacy 9(4), 1990, p. 286-292.
Scott DA, Fox JA, Philip BK et al. Detection of intravenous fluid
extravasation using resistance measurements. Journal of Clinical
Monitoring 12(4), 1996, p. 325-330.
MDA publications
DB 9801 Medical device and equipment management for hospital and
community-based organisations
DB 9801 Supplement 1 Checks and tests for newly delivered medical
devices
DB 9801 Supplement 2 Guidance on the sale, transfer of ownership
and disposal of used medical devices
DB 2000(02) Medical devices and equipment management: repair
and maintenance provision
Directive Bulletin 18 The Medical Devices Regulations: implications
on healthcare and other related establishments
MDA/2003/001 Reporting adverse incidents & disseminating medical
device alerts
SN2002(17) Management of loaned medical devices, equipment or
accessories from manufacturers or other hospital
Further reading
A Guide to RIDDOR 1995. L73. Sudbury: HSE Books, 1996. ISBN
0717610128.
Medical Devices Agency. Equipped to care. 2000
ISBN 1 84182 170 5
Medical Devices Agency. Devices in practice a guide for health and
social care professionals 2001. ISBN 1 84182 359 7

52

Appendix 1

APPENDIX 1 Choosing infusion devices according to

therapy category
Information about the technical performance of infusion devices is provided by the MDA Infusion
Pump Evaluation programme of the Device Evaluation Service, which is funded by the National
Health Service to assist NHS Trusts in the purchase and use of infusion pumps. It is intended to
supplement information already available to prospective purchasers, including that supplied by
manufacturers. Independent and objective evaluations of pumps are carried out by our Infusion
Pump Evaluation Centre on a unit supplied by the manufacturer.

1 Therapy categories, performance parameters and safety features

Pumps are designed for a variety of clinical applications and their performance characteristics will
vary. The same level of technical performance of pumps is not necessary for every clinical therapy.
We have divided therapies into three major categories according to the potential infusion risks to
help purchasers and users select the pump(s) most appropriate to their needs.
These categories are shown in Table 4(a) with a list of the performance parameters critical to each,
and the important safety features are given in Table 4(b). These have been selected on the
principle that, in general, the greater the potential risks associated with therapies, the higher the
performance needed and the more important are the safety features.
The performance of individual pumps is measured against the selected parameters in the
MDA evaluation of infusion devices. The evaluation data is published on the MDAs
NHSNET site, http://nww.mda.nhs.uk/pumpevaluation and also in paper reports.
Table 4a: Therapy categories and performance parameters
Therapy
category

Therapy description

Patient group

Drugs with narrow

therapeutic margin
A

Drugs with short half-life

Any infusion given to
neonates
Drugs, other than those
1
with a short half-life

TPN
Fluid maintenance
Transfusions
Diamorphine

TPN
Fluid maintenance
Transfusions

Any
1

Any

Neonates

Any except
neonates
Volume
sensitive except
neonates
Any except
neonates

Any except
volume sensitive
or neonates

53

Critical performance parameters

Good long-term accuracy
Good short-term accuracy (see below)
Rapid alarm after occlusion
Small occlusion bolus
Able to detect very small air embolus
(volumetric pumps only)
Small flow rate increments
Good bolus accuracy
Rapid start-up time (syringe pumps only)
Good long-term accuracy
Alarm after occlusion
Small occlusion bolus
Able to detect small air embolus
(volumetric pumps only)
Small flow rate increments
Bolus accuracy

Long-term accuracy
Alarm after occlusion
Small occlusion bolus
Able to detect air embolus (volumetric
pumps only)
Incremental flow rates

Appendix 1

Notes on Table 4a
1
The half-life of a drug cannot usually be specified precisely, and may vary from patient to patient.
As a rough guide, drugs with half-lives of the order of five minutes or less might be regarded as
short half-life drugs.
2

Diamorphine is a special case. The injected agent (diamorphine) has a short half-life, whilst the
active agent (the metabolite) has a very long half-life. It is safe to use a device with performance
specifications appropriate to the half-life of the metabolite.
3

Not all infusions require a pump. Some category C infusions can appropriately be given by gravity.

Table 4b: Important safety features in descending order of importance

Anti-free flow device in administration set

Free-flow clamp in pump when door opened
Provision against accidental modification of settings
Two distinct actions to change rate
Two distinct and/or simultaneous actions to initiate bolus
Syringe barrel clamp alarm, door open alarm or equivalent
Syringe plunger disengagement alarm or equivalent
Patient history log
Volume infused display
Technical history back-up
Battery back-up

54

Appendix 1

START

Is a drug being
delivered?

Is the patient a
neonate?

Does the drug

have a short
half-life or
narrow
therapeutic
index?

Category A Therapy

Is the patient
volume
sensitive?

