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Medical Device and

Equipment Management
for Hospital and
Community-based
Organisations

BULLETIN
MDA DB 9801
JANUARY 1998
REGISTRATION

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available, please complete the form included.

ACKNOWLEDGEMENTS

We are grateful to everyone who has contributed to and commented on this


bulletin, both within MDA and from the NHS, Scottish Healthcare
Supplies, the Welsh and Northern Ireland Offices, the community sector,
and the medical devices industry. Many organisations made contributions,
including ABHI, BAREMA, BSTA and IPEM.

Among many others, we thank:

Ian Brett, Nigel Cripps, Graham Dymond, Richard Finney, Pat Flanagan,
David Head, Kevin Hogan, Kate Kuhn, Michael Mandelstam, Tim
Mossman, Richard North, John Reed, Paul Sim, Siân Storey, Chris Quinn,
Maggie Winchcombe, Brian Wilson, and Duncan Wilson for notable
contributions.
EXECUTIVE SUMMARY

This bulletin is written primarily for people responsible for purchasing,


deploying, maintaining and repairing medical devices in hospital and in the
community. This will include managerial, technical, and clinical staff.

Many of the decisions involved have a direct impact both on professionals


and patients, and input from these groups is needed during the decision-
making process. We argue for setting up broad based consultative groups to
oversee both purchasing decisions and device management.

The two factors with the greatest impact on device safety are training and
maintenance. We stress throughout that user knowledge and skills have
major implications for safety. Instructions must be clear, concise, and
readily available. Training needs to be timely and effective, and include
procedures for the routine maintenance of devices by users. Planned
preventative maintenance, carried out following manufacturers’ guidance by
properly trained technicians, is the other key element in ensuring devices
are safe and reliable. Users and technicians need to understand the basic
principles on which devices work (generic training) as well as how to use a
particular model (specific training). Training programmes should include
input from manufacturers.

Within the context of a general guide to good practice in the management


of medical devices, we have aimed to provide balanced information for
groups developing local policy in key areas, including whether:

• to use a central pool or library, or distribute devices among


clinical units;

• to standardise on a single model;

• to perform extensive acceptance tests on every device delivered;

• to use a third party maintenance and repair organisation;

• to impose administrative controls on prescribers.

The medical device industry is now regulated by the Medical Device


Regulations, and this change increases the responsibilities of suppliers,
especially with regard to the safety of products and the provision of users
with adequate information. We cover the likely effects of the legislation,
and summarise other legislation which impinges on the possible liabilities
of healthcare organisations. This area is complicated by the growing
plurality of arrangements for the supply, ownership and use of devices,
which are now frequently lent or leased by suppliers, and used by
unsupervised patients at home. We review possible strategies for
maintaining control of devices in the community.

The role of the MDA is to provide advice on purchasing, investigate


adverse incidents, disseminate safety information, and to act as the UK
Competent Authority - the regulator for the medical devices industry.
CONTENTS

1 Introduction................................................................................. A1
1.1 Summary.................................................................... A1
1.2 Scope......................................................................... A1
1.3 Terminology.............................................................. A2
1.4 Organisations and roles............................................. A4
1.5 Medical Devices Agency........................................... A6
1.6 Best practice.............................................................. A7
1.7 England, Scotland, Wales,
and Northern Ireland................................................. A7
2 Strategies for deploying devices................................................. B1
2.1 Summary.................................................................... B1
2.2 Pros & Cons of equipment stores, pools
and libraries............................................................... B1
2.3 Professional user-centred device management.......... B2
2.4 Risk assessment......................................................... B3
3 Purchasing................................................................................... C1
3.1 Summary................................................................... C1
3.2 Overseeing................................................................ C2
3.3 Legal Liabilities........................................................ C2
3.4 Decision making....................................................... C2
3.5 The purchasing process............................................ C9
3.6 Other methods of acquisition................................... C10
4 Instructions................................................................................. D1
4.1 Summary................................................................... D1
4.2 Legal requirements................................................... D1
4.3 Effectiveness of instructions.................................... D2
4.4 Evidence of giving instructions................................ D4
4.5 Providing instruction with loan equipment.............. D5
4.6 Revised instructions.................................................. D5
5 When a new device is delivered................................................. E1
5.1 Summary................................................................... E1
5.2 Acceptance checks.................................................... E1
5.3 Storage...................................................................... E4
5.4 Procedure for starting to use a new device............... E6
6 Prescription................................................................................. F1
6.1 Summary................................................................... F1
6.2 Professional prescribing of equipment..................... F1
6.3 Administrative and technical support for prescribers. F2
6.4 Prescribing policies and safety................................. F2
7 Records....................................................................................... G1
7.1 Summary................................................................... G1
7.2 Purpose of record keeping........................................ G1
7.3 Computer databases.................................................. G1
7.4 Record-keeping procedure........................................ G2
7.5 Recall of equipment.................................................. G5
8 Maintenance and Repairs........................................................... H1
8.1 Summary................................................................... H1
8.2 Division of responsibilities....................................... H3
8.3 Choice of maintenance and repair organisation....... H3
8.4 Routine maintenance................................................ H5
8.5 Cleaning and decontamination................................. H9
8.6 Planned preventative maintenance........................... H11
8.7 Breakdowns.............................................................. H11
8.8 Replacement criteria................................................. H12
8.9 Inspection, maintenance and repair of equipment
in the community...................................................... H12
9 Training...................................................................................... I1
9.1 Summary................................................................... I1
9.2 Training for professional users................................. I1
9.3 The Technical Supervisor's role................................ I2
9.4 Training for End-Users............................................ I2
9.5 Safety training for staff............................................ I2
10 Community issues................................................................... J1
10.1 Summary. .............................................................. J1
10.2 Integrated material................................................. J2
10.3 Delivery and commissioning of loan equipment.. J2
10.4 Collection of equipment when no longer needed. J2
10.5 Checking and testing of returned equipment........ J3
10.6 Adaptation of equipment....................................... J3
10.7 Insurance............................................................... J3
10.8 Device safety for surgeries.................................... J3

Appendix A1 Legislation............................................................. i
A1.1 Acts of Parliament.................................... i
A1.2 Statutory instruments............................... iii
A1.3 Selected EU directives............................. vi
A1.4 CE-marking for purchasers...................... vi
Appendix A2 Bibiliography.......................................................... xv
A2.1 MDA Publications.................................... xv
A2.2 Relevant Health and Safety
Executive publications............................. xvii
A2.3 Relevant Department of Health Circulars xvii
A2.4 Selected other reports with relevant
recommendations.................................... xix
Appendix A3 Preparation of medical devices for return to service
departments: infection hazards............................... xxvii
Appendix A4 Contact details - arrangements for reporting
incidents and ordering publications....................... xxxi
A4.1 MDA......................................................... xxxi
A4.2 Scotland, Wales and Northern Ireland...... xxxi
A4.3 Other organisations................................... xxxii
1 INTRODUCTION

1.1 SUMMARY The scope of the bulletin (which replaces HEI 98: “The management of
medical equipment and devices”) has been extended to cope with the
increasing use of medical devices in the community, and recent changes in
legislation, especially the introduction of CE marking for medical devices.
Definitions are provided for the terms used, drawing clear distinctions
between the clinically-trained and technically-trained staff who are involved
with the use, maintenance and supervision of medical devices.
The role of the Medical Devices Agency (MDA) is to promote the safe and
effective use of devices. We include information about the equivalent
organisations in Scotland, Wales and Northern Ireland.
The overall aim of the MDA is to ensure that whenever a medical device
is used, it is:
• suitable for its intended purpose;
• properly understood by the professional user;
• maintained in a safe and reliable condition.

1.2 SCOPE This bulletin has been prepared by the Medical Devices Agency after wide
consultation. It emphasises the care and maintenance issues directly related
to medical devices and offers guidance both for organisations which use
devices, and those which supply them to users. Target organisations include
community stores, hospitals, and surgeries. We concentrate mainly on
devices for which users have to be trained and regular maintenance is needed.
The main topics covered are:
• how to purchase the most appropriate device (Section 3);
• acceptance tests for newly delivered devices (Section 5);
• adequacy of instructions (Section 4);
• ensuring a client or patient is prescribed the best device (Section 6);
• maintenance and servicing (Section 8);
• record keeping (Section 7);
• training (Section 9).

A1
Section 10 covers issues peculiar to medical devices in the community.
Many topics crop up in several sections, and we have included cross
references, using an arrow mark ( ). Fig. 1 illustrates the cyclical process in
which devices are prescribed for a given patient, and then prepared for
re-use. It shows how different aspects of this process are covered in the
various sections of this bulletin.

Fig 1 Prescription,treatments, and re-use

Patient’s
clinical need Devices
available
for use
Section 7.4

Documentation

Section 8.6

Maintenance

Section 8.4
Prescriber
selects
device Check

Section 8.5
Section 5.2
Clean
Professional
user checks
Professional
user monitors

Application

This bulletin replaces HEI 98, “The management of medical equipment and
devices”, which was first published in 1982. We have updated the
guidelines in that document following recent changes in legislation, and
extended them to take account of the increasing use of medical devices in
the community.

The two major shifts in emphasis are that manufacturers’responsibilities for


safety have been extended under the Medical Devices Regulations, and that
Hospital Trusts have responded to the loss of crown immunity by introduc-
ing risk management procedures.

1.3 TERMINOLOGY The following terms have been defined for the purposes of this bulletin:
Carer: A lay helper, often unpaid, who looks after an end-user (e.g.
patient’s spouse).

A2
Client: Someone who enters the community equipment provision system
via a social services department.

Clinical supervisor: A clinically trained person responsible for the safe use
of a medical device (e.g. ward manager).

Community healthcare: Any healthcare provision outside a hospital,


including private nursing homes and practices.

Device management procedure: A document including policies for


purchase, responsibilities for maintenance and training, and actions needed
in cases of breakdown or adverse incident.

Device provider: An organisation which issues equipment to an end-user


(e.g. Disablement Services Centre).

Device purchaser: An organisation which buys or leases products from the


supplier.

End-user: A patient or client who uses a medical device unsupervised at


home (e.g. wheelchair user).

Medical device: Table A1 gives examples - most healthcare and disability


equipment is included.

Planned preventative maintenance: servicing operations carried out at


fixed intervals by technical staff.

Prescriber: A person who decides which is an appropriate device for a


given patient or client (e.g. occupational therapist).

Professional user: Qualified person using devices as tools (e.g. dentist).

Supplier: The manufacturer, or their agents.

Routine maintenance: Inspection and device-care operations carried out


by end-users and professional users.

Technical supervisor: A person in charge of acceptance testing,


installation, repair and maintenance (e.g. biomedical engineering
department manager).

User organisation: A device purchaser which either uses devices (e.g. a


hospital trust) or loans them to end-users (e.g. a community store).

A3
Table* A1.Medical devices under the Medical
Devices Regulations

Equipment function Examples

Diagnosis or treatment of disease syringes, dressings, catheters, surgical


instruments, anaesthetic equipment,
implants, scanners, X-ray machines,
diagnostic laboratory equipment

Monitoring of patients ECG, pulse oximeter

Critical care ventilators, defibrillators, baby incubators

Care of disabled people orthotic and prosthetic appliances,


wheelchairs,hoists, walking aids

Care in the home urine drainage systems,


domiciliary oxygen therapy systems,
pressure care equipment

Emergency services stretchers, trolleys, resuscitators

* Tables in this bulletin are primarily checklists - only some of the possibilities listed will be
relevant to any given organisation.

1.4 ORGANISATIONS We have used standard terms to describe the organisations and people
AND ROLES involved, to avoid confusion. The term “user” is a particular problem, with
three different meanings:

• manufacturers often refer to purchasers as “users” - this becomes user


organisation in this bulletin;

• the trained and qualified person who operates a device for the benefit
of a patient or client is the professional user;
• the patient or client who uses the device themselves is the end-user.

As well as prescribers, professional users, and end-users, people with


technical or managerial roles are often involved. These divide into two groups -
those with engineering, physics or technical training, and those with a clinical
background - technical supervisors and clinical supervisors.

A4
In the simplest cases only one individual performs all the roles - a dentist
working in the community buys her or his X-ray machine, supervises
maintenance, and is the professional user.

Sometimes there are only two people: a prescriber such as an optometrist,


and the end-user of the contact lenses they provide.

More complicated examples in larger organisations involve up to four


people: for example, a patient in hospital has a ventilator prescribed by a
doctor, and operated by a nurse. Both the ward manager (clinical
supervisor) and the medical engineering department manager (technical
supervisor) have supervisory roles. Table A2 lists the many alternative
names for medical engineering departments.

Table A2 Medical Engineering department names


Abbreviation Name
BME Biomedical Engineering
CE Clinical Engineering
EBME Electronic and Biomedical
Engineering
EME Electromedical Engineering
MEMO Medical Equipment Maintenance
Organisation
MEMS Medical Equipment Maintenance
Service
MP Medical Physics*

* Some medical physics departments are staffed only by physicists and work on metrology,
dosimetry, and equipment quality assurance and only undertake limited equipment maintenance
- in such cases there will generally be a separate engineering department.

In the community, a client is prescribed a pressure-relieving mattress by an


occupational therapist, and lent the mattress by the Community Store (the
device provider). The store manager is the technical supervisor, and the
client (the end-user), or their carer, operates the mattress.

Defining the responsibilities of the various participants and identifying their


training needs is one of the main aims of this bulletin. We have found that
lack of clarity has led to inadequate patient care, or even harm.

A5
We have distinguished between supervision - the direct day-to-day control
of devices, and overseeing - the generation of guidance and policy for
supervisors and purchasers.

1.5 MEDICAL The MDA has been providing advice in this area for over 25 years.
DEVICES Illustrative examples of MDA experience are provided, set in boxes
AGENCY (MDA) throughout the text of this bulletin. While not intended as guidance, these
examples are concrete and varied, and aim to help focus thinking, and to
show how people have responded to conflicting pressures, especially
financial stringencies.

The MDA collates and investigates reports of adverse incidents (hazardous


or potentially hazardous occurrences involving medical devices, which have
harmed patients, end-users or professional users, or put them at risk), and
this activity provides an overview of the causes of problems with medical
devices. These include:

• inappropriate use;
• inadequate training;
• poor quality, obsolete, or worn-out devices (but see Examples A1 and A2);
• mistakes in servicing or lack of servicing;
• incompatible ancillary equipment (e.g. leads, probes, infusion sets);
• poor documentation (e.g. service history or manuals missing).

Example A1 When should defibrillators be Our experience is that, unless


scrapped? positive steps are taken, the
MDAreceived a query from an Ambulance trust about the same adverse incidents happen
possible hazards of using old monitor/defibrillators: again and again. We can issue
“this trust does not have a time-based replacement Hazard and Safety Notices, but
programme. ..some of our machines have been in service
for 10 years.” ( Sections 3.4, 7.4, and 8.8.) these are effective only if safety-
conscious local management
Examination of MDA Adverse Incident files showed no makes sure the information
evidence of increased failure rates due to age. MDAadvice reaches professional users (and
was that, if manufacturer’s instructions regarding end-users where relevant), and
preventative maintenance were followed and if equipment
is then acted upon. Good device
met the tests defined in those instructions, the equipment
was safe to use. management could in many
cases prevent adverse incidents
However staff may not know how to use old-model
defibrillators in an emergency, because their training has
occurring, or reduce their
been on more recent models, and manufacturers may not potential for harming people.
provide service support for old models.
Decisions affecting devices
should be taken by people with
appropriate qualifications and experience who are assigned specific
responsibilities. A mistake in the selection of a device at the time of
purchase can mean that it will never give satisfactory service. The MDA

A6
runs a programme to evaluate medical devices; and publishes reports with
in-depth technical and user information covering single products and
comparative reviews of all the products on the market. Specialist technical
and other advice is available from the appropriate Evaluation Centre
( Appendix A4.1).