Is the drug
diamorphine?

Category B Therapy

Figure 2 Decision tree for selecting the appropriate therapy category

55

Category C Therapy

Appendix 1

2 The performance parameters explained

2.1 Accuracy
The pattern of delivery of fluid from an infusion pump is very dependent on the type of pump used.
These three graphs show typical flow patterns from a syringe pump, a volumetric pump and an
ambulatory pump. Each of these pumps delivers fluid accurately (better than 5% of set rate) over
long periods, but only the syringe pumps deliver fluid accurately over very short periods (a few
minutes).

Typical syringe pump

Flow rate (ml/h)

Flow rate set to 1 ml/h

2.0
1.0
0.0
0

15

30

45

60

75

90

105

120

75

90

105

120

75

90

105

120

-1.0
Time (minutes)

Typical volumetric pump

Flow rate (ml/h)

Flow rate set to 1 ml/h

2.0
1.0
0.0
0

15

30

45

60

-1.0
Time (minutes)

Typical ambulatory pump

Flow rate (ml/h)

Flow rate set to 1 ml/h

5.0
3.0
1.0
-1.0

15

30

45

60

Time (minutes)

56

Appendix 1
Long-term accuracy
Hour-to-hour variability of flow is particularly important for the more critical applications. For
instance, overall accuracy is important with drugs whose therapeutic margin is narrow. Therapeutic
margin is a property of the particular drug and is the ratio of the toxic dose (TD) to effective dose
(ED). It is seldom less than 2. There is wide variability in the therapeutic margins and half-lives of
some drugs between one individual patient and another.
Short-term accuracy
Minute-to-minute variability of flow becomes very important where drugs with short half-lives are
being administered. The importance derives from the need to prevent undesirable fluctuation of
effect-site concentration of the drug. There is documented evidence that minute-to-minute
variability of flow can cause variation of physiological parameters and consequent difficulties in
management, in both adults and neonates, where the half-life of the drug is short.
Short-term accuracy is expressed by the concept of constancy index. This is the shortest period
during the pumps steady-state operation over which measurement of output consistently falls
within 10% of the mean rate. The data are derived from the flow tests performed over 24 hours at
1ml/h. Flow is recorded at 30 second intervals over the final 18 hour period. And the average rate
compared with flow over each short period.
The principle is that the constancy index of the pump should be less than or equal to the half-life of
the drug used. Syringe pumps have a shorter constancy index than volumetric pumps i.e. a low
constancy index indicates good short-term flow rate accuracy. Battery operated ambulatory pumps
frequently have a constancy index in excess of 31 minutes making these particular devices
unsuitable for use with short half-life drugs.
For the purposes of this bulletin the half-life of a drug is the time taken for the concentration of
that drug to be reduced by 50 % either by metabolism or excretion.
2.2 Time to alarm following occlusion
The occlusion alarm is the response to a build-up of pressure of fluid in the line. Infusion pumps
are positive pressure devices; that is the pumping mechanism will generate a pressure in the
infusion line in order to maintain fluid delivery at the set rate. Under some circumstances the
infusion line or catheter may become totally occluded therefore preventing fluid flow to the patient.
The device will initially continue to pump, but with the line blocked, the fluid remains in the line and
the line pressure increases. At some line pressure limit the pump will stop and alarm (see section
6).
From the onset of a total line occlusion the patient receives no infusion therapy. In some critical
applications involving the use of drugs which have a short half-life and result in an immediate
pharmacological or physiological response (e.g. adrenaline, dopamine, dobutamine, dopexamine,
insulin) the plasma concentrations of drug may drop rapidly following cessation of delivery. In the
case of short half-life vasoactive drugs used to maintain cardiac output it is known that if the
infusion stops then the patients condition can deteriorate rapidly.
2.3 Occlusion bolus following release of occlusion
Occlusion bolus is the volume of fluid stored under pressure in the giving set following occlusion.
The term has been introduced to try and eliminate confusion between desired, deliberately
administered bolus and undesired occlusion bolus. There is a potential risk to the patient when
this occlusion bolus is released after the occlusion is removed.
57

Appendix 1
2.4 Air embolus detection (applies to volumetric pumps only)
Small volumes of air injected intravenously are considered a hazard by some clinicians. Volumetric
pumps provide either a mechanism for preventing the pumping of air or an air detection system.
2.5 Bolus delivery accuracy
Elective bolus There are circumstances when a bolus is deliberately given. This should be as
accurate as practicable in order to avoid difficulties in patient management.
2.6 Start-up time
This is a newly defined performance parameter. It is the time taken for the flow to become
established in a consistent pattern. This is negligible in volumetric pumps, but generally significant
in syringe pumps.
The new categories of therapy are intended to help users select an appropriate pump for their
application. Hospitals will need to take steps to facilitate effective use of the scheme.
Implementation methods may vary.