Example A2 Worn out pressure-relief mattresses


Foam pressure-relief mattresses no longer fulfil their function after long use, and
may even cause harm, despite appearing fit for issue from a community store when
subjected to a cursory visual inspection.
An adequate inspection should include:
• a careful check for permanent indentations in the central area of the mattress;
• a check for tears in the cover - moisture ingress is known to accelerate loss
of core resilience;
• if possible, the use of a spring-loaded calliper to compare the thickness
under load at a corner (unworn) with the centre of the mattress.

1.6 BEST PRACTICE Device purchasers and providers should develop and implement a device
management procedure. The aim is to ensure that whenever a medical
device is used, it should be:
• suitable for its intended purpose;
• properly understood by the professional user;
• maintained in a safe and reliable condition.
The device management procedure should include policies for the purchase,
acceptance, maintenance, repair, monitoring and replacement of devices,
and for the training of users. This is necessary to ensure the safety of
professional users, patients, and third parties.

This bulletin provides guidance on setting up such policies. Its aim is to


provide guidance for optimising the safety, availability and usefulness of
medical devices within existing provision and prescribing practice, rather
than to examine policy changes.

1.7 ENGLAND, Although the MDA has a UK-wide role as the Competent Authority (the
SCOTLAND, medical device industry regulator - see Appendix A1.4), the agency is
WALES AND directly responsible for investigating incidents and publishing safety
NORTHERN information only in England.
IRELAND
In Scotland and Wales the Scottish and Welsh Offices respectively have
overall responsibility for the safety of medical devices. Incident
investigation in Scotland is conducted by Scottish Healthcare Supplies, and
in Northern Ireland by the N.I. Defect and Investigation Centre.

A7
Appendix A4.2 contains all the relevant contact details, and references to
regionally produced documents on how to report incidents.
In practice all these bodies cooperate closely, and in many cases the same
(or very closely similar) safety publications are issued throughout the UK,
although often with different reference numbers. Appendix A2 gives
regional reference numbers for some recent publications.

A8
2 STRATEGIES FOR DEPLOYING,
MONITORING AND CONTROLLING
DEVICES

2.1 SUMMARY The decision to set up a device pool or library is a difficult one. We weigh
up advantages and disadvantages, setting improved utilisation and
maintenance against problems of accountability, access, and tracking.
In a hospital context engineering and clinical staff share the device
management tasks and responsibilities. This can lead to communication
problems, and confusion about who is responsible for training and for safe
device operation. Possible solutions include appointing a medical device
coordinator, and setting up a broad-based medical device group. Risk
assessment is a useful technique for improving device safety.

2.2 PROS AND CONS There are two fundamentally different ways in which devices are deployed:
OF EQUIPMENT
STORES,POOLS • A central store, pool or library owns the device and is responsible for
AND LIBRARIES it. The device is borrowed by the professional user or the end-user
when needed. Examples are pressure relief cushions and mattresses
issued by community stores, and infusion pumps and ventilators in
many hospitals.
• The device belongs to the professional user, or the user’s unit or
department. Examples are fixed installations such as large X-ray
machines, and smaller, critical-care devices in some intensive therapy
units. Artificial limbs issued to amputees are a community example.

Belonging in this sense is nothing to do with legal ownership - these ways


of deploying devices apply equally whether they are sold, lent, or leased by
the manufacturer or supplier. There are important issues, mainly concerning
liability, to do with leasing or lending - these are covered in section 3. (
Example C1, and Section 3.3.)

Where it is practicable, the pool system (e.g. community stores; pools and
libraries in hospitals) has big advantages. The return-to-store/re- issue
process lends itself to regular inspection and routine maintenance. For
example devices with rechargeable batteries can be checked and subjected
to a discharge/recharge cycle each time a device returns from use, thus
maintaining high standards of reliability in the event of a power failure. (
Example B2)

B1
Table B1 Advantages and dIsadvantages of the
pool system

Advantages of the pool system


Topic Notes
Fewer devices needed for a Local reserve stocks are
given level of activity unnecessary
Central purchasing, These are easy to implement in a
maintenance and record- single central store
keeping policies
Preparation for re-use Procedures for cleaning,
decontamination, checking and
calibration can be implemented
centrally
Disadvantages
Accountability Responsibilities are divided
between clinical and technical
supervisors (see Section 8.2)
Tracking A pool system needs additional
record-keeping to track the
current locations of all devices
(see Example B1).
Access Out-of-hours access may need to
be organised (see Example B1)

However pool devices, like cars in a car pool, acquire a characteristically


battered look - they are moved around a lot, and there is a perception that
people are less careful when the device does not “belong” to them.

2.3 PROFESSIONAL When the device belongs to the professional user’s unit (e.g. an intensive
USER-CENTRED therapy unit), the person with primary responsibility for device
DEVICE management (the clinical supervisor) is generally someone working in the
MANAGEMENT unit, who has the responsibility for the way users treat the device and the
state they leave it in. The clinical
Example B1 Equipment pool - problems with supervisor’s responsibilities also
out-of-hours access.
include performance checks prior to
The biomedical engineering department in a large
use and routine maintenance (see
hospital runs a successful equipment pool system
for infusion pumps and ventilators. In order that section 8.4) such as charging
users can acquire a device when the department is batteries (Example B2).
closed, there is an open access store. This causes
record keeping and tracking problems, and has In many hospitals some important
safety implications since it relies on people using aspects of device management, such
the store knowing which device is appropriate for as record keeping and scheduling
the patient, and being able to find it. In practice the servicing, are often controlled
only way to locate equipment accurately is to
check relevant wards daily and note locations of outside the unit, and responsibility
particular devices. is split between the clinical and
technical supervisors.

B2
The hospital technical departments responsible have many different names
(see Table A2) and in this bulletin we have used Biomedical Engineering
(BME) as a generic term.
2.4 RISK
ASSESSMENT The split in responsibilities between clinical and technical supervisors has
- PROFESSIONAL some disadvantages which must be addressed if risks to patients are to be
USER INPUT controlled. Two elements of the working relationship need particular attention:

Example B2 Infusion pumps failure during • consent - professional users should


patient transfer.
be consulted about changes and be
Premature battery failure is a common device
persuaded of the need for them.
problem during the transfer of critically ill
children by ambulance between specialist units. They must feel secure and in
MDA investigations of 3 infusion pumps which control when changes are
failed showed that average battery capacity had introduced (Example B3).
been reduced by 85% due to poor battery
maintenance procedures. The capacity of some
types of rechargeable battery will only be • stimulus - someone should be
maintained if they experience regular charge/ responsible for risk assessment.
discharge cycles. Possible solutions to the Their objectives should include:
problem are regular pump servicing including encouraging improvements in
cycling the batteries, or the regular use of the
working practice which
pump in battery operated mode, rather than on
AC mains power. progressively reduce patient risk;
communicating the outcome of
risk assessments; and stimulating
continued improvement (Table B2).

Example B3 Record keeping for infusion


pumps Some hospitals have fostered the consent
The Scottish Office Home and Health
element by setting up a medical devices
Department document "The management of group with wide representation of
infusion systems" recommended improvements clinical and engineering staff as well as
in record keeping for infusion treatments. A purchasing administrators (Example B4).
hospital has done this by producing a 2-layer self
duplicating form (Fig 2), based on Appendix 7 of
Similarly some hospitals have appointed
the above document. The design was monitored
by a project team representing several an experienced nurse as the medical
directorates, and discussed with the trust’s drugs device coordinator, and allocated tasks
and therapeutics committee. including those shown in Table B2. The
The top layer of the form has an adhesive top coordinator needs training in risk
edge for attachment to patient notes, and the assessment techniques.
bottom layer is sticky backed, and wraps round
the syringe barrel or the infusion line. Staff gain
the security of a visible record of treatment
without extra form filling

B3
Fig 2 INFUSION IDENTIFICATION LABEL

Patient / Client Name


Record Number:
Date:
Start Time: (24 hr clock)
Drug / Concentration (s):

Diluent Solution:
Total Volume:
Infusion Start Rate:
Device Name & Number:
Route used for infusion
Continuous (C) / Variable (V) Infusion

Completion Time if (C); use 24hr clock

Checking Staff Names Signatures


1 1
2 2

In some cases the medical


Example B4 Terms of reference of a hospital medical
devices group. device coordinator will also
A hospital has recently set up a medical devices group: an act as MDA liaison officer,
inter-departmental working party for developing procedures for reporting incidents, receiving
decontamination has been extended and has taken on a wider
copies of all MDA
remit, providing advice on equipment purchase, questioning
whether full running, maintenance and consumables costs publications, and making
have been considered when preparing an equipment purchase sure they reach their
bid (>Table C1). The group also seeks to intended readers (see
Appendix A4.2 for
• take risk management decisions; arrangements in Scotland,
• increase awareness of training issues;
Wales and N. Ireland).
• co-ordinate an equipment inventory;
However, when trusts
operate on several sites, it
• draw up guidelines for equipment decontamination;
may be helpful to have an
• discuss equipment management procedures.
MDA liaison officer for each
site, or for each directorate.

B4
Table B2 - Checklist for medical device coordinator
responsibilities

Area Task
Meetings Set up and service medical
devices group
Training • Run broad-based training sessions
- eg doses, dilutions, syphoning,
pressures, for ITU staff.
• Organise participation in a suitable
training scheme (see Example I1).
Information Identify key workers in each
directorate, who will keep ward
document collections up to date:
equipment manuals, training records,
MDA notices and device bulletins,
text books.
Risk assessment Devise protocols. Visit wards, apply
protocol, repeat visits to ensure
action is taken to reduce risk score
See “Risk management in the NHS”
NHS Executive 1993
(Appendix A2.4).
User/technical department interface Improve lines of communication
between users and maintenance
organisations.

B5
3 PURCHASING EQUIPMENT

3.1 SUMMARY A broad-based purchasing advisory group can help formulate a purchasing
policy which takes into account the needs and preferences of professional
and end-users, while remaining consistent and well controlled.

We review purchasing decisions of increasing complexity: direct


replacement, replacement with a new model, and acquiring a novel type of
device. In each case it is important to estimate total costs, including
amongst other costs, installation, training, consumables, maintenance,
and repair.

Fig 3 The purchasing process

YES
Has the
Oversight by purchasing
need changed?
advisory committee
NO

YES
More of Negotiate Re-order
the same?

NO

Market survey

Technical
specification Evaluation
reports
Collect
Financial data
data

Regulatory User
compliance experience

Compare cost Order


& features Negotiate

New device
supplied

Section 5.2

Acceptance tests Log details

Section 9 Section 4.3

Provide professional user Secure supply of Modify instructions


& technical staff training any consumables if required

Device ready for use

C1
The choice of model depends, amongst other factors, on fitness for use,
safety, reliability, and ease of maintenance. Relevant information needs to
be obtained from the manufacturer before purchase, including standards
complied with, manuals available, warranty details, availability of training
for users, and maintenance contracts.

There is a checklist for drafting orders, and a concluding section covering


borrowed equipment, and in-house manufacture.
3.2 OVERSEEING
Many hospitals have found it helpful to set up a purchasing advisory group
which includes clinical engineering and finance expertise and informs the
purchasing decisions. Figure 3 shows how such a committee can oversee
the complex process of making purchasing decisions.

In cases when patients are end-users (devices such as artificial limbs or


wheelchairs), local groups of users based around Disablement Services
Centres can be consulted about purchasing decisions. National groups,
such as the Limbless Association may also be able to provide useful
information. This results in greater satisfaction of end-users, and also
contributes to increased cost-effectiveness of the service. If equipment
serves its purpose well, is aesthetically pleasing and comfortable to use,
then end-users are likely to take better care of it, leading to reduced
maintenance work and improved safety.

3.3 LEGAL Employers have duties to their employees: for example purchasers of lifting
LIABILITIES and handling equipment need to know the Manual Handling Regulations
1992 (Appendix A1.2). Devices should comply with the Medical Devices
Regulations, which concern organisations supplying equipment as well as
manufacturers (Appendix A1.4).

3.4 DECISION- The simplest type of purchase involves adding to existing stock or
MAKING replacing worn out devices. Within this category, the simplest decision is
to buy the make and model currently in use. The case for purchase, and the
tendering, servicing and training arrangements will already be in place.
Considerable savings and benefits result if a single product model is used
for a given application throughout an organisation. Maintenance is
simplified and safety is optimised because user errors resulting from
confusion between similar devices are eliminated. However reliance on a
single model can cause problems if there is a sudden failure (due, for exam-
ple, to year-2000 compliance problems; see MDA DB9704, Appendix
A2.1), or a manufacturer’s recall of faulty devices, or if a manufacturer
goes bankrupt or withdraws a product line. It can also weaken the purchas-
er’s negotiating position with the supplier.

C2
For products like wheelchairs and orthoses, different models may best suit
the needs of individual end-users.
Case for replacing with a new model
Technological change may mean that more recently designed models have
significant advantages in terms of safety, performance, or value for-money,
which outweigh any extra expenditure involved in tendering, training, and
maintenance. In some cases new technology reduces running costs to such
an extent that replacement of existing devices can be self-financing (see
Example C1).

Example C1 New anaesthetic machines for


Which product meets our needs?
old. If the decision is taken to replace or add
A hospital needed to replace 15 elderly to stock with a new make or model,
anaesthetic machines - but the capital cost was
over half the total annual equipment budget. The then we move on to model selection.
selection of a machine with circle system
Case for introducing a novel device.
breathing capabilities enabled projected annual
savings on costs of anaesthetic agents sufficient The introduction of a novel type of
to pay leasing costs on new machines. Possible
problems are that all the new machines will be of
device to extend the range of clinical
facilities available (such as a thermal
a single type, increasing vulnerability to a recall.
Leasing has complex financial implications, imaging system for a hospital, or ambu-
which need expert review. NHS Executive latory infusion pumps for a community
( Appendix A4.3 for contact details) restrict the
store) is more complicated. The profes-
permitted financial arrangements and NHS
Supplies can advise on what is permissible. sionals concerned with the use or pre-
scribing of the new device need first to
make a case for the new clinical activity in which it will be used, demon-
strating that this activity has clear benefits for the patient and/or the organi-
sation, and that it is not possible to match these using existing equipment.
Before moving on to model selection criteria, it is important to make a real-
istic estimate of total costs, (Table C1) including maintenance, training,
and running costs, and to make sure that the likely benefits outweigh these
costs. This should be done for all short-listed devices. The Audit
Commission report “Goods for your health: improving supplies manage-
ment in NHS trusts” - summarised in Appendix A2.4 - offers useful guid-
ance in this area.

C3
Table C1 Total Costs checklist. In any given case only
some of these will be relevant

Cost Notes
Price In some cases manufacturers will seek to
offset low purchase prices with expensive
contracts for consumables or servicing.
Tendering Resources needed to manage and participate
in tendering process.
Risk assessment
Installation Special services (power, water, gas,
electricity) and minor building works.
Environment and safety costs.
Professional user costs Local production of procedure manuals, if
needed. Training sessions for all relevant
staff. Updating store catalogues. Complex
devices may need additional staff.
Consumables, accessories Consumable costs - are third party
and upgrade consumables or accessories cheaper
than those produced by manufacturer? Are they
fully compatible? Are they acceptable (Safety,
contract with manufacturer)? (see Example
C2). Are hardware or software upgrades
planned? - costs of retro-fitting?
Overheads Is personal protective equipment (e.g. masks,
goggles, film badges) needed?
Environmental or health monitoring costs.
Utilities Operational costs, including electricity, water,
laundering and cleaning.
Maintenance Maintenance contracts, spare part costs.
Repair Call-out charges - possible need for back-up
devices in case of failure ( Section 8.7).
Insurance costs Indemnity insurance may be needed.
Disposal Devices containing radioactive isotopes are
expensive to dispose of properly.

Example C2 Compatibility of slings and hoists


Using only those combinations of slings and hoists recommended by the manufacturer avoids
safety problems caused by incompatible slings. Factors affecting compatibility include:
• type of attachment - chain, strap, clip-on attachment;
• sling locating arrangement on spreader bars;
• dimensions of sling.
Using the wrong sling can unbalance the hoist. A risk assessment must be carried out if the use of
a third party sling is contemplated, with guidance from both sling and hoist manufacturers,
professional judgements of suitability, and advice from insurers.

C4
Model selection.
Selecting a particular manufacturer and model is the final stage of the
decision-making process.

The Medical Devices Regulations (see Appendix A1.4) will ultimately


result in all medical devices carrying a CE marking, which indicates com-
pliance with the Regulations. Thus the CE marking is no help in deciding
between models. Price, safety in the intended application (see Example C6),
quality, clinical preferences, the preferences of end-users (see Example C3)
and the implications of legal requirements are the major considerations.

In general, if a device is CE-marked, purchasers will not need to use


standards compliance to be sure that it is safe. However standards will
sometimes need to be cited in purchase
Example C3 Human and financial costs of
contracts to make sure a device is fit for
short term contracts.
the application envisaged - for example to
Purchasers who provide artificial limbs must
weigh the potential advantages of lower costs ensure it has compatible connectors.
resulting from the continual negotiation of short-
term contracts against the costs - financial and Purchasers should always consider the
human - of disruption to the longstanding training and maintenance implications of a
relationships between patients and providers of
prosthetic services. purchasing decision:

• Well-maintained equipment used by well-trained staff minimises


risks;

• In the event of an adverse incident, discovery of failures in training or


maintenance may lead to a finding of liability by the courts, potentially
leading to very large awards of damages (see Section 8.3).
Example C4 Innovative use of tendering
process to gain professional input. Procedures should be reviewed or
A community store requested all tenderers to introduced to ensure adequate inputs from
provide a sample device and its instruction clinical and professional staff,
manual on short-term loan, as a condition of especially on safety-related topics
tender. An open day was held, to which all (see Example C4).
prescribing professionals were invited. They
were asked to examine candidate devices and fill
in a questionnaire, which was heavily biassed to Table C2 lists possible factors to take into
safety considerations. Questionnaire analysis consideration.
was available to the purchasing group when it
considered tenders.

C5
Table C2 Model selection criteria

Factor Notes
Life cycle/replacement For many items, especially disability
equipment, the price is linked to solidity of
construction and quality of materials, and
hence to the useful life of the device.
Section 8.8 lists criteria for deciding when
a device needs replacing.
Fitness for intended application The device chosen must meet the user
organisation’s performance specification,
but unnecessary features may be a
disadvantage - complicated devices tend
to break down more frequently and are
harder to use (see Example C5). The MDA
Evaluation Centres ( Appendix A4.1)
offer a service on specifications.
Guarantee/warranty Compare terms. Are these negotiable?
Safety Which safety and performance standards
have been complied with? - Do MDA
publications reveal persistent problems?
(see Appendix A4.2 for equivalents in
Scotland,Wales and Northern Ireland). Can
professionals identify safety problems?
(see Example C6).
Reliability Have other users experienced problems
and 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 Does the manufacturer give free access to
technical advice, for professional users and
technical staff? - is there a 24-hour help-line?
Diversity Will this choice increase the number of types
of the device in use, and could this be to the
detriment of safety?

C6
Information about specific models
Example C5 A ventilator manufacturer
responds to market forces.
The MDA can provide a good deal of
A manufacturer replaced an existing ventilator
model with a version with a wide range of new information needed to choose the most
features, enabling many different ventilating suitable device, either in its publications
modes to be selected. Users found the new or from its Evaluation Centres
version hard to operate - choosing a given mode (Appendix A4.1).
was complicated, and there were safety concerns
about the possibility of selecting dangerously
inappropriate settings. The manufacturer saw the However the supplier is generally the
opportunity to produce a simplified version - main source of information about a given
essentially the same ventilator with a new front product. NHS Supplies has produced a
panel with simplified controls, enabling only a
limited range of functions to be selected. Both
pre-purchase questionnaire (PPQ -
models are offered for sale, leaving customers to Appendix A4.3) which many hospitals
decide which version meets their need. send to suppliers to gain information
about products. Table C3 is a checklist
of possible questions to ask potential suppliers, in order to generate useful
information about a proposed device. This list assumes the situation after
June 1998, when all new devices placed on the market must be CE-marked
under the Medical Devices Regulations. Note that active implantable
devices (e.g.pacemakers) and in vitro diagnostic devices are dealt with
under separate directives, and that custom-made devices, and devices
intended for clinical investigations are special cases ( Appendix A1.4,
which includes the definition of “placing on the market” ).

Example C6 - Professionals foresee safety A useful summary of purchasing issues,


problems. including the effects of public
One make of a sliding-turning band (for example procurement law and when you need to
for transferring a patient from bed to wheelchair) publish invitations to tender throughout
is cheaper than another. However, the cheaper
model has handles at each end, which may have
Europe, is included in “Purchasing medical
the effect of encouraging professional users or equipment” a briefing document from the
non-paid carers to use the band as a lifting sling joint NHS Confederation/ NHS Supplies
- for which it is not designed - to the detriment of working party. Summaries of this and
their health and safety. Thus, on grounds of
other documents providing advice on pur-
safety, the more expensive product should
be purchased. chasing are in Appendix A2.4.

C7
Table C3 Pre-purchase enquiries for medical devices

Topic Notes
CE-marking (establishes that device Device class.
complies with statutory regulations) Notified body involved (where relevant).
Standards (manufacturers are not Details of any quality and safety
obliged to comply with standards) standards which have been applied either
to the device or the manufacturing and
inspection processes.
Instructions Suitable for end-user. Suitable for
prescriber or professional user
( Section 4.3).
Service/repair manuals Availability and conditions of supply. Do
manuals include: circuit diagrams,
preventative maintenance schedules, trouble
shooting, repair procedures, parts list,
special tools list? Costs?
Warranty Details of cover.
Installation To be carried out by manufacturer
/supplier? Details of accommodation and
services needed. Is special
decontamination equipment needed?
(see Section 5)
Training For professional users?
For technical staff, to enable them to do all
maintenance and repair operations?
Costs?
Maintenance and repairs Can the manufacturer/supplier do this
work? On-site if needed? Response times?
Is loan equipment available to cover
periods when a device is being repaired or
serviced ( Section 8.7)? Contracts
available, costs. Does the maintenance
organisation conform to a quality
standard? Can the user organisation buy
spare parts? - For how long is parts
availability guaranteed?
Which third party servicing organisations
are approved by the manufacturer?

C8
3.5 THE PURCHASING Central Control
PROCESS
Many organisations have financial control instructions which designate a
central purchasing department as the sole body authorised to purchase or
acquire goods or services. One advantage is that a well-ordered decision-
making process can be maintained. This is nullified if individuals can place
orders without any checks on the devices selected. Particular problems arise
with donations to specified wards or directorates. However centrally
controlled purchasing can be slow and bureaucratic, and conflict with
delegation and de-layering policies.

Tender adjudication

Some of the MDA Evaluation Centres offer a tender adjudication service,


particularly for complex high-value imaging equipment.

The contract

The important thing about contracts (which can contain any lawful
conditions both seller and purchaser agree to) is that they must be agreed
before you commit yourself to a purchase. You will generally not be able
to renegotiate after the purchase has been agreed. It is possible to build
flexibility into a contract - say to agree a purchase “subject to satisfactory
replies to our questionnaire”, if there has been a delay in completing the
questionnaire. But this could lead to a lot of very expensive legal
clarification of the exact meaning of the word “satisfactory”. Many
contractual conditions are only relevant when things go wrong, not when
the relationship between seller and purchaser is a smooth one.

The order
Table C4 contains a checklist for drawing up an order.

C9
Table C4 Ordering checklist. In any given case, only a
subsetof these c hecks are likely to be relev ant

Topic Notes
Device details Type number, software version, power
supply details, professional user chosen
options, standards complied with - as
agreed and where relevant.
Manuals Professional user manuals, end-user
manuals, servicing manuals, other
technical literature (parts list, circuit
diagrams, cleaning instructions).
Warranty Specify agreed terms.
Ancillaries Leads and connectors, probes and
sensors, calibration equipment.
Consumables
Installation/commissioning Any work which the manufacturer or
supplier is to do.
Training For users or servicing personnel,
including initial training on delivery,
and on-going training needs during
operation.
Acceptance procedure Details of your acceptance procedure
(see Section 5.2).
Quantity, price, terms, discount
Maintenance agreement Intervals and response times - level of
service required and agreed cost.
Any other conditions of supply e.g. a ceiling on future prices for
consumables and spare parts.
Delivery date
Delivery point All deliveries should be addressed to a
single named department, so devices
do not get put into service without
checks (see Section 5.2).

3.6 OTHER METHODS Borrowing


OF ACQUISITION Hospitals often loan each other devices to avert temporary problems, and
manufacturers loan products for evaluation, or as an incentive to purchase.
In either case it is important to be clear about where responsibility lies
for any problems which arise when you use borrowed devices
(see Example C7).

C10
NHS Supplies has a standard indemnity
Example C7 Electric operating table appears.
form which should be used for equipment
A BME manager was called out to repair an
loans from manufacturers. They have
electrically operated operating table after a
reached global loan agreements with
breakdown. The table proved to be on loan from
several leading manufacturers, allowing
a manufacturer, the loan having been negotiated
the loaning of equipment to proceed
by surgical staff without reference to the BME
throughout the NHS in England. Similar
department. Concerns included the lack of
global agreements exist for Scotland,
electrical safety checks, the non-availability of
Wales, and Northern Ireland. Borrowed
manuals, possible effects on purchasing
devices must go through the same
decisions, and liability in the event of an adverse
acceptance procedure as newly purchased
incident.
items ( Section 5), and the administra-
tion of the loan should be handled by the central purchasing department.
The use of an indemnity form does not remove the need for manufacturer’s
quality control inspection, or for acceptance tests conducted by the borrower.

In-house manufacture

Many larger BME departments have an excellent tradition of innovative


design and construction of medical devices. However the advent of CE
marking is an added complication, because they might have to comply with
Medical Devices Regulations at the design, manufacturing, and clinical
evaluation stages (see Appendix A1.4, and the MDA Directive Bulletin 18a).
Custom-made devices - tailored to the
Example C8 Home-made spirit levels cause
needs of a single patient or client - are a
infection
special case ( Appendix A1.4). Although
A patient in an ITU died, and a number of others they do not need a CE marking, they are
were made ill as a result of an outbreak of still subject to the Medical Device
multi-resistant Pseudomonas aeruginosa. The Regulations.
source of the organism was tap water, and the
route by which it reached patients was by a Special care is needed to ensure that there
home-made spirit level used for central venous is adequate documentation for novel or
pressure measurements. MDA HN9609 unusual devices. A manual is essential,
(Appendix A2.1) recommends the use of including relevant information, such as
commercially available items. who holds circuit diagrams and computer
programs, where relevant.

Modifying and change of use

Modifying existing devices, or using them for purposes not intended by


their manufacturer, counts as manufacture of a new device under the
Regulations (see Appendix A1.4) and may have safety implications (see
Example C8). Once again the modified device can only be used without a

C11
new CE marking “on site” (i.e. within the same legal entity); the original
manufacturer’s liability will be limited; and the organisation could be
exposed to legal action if the device was implicated in an adverse incident.
Adapting devices such as orthoses or prostheses to suit an individual
end-user, following manufacturers’ guidelines, does not involve any change
of use.

Refurbishment

The term “refurbishment” is often used in the community sector for the
process of routine cleaning and maintenance which precedes the re-issue of
an item. This process is not generally “full” refurbishment. Store operators
will want to make sure that no confusion arises, because fully refurbishing
a device involves affixing a new CE-marking under the Regulations. The
best method of avoiding this problem may be to make sure that the manu-
facturer supplies suitable instructions for the cleaning and maintenance
process (making clear that what is involved is maintenance) and to follow
such instructions. The availability of maintenance instructions could if nec-
essary be made a condition of purchase.

Full refurbishment will normally either be carried out by the manufactur-


er, or following the manufacturer’s instructions for refurbishment. The key
point is that the device is put into use again “as good as new”, under the
name of the refurbisher.

After 14th June 1998 anyone doing full refurbishment as a business must
comply with the Medical Devices Regulations (see Appendix A1.4). This
may include third party organisations running community stores for social
services or healthcare trusts. The MDA view is that the regulations will not
apply if the refurbisher is a healthcare organisation which already owns the
device, and intends to use it only for its own patients. In this case the
device remains within the same legal entity throughout.

Cannibalising

Cannibalising is the process of replacing parts which have failed in service


with ones taken from other broken devices. At its most pernicious, whole
wheelchairs, for instance, are assembled from second-hand parts from many
different manufacturers.

Cannibalising cannot be recommended:

• Using spare parts of unknown quality and suitability could be negligent;


• Manufacturers will not accept liability in these circumstances;
• Traceability is impossible in the case of a manufacturer’s recall.

C12
4 INSTRUCTIONS

4.1 SUMMARY Good clear instructions have a crucial role in the safe and effective use of
medical devices. The Medical Devices Regulations make the manufacturer
responsible for supplying appropriate instructions.

User organisations must make sure that professional users and end users
have access to manufacturers’ instructions, and that, when necessary, the
information in the instructions is explained and expanded during training.
They may need to consider adding to or replacing manufacturers’
instructions in cases when they are inadequate - either because of the
context in which the device is being used, or because users have special
problems.

Loan equipment may need new sets of instructions each time it is issued,
and a procedure should be put in place to ensure that end-users have
received instructions and are aware of their importance.

Manufacturers sometimes update instructions, and user organisations need


to have systems for replacing existing instructions with revised versions,
and ensuring that the new versions apply fully to the device in question.

4.2 LEGAL Manufacturers’ instructions, as well as being practically helpful, make an


REQUIREMENTS important contribution:
• to patient and professional user safety;
• from a legal point of view.

Instructions may be either part of the labelling of a device, or a separate


manual.

The Medical Devices Regulations (Appendix A1.4) have requirements


covering the provision of adequate instructions and labels. Paragraph 13 of
the Essential Requirements (Annex 1 to the Directive, “Information
supplied by the manufacturer”), says “Each device must be accompanied by
the information needed to use it safely...taking account of the training and
knowledge of potential users....Instructions for use must be included in the
packaging for every device.” (There are exceptions for some low and
moderate risk devices.)