3 Syringes and administration sets

The brand of syringe used can significantly affect the performance of syringe pumps. Hospitals
should be aware of the consequences of substituting a poorer quality disposable syringe. The use
of administration sets which are not recommended by the pump manufacturer in volumetric pumps
can also significantly affect pump performance.

4 Training, standardisation and configuration

Selection of the appropriate pumps can only be effective as part of a general policy for the safe use
of devices. In view of the fact that many adverse incidents with infusion devices are due to user
error:

a. Training
The greatest possible step towards safe operation of infusion devices is to require that all
staff who use an infusion device have been specifically trained in its use.

b. Standardisation
Reducing the variety and number of different models that each user has to operate is also
known to improve safety. A high degree of standardisation will minimise both training
needs and the risks of user confusion or error. Ideally staff in any one clinical area should
be trained in the use of and have access to only to a very small range of infusion devices
(typically one type of syringe pump and one type of volumetric pump). Hospitals that
operate an equipment store or pump library will have an advantage in implementing such
standardisation.

58

Appendix 1

c. Configuration

It is safest and therefore strongly recommended that all devices in one clinical area
are configured identically. Confusion and consequent errors can arise if apparently
identical infusion devices behave differently. (A possible exception to this is occlusion
alarm level, which may need to be matched to individual infusions e.g. higher
occlusion alarm level if a very long narrow cannula is being used.)

Configuration should be done centrally by technical staff and not at the bedside (again
with the possible exception of occlusion alarm level).

It should be remembered that local re-configuration of devices will not necessarily

reproduce the settings used for the MDA evaluation. This should be taken into account
when managing risks. It may, for instance, be necessary to increase the occlusion
alarm level if a long and narrow vascular access device is in use. This will also
increase time to alarm and occlusion bolus above the levels measured in the MDA
testing of the device.

59

Appendix 2

APPENDIX 2 Information for procurement of infusion devices

1. MDA Device Evaluation Programme
The MDA runs an independent programme to evaluate medical devices and equipment used for
diagnostic imaging, general medical and pathology purposes. Devices are assessed for
performance and safety in clinical and, where appropriate, laboratory environments.
This provides clear guidance on what the equipment can do, its ease of use, reliability and
suitability for different settings and applications. Comments from users are included whenever
possible. The MDA publishes the results as a series of evaluation reports. Approximately 100
reports are published each year, covering over 300 devices. The reports can be in-depth (focusing
on a single device) or comparative (reviewing a selection of devices).
How to order reports
A catalogue lists all the current and forthcoming evaluation reports, and includes details of reports
published since 1995. For further information, or to order the catalogue or a report, contact:
Device Evaluation Orders Department
Medical Devices Agency
Room 1207
Hannibal House
Elephant and Castle
London SE1 6TQ

Tel:
Fax:
E-mail:

020 7972 8181

020 7972 8105
[email protected]

2. Purchasing process criteria

2.1 Proposed timescales
The NHS Purchasing and Supply Agency has set the following timescales.
Table 5

Proposed timescales for purchasing process

Process

Week

EU advertisement issued

1-6

Closing date for responses

Pre-offer discussions with suppliers, supplier presentations and start of

evaluations/trials

7-12

Issue invitations to offer

13

Return of offers to trust

19

Summary of offers produced

22

Award of business meeting

23

Award of business by (dependent on progress of evaluations/trials)

27

Delivery

27-33

Clinically operational

27-33

Issue award notice

33

60

Appendix 2
2.2 Selection criteria
The following factors should be taken into consideration to help select the appropriate infusion
system.
Table 6

Infusion system model selection criteria

Factors

Notes

Fitness for intended

application

The infusion system chosen must meet the organisations

performance specifications, taking into account the pump
therapy categories in Appendix 1. The MDA Evaluation
Centre offers advice on specifications.

Life cycle/replacement

Section 9.6 lists criteria for deciding when an infusion

system needs replacing.

Guarantee/warranty

Compare terms. Are these negotiable?

Safety

Which safety performance standards have been complied

with? Do MDA publications reveal persistent problems?
Can professional users identify problems?

Reliability

Have other users experienced problems or failures?

Service support

Are spares readily available and is service support

guaranteed? For how long? Is response time guaranteed?

Maintenance requirements

Intervals between service, frequency and complexity of

checks and calibrations needed during operation.

Technical advice and training

Does the manufacturer give free access to technical advice

and training, for professional users and technical staff? Is
there a 24-hour help-line?

Diversity

Will this choice increase the number of types of infusion

system in use, and could this affect safety?