Manufacturers must supply information about “the nature and frequency of


the maintenance and calibration needed to ensure that the devices operate
properly and safely at all times”.

Labels also have to indicate “any special storage or handling conditions”.

D1
4.3 EFFECTIVENESS Safety issues do not stop with the device itself. Professional and end users’
OF INSTRUCTIONS awareness of relevant information is a crucial and possibly decisive factor.
FOR USE - THE Professional users should refer to manufacturers’ instructions when
NEED FOR prescribing devices. Instructions should give indications for and against the
TRAINING use of a device, including the type of use intended, and categories of
patient/client for whom the device is suitable. They should describe risks to
the patient and side effects, allowing the prescriber to weigh these against
expected benefits.
Clear responsibilities should exist for ensuring that essential information is
given to professional users and end-users (see Example D1 and Section 5.4).

Example D1 Problems with a near-patient Special problems arise when an


testing device organisation has a stock of superficially
A known diabetic was admitted to a hospital similar products with applications which
Accident & Emergency Department exhibiting need to be restricted for safety reasons.
signs and symptoms of diabetic ketoacidosis. One solution to this problem is to devise a
The patient’s blood glucose was measured at the classification and attach labels to devices
point of care using a blood glucose meter. A indicating their class. Posters at the point
separate sample sent to the hospital laboratory of use show which category is suitable for
gave a markedly different result. Insulin which application (Example D2).
treatment of diabetic ketoacidosis is titrated
against blood glucose concentrations. The Many community stores produce
hospital reported the inadequate performance of
catalogues of all the equipment they
the ward-based meter to MDA.
supply which contain guidance for
prescribers, including contraindications.
A review of the manufacturer’s instructions for
This information derives from
the meter revealed a number of contra-
manufacturer’s instructions. In some cases
indications for use (including ketoacidosis) of
prospective prescribers have to attend a
which the professional users were unaware.
training course before being issued with
Blood glucose meters may be used for the sole
their catalogue.
diagnosis and treatment of certain clinical
Instructions for the end-user
conditions. In all cases professional users should
be aware of the manufacturer’s instructions andExtra care is needed in the case when the
any contra-indications. Such information shouldend-user is a patient for whom the device
has been prescribed. Providers of equip-
be incorporated into training of all staff involved
in extra-laboratory blood glucose measurement -ment for end users should be aware of the
this is a case when instructions need legal provisions under which they may
supplementing with training. incur liability, which are outlined in
Appendix A1.
Prescribers and providers should be aware that a failure to pass on to the
end-user the manufacturer’s original instructions on how to use a device
may not only compromise the end-user’s ability to use the device safely, but
also lay the provider open to legal liability. For example failure to pass on

D2
the manufacturer’s instructions about safe
Example D2 Risk categories for infusion
pumps. use of a product could be seen to be the
Some hospitals have devised a strategy for cause of an accident - which could lay the
linking infusion pump performance to risk for authority open to legal liability, under for
various therapies. example,:
Typically there are three pump categories:
neonatal (the highest category); high risk • the Consumer Protection Act 1987,
applications; and lower risk applications. Pumps
are placed into a category using criteria based s.10 (in the case of a medical
on the MDA DB9503 (Appendix A2.1), and a device);
colour-coded N, H, or L label is attached to
every pump. A poster at the point of use has two • the General Product Safety
lists of drugs - high risk infusions for which
only high risk or neonatal pumps can be used
Regulations 1994 (in the case of a
(e.g. morphine, insulin) and lower risk consumer product not covered by
infusions, for which any pump is suitable (e.g. other specific legislation);
sodium chloride 0.9%, and glucose 5%). There
is a warning only to use neonatal category
• the common law of negligence.
pumps for any infusion given to a neonate.
Such systems have been found useful, but there
may be some problems: End-users with particular problems
• PCA (patient controlled analgesia) and
anaesthetic pumps have different controls Some users with particular disabilities or
and functions, and must never be used medical conditions will need special
instead of a general-purpose infusion pump. instructions and training from their
Labelling should indicate the type of pump
as well as the performance level;
prescriber. Basic safety and maintenance
information will also need to be supplied
• some pumps have settings which can be
altered by the user, changing their category; to all users by administrative or stores
• the infusion risk category depends not only staff. Thus the manufacturer’s instruc-
on which drug is being used, but also on the tions about safe use and maintenance of a
strength of the solution; hoist should be passed on to all end-
• there is no universally accepted procedure users. However, in addition, the pre-
for assigning a pump or drug to a category; scriber may give additional specific infor-
• a complete risk assessment must take the mation to the user and the carer, in the
patient into account as well as the drug and
the pump - systems should not be so rigid light of their particular needs and daily
that clinical judgement is fettered. routines.

Sometimes the basic information may go beyond aspects of the hardware


itself and its basic use, and indicate generally who might or might not
use it safely.

Suitability of manufacturer’s instructions

Prescribers need to be aware that some end-users (for example people who
are blind or confused) will not have access to the information in the basic
instructions, and will need special training.

D3
In such cases the user organisation may supply its own instructions, though
it will need to do so carefully, since “defensive” legal advice might suggest
that this invites legal liability. Equally, however, the provider may be
inviting liability if it knowingly passes on inadequate instructions supplied
by the manufacturer.

It may also be necessary to write instructions locally if devices are linked to


serve a novel function - for example connecting a blood analyser to a
computer system to permit automatic updating of patient records.

Table D1 provides a checklist for writing better instructions. In some


situations end-users need a telephone advice line as well as written

Table D1 Adequate instructions for end-users

Topic Notes and problems


Placement Should instructions be printed on the device
itself, or its immediate packaging, or supplied
as a leaflet?
Content Instructions must be precise and clear, and
should include commonsense advice.
Print size Users may have visual impairment.
Technical or difficult language Users may lack technical knowledge -
instructions must be comprehensible.
Translation from foreign language May not be accurate.
Translation into other languages End-users must understand the instructions.

instructions (see Example D3).


User organisations may wish, when operating a tendering process for
purchase of the items of equipment, to impose as a contractual condition
that the manufacturer must supply adequate instructions - the adequacy to
be determined by the purchaser, who must review the instructions and agree
their content.

If user organisations do draft their own instructions, they should submit


them to the manufacturer for approval.
4.4 EVIDENCE OF
GIVING User organisations may need - in the event of litigation - to be able to call
INSTRUCTIONS on evidence that instructions were given to end-users in respect of certain
types of equipment. For example, users of equipment could be requested to
sign statements to the effect that they have received written or oral
instructions - or both.

D4
Of course, quite aside from potential litigation, such a requirement is likely
to have the beneficial effect of creating a procedure whereby equipment users
do, as a matter of course,
4.5 PROVIDING receive instructions, and realise
Example D3 Home dialysis.
INSTRUCTIONS
WITH LOAN Patients using peritoneal dialysis equipment at that they are important.
EQUIPMENT home need more comprehensive backup than can
Even if the manufacturer
be provided by written instructions. A 24-hour
provided good quality
helpline gives access to expert advice, and home
instructions initially, which
dialysis nurses can be called out to help in the
were passed on to the end-
patient’s home. user of the equipment, they
will often not be returned
with the equipment. Thus, when the provider comes to reissue the equip-
ment following refurbishing there may be no instructions. Providers will

Table D2 Methods of producing instruction for


equipment loaned to patients.

Strategy Problems
Keep master copy and photocopy* May need manufacturer ’s permission.
Request additional sets Must be for the relevant model.
Attach instructions Some manufacturers screen print onto
rigidly to device. instrument cases (eg infusion pumps), but
attached instructions must survive cleaning
and decontamination (see Example D4).

need to adopt one or more of the various options in table D2 to counter


this.
4.6 REVISED * see Revised Instructions, Section 4.6.
INSTRUCTIONS
Manufacturers sometimes issue revised instructions, incorporating safer
methods of using devices, and clearer
Example D4 Attempt to attach instructions
guidance. It is important to :
permanently to a device.
A community store produced instructions on
printed plastic cards which clipped to hoists with • make sure that manufacturers keep
a key ring. They were, however, generally records of purchasing
missing when hoists were returned. It may be organisations, and automatically
necessary to ask end-users not to remove the send them copies of revised
instructions, or to make them very hard
to remove. instructions;
• check with the manufacturer that
revised instructions are actually
appropriate to the products in
service - there may have been upgrades or soft-
ware changes;

D5
5 WHEN A DEVICE IS DELIVERED

5.1 SUMMARY Acceptance checks aim to weed out faulty products and those damaged in
transit. Tests to discover whether a device is suitable for its intended
application, or whether it complies with standards are inappropriate after
delivery - this information must be generated before the device is
purchased. Manufacturers are encouraged to include a list of suitable
acceptance checks in the manual.

Some checks (for example for visible damage, and that the order is
complete) can be carried out by storekeepers or secretarial staff. Many
functional checks can be carried out by professional users or end-users,
given suitable instructions. In general calibrations and safety tests need
specially trained staff.

Large complex devices (such as sterilizers or imaging systems) need


specialists to install and commission them.

Poor storage conditions can render devices unserviceable - poor physical


conditions, and stock rotation failures are typical examples.

When a new device is first put into service, records need updating, staff
need training, and planned preventative maintenance put in place.
Professional users should be
aware when they are the first Example E1 Trolley tests in a community
person to use a new device. store
The swivel castors on a trolley were not properly
5.2 ACCEPTANCE Rationale for acceptance fixed during refurbishment, and easily dropped
CHECKS checks out in use. An end-user had an accident at home
using a newly refurbished trolley, and was
Manufacturers using the CE injured. This may result in legal action against
marking are demonstrating the store which loaned the trolley if it can be
that their products are safe shown that a reasonably competent provider
and comply with the Medical would have inspected the trolley.
Devices Directive (see
Providers/distributors within the supply chain (ie
Appendix A1.3). However all
not manufacturers) who knowingly supply
manufacturers have a small
unsafe medical devices might also incur
proportion of out-of-box
criminal liability under s.10 of the Consumer
failures, so trying to put a
Protection Act 1987 (see Appendix A1.1).
new device into service with-
out checking it can waste
time and resources. Furthermore, an organisation might be found negligent
in some situations if harm occurs which could have been prevented by
acceptance checking (Example E1).

E1
Acceptance checks are clearly not only good practice with the safety of the
end-user in mind, but also a safeguard against litigation.

Purchasers report contrasts in quality between different suppliers, and


also in relation to different shipments of the same product from the
same supplier.

Scope of acceptance checks

Acceptance checks, when equipment is first delivered, aim to ensure that the
correct device has in fact been delivered and satisfies the following criteria:

• it has been delivered complete and is in good condition without visible


defects (see Example E2);

• it is in full working order and performs as expected;

• it passes standard safety inspections applied to all the equipment in the


organisation (for example electrical safety tests);

• the controls are set to standard values for the intended application
(see Example H6).

Example E2 Burns from phototherapy device It is important to distinguish between


A patient receiving phototherapy treatment acceptance checks for newly delivered
suffered burns. The lamp - a newly delivereddevices and type-testing or attempting to
device - proved to be operating without an prove compliance with standards. Type-
essential UV filter, and to be positioned too close
to the patient. testing is not recommended or
MDA HN9606 (Appendix A2.1) describes the
appropriate for products which have been
purchased and are to be put into service,
incident. It is likely that both acceptance checks
and staff training for a new device were because in some instances it has the
inadequate. potential to damage the device under test,
and is outside the competence of most
BME departments. Appendix A1.4 gives an account of the role of standards
compliance in the CE-marking process.

Acceptance checks serve to weed out faulty product items which have
slipped through the manufacturer’s quality assurance process, or have been
damaged in transport or storage. They do not aim to test whether a given
device model is suitable for its intended use - this must be done before
purchase ( Section 3.4).

E2
When an organisation has a technical or engineering department, this can
supply the expertise needed to assess safety. Otherwise, non-technical checks
can be conducted by clinical or administrative staff, and maintenance
organisations must be relied on for technical checks (Table E1).

Section 8.4 covers acceptance checks needed after maintenance.

Acceptance procedures

Complex pieces of equipment which need to be installed and commis-


sioned should have a comprehensive set of prescribed acceptance tests.
Steam sterilizers (autoclaves) and X-ray equipment are examples of devices
which have special guidelines for installation. For other commissioning
regulations and NHS guidelines, see Appendixes A1 and A2. In these cases
installation and commissioning will need to be supervised by qualified
persons, and might involve independent experts, from MDA evaluation
centres, for example (see Example E3).

Example E3 - A hospital acquires a new For portable equipment, a variety of


imaging system. acceptance testing procedures may be
A hospital decided to extend its capabilities by
necessary - electrical safety tests for
acquiring a magnetic resonance imaging system,
example. Manufacturers may recommend
so that patients could be treated locally, instead
certain forms of acceptance testing in the
of have having to travel long distances.
device manual.
The MDA’s Evaluation Centres were closely
involved in the purchasing decision and the
All equipment new to an organisation (on
installation acceptance procedures:
loan as well as newly purchased) should
• giving advice on the specification,
including maximum resolution capacity,
be checked before issue to users (see
shielding, and manufacturers; Example E2). A central delivery point for
all products helps ensure that this is done.
• tender adjudication;
• advice on installation and acceptance The situation is complicated when
commisioning procedures;
hospitals provide devices for patients to
• training for radiographers. use at home, after they have been
discharged (Example E4). Table E1 provides a checklist for developing an
acceptance check protocol.

E3
Table E1 Acceptance checklist

Time Possible checks


Immediately on delivery • Check packaging for damage.
• Check goods against order - leads,
accessories, manuals, consumables.
• Check any identification labels against
invoice - model numbers, mains voltage.
• Check device for obvious defect or damage.
During functional and safety tests • Follow manufacturer’s instructions for
setting up and testing device.
• Check that device performs within
original specification. *
• Unless manufacturer's instructions
specifically advise against, perform
relevant safety tests.* ✝
Before first use • Perform the same checks used when a
device is returned to use after maintenance
(see Tables H5 and H6).*
• Recheck suitability of device for intended
application - see Section 6.*

* checks needing technical or clinical training.


† for example the hoist load tests needed for insurance purposes, and electrical
safety tests.
People carrying Example E4 Acceptance testing of loan enteral feeding pumps
out checks for community use.
should be A dietetics unit provides clinical support for patients using enteral
adequately feeding pumps in the community. Patients are trained to use their
trained (see pump before discharge from hospital, and are usually lent a pump
from a stock which the hospital maintains for this purpose.
Section 9).
Sometimes the pump is supplied directly by the manufacturer.
The manufacturer owns all the pumps, and is responsible for
5.3 STORAGE Inappropriate technical support and maintenance once the patient is back home,
storage of items replacing faulty pumps when necessary.
affects their Problems arise if the hospital BME department takes a long time
subsequent safe to do acceptance tests on pumps going into stock, or if they insist
that all replacement pumps must be tested in hospital before issue
use (see to patients. The manufacturer is addressing these difficulties by
Example E5). improving documentation:
Manufacturer’s • Instructions for professional users include a full functional
information and check, and pump care procedures;
instructions both • Instructions for end-users (supplied with a training video)
on storage con- include a checklist headed “Before using the pump”, with a
freephone helpline number. In addition, clinical staff who are
ditions and shelf
trained in the use of the device should check the pump when
life should be visiting the patient's home to monitor treatment.
followed. Table Hospitals could decide that professional and end-user tests
E2 is a storage constitute adequate acceptance checks for these devices, and that
checklist. they do not need to pass through the BME Department for
acceptance testing.

E4
Table E2 Storage issues

Topic Problems
Physical conditions • dirty or wet conditions;
• inappropriate temperature or humidity -
labels on packaging should indicate
appropriate storage conditions.
Storage system • stacks too high;
• fragile equipment stored too far off the
ground, likely to be damaged by falling
from shelves.
Separation of equipment needing • inadequate space for demarcated areas for
decontamination and repair from quarantine etc;
equipment ready to issue • inadequate labelling of zones;
(see Appendix A3) • inadequate packaging and labelling
of refurbished equipment.
Shelf life and stock rotation • no stock handling procedures, so earliest
deliveries are not issued first;
• inventory system does not identify out-
of-date stock;
• excessive storage times cause rubber
components to set in position
(ventilators), lubricants to migrate
(motor-driven devices) and wood to dry
out and shrink (crutches);
• shelf life of batteries and sterile products
is exceeded;
• rechargeable batteries may be damaged if
not subjected to regular charge/discharge
cycles.

Apart from possible dangers to the end-users of the equipment, poor storage
conditions also put the organisation at legal risk.

E5
Issues related to storage are Example E5 Poor storage causes problems
usefully addressed by a with endotracheal tubes
quality assurance system. A series of incidents occurred in a hospital when
endotracheal tubes failed to retain their
Table E3 lists topics which connectors, resulting in the loss of ventilation
5.4 PROCEDURE FOR during anaesthesia.
STARTING TO may need inclusion in this
Investigation showed that the tubing had suffered
USE A NEW procedure. These are primarily an irreversible loss of resilience due to poor
DEVICE the technical supervisor’s storage conditions - tubes had been stored in an
responsibility, but training unheated basement office where temperatures
will need liaison with the fell below freezing.
clinical supervisor.

Table E3 New device checklist

Topic Action
Record keeping Enter new item into inventory ( Section 7.4)
Attach label with local serial number.
Training Organise appropriate training for users:
• For new models of a familiar device:
professional users need to know how the
operator’s manual is organised, how any
controls and adjustments work, and to be
aware of potential errors arising from
misleading similarities to existing devices
(see Example E6);
• For complex or novel devices, formal training
sessions, possibly run by the manufacturer
are needed;
• Any necessary training for technical and
maintenance staff;
• Update training records.
Planned preventative • Inform users about day-to-day checks
maintenance and operations.
• Note which servicing organisation is
to be used.
• Work out date for first service, enter
in record keeping system.
• File maintenance manuals.
Labels and documentation Attach appropriate labels, possibly:
• Warning professional users that this is a new
device, and they should monitor
treatment carefully;
• Warning end-users to wait until they have
been trained;
• Giving date when preventative maintenance
will be needed;
• Giving basic instructions.
Make sure copies of manuals are supplied to
users with device (e.g. place on ward
reference shelves).
For large items, open a log book (to remain
with device) - enter acceptance test results,
who to contact in case of problems.

E6
You should treat all devices
Example E6 Hourly and Daily rates.
coming into your
Two infusion pumps made by the same
manufacturer have identical front panels, except organisation the same way,
that one pump is calibrated in mm/hour and the whether they are bought,
other in mm/day. After several adverse incidents leased or rented, borrowed or
(including fatal overinfusions) in which rates 24 on trial. Standard
times too slow or too fast were inadvertently
administered (by choosing the wrong pump) the procedures for testing newly
manufacturer supplied new stick-on labels to serviced devices ( Tables H5
cover the front panels, colour coded and with and H6) before they are
very prominent 1hr and 24hr legends. See MDA returned to use should be
HN9506 (Appendix A2.1) for more details.
Despite these changes, MDA is still receiving
applied to all devices which
similar adverse incident reports. are brand new or new to your
organisation.

E7
6 PRESCRIPTION OF DEVICES

6.1 SUMMARY User organisations are responsible for making sure that prescribing deci-
sions are made by staff with appropriate professional qualifications and
suitable experience. They may wish to limit the range of devices a given
professional group are allowed to prescribe.

Prescribers need administrative and technical support, including ready


access to technical information and advice, and to safety information. In
some situations a technician can usefully share the decision as to which
device is best for a given patient or client.

Safety must always be an over-riding consideration for prescribers, but user


organisations should beware of totally inflexible regulations, which can
sometimes result in end-users being denied the best device.

6.2 PROFESSIONAL The prescription of equipment is the responsibility of the prescribing


PRESCRIBING professionals, and user organisations will need to introduce and manage
OF EQUIPMENT procedures and policies which ensure that the prescription of different types
of equipment is undertaken by suitably qualified and experienced staff
(see Example F1).

In addition, where joint working


Example F1 Support Seating for severely dis-
arrangements are in place and involve
abled children
the “crossing of professional boundaries”
The prescription of equipment for severely
disabled children is a sensitive issue: the wrong in prescribing, providers will wish to
equipment can have permanently detrimental clarify where professional and legal
effects on the child, causing or exacerbating responsibility for prescription lies.
postural problems, skeletal deformity etc. For example, some health authorities in
Recognising this, a social services department
which does not employ specialist paediatric England and Wales have drawn up joint
occupational therapists has requested NHS arrangements with social services
paediatric therapists to carry out assessments on departments to allow NHS district nurses
its behalf. to provide equipment normally the
province of social services occupational
therapists (e.g. bath boards), and vice versa (e.g. OTs may issue com-
modes). Providers will need to be clear about where professional responsi-
bility for the issue of equipment lies, where continuing responsibility lies to
monitor the equipment and the condition of the end-user, and thus where
legal liability, in case of mishap, falls.

Organisations can adopt policies limiting which equipment certain


professionals may prescribe. Social service departments may restrict the
prescribing powers of, for example, occupational therapists both in terms of

F1
devices and client groups. Any contraventions of such policies may not
only put the end-user of equipment at risk, but - should an accident
occur - put the provider on the legal defensive, because its own policy had
been contravened. Example F2 illustrates the potential problems which can
arise if non-professionals are allowed to make prescribing decisions.

6.3 ADMINISTRATIVE Administrative and technical


Example F2 Stores Officer denies patient
AND TECHNICAL support can help prescribers crutches
SUPPORT FOR avoid hazards. Computer Some years ago, the health service ombudsman
PRESCRIBERS databases (see Example F3, found maladministration when a person leaving
Section 7.3) can build in hospital was denied crutches - not on the basis of
certain safeguards in relation a clinical decision, but of an administrative one,
made by a Stores Officer who was running out of
to safety, based on the
crutches (because they were not being returned).
information about the
equipment supplied by the
manufacturers.

When prescribing and fitting take place in separate institutions and involve
different people - prostheses are an example - then the prosthetist (the fitter)
will sometimes need to refer patients back to the consulting surgeon (the
clinician) if the device proves
Example F3 Computer systems picks up pre- unsuitable either initially or on follow
scribing mistakes.
up. In some cases the best strategy is to
The computer tracking system in a community
allow the technician to share some of
store logs the manufacturer’s maximum weight
capacity of hoists or commodes on the computer the responsibility for choosing the most
record of particular types of equipment. When a appropriate device. (Example F4).
request is input by the prescribing professional
(directly or via an administrative officer) for such
an item of equipment, the computer requires the
inputting of the proposed user’s weight. The
request may then not be accepted by the system
if the weight of the user exceeds the upper stated
weight-bearing capacity of the equipment.

6.4 PRESCRIBING Providers, and their


Example F4 Therapist and technician jointly
POLICIES AND professional prescribing staff, decide on the best chair raiser.
SAFETY necessarily develop policies The therapist recommends chair raising blocks
on safety. These should be for somebody assessed in a day centre. However,
based on reliable, up-to-date she has not visited the person’s home - so she
information - and, whilst a does not specify the particular make of block. It
is the experienced driver/technician who visits
premium must be placed on
(with two or three different types of block) who
safety issues, such policies makes the decision about exactly which make of
should not lapse into rigidity block can be used safely with the particular chair
which in some cases may be in question.
based more on administrative
convenience than on safety.

F2
This can happen in two main ways: organisations can misinterpret
statements made by a regulator (see Example F5); or they can formulate
policies in a way which allows no exceptions to rules .

For instance many social services


Example F5 User denied an appropriate hoist departments have guidelines indicating
sling.
that people with conditions such as mul-
An experienced carer - a woman caring for her
disabled husband - requested a two piece sling for
tiple sclerosis or severe epilepsy may be
use with the hoist already in the home. The social unable to use stairlifts safely. However,
services department staff told her that this was on occasion such guidelines might
impossible because of “European regulations”. become so rigid that prescribers cease to
This was misinformation: in fact what they should
take any notice of individual circum-
have referred to was an MDA Hazard Notice.
stances, diagnosis and prognosis. Were
MDA issued the Hazard Notice following an
incident in which a patient fell from a two-piece this to occur, then particular end users
sling and died two days later. The notice did not who could in fact use the stairlift safely
advise against the use of two-piece slings, but might be unfairly denied. In addition,
pointed out that they should be used carefully and the ombudsman - and even the law
selectively, in accordance with instructions - and
that carers and users should receive full instruc- courts (in judicial review) - might in
tion. The notice also referred to the fact that most some circumstances find against the
suppliers of band slings advise that they are not social services department, on the
suitable for certain people: those with extensor grounds that it had “fettered its
spasm, flaccid stroke subjects, confused people or
discretion” - i.e. that it had not properly
those with painful shoulders (Hazard(94)18
Appendix A2.1). exercised its discretion in coming to
a decision.

F3
7 RECORD KEEPING

7.1 SUMMARY Accurate and accessible records are a key factor in effective device
management. The primary functions of records include identifying the stock
of devices currently available for use, and ensuring prompt planned
preventative maintenance and rapid repairs.

Secondary functions include providing an inventory, logging service


histories, and generating management information about running costs.
Computer databases are potentially an effective and flexible way of keeping
records, but problems can arise through lack of protection against hardware
failures, and inadequate database maintenance, leading to inaccuracies.
In some cases it is convenient to have separate, cross-linked, databases
serving the inventory and maintenance functions.

7.2 PURPOSE OF Accurate and consistent record keeping is central to good equipment
RECORD management. Clear records should be kept from the outset, enabling the
KEEPING organisation to trace individual products (e.g. by serial number), or at least
particular types or batches of devices throughout their whole life.
Information available should include:

• the current location of a given item;


• its history - supplier, purchase date, service history;
• how many items are available for use (or loan);
• how many are undergoing repair or servicing.

Furthermore this will enable organisations to take appropriate action


following a manufacturer’s recall, and to satisfy various legal concerns. For
example, under the Consumer Protection Act 1987, civil liability which
would normally be attributed to the manufacturer for a defective product
transfers to the provider if the manufacturer cannot be identified.
Consumers must bring an action for harm caused by defective products
within 10 years. Department of Health guidance states that in respect of
products supplied, records should be kept for 11 years (HC(89)20)
Appendix A2.3.

7.3 COMPUTER The principles of record keeping are the same whether the information is
DATABASES stored in a manual system or a computer. Computer-based systems have
great advantages of speed and flexibility, but many problems have arisen.
Table G1 is a checklist for computer databases.

G1
Table G1 Computer databases

Issue Notes
Accuracy • Input validation is needed to avoid errors.
• Data on location of loan equipment becomes
out of date if people move the equipment
without updating the database.
Content Databases should contain sufficient but not
excessive data.
Flexibility • With purpose-written software, it is often
hard to obtain any outputs except those
planned when the system was set up.
• Proprietary relational databases will allow
flexible searches.
Reliability • A constant backing-up process is needed to
avoid permanent loss of data when drives
and discs fail.
• Hardware and software should be year 2000
compliant. (See MDADB9704, Appendix A2.1)
Stability A database on a single computer, or a very
small network, is much less likely to be
unavailable due to system crashes than one on a
large, unstable network

The ideal is to have all the data about a given device held on a single
database, available both to the professional users and the maintenance
department. It is better to have a limited computer-based system which is
wholly reliable and up-to-date, than a more sophisticated one holding a mass
of corrupt or obsolete data. The simplest way to ensure reliability is to have
one well-trained person doing all the data entry work, with data forms for
professional users and engineers to fill in. However this slows things up, and
systems in which the users and engineers do their own data entry can work
well, provided the system is easy to use, and good training has been provided.

7.4 RECORD
Inputs
KEEPING
PROCEDURE Table G2 summarises possible inputs to a device database. Simpler
databases are easier to maintain, so the minimum number of categories
should be used.

A record-keeping system should be able to generate the following outputs:

• When a device needs planned maintenance or calibration;


• When a device needs checks or tests;
• Overdue reminders for the above at intervals;
• When a device reaches the end of its planned life.

G2
Table G2 Possible inputs to a device database

When a new device arrives • Order number;


• Date of purchase;
• Local serial number (see Example G1);
• Supplier;
• Manufacturer, model, manufacturer’s serial
number, serial numbers of
component modules;
• Results of acceptance tests;
• Warranty details;
• Date of first service;
• Information about application, e.g. pump
category, hoist safe working load.
When a device is issued • Location (in a hospital);
• End-user’s address (devices on loan
in the community);
• Issue date.
When a device is returned to • Reason for return;
BME dept./store • Date of return.
When an engineer/technician • Nature of problem;
is called out • Location;
• Action taken;
• Date.
When device is in the workshop • Servicing and calibration (see Table G3)
details (including parts replaced);
• Results of safety/functional tests;
• Any modifications, including
software updates;
• Location on return to service;
• Relevant dates.
When a device is disposed of • Copy details from active database to archive;
• Record disposal details on archive.

Example G1 - Bar codes for local serial Other useful outputs include running costs and
numbers. reliability information. These can both be relevant
A community store attached pre-printed bar code to future purchasing decisions. If a high level of
strips to equipment to identify it during its life.
These facilitated stock-taking and servicing breakdowns occurs with a given model, then users
record keeping, but usage and regular cleaning should contact the Medical Devices Agency, which
posed a threat to such strips: user organisations will investigate the cause.
may be well advised to sample different brands
in order to choose the most durable - and to place
the strips in a semi-concealed position on the Cross-referencing between databases
equipment (to discourage people from peeling
them off and to provide additional physical It is sometimes administratively
protection). convenient to split the inventory/tracking function
and the maintenance/repair function into two

G3
Fig 4 Records from tw o linked databases

Code : 02305
Type : SO2MON
Maker : XXXXXX
Nodel : 3800
SN : FBFZ00769
Location : OCH_ITU
RepCost : £1,650
AcqDate : 1997/02/06
Supp1ier : xxxxxx
OrderNo : DBA10010
AssocEquipment : N
AssoCode : N
PCost : £1,650
Entered : 18-Feb-97 Inventory
RepCostDate : 18-Feb-97
record

JOB : 04203
CODE : 00029
DATE IN : 28/04/97
DATE OUT : 28/04/97
DTIME : 1
FAULT : MONITOR NOTRUNNING ON BATT.
DEFIB OK.
WORK DONE : REPBAT (COMPAT LP6-1000 FROM STOCK.
FUNCTTEST.
MHOURS : 1.0
ENG : DT Maintenance/
STEST : Y
MATCOST : £60.00 repair record
LABCOST : £15.00
TOTCOST : £75.00

separate databases. Some necessary information may only be available from


a third database holding the patient/client records. It is vital to be able to
cross-reference these databases - for instance to obtain the service history of
a device which has failed. This can be achieved by using the same local
serial number for a given device in all the databases. Fig. 4 gives examples
of typical records from a linked inventory and service/repair database - the
code records the local serial number of the device in each case. The
inventory record shows the entry on the database for a pulse oximeter - the
service record is for a single job, repairing a defibrillator. Table G3 is a
checklist of possible inputs for a maintenance database.