61

Appendix 3

APPENDIX 3 Pressure in infusion systems

3.1 Pressure delivery methods
Pressure developed within the infusion system is used to deliver fluid to the patient, using one of
the following basic techniques:

Gravity
Positive pressure

Gravity devices
The hydrostatic pressure on a column of fluid delivers the fluid to the infusion site.
Pressure generated within a gravity system is limited by the height of the fluid container above the
infusion site. The maximum pressure that can be exerted is derived from the equation
Pressure p=gh

Equation 1

where g is the constant acceleration due to gravity, h is the height of the fluid container above the
infusion site and is the density of the fluid.
Positive pressure devices
These devices generate pressure by mechanical means. Force is applied to the fluid to drive it
through the infusion tubing. Examples are a syringe pump, volumetric pump or elastomeric device.
In these devices, flow can be maintained whether the reservoir of fluid is level with or lower than
the infusion site.
Pressure in a tube where flow is occurring can be modelled by the equation:
Pressure drop

Flow rate X Viscosity X Cannula length

Diameter

Equation 2

3.2 Pressure at infusion site

In a typical adult, venous pressure can vary between small negative values (-10mmHg) in the large
veins situated vertically above the heart, up to 80mmHg in dependent peripheral veins. Since a
column of liquid exerts pressure at its base, pressure in the leg veins can sometimes rise to quite
high values. An ambulant patient with a cannula situated in a peripheral arm vein might present a
baseline site pressure of up to 30mmHg.

3.3 Occlusion alarm mechanisms

All powered infusion devices have mechanisms for detecting when the flow has ceased. These are
based on measuring the increase in pressure, either directly or remotely.
Gravity devices register that no flow is occurring when drops cease to fall.

62

Appendix 3
Positive pressure devices have several different means of detecting no flow. Their occlusion
response is characterised in terms of three measurable parameters:

pressure at alarm;
time to alarm;
bolus released when occlusion is resolved.

Minimising patient risk

Alarms are principally provided to minimise the hazard to the patient.
For some of the more critical drugs, current technology cannot provide alarms that activate
sufficiently rapidly to provide safe warning of the cessation of therapy. It is therefore essential that,
when short half-life drugs are used, there is additional monitoring of the patient. For less critical
drugs, alarm within five minutes of the onset of occlusion is probably adequate.
High pressure at alarm may not directly place the patient at risk. However, placing a limit on
pumping pressure ensures that the bolus and time to alarm are both minimised. This will remain
the case while current mechanisms for detecting occlusions are used. There is more than one
method of sensing the pumping pressure, however, and some methods are more effective than
others.
Types of occlusion detection mechanisms
The two main types of mechanism are:

In-line pressure monitoring;

Indirect sensing of pressure within the pumping mechanism.

In-line pressure monitoring

In-line pressure monitoring measures the expansion of a compliant segment of the infusion tubing,
downstream of the pumping mechanism.
It is a more accurate form of monitoring and is therefore the best option where the application
requires continuity of therapy. It is more complex to achieve and usually requires the administration
set to include a pressure disc, thereby increasing costs.
Indirect measurement of pressure
Indirect methods of sensing pressure are achieved by measuring the drive force, drive pressure or
motor current.
Such methods can give false values. For example, where poor quality sticky syringes are used in
syringe pumps, a very high force is required to move the syringe plunger or bung from a stationary
position. This is sometimes referred to as stiction. This force can vastly exceed that required to
sustain movement of the plunger during a running infusion. Although no pressure is exerted on the
fluid whilst the bung sticks, the pump calculates the pressure as though the bung is free to move.
As a result, the pressure in the fluid is overestimated.
When a sticky syringe is used, the occlusion alarm pressure must be set at an abnormally high
level to allow for the high force at start-up.
Some more sophisticated indirect pressure measuring systems are introducing a feature that
permits a large start-up force, but will alarm at lower running forces. However, this feature does
little to reduce alarm time and bolus at alarm for the most common cause of occlusion, namely
leaving a stopcock closed at the start of the infusion.
63

Appendix 3

3.4 Bolus or cessation of flow due to raising or lowering of pump

The figure illustrates a test where a syringe pump running at 5 ml/h is first raised (note the bolus
delivered) and then lowered (note the suckback and delay to therapy).
Pump raised by 136cm
Bolus of 0.1ml delivered to patient

Flow rate (ml/h)

15.0
10.0

pump level
with outflow

pump 136 cm below outflow

pump 136 cm above outflow

5.0
0.0
-5.0
-10.0

Figure 3

60

120

180

240

300

Time (minutes)

360

420

480

Pump lowered by 272cm

Bolus of 0.4ml sucked back
Note time taken to re-establish set flow rate

Example of bolus and delivery delay due to raising and lowering of

a syringe pump

3.5 Extravasation and in-line pressure monitoring

Centres using in-line pressure monitoring have noted that pressure rising by a few mmHg is a
possible predictor of a positional IV occurring. Positional IV means extravasation owing to
displacement of the cannula. Such a small pressure rise only becomes apparent if in-line pressure
is one of the parameters recorded at regular intervals on patient data sheets.
These centres claim that incidence of extravasation can be reduced by:

monitoring in-line pressure

inspecting and/or manipulating or re-positioning the cannula when small changes in baseline
pressure occur.