G4
Table G3 Inputs to maintenance database ( Table H6)

Heading Notes
Date taken out of service
Reason Planned maintenance or fault.
Faults detected or reported Use fault codes to facilitate analysis -
develop lists of codes for each type of
device.
Date on which work commenced
Parts fitted Serial numbers, costs.
Calibration and performance checks. Log data.
Safety tests Record which tests performed and
their results.
Time taken Costing purposes.
Date on which returned service Down time data generation.
Date for next service.

7.5 RECALL OF When a product Example G2 Using a computer data base to recall loan
EQUIPMENT is recalled equipment.
because it is A computer system operated by a community store allowed
faulty and poses cross referencing between the users’file and the equipment file.
a risk to profes- It was thus possible to identify quickly and reliably the location
of devices by batch and by individual serial numbers, enabling
sional users or
rapid implementation of recalls.
patients, a list of
locations of all
the relevant devices must be generated. Some recalls apply only to a given
range of serial or lot numbers, so these data must be available (see box G2).

G5
8 MAINTENANCE AND REPAIR

8.1 SUMMARY Keeping medical devices safe and effective needs both routine maintenance
procedures supervised by professional users, and planned preventative
maintenance carried out by suitably trained technicians.

Management needs to take decisions about the most appropriate strategy for
repairs and planned preventative maintenance: to use an in-house
engineering department, a third party servicing organisation, or
manufacturers’ servicing facilities.

Any servicing organisation must have properly trained staff, the correct
manuals and tools, access to spare parts approved by the manufacturer, and
adequate quality control.

Professional users and end-users are responsible for routine maintenance -


the regular cleaning, preparation for use, and checking of devices. Cleaning
and decontamination have safety implications, and Appendix A3 covers
this area in detail.

Planned preventative maintenance should follow manufacturers’ guidance


on procedures and staff training - if this, for any reason, is not practicable,
proposed changes should be approved by the manufacturer, preferably
before purchase. Devices which need maintenance work must be cleaned
and, where relevant, decontaminated before release.

Example H1 Total quality assurance in a Breakdowns can be dealt with either by


hospital biomedical engineering department. substituting an equivalent device, or by
A hospital BME department has introduced an
rapid repair. In both case planning is
ISO9002 based Total Quality Assurance system.
The quality manual defines the management needed - to be sure that suitable replace-
system, and provides an index to quality ment devices are available in the first
procedure documents, which cover all the case, and that maintenance contracts
department’s working practices. specify adequately short response times
Although the system has overhead costs (mainly
activity recording and quality audits) it is effec- and maximum down times in the second.
tive, and well-liked by staff.
Devices and equipment used in the
A similar department in a different hospital had
to abandon ISO9002 because the overheads couldcommunity present special difficulties:
not be supported, possibly because their system
routine maintenance depends on the end-
was too complicated and over-prescriptive.
user, who needs adequate instructions and
training. Planned preventative
maintenance is complicated by the need to locate devices and pick them up
from end-users’ homes.

H1
Breakdowns must be reported by end-users, who need to know when a
device is failing, and how to report defects.

Finally, a system is needed for deciding when to replace both hospital and
community devices. Criteria suggested include unacceptable levels of wear
and damage, chronic unreliability, and obsolescence.

Table H1 Responsibilities for maintenance

Hospital • Procedures for placing maintenance contracts.


/facility • Ensuring recalls and safety-related modifications take place.
management • Deciding when to use in-house, manufacturer, or third party
maintenance and repair organisations*.
• Setting training budgets which allow adequate training in
device use, safety, and maintenance.

Technical • Authorising staff to do jobs, based on their training and


Supervision experience*.
• Organising manuals, ensuring spares, tools, and test equipment
are available.
• Monitoring quality control of devices following maintenance
and repair work.
• Supervising contractor’s staff.
• Overseeing record keeping,✝ scheduling services.
• Keeping in touch with professionals users.
• Taking overall responsibility for safety.
• Giving advice to management on: technical content of repair
and maintenance agreements, what to do in a major crisis.

Clinical • Supervising routine maintenance.


Supervision • Attending commissioning of new equipment.
• Organising staff training for using new and existing
equipment.
• Overseeing planned maintenance - negotiating schedules;
dealing with necessary interruptions to maintenance
schedules.
• Overseeing handing over and receiving back devices,
making sure devices are decontaminated before release
( Section 8.5, Appendix A3).
• Checking records to see that maintenance intervals are not
exceeded.
• Making sure maintenance engineers have suitable working
conditions.
• Planning fallbacks in case of equipment failure.
• Giving advice on user interests in maintenance and repair.

*see Table H2 ✝ see Tables G2, G3 and H4.

H2
8.2 DIVISION OF Keeping a device working reliably and safely needs :
RESPONSIBILITIES
• a clear division of responsibilities between: senior management,
technical supervision, and, in hospitals, clinical supervision (see
Table H1);

• good communications between these elements, and free access to


information by all;

• a routine maintenance policy - professional users and end-users need


to know their responsibilities, and may need training;

• well-organised planned preventative maintenance.

Table H1 makes some proposals for a possible distribution of


responsibilities for servicing equipment.

8.3 CHOICE OF Table H2 lists prerequisites which apply equally whether maintenance and
MAINTENANCE repair work is undertaken in-house, by the manufacturer, or by a third party
AND REPAIR maintenance organisation. If a third party maintenance organisation
ORGANISATION subcontracts work, each of the subcontractors must fulfil the criteria in
Table H2. Table H3 is a checklist of possible advantages and disadvantages
of the three methods.

The training of technical staff is a key element in safe and effective


maintenance work. We have distinguished between the generic staff
training, which teaches the principles on which medical devices work, and
specific training relating to a given model of a given device. Both are
generally necessary - it is certainly dangerous for people without adequate
generic training to work on medical devices. Both engineering/technical
staff and professional users need training.

Manufacturer’s guidance on maintenance should always be followed,


especially when a manufacturer says a given component should not be
repaired. Section 3.6 covers refurbishment, as distinct from maintenance.
If the purchasing organisation’s intention is not to return devices to the
manufacturer for maintenance or repair, it is important to include
arrangements for maintenance staff training, availability of spares, and
approval of any proposed use of third party servicing organisations (see
Table H3) in the original purchase contract. It may not be possible to
resolve these issues after purchase (see Section 3.4).

H3
Similarly, any contract with a third party servicing organisation should
specifically address compliance with manufacturer’s recommendations:

• by the third party agreeing to follow the manufacturer’s


recommendations, or

• by including evidence that the manufacturer approves the revised


procedure, or

• by the third party accepting full liability for inadequate maintenance,


and maintenance-induced faults.

Maintenance organisations sometimes take the view that a fully qualified


maintenance engineer’s training is already adequate to deal with simple
devices, and that additional training such as a manufacturer’s training
course is not necessary. The manufacturer’s views should be sought
before purchase.

Table H2 Requirements for effective planned


preventative maintenance and repair

Personnel • Adequate generic training (engineering and technical


qualifications);
• Specific training for the given device (if
required by the manufacturer) - training records should
be available, including certificates of attendance from
manufacturer’s training courses;
• Ability to work in demanding environments - in
treatment facilities in hospitals, and client’s homes.
Hardware • Adequate provision of general workshop tools
and facilities;
• Special tools may be needed for a particular device;
• Test and calibration equipment, calibrations should be
traceable and kept up to date, as required by ISO9001/2;
• Spare parts - parts needing regular replacement should be
in stock.
Documentation • User manuals;
• Repair/Maintenance manuals including any revisions;
• Circuit diagrams/engineering drawings;
• Maintenance schedule.*
Quality control • Inspection and tests before return to use to demonstrate
the device is working within the manufacturer’s
specification;
• Record keeping;✝
• Quality assurance.

*see Table H5 for routine maintenance ✝ see Table G3

H4
Table H3a Some advantages and disadvantages of doing
maintenance in-house, as compared to using
an outside servicing organisation

Maintenance/ Advantages Disadvantages


repair
organisation

Outside • Predictable costs; • Increases routine


organisations • Possible to specify maintenance workload;
response times; • Harder to maintain cover
• Possible to specify for critical care
equipment down times. breakdowns;
• Equipment may need to
be sent to distant
locations for repair and
servicing.

In-house • Fast response possible for • Fixed overheads;


breakdowns; • Hard to maintain
• Technical staff can work adequate stocks of spare
closely with professional parts across a wide range
users; of devices;
• On site repairs can lead to • Special tools and test
short down times; equipment may not be
• May generate revenue, available;
taking in work from other • Training costs high -
organisations; manufacturers sometimes
• Often less costly than an reluctant to provide training;
outside organisation for a • In-house staff are
given level of service. typically generalist rather
than specialist.

Any departure from manufacturer ’s recommendations will inevitably carry


a risk of increased liability in the event of an adverse incident.

8.4 ROUTINE This includes inspection and device care operations performed by end-users
MAINTENANCE and professional users, as distinct from planned preventative maintenance
operations, carried out by engineers or technicians. End-users in the
community will need to perform a limited set of operations such as:

• simple equipment care, including cleaning;


• noting when malfunctions or obvious damage has occurred, and
stopping using the device;
• contacting the servicing organisation. (see Table H4).

H5
Table H3b Comparing third party, and manufacturer’s
servicing organisations

Maintenance/ Advantages Disadvantages


repair
organisation

Manufacturer • Same build standard as • Contracts with many


original device, with separate manufacturers
modifications and updates need to be negotiated and
incorporated. updated.
• Assured access to spares. • Staff needed to administer
• Remote diagnostics via the maintenance system,
computer network despatching, and receiving
sometimes available. devices.
• No problems with • Quality control must be
warranty/liability. monitored.
• Availability of training • Response times may be
for professional users. long, depending on the
contract.
• Clinical staff need long
lists of help-line numbers.

Third party • Often cheaper than • May only be available for


manufacturer. certain devices -“unpopular”
• Possible to have an on-site devices and very small
engineer to cope with numbers of devices are
breakdowns. often excluded.
• Fewer external • Manufacturers may be
organisations to deal reluctant to train personnel.
with. • Possible liability problems.

End-users should receive appropriate training. For example, for devices


whose batteries need removing before recharging, they should be shown
how to remove and insert batteries, told how long to charge them for (see
Example H2), and warned of the dangers of substituting different battery
types. For devices with moving parts such as orthoses, they should be
shown the areas in which wear first becomes evident, and warned of the
signs of incipient failure, for example cracks developing around screw
holes. Table H4 covers problems which arise when users are not equipped
to carry out these tasks.

H6
Table H4 Routine maintenance problems

Problems Notes

Failure to note emergent defects Worst case physical, mental and


perceptual capacities of user must
be taken into account. Some defects
are intrinsically hard to detect, e.g.
loss of effectiveness in pressure
relief products ( Example A2).

Failure to report defects. Motivation of end-user and quality


of service:
• access to contact details;
• quality of response to enquiries;
• effectiveness of repair/replacement
service.

Difficulties with maintenance tasks Instructions may need to be detailed,


lengthy, and difficult to perform.
(see Example H2).

End-user’s condition changes. • Decline in physical condition can


render existing equipment unsafe.
• Cognitive problems may increase
likelihood that faults will not be
reported.

Example H2 Typical instructions for charging Table H5 provides a checklist for


lead-acid wheelchair batteries. routine maintenance operations which
• Keep naked flame (including lighted professional users can undertake. In a
cigarettes and matches) away from battery. hospital context, an effective
• Use the specific charger supplied with the
wheelchair.
routine maintenance system can
• Avoid body contact with the acid which will greatly reduce the workload of a
burn. technical servicing organisation.
• Charge the battery regularly as per Professional users who have received
manufacturer’s instructions even when the
some basic training may be expected to
wheelchair is not in use.
• Keep the battery terminals clean and covered sort out simple faults (eg no mains power,
with petroleum jelly. device needs resetting by switching off
• There should be ventilation wherever the and on again), and will be able to give
charging is done, but the charger should not technical staff useful information about
be used out-of-doors.
• Contact the provider if there are any difficulties the nature of more complicated problems.
or problems.

H7
Table H5 Routine maintenance and device management
for professional user s

When? Action

Device • Obtain technical advice;


malfunctions • Withdraw from service if necessary (Example H3);
• Note problems and action.

Before use • Check leads, probes, ancillary pipework in good


order and properly assembled (Example H4);
• Check reassembly if device has been dismantled for
cleaning and decontamination;
• Do relevant functional and calibration checks, noting
results;
• Check settings of controls.

At specified • Inspect, checking known problem areas;


intervals (daily, • Note results;
weekly) • Remove from service if tests failed.

After use (and • Clean;


before releasing • Decontaminate (see next section);
for servicing) • Safely discard single use devices or other accessories
which cannot be reused.

When sending a • Include all the probes and leads needed to operate
device to be device;
repaired or serviced • Enclose as full an account as possible of any
problems (see Example H3).

When a device In addition to standard “before use” checks:


has undergone • check output levels where relevant (eg defibrillators);
maintenance • check that appropriate programs have been selected
(eg ventilators) (see Example H6).

When a serious First, take steps necessary for the well-being of the
adverse incident patient and/or staff, then:
has occurred • avoid altering settings, switching off equipment, or
(e.g. when a removing patient leads, infusion sets, ventilator tubing
patient or staff etc from any device;
member has • leave any fluids in device;
been injured or • note details of all medical equipment connected to
put at serious the patient - device type, make, model, and serial
risk) numbers;
• retain packaging for details of consumables;
• note what all displays are showing;
• note setting of controls and limits for alarms;
• with assistance from BME department if necessary,
record the contents of the computer memory logs for
any devices (eg infusion pumps) which have them;
• if possible, contact MDAbefore moving or disman-
tling the equipment (see Example H5 and Fig.5).

H8
Fig 5 Adverse incident repor ting form

CRITICAL INCIDENT ANALYSIS

• Description of incident

• Action taken to avoid harm

• Were there any deleterious effects in the patient as a result of the incident?
If so, please describe

• What, if any, were the factors contributing to this incident occurring?

• Date of incident • Title and grade of person reporting

• Time occurred (24hr clock please)

• Staffing levels (fill in as appropriate)


Nursing: (No. of nurses on duty and their grades) or
Medical: (No. of juniors and seniors)

8.5 CLEANING AND These operations are vital both in the hospital context when equipment is
DECONTAMINATION returned for servicing and repair, and for community equipment providers,
when loan equipment is returned to their store.

A failure to have effective procedures in


Example H3 Professional user report forms. place will not only put staff and the
In response to BME department complaints
about equipment returned with only a scrap of end-users of equipment at risk, but also
create a danger of legal liability being
paper towel labelled U/S attached, a hospital has
introduced a user report form (Fig 6), which is incurred if for example unsafe equipment
filled in by the user who discovers the is supplied to community end-users (eg
malfunction, and returned to the workshop with
variously under s.10 of the Consumer
the device.
Protection Act 1987, the General Product
Safety Regulations 1994, and the common law of neglience).

H9
Fig 6 Fault reporting form

Electronic Medical Device - fault reporting form


Please attach this form to faulty equipment when sending to EME dept.

Date & Time Fault Identified:

Device Model/Name:

Device ‘ZE’Number: (can be found on the red badge attached to device)

Description of Fault: (Report the last settings of the device and what you think the problem is)

Name of person reporting the fault: (print name as well as signing)

Contact Point and Telephone Number: (Ward / Dept Name)

Example H4 Checking anaesthetic machines


The Association of Anaesthetists has published a checklist for anaesthetic apparatus,
giving a list of simple checks to be carried out at the beginning of each operating
session (Appendix A2.5). These cover the correct assembly of the anaesthetic
machine and the ventilator, the correct function of monitors, and the correct setting of
alarms. The booklet notes “These checks are the responsibility of the anaesthetist and
must not be delegated to other personnel”, suggests that a record be kept in a log book
attached to the anaesthetic machine, and says “The ‘first-user’ check after servicing is
especially important and must be recorded as such.”

The Department of Health has issued


Example H5 A difficult incident investigation.
various guidance including HSG(93)26,
In a recent incident a patient died while connected
to an external pacemaker and a monitor. The “Decontamination of equipment prior to
monitor had apparently failed to alarm. The inspection, service or repair”. Further
incident was reported to MDA36 hours later, by advice is given in the Microbiological
which time the electronic internal record of the
Advisory Committee manual
monitor setting had been lost (it is maintained for
3 hours after switch off). The monitor returned (Sterilization, disinfection and cleaning
to its default settings when power was restored,of medical equipment Appendix A3).
and no fault could be discovered. Furthermore Providers should also look to
no one knew which pacemaker had been
manufacturers’instructions - which
involved.
The cause of the problem was thus impossible to should legally, in some circumstances,
determine. carry “information about the appropriate
processes to allow reuse, including
cleaning, disinfection, packaging and, where appropriate, the method of
sterilization of the device.” (Medical Devices Regulations). Appendix A3
gives guidance on setting up local procedures in this area.

H10
Table H6 Planned preventative maintenance checklist

Heading Notes

Service interval Should allow for average unavoidable delays in removing


equipment from service.

Initial inspection • Is the device clean? - has it been decontaminated?


• Likely problems - areas to check for wear.
• Note settings of controls.

Parts replaced Methods for fitting parts and reassembling device.


Calibration Values to be set, with tolerances.
Performance Acceptable limits.
Functional/safety tests Electrical safety tests where relevant. Test, e.g. brakes on
wheelchairs, kneelocks on artificial limbs.

Return-to-use checklist • Input details to maintenance database (see Table G2).


• Check device is complete with leads and probes
where appropriate, and is properly assembled.
• Return controls either to zero or to the settings noted
at initial inspection (see Example H6).
• Stick on a “JUST SERVICED/ date” label, and a note
of any alterations in control settings.

8.6 PLANNNED Manufacturer’s guidance should be followed concerning the frequency of


PREVENTATIVE planned preventative maintenance, and the checks and operations to be
MAINTENANCE carried out.

Table H6 provides a checklist for planning and carrying out preventative


maintenance.

8.7 BREAKDOWNS An efficient servicing Example H6 Overinfusion incident following


organisation aims at rapid maintenance.
A patient suffered overinfusion while using an
recovery from breakdowns. infusion pump at home. The pump came from a
The simplest method is often special stock maintained for domicilary
to substitute a similar device applications, all of which were set to a single,
in working order, though this standard, infusion rate. The pump in question
was returned, following maintenance, set to its
requires increased stock
highest rate, and issued without the rate being reset.
levels, and is not always
possible (e.g. large X-ray Maintenance organisations should reset controls
machines in hospitals; before returning devices, all newly serviced
devices should be checked carefully before
artificial limbs and specially
reissue, and have a label attached with the date
adapted wheelchairs in the on which maintenance was carried out.

H11
community). Increased stock levels can be set against the likely costs of, for
instance, paying a third party servicing organisation for 24-hour fast
response cover, or manufacturer’s call-out fees for engineers.

The next option is rapid repair; in-house servicing organisations have a


major advantage here, with qualified personnel and spares immediately
available. Repairs should be carried out with the resources and systems
listed in Table H2 in place.

Wherever possible temporary repairs should be avoided. If some temporary


expedient is needed to keep a critical device running (say during surgery),
the device should be withdrawn from service and properly repaired before it
is used again.

8.8 REPLACEMENT For both hospital and community devices, a stage is reached at which
CRITERIA replacement must be considered. Informed purchasing decisions (see Table
C2) involve making an estimate of the likely length of life of each device.
This estimate should be held in the inventory record, and a possible
procedure for determining when a device should be decommissioned is to
inspect it when the estimated length of life has elapsed. If any of the
following six criteria apply, the device is no longer serviceable:

• Worn out beyond economic repair;


• Damaged beyond economic repair;
• Unreliable (check service history);
• Clinically or technically obsolete;
• Spare parts no longer
Example H7 - Do wheelchairs need an
available;
odometer?
• More cost-effective or Many NHS wheelchair services need to have a
clinically effective policy on maintaining wheelchairs on loan to
devices have become people in the community. Recommended
available. periodic servicing and testing will not only vary
between different types of wheelchair (eg
manual or electric), but also on the type of usage
If the device survives this and the user. Thus, manufacturers’ recommen-
test, a date should be set for dations that a wheelchair be checked after a
retesting - say, in a year ’s certain period of time are of limited use. The
provision of a distance-travelled meter could be
time. considered, but the information would need
careful interpretation - some users spend 18
8.9 INSPECTION, The maintenance of hours a day in their wheelchair, but only ever
MAINTENANCE, equipment in the community move a short distance. For providers the
AND REPAIR OF difficulty lies in deciding between frequent
presents added problems.
checks, and a regime of less frequent checks
EQUIPMENT IN Community equipment, in which appears to contradict the manufacturer’s
THE COMMUNITY terms both of the state of the recommendations and hence may put the
hardware and of its safe use provider at increased risk in case of litigation.
by particular end-users, is

H12
less amenable to the monitoring and inspection possible in a hospital.
(However evidence over a number of years about the condition of hospital
wheelchairs suggests that difficulties remain even within institutions
relating to the safety of basic, widely-used equipment.)

Manufacturer’s guidelines on the frequency and nature of servicing opera-


tions should be followed (see Section 4).

Providers should put procedures in place which enable those clients most
likely to be put at risk by a device failure to be identified and appropriately
monitored.

Regular planned maintenance of major items of equipment

When supplying major items of equipment such as hoists or stairlifts,


providers will normally put in place regular maintenance and servicing
procedures, either operated by the provider or contracted out. Such
procedures may range from periodic brief visual inspection to periodic
full testing.

Table H7 Checklist for inspection and repair priorities


in the community

Topic Action

Equipment returned from loan ALWAYS clean, inspect, and service


if necessary.

Potentially hazardous equipment Inspect regularly, e.g.


(e.g. chairs, lifts, and mattresses twice a year for hoists, slings and
which are electrically powered) harnesses (SAB(89) 14, Appendix A2.1)

Equipment loaned to vulnerable • maintain register of vulnerable


end-users (see Table H4) end-users - visit regularly;
• get professionals to identify end-
users whose condition is rapidly changing,
possibly rendering prescribed devices
inappropriate, and to set date for inspection.

Encouraging defect reporting by • remind them to inspect devices in the home;


professional visitors (eg district • encourage immediate reporting;
nurses, occupational therapists, • provide a helpline for reporting faults and
physiotherapists) giving advice on action.

Encouraging defect reporting by • keep in touch at 3-monthly


end-users intervals by phone or letter;
• always ask about any device problems;
• remind end-users how to report problems.

H13
In the case of some types of equipment, sample “spot” checks (see Table
H7), in addition to programmed maintenance and servicing, may also be
employed to check on the safety of equipment in use. In addition, end-users
should anyway be encouraged to make contact with the service provider
should they suspect a possible problem
Example H8 Grants for installing
stair lifts. or defect in the equipment.
Some housing authorities provide disabled
facilities grants for people to install stairlifts Maintenance and servicing of simpler
which belong to the grant applicant not to the items of equipment.
authority. The authority may advise the
applicant about maintenance and servicing
arrangements, but the responsibility for these Different problems arise with simpler
clearly lies with the applicant. However, this devices which lack obvious hazards.
position becomes confused if, as happens in Manufacturers may provide insufficiently
some areas of the country, social services
departments pay for maintenance and servicing
detailed recommendations on servicing
for people on income support. for items which clearly require it.

Where manufacturer’s instructions are absent or inadequate, and useful


information cannot be obtained from the manufacturer, providers may need
to categorise different types of equipment in terms of risk and on that basis
arrive at reasonable maintenance and servicing schedules (see Example
H7). The provision of
Example H9 Disabled people become employers and
adequate instructions is
maintenance managers.
Under the new Community Care (Direct Payments) Act 1996, local an essential require-
authorities are empowered to make payments direct to certain groups ment for devices CE-
of people (basically, disabled people between the ages of 18 and 65) marked under the
- so that they can purchase their own community care services, Medical Devices
including disability equipment. The responsibility for arranging
maintenance and servicing will lie with end-users. However, social Regulations and the
services departments making such payments should consider advis- MDA should be
ing people fully about their responsibilities as employers or owners informed about non-
of equipment, how to go about fulfilling them, and to include with- compliances.
in the payment essential elements (e.g. for training of a carer). The
guidance also advises that local authorities “will need to bear in
mind the specialist expertise that may be needed to ensure that Many items such as
equipment purchased is safe and appropriate, and the question ofcommodes, walking
whether making a direct payment is a cost-effective way of purchas-
frames or bath boards
ing such equipment” Authorities would also need to clarify, with the
may be issued on long-
user, the ownership of any equipment, and where responsibility lies
for its ongoing care and maintenance. For these reasons the term loan to end-users,
Department considers that direct payments are unlikely to be whose “active” file is in
appropriate for purchasing complex and expensive pieces of practice closed (eg after
equipment, although they may well make sense for smaller, less six months) although
specialised items (see Department of Health guidance 1997,
Appendix A2.3). the equipment remains
on loan. Providers such
as local authority social services departments have to balance the difficulty

H14
Example H10 Training for a carer. of keeping checks on up to 50000 items
In respect of one particular severely disabled of equipment on loan at any one time
patient, the carer was specifically asked by his with the need to ensure that safety
manager to report any change in the person’s remains a high priority.
condition which makes use of the hoist more
difficult. Over a period of time, the carer failed
to report just such a change, and despite the Table H7 provides a checklist for
training sessions he had received, began to use inspection and maintenance priorities for
unsafe handling techniques. As a consequence equipment in use in the community.
he sustained a back injury and sued his employer.
The employer argued that it neither breached its
statutory duty under health and safety
legislation, nor its duty of care in the common
law of negligence.

Responsibilities for maintaining equipment.

Some of the responsibility for maintaining equipment and reporting defects


clearly lies with the end-user ( Section 8.4).

If equipment is on loan, the provider retains a greater responsibility than if


it simply transferred into the ownership of the end-user (Example H8). In
some cases the end-user does become legally responsible for maintenance
(Example H9).

Example H11. An accident with a faulty Responsibilities of staff.


orthotic device.
The user of a lower limb orthotic device reported
Under health and safety legislation, staff
that it was showing signs of wear, and was have a duty to look after their own health
offered an appointment several weeks in the
future. She had no choice but to continue usingand safety and that of others who may
come into contact with equipment they
the device: a week later fatigue caused the side
strut to snap and injure her leg. are using. For example, under the Health
and Safety at Work etc. Act 1974
(Appendix A1.1), an employee must take reasonable care for their own
health and safety, and under the Manual Handling Operations Regulations
1992, an employee “must make full and proper use of any system of work
provided for his use by his employer”.

A provider of equipment for use by an unpaid carer is in a position some-


what analogous to an employer, and should consider providing training for
the home carer in lifting and handling techniques (including the use of
hoists and hoist slings), and of health and safety generally (see Example
H10). The training should make clear that the carer has a responsibility to
take care of their own health and safety. Unpaid carers should be monitored
and supported by their care manager, who should decide when refresher
courses are needed.

H15
Repair of equipment whilst still in use.

This section concerns the actions taken by providers to deal with faulty
items of loan equipment( Section 8.7 and Table H7).

Providers should ensure that (written) instructions are given to users,


informing them about whom to contact in case equipment appears to be in
need of repair. This may apply not only to major items of equipment such
as hoists or stairlifts, but also smaller items, such as bath seats with, for
example, missing screws or exposed metal. Providers should also adopt
particular policies on repair - to ensure least disruption to the user, efficient
use of repair resources, and appropriate response times, taking account of
the patient’s level of dependency on the equipment.

In some circumstances failure to respond promptly to requests for repair


could lead to litigation if an accident were to occur as a result of continued
- and perhaps unavoidable - use of the faulty equipment (see Example
H11). Stipulated response times may vary from “immediate” in case of
emergency situations (eg malfunctioning oxygen concentrator), to very high
priority in urgent cases involving the total loss of independence
(malfunctioning hoist preventing a person getting out of bed), to lower pri-
ority for less urgent situations.

It may be preferable for both user and provider to have a general policy of
not attempting major repairs to portable equipment in the user’s home, but
instead supplying a replacement and repairing the faulty item off-site. Such
a policy means that stock levels must be adequate to provide replacement
devices ( Section 8.7). Where replacement is not possible, on-site repair
might need to be considered if the user’s independence is at risk. In
addition, removal of the equipment with no replacement might entail
increased costs of caring for the person by other means.

H16
9 TRAINING

9.1 SUMMARY Training is a key element in device safety, and training needs have been
extensively covered in earlier sections:
• training for professional users: Section 2.4;
• instructions need supplementing with training: Section 4.3,
Example D1;
• training needs when a new device is introduced: Section 5.4;
• generic and specific training for technical staff: Section 8.3;
• training needs for effective maintenance work - access to manufacturer’s
training courses: Section 8.3;
• training for end-users: Section 8.4.

This section provides checklists for the training needs and responsibilities
for professional users (including choosing the correct device, setting it up
properly for use, and recognising malfunctions) and technical supervisors
(providing training for professional users, planning technician training, and
monitoring its quality).

All staff need training in the safe use of equipment: in the case of equip-
ment for lifting and handling, user organisations have statutory duties.

9.2 TRAINING FOR Professional users need to understand the normal operation of the device.
PROFESSIONAL Where relevant they should:
USERS
• be aware of differences between models of a given device, where
these affect safety or device function;
• be able to assemble the device if it needs disassembly for cleaning,
and fit relevant accessories;
• be able to set the controls appropriately;
• be able to link the device to a patient effectively, causing a minimum
of discomfort;
• be able to show the patient or client how to use a device.

If the device malfunctions, they should be able to:

• recognise malfunctions;
• correct them, or withdraw device from service.

When the device is removed from service, professional users should know
how to clean it and to organise decontamination.

I1
Example I1 Finger on the Button The MDA perception is that many adverse
training incidents in hospitals occur during the
This is a proprietary training system early hours of the morning, and that some-
combining open learning, study days, skills times the staff involved (night staff and
training, and competence assessment. The
open learning element reduces problems for bank nurses especially) have not been able
the shift-worker, and the training and to complete relevant training. Clinical
assessment day tests competence to defined supervisors should audit training records,
standards. and ensure that all professional users are
Training is currently available for infusion
properly trained.
pumps and cardiotocograph monitors.
Contact details are in Appendix A4.3.