However, no controlled study has been published that confirms these findings. Furthermore,
reports in the literature seem to contradict this and suggest that no measurable increase in
baseline pressure occurs during infiltrations (Phelps 1990). Additional monitoring of the patient is,
however, a common-sense approach and does not disadvantage the patient
Manufacturers are attempting to design infusion pumps with mechanisms that alert the user to
potential extravasation (Scott 1996). Only one manufacturer is currently marketing a device with
this technology. In its current form, the mechanism for detecting extravasation adversely affects
short-term flow rate variability. Users should decide whether the benefit outweighs the
disadvantage.

64

Appendix 4

APPENDIX 4 Infusion devices: types, features and functions

Classification
Infusion devices can be classified according to their power source as:

gravity controllers;
infusion pumps (pneumatic, mechanical or electrically powered devices).

1 Gravity controllers
1.1 Application
Gravity controllers are most suited to lower risk applications, including fluid replacement therapy, provided
the low delivery pressure is sufficient to sustain the set flow rate.

1.2 Types of gravity controllers

Drip rate controllers
Drip rate controllers look like a pump, but have no pumping mechanism. They rely instead on
standard solution sets. The desired flow rate is set in drops per minute and controlled by battery or
mains powered line occlusion valves. The controls tend to be few and simple to operate. All
models have a drop sensor. More advanced models incorporate a flow status system, which gives
a visual indication of resistance to flow.
Volumetric controllers
At present, there are no devices of this type with CE marking. They therefore cannot be purchased
for use in the UK.

1.3 Usage considerations

Gravity controllers rely solely on gravity to provide the infusion pressure. Therefore, the fluid
container must be placed sufficiently high above the infusion site to achieve the desired flow. A
drop sensor, attached to the drip chamber of the administration set, monitors the drip rate. A
variable mechanical clamp within the device, acting on the delivery tube, controls the flow and thus
the drip rate, to achieve the set rate.
Control against over-infusion is effective, but under-infusion can result from increased resistance to
flow. This can be avoided by using a drip rate controller with a visible flow status system.

1.4 Accuracy of drop controlled devices

The drop counting mechanism used in gravity controllers is highly accurate in delivering the
required number of drops. However, the accuracy of volume delivery depends on the accuracy of
the conversion from drops to millilitres. The nominal drops/ml for a set, or conversion chart values,
are approximate, so the actual drops/ml may differ considerably.
The volume of fluid in a drop depends on:

the fluids composition, temperature and surface tension;

the drip rate set;
the size, shape and condition of the drop-forming orifice.
65

Appendix 4

Most simple aqueous solutions of electrolytes, lactates or dilute sugars give drop volumes fairly
close to the expected nominal 20 drops/ml. However, the drop volume for total parenteral nutrition
(TPN) mixtures, fat soluble vitamins and solutions containing alcohol will be lower than expected,
increasing the infusion time. With all fluids, the drops/ml value falls and the drop volume rises as
the delivery rate increases.
For the majority of infusions these variations are acceptable. But where the volumetric accuracy
is critical, an infusion pump (volumetric or syringe) must be used.

1.5 Gravity controllers and extravasation

It is widely thought that gravity devices minimise the risk of extravasation. Yet it is difficult to find
evidence in the literature to support this view and recent studies suggest there is no such link. For
historical reasons, however, some types of vesicant are still given by gravity controller in the
expectation that extravasation will be less likely to occur.
The following points should be noted:

The link between pressure and extravasation is hypothetical. Not enough is known about the
mechanisms by which extravasation occurs. Further research is therefore needed.

Positive pressure devices can often be configured to alarm at pressures less than that exerted
by the column of fluid in a gravity method of administration. If minimal pressure is required, it is
preferable to use a device with configurable alarm pressure and in-line pressure monitoring,
not a controller.

The use of a gravity controller inevitably reduces the volumetric accuracy with which a fluid can
be administered.

2 Infusion Pumps
These pumps use an active method to overcome resistance to flow by increased delivery pressure.
Volumetric or syringe pumps are the most common. Other methods include elastomeric,
pneumatic, clockwork or spring. Another option is drip rate, although this is not recommended for
use in the UK.
See Appendix 1 for guidance on selecting the correct device for a specific application.

2.1 Volumetric pumps

2.1.1 Application/usage considerations
These pumps are the preferred choice for medium and high flow rate and large volume infusions.
Their wide range of features makes them suitable for category A and B therapies, depending on
the performance parameters, which can vary widely. However, volumetric pumps are most suited
to administering fluids in categories B and C and at higher flow rates.
Most volumetric pumps will perform satisfactorily at rates down to 5 ml/h. Although the controls can
set rates below 1 ml/h, these pumps are not considered appropriate for delivering drugs at such
low rates.

66

Appendix 4
2.1.2 Features
Volumetric pumps are powered by mains or battery. The rate is selected in millilitres per hour
(ml/h) or micrograms per kilogram per hour (g/kg/hr).
Most volumetric pumps have the following features:

automatic alarm and shut-down: this is triggered if air enters the system, an occlusion is
detected or the reservoir or bag is empty;
pre-set control of the total volume to be infused and digital read-out of volume infused;
automatic switching to keep the vein open (KVO) rate at the end of infusion;
automatic switch to internal battery operation if the mains supply fails. Battery power can also
be used if no mains power is available e.g. during transportation.

Additional features can include:

micro and macro delivery modes;

computer interface;
operator call alarm;
a drop sensor used for monitoring and alarm purposes (such as an empty container)
rather than as a control of the delivery rate;
primary and secondary (piggyback) infusion capability;
technical memory log for incident analysis some can record the settings and alarms for
operations over the past two days or a thousand data points;
set based anti free-flow mechanism.

Features such as air-in-line detection or a mechanism that cannot pump air and comprehensive
alarm systems make intravenous (IV) infusion much safer.
2.1.3 Types of mechanisms
There are two types of volumetric pumps:

peristaltic;
dedicated cassette.

Peristaltic mechanisms
There are two types of peristaltic mechanisms:

linear peristaltic;
rotary peristaltic.

Both mechanisms consist of fingers, cams or rollers that pinch off a section of the set.
In linear peristaltic mechanisms (see Figure 4) fingers or cams are located on a camshaft. As the shaft
rotates, each pinched off section delivers its volume to the patient. These mechanisms are the most
common.

67

Appendix 4
In rotary peristaltic mechanisms (see Figure 5) rollers are located on a hub which, as it rotates,
delivers the volume in each pinched off section.
The volume delivered varies according to:

the size of the cams, fingers or rollers;

the tube or set they are gripping;
the speed at which they rotate or shuffle.

Owing to this variance, these mechanisms are usually designed for a particular administration set.
Dedicated cassette
Some dedicated sets or cassettes have a distal and proximal line attached to a collapsible chamber.
The chamber may include valves and flexible membranes that align with pistons or rams in the pump.
Others consist of a rigid pumping chamber complete with a piston and a valve (see Figure 6). It is
inserted into the pump and located over driving shafts that operate the piston and the valve.
2.1.4 Setting correct pressure levels
In common with all pumps, volumetric pumps can develop high pressures. Although the pressure is
lower than in drip rate pumps, careful attention must be paid to this.
The pressure in most volumetric pumps is limited to a pre-set value, which can be configured far
lower than the default. If this level is exceeded, an alarm is set off. The occlusion pressure should
be set as low as possible in order to give early warning of genuine occlusions. The lowest feasible
level will depend on what pressure raisers are present in the line (see Appendix 3).
2.1.5 Correct use of administration sets
Most volumetric infusion pumps are designed for use with a specific type of infusion set. Therefore,
the accuracy of delivery and of the occlusion pressure detection system depends on the set.
Some volumetric pumps use low cost standard infusion sets but it is important to note that the
pump must be configured correctly for the specific set.
Sets that are incorrect, or not recommended, might appear to operate satisfactorily. But the
consequences for performance, particularly accuracy, can be severe. For example,

under-infusion can result if the internal diameter is too small;

free-flow through the pump, over-infusion or leakage back into the bag or reservoir can result
from tubing that is less flexible or has a larger outside diameter;
tubes can rupture if the construction materials are not sufficiently strong to withstand wear from
the pumping action;
air-in-line and occlusion alarm mechanisms can be disabled through using the wrong set.
Air-in-line detectors on pumps use ultrasonics or optics to detect air bubbles in the line. Again, these
detectors will have been designed for use with a particular set.
The action of the mechanism, which compresses and stretches the set during infusion, causes the
set to wear out over time and this inevitably affects the accuracy of delivery. Recommended sets
are designed in such a way that, except for large volume, high flow-rate infusions, wear and/or
work hardening of the material will not adversely affect the accuracy. The current international
standard for infusion devices (IEC 60601-2-24) does not specify the testing of pumps at maximum
flow rates. Therefore some fall-off in performance at high flow rates should be expected.