The MDA Evaluation Centres offer training for professional users for cer-
tain devices (see Appendix A4.1 for contact details).

9.3 THE TECHNICAL The technical supervisor should:


SUPERVISOR’S
ROLE • organise training for professional users when necessary (see
Example I1);
• ensure technical staff attend relevant courses;
• check the quality of courses;
• directly supervise people working with new devices.

9.4 TRAINING FOR Clinical supervisors need to make sure that training for end-users enables
END-USERS them to use a device safely and effectively, and to perform routine mainte-
nance (see Section 8.2). For example, end-users of ambulatory infusion
pumps should be aware of:

• how their device works, including special features such as bolus delivery;
• the risks of syphoning if a syringe is removed from a driver.

9.5 SAFETY Safe use of equipment by staff often requires training (see Example I2).
TRAINING FOR Safety training for staff is often undertaken in response to Health and
STAFF Safety Regulations - in the case of training for lifting and handling, the
Manual Handling Operations Regulations (see Appendix A1.2).

Organisations should be discouraged from taking a limited view of their


responsibilities, and where possible, should provide the same standards of
equipment and training for end-users as they do for staff.

Some providers - concerned with their duty under the Regulations - adopt a
policy of providing lifting equipment for their own staff to use in people’s
own homes - but not for end-users or their carers to use themselves.

I2
One reason for this policy is that the
Example I2 Staff training forusing lifting
and handling equipment Regulations place a duty on employers
Some NHS and social services departments towards their own employees, and not
(in Northern Ireland the Health Department towards anyone else. Apart from the fact
has sole responsibility) have both instituted that this practice may have unfortunate
training in lifting and handling techniques,
and purchased - and trained staff to use - lift- consequences for the safety of users and
ing, handling and training equipment. Such carers, providers should bear in mind that,
equipment includes, for example, hoists, given the greatly raised awareness of the
bath lifts, turntable discs, non-slip (“one dangers of back injuries from lifting, legal
way”) sheets, turning bands etc.
Specialist trainers can be used to ensure that
liability could arise (for example in
all staff involved in manual handling receive negligence) in respect of end-users and
training, with refresher sessions to keep carers injured.
up-to-date with manual handling/lifting
techniques. A discrete budget devoted
to staff safety can help identify and cost
safety activities.

I3
10 COMMUNITY ISSUES

10.1 SUMMARY Community equipment needs to be delivered to and picked up from


end-users’homes - these processes must include checks that: the correct
equipment has been delivered in good order, the end-user has received
training - or has been told not to use the device until trained, and that the
delivery and collection process does not risk cross-contamination.
Procedures are necessary to make sure that equipment is picked up as soon

Table J1 Community topics in main body of bulletin

Area Topics covered (Section)

Purchasing End-users in purchasing groups (3.2)


Sling and hoist compatibility (3.4)
Tendering for stores (3.4)
Adapting orthoses and prostheses (3.6)
Refurbishing/cannibalising wheelchairs (3.6)

Instructions Instructions for the end-user (4.3)


End-users with particular problems (4.3)
Evidence of giving instructions (4.4)
Instructions for loan equipment (4.5)

When a new device is delivered Acceptance checks for community stores (5.2)
Storage problems (5.3)

Prescribing Prescribing in the community (6.2)


Support seating (6.2)
Crossing SS/HS boundaries (6.2)
Patient denied crutches (6.2)
Prescribing mistake detected by database (6.3)
Best chair-raiser (6.3)
Stair lifts for MS patients (6.4)

Record Keeping Bar codes in a community store (7.4)


Recall of loan equipment (7.5)

Maintenance and repair End-user maintenance (8.4)


End-users with limited capabilities (8.4)
Charging wheelchair batteries (8.4)
Cleaning and decontamination for stores (8.5)
Major items: hoists and lifts (8.9)
Choosing service intervals for wheelchairs (8.9)
Repair of equipment still in use (8.9)
Maintenance priorities (8.9)

Training Training for end-users (9.4)


Training for staff (9.5)

J1
as it is no longer needed and that it is adequately prepared for re-issue on
return to the store.

Device selection, user training, maintenance and safety are issues which
must be addressed for devices used in surgeries. The procedures proposed
for hospital devices are unnecessarily complicated for small surgeries, but a
proper allocation of responsibilities is needed.

Three problem areas are covered - sterilization, dental X-ray equipment,


and resuscitators.

10.2 INTEGRATED The premise on which this bulletin is based is that good device manage-
MATERIAL ment is the same for hospitals and for the community. At every stage we
have included community examples and covered issues relating to end-
users (Table J1).

This section deals with some remaining issues.

10.3 DELIVERY AND Procedures for the delivery of equipment should pay attention to safety
COMMISSIONING issues in terms, for example, of avoidance of cross-infection (see Example
OF LOAN J1), delivery of the correct item, and commissioning (Table J2).
EQUIPMENT Clear procedures relating to
Example J1 Delivery and collection
different types of equipment are
methods which reduce cross infection
likely to contribute to greater risks.
safety. Thus a computer system This can only be achieved by using a van for
may identify equipment in terms delivery one day (or morning only), and
of whether it is simple, requires collection the next (or afternoon only) -
followed by cleaning of the van after each
assembly, requires fixing, round.
requires that a prescribing
professional be present, requires special instructions for the end-user - and
so indicate the time and personnel needed to ensure successful and safe
delivery, installation and end-user training.

10.4 COLLECTION OF From the point of view of both economics and safety, providers will wish to
EQUIPMENT have systems in place which ensure the appropriate collection of
WHEN NO equipment when it is no longer needed by users. In some instances team
LONGER budgets are credited as equipment is returned to store, putting pressure on
NEEDED
prescribers to monitor returns.

Collection systems may involve regular or semi-regular postal


communications (e.g. postcards) with users, providing with them with a
contact point should they no longer require equipment.

End-users may often not know, or remember, where to return the


equipment. Clearly marked equipment may help. Joint health and social

J2
services stores (run either by the statutory services themselves or on their
behalf by an independent third party) can make efficient collection of
equipment easier - because there is locally one obvious place for return of
equipment.

When loan equipment is withdrawn because it is faulty, the provider may


have to meet the short-term needs of the user by supplying extra personal
care, until an equivalent
replacement product is found. If Example J2 Destabilising a wheelchair
A provider may inadvertantly destabilise a
there is no equivalent suitable wheelchair by changing the frame structure
product immediately available, to accommodate a reclined backrest angle
then longer term alternatives without considering stability effects, or
may have to be considered. consulting the manufacturer. In so doing it
will have affected the safety properties of
the wheelchair, and thus probably invalidated
10.5 CHECKING AND Authorities need to have in place the CE marking which the manufacturer
TESTING OF well-organised and understood placed on the wheelchair as a sign that it
RETURNED procedures for cleaning, conformed to the essential requirements of
EQUIPMENT the Medical Devices Regulations 1994
decontaminating (see Section 8.5
(Appendix A1.4). It is possible that in some
and Appendix A3), then check- circumstances the provider will have also
ing, testing and preparing for become, for the purposes of Part 1 of the
re-issue ( Section 8.9) returned Consumer Protection Act 1987 (Appendix
equipment before it is returned A1.1), “the producer” of a new product, and
incur civil liability in the event of a
into store for reissue. Where subsequent accident.
possible, manufacturer’s
instructions or recommendations on checking and refurbishing should be
followed. Staff undertaking such checking and testing should have the
appropriate expertise.

10.6 ADAPTATION
Providers must ensure that if they adapt equipment, the product remains
OF EQUIPMENT safe (see Example J2). They should also be aware that there are particular
legal implications arising from such activities (see section 3.6).

Equipment loaned by the NHS or social services departments normally


10.7 INSURANCE
remains the property of those statutory services, and users cannot be
required to insure it.

However, where end-users are using equipment in public places (e.g.


powered wheelchairs), it may be advisable for them to consider third party
insurance against personal liability in case of accident (see e.g. HSG(96)34
(Appendix A2.3) concerning powered wheelchairs).

Most doctor’s and dentist’s surgeries own and use substantial numbers of
10.8 DEVICE SAFETY medical devices, as do chiropodists and physiotherapists. But the actual
FOR
amount of equipment in any given surgery is not generally enough to
SURGERIES
warrant setting up procedures for device management of the sort advocated
elsewhere in this bulletin (but see Example J3).

J3
Example J3 Device management in a However the key issues: device selection,
large general practice user training, and device maintenance and
A 9-partner GP surgery has 2 autoclaves, 4 safety testing, still all need to be addressed, if
nebulisers, 2 ECG machines, and several devices are to perform effectively and safely.
glucose and cholesterol measuring devices.
A member of staff responsible for estates
and equipment fulfils the technical supervisor Device selection
role, and organises servicing of equipment.
There is a third party servicing contract with Practitioners should be aware of the MDA
the local hospital’s BME department, and evaluation reports (see Appendix A2.2), which
various arrangements for external checks on offer guidance on which model to choose.
the calibration of diagnostic equipment.
Important sources of information are other
practices, and Practice Nurse Facilitators.

In general one person will be making a case for purchase (see Example J4)
and should be responsible both for gathering information before the
decision to purchase is made, for checking
Example J4 A GP selects equipment the device on delivery, and for organising any
In one large practice, equipment is selected
by “the practitioner with the greatest interest necessary training. Because all servicing will
in the area, but the purchase is authorised by generally be done by the manufacturer, cost
the partners”. It was noted that the selection and availability of servicing is going to be an
usually involved a trawl of the literature, but important factor in the selection decision.
that reference was often made to someone at
the local hospital with expertise in the
particular area. In the case of dental anaesthetic equipment,
the Poswillo report establishes the principle
that the anaesthetic and resuscitation equipment available when someone is
given a general anaesthetic in a dentist’s surgery must not fall below the
standard of hospital provision (see Example J5).

Maintenance and safety testing

Example J5 The Poswillo report on Particular care is needed when devices are
general anaesthesia, sedation and reissued to different patients. Nebulisers are a
resuscitation in dentists surgeries typical example. Reusable parts should be
The report specifies particular equipment for thoroughly cleaned and serviced following
anaesthetic monitoring: An electrocardio-
graph, a pulse oximeter, and a blood the manufacturer’s instructions, and any parts
pressure monitor. A capnograph is also (e.g. face masks) which are designated for
specified when tracheal anaesthesia is used. single patient use should be discarded on
A defibrillator must be available. return and replaced before reissue.
“Equipment conforming to recognised
standards should be purchased and installed,
regulary serviced and maintained in We have identified three areas in which
accordance with manufacturers’ instructions”. regular testing and maintenance has
important safety implication, and where
current practice may not be adequate.

J4
i) Sterilizers.
Sterilizers contain a large amount of energy when operating, so they
must comply the Pressure Systems and Transportable Gas Containers
Regulations 1989 (Appendix A1.2). These require the sterilizer
chamber to be tested at minimum 14 month intervals by a competent
person (pressure vessels). This may be undertaken by the insurer of
the sterilizer as part of their annual risk assessment. Insurance cover
for sterilizer must be with a specialist insurer: risks to staff must
be covered.

Users must be clear that the pressure vessel check does not test the
efficiency of the sterilization process and it does not check any other
safety aspects of the sterilizer, or its safety features such as door interlocks.

The Health Technical Memorandum 2010 (published by HMSO, see


Appendix A2.5) provides comprehensive advice from NHS Estates
(Dept. of Health) on sterilization. The MDA Device Bulletin DB9605
“The purchase, operation and maintenance of benchtop steam
sterilizers” (Appendix A2.1) provides guidance specific to benchtop
steam sterilizers which are not equipped with a vacuum cycle; it is a
useful guide to best practice. It notes that “failure to carry out periodic
tests and maintenance tasks could compromise safety and may have
legal and insurance implications for the user and owner of the sterilizer.”

The tests of safety and effectiveness include a daily and weekly test to
show that the sterilizing cycle is operating correctly, weekly safety
checks, and more searching quarterly and annual checks - some of
which must be carried out by someone qualified to test sterilizers,
known as a Test Person (sterilizers). Quarterly and annual tests are
often included in maintenance contracts, and the maintenance
engineers should be qualified Test Persons.

Instruments which are wrapped or placed in pouches, or instruments


with lumens, can only be sterilized in properly validated sterilizers
equipped with a vacuum stage.

An Authorised Person (sterilizers) is an independent expert who will


provide advice on all aspects of sterilizers and sterilization processes.
A list of AP(s)s is maintained by the Institute of Healthcare Engineers
and Estates Managers ( Appendix A4.3).

ii) Dental X-ray equipment.


Tests of small X-ray machines tend to be limited to 3-yearly postal
tests, when films provided by the National Radiological Protection
Board (Appendix A4.3) are exposed and returned for processing
and checking.

J5
Any changes in the exposure needed for routine X-rays may indicate
a malfunction.

iii) Resuscitators.
Dentists are advised by the Department of Health to have resuscitators
available. The equipment needed depends on the complexity of the
procedure - for local anaesthesia a kit containing a bag and a source of
oxygen is adequate. Requirements are pro-
Example J6 A resuscitator failed when
gressively more demanding if sedation or
needed.
A rubber resuscitation bag in a long-stay general anaesthesia is used.
psychiatric hospital was found to have
perished when an emergency resuscitation The problem is to maintain equipment and
became necessary. MDA issued a Safety training for devices which are almost never
Notice SAB91(46) Appendix A2.1,
recommending regular checks of valves and used (see Example J6).
rubber components of bags kept for use in
rare emergencies. Best practice is to check emergency
Legal action against the hospital ensued. resuscitation equipment daily, including:

• pressure in oxygen cylinder;


• bag working - rubber components and valves in good order;
• any drugs still in date;
• any sterile materials in date, and packaging undamaged.

J6
Appendix A1.Legislation

The following selective references to legislation are accompanied by a


number of summaries. When making policies or engaging in disputes, the
original legislation (as amended) should be consulted and professional
advice sought.

A1.1 ACTS OF Defective equipment at work


PARLIAMENT Employers’Liability (Defective Equipment) Act 1969
(except where Imposes strict liability on employers for injuries caused to employees
stated, Acts and by defective equipment - where the defect is wholly or in part the
Statutory
Instruments manufacturer’s fault. This includes where the defect is wholly or
apply in Scotland) partly the fault of a third party, not necessarily the manufacturer.
(Therefore, the employer needs to have a contractual indemnity
against manufacturers).

Health and safety at work


Health and Safety at Work etc. Act 1974. Employers must ensure, so
far as reasonably practicable, the health, safety and welfare at work of
employees. This covers eg plant and systems of work; handling/storage
of articles and substances; information, instruction, training,
supervision; any place of work under the employer’s control; working
environment. The employer must also ensure, so far as is reasonably
practicable, that non-employees who may be affected are not exposed
to risks to their health or safety.
Employees must take reasonable care for the health and safety of
themselves, and also of other people who may be affected by the
employees’ acts or omissions.

Product Safety
Consumer Protection Act 1987, Part 1. Imposes civil liability on
manufacturers (“producers”) who supply defective products which
cause harm or damage to somebody. However, there are various
defences, including the state of knowledge at the time the product was
supplied by the manufacturer: a defence sometimes known as the
“development risks defence”. Actions can be brought up to 10 years
after the product was supplied: hence the recommendation, by the
Department of Health, to keep records for at least 11 years.

Suppliers, too, may incur liability, if they are unable, within a


reasonable time, to identify the person who supplied them with the
product. (This makes