68

Appendix 4

Figure 4

Linear peristaltic pump

69

Appendix 4

Figure 5

Rotary peristaltic pump

70

Appendix 4

Figure 6

Dedicated cassette set

71

Appendix 4

2.2 Syringe pumps

2.2.1 Application
These pumps are the preferred choice for lower volume and low flow rate infusions. Users should
be aware that the flow delivered at the start of an infusion may be considerably less than the set
value. At low flow rates the backlash must be taken up before a steady flow rate is achieved. At
low flows it can be some time before any fluid is delivered to the patient.
2.2.2 Mechanism
Syringe pumps drive the plunger of a syringe forward at a controlled rate to deliver the substance to
the patient. The rate can be continuous or in steps, delivering a number of boluses in a given time.
The syringe is clamped or located in the pump with its plunger attached to a moving carriage (see
figure 7). As the carriage moves forward the syringe is emptied. In most cases the carriage is driven
forward by means of a nut attached to a lead screw. As the screw rotates, the nut moves along it,
taking the carriage and the syringe plunger with it and so emptying the syringe.
2.2.3 Features
The features of syringe pumps vary widely, so each model must be assessed separately. The most
recent and expensive models have many features, including delivery pressure displays and in-line
pressure monitoring.
In most modern pumps the default pressure is limited and there may be a facility to set very low
occlusion alarm pressures. This benefits the patient by resulting in shorter times to alarm and
reducing the chance of occlusion bolus hazard. It also avoids the delivery pressure rising to a high
value, if a catheter becomes occluded or displaced
2.2.4 Usage considerations
Syringe pumps have been designed to give optimum performance when placed approximately
level with the infusion site. It is not advisable to place the pump well above the infusion site as,
even in modern designs, some siphoning can occur in this position.
NB: When the administration set has been connected to the infusion site, the vertical
position of the device and giving set in relation to the site should be altered as little as
possible. If the pump is raised above the infusion site whilst the liquid is being delivered, it
can result in a large bolus being delivered to the patient. (See Section 6 and Appendix 3).

72

Appendix 4

Figure 7

Syringe Pump

73

Appendix 4

2.3 PCA Pumps

2.3.1 Application
These pumps are designed specifically for use in patient controlled analgesia (PCA).
Unlike a general-purpose infusion pump, a PCA pump has the facility for patients to deliver a bolus
dose themselves. This is achieved by operating a switch or pressure pad connected by a cord to
the pump.
Protection against free-flow is especially important with PCA pumps, particularly if the patient may
be unsupervised for some of the time.
Most PCA pumps have a memory log, accessed through a display or downloaded via a printer or a
computer. This enables a clinician to determine when, and how often, the patient has made a
demand and the total volume of drug infused over a given time.
2.3.2 Types of PCA Pumps
PCA pumps are typically syringe pumps, as the total volume of drug infused can usually be
contained in a single-use syringe.
Some PCA pumps are based on volumetric designs. For example, there is a range of miniature
battery powered volumetric pumps designed for PCA applications that have disposable internal
fluid reservoirs.
PCA pumps can be:

disposable: powered by battery or other means, including pneumatic and elastomeric.

non-disposable: powered by mains or battery.

2.3.3

Programming options

PCA pumps can be programmed by clinical staff in different ways. Options include:

loading dose;
continuous infusion (basal rate);
continuous infusion with bolus on demand;
bolus on demand only, with choice of units (ml or g/ml, etc.) and variable lockout time;
drug concentration.

Once programmed, a key or software code is needed to access control of the pump. In some
cases, patients are given limited access in order to change some parameters.

74

Appendix 4

2.4 Anaesthesia pumps

2.4.1 Application
These are syringe pumps designed for anaesthesia or sedation and must be used only for this
purpose. They should be clearly labelled ANAESTHESIA PUMP and restricted to operating
theatres and high dependency areas.
2.4.2 Features
Anaesthesia pumps are designed so that the rate can be adjusted, and other functions accessed,
during infusion. These pumps infuse over a higher flow rate range than normal syringe pumps and
have a high rate bolus facility. This means that the induction dose can be delivered quickly in a
single operation.
Other features include:

programming for body weight and drug concentration;

drug-specific smart card system. This automatically calibrates the pump for the drug being
infused;
built-in drug libraries;
interface with computer control and monitoring.

These facilities are software enabled, for example by programming and smart card, in a pump that
is otherwise suitable for other applications. It is vital that management initiates policies to
ensure that these facilities are disabled before the pumps are used in other applications. If
this cannot be achieved, the pumps should not be used for other applications.

2.5 Ambulatory pumps

2.5.1 Application
Ambulatory pumps have been designed to allow patients to continue receiving treatment or therapy
away from a hospital, thereby leading a normal life during treatment. The size and design of these
pumps means patients can carry them around in a form of holster.
Therapies that can be administered by ambulatory pumps include: analgesia, continuous and PCA,
antibiotic or antiviral infusions, chemotherapy and hormone delivery.
2.5.2 Accuracy
The accuracy of ambulatory pumps depends on factors including:

back pressure;
temperature of the flow-limiting element;
temperature and viscosity of the fluid.

Figures for flow rate accuracy given in manufacturers instructions do not take into account
deviation from standard conditions. In some circumstances a significant reduction in the flow rate
may lead users to think that there is a defect in the system, although the remaining volume of fluid
is often significantly higher than expected.

75

Appendix 4
2.5.3 Electrical and non-electrical ambulatory pumps
Ambulatory pumps can be powered by electricity or by other means.
Pumps not powered by electricity may lack the accuracy and some of the features (such as alarms) of
electrically powered pumps. However, they offer a cost advantage when used for non-critical
infusions.
Electrically powered ambulatory pumps sometimes use smaller versions of the pumping mechanisms
used in volumetric and syringe pumps. Depending on the pumping mechanism, rates of flow range
between 0.01 and 1000ml/h. The features of different models vary widely. Delivery rates can be set in
mm of syringe travel per hour or day, ml of fluid per hour or day or dose units. Some can also be
programmed for different delivery modes.
2.5.4 Reusable and disposable ambulatory pumps
Reusable pumps consist of a container or syringe that is emptied by gas pressure or a spring that is
compressed when the pump is primed. The gas, usually carbon dioxide, is produced from a chemical
reaction at the start of the infusion. The delivery rate is determined by the rate at which gas is
released, its pressure and/or a capillary line attached to the syringe or container. The container, bag,
syringe and gas cartridges are thrown away when empty. The rest of the device is reused.
Disposable devices include infusers and bolus-only analgesia devices controlled by the patient.
They consist of a calibrated bolus chamber, filled from an elastomeric reservoir or syringe by a
capillary tube. The patient flushes the chamber to receive the bolus.

2.6 Drip rate pumps

MDA does not recommend this type of pump. Although no manufacturer currently sells these
pumps in the UK, their use in hospitals persists.

76

Appendix 5

Appendix 5 Contacts
Finger on the Button Training
Scitech Educational Ltd
Kent Innovation Centre
Millennium Way
Thanet Reach Business Park
Broad Stairs
Kent
CT10 2QQ
Tel 01843 609 299
Fax 01483 609 301
Email [email protected]
Liz Pearson
Senior Buyer
NHS Purchasing and Supply Agency
80 Lightfoot Street
Chester
CH2 3AD
Tel 01244 586850
Fax 01244 586760
Email [email protected]
Mark Roberts
Buyer
NHS Purchasing and Supply Agency
80 Lightfoot Street
Chester
CH2 3AD
Tel 01244 586842
Fax 01244 586760
Email [email protected]
John Slater
Buyer, Medical Equipment
Equipping & Technical Branch
Scottish Healthcare Supplies
Trinity Park House
South Trinity Road
Edinburgh
EH5 2SH
Tel: 0131 551 8796
Fax: 0131 559 3927
Email: [email protected]

77

DISTRIBUTION
This Device Bulletin should be brought to the attention of: clinical managers; hospital and community users
of infusion devices; medical device co-ordinators; medical engineering staff; those in charge of
procurement; and liaison officers (for onward distribution).

TECHNICAL ENQUIRIES
Enquiries concerning the content of this Device Bulletin should be addressed to:
Samantha Tham
Medical Devices Agency
Hannibal House
Elephant & Castle
London
SE1 6TQ

Jim Lefever
Medical Devices Agency
Hannibal House
Elephant & Castle
London
SE1 6TQ

Tel: 020 7972 8241

Fax: 020 7972 8113
Email: [email protected]

Tel: 020 7972 82

Fax: 020 7972 8113
Email: [email protected]

HOW TO OBTAIN COPIES

Copies of this Device Bulletin are free to health and social care providers and may be obtained on written
request from:
Department of Health
PO Box 777
London
SE1 6XH

Fax: 01623 724 524

Email: [email protected]

Quoting reference MDA DB2003(02)

Private healthcare establishments and companies can order copies at a charge of 75 per copy from:
Medical Devices Agency
Business Services
Hannibal House
Elephant & Castle
London
SE1 6TQ
Fax: 020 7972 8124

Tel: 020 7972 8360

Email: [email protected]

Our website lists all current Device Bulletins and safety warnings: http://www.medical-devices.gov.uk
Note
Medicines and Healthcare products Regulatory Agency (MHRA)
The Medical Devices Agency (MDA) and the Medicines Control Agency (MCA) will merge to form the
Medicines and Healthcare products Regulatory Agency (MHRA) in April 2003.
CROWN COPYRIGHT 2003
Medical Devices Agency
An Executive Agency of the Department of Health
Mar 03 20K
ISBN 1 84182 689 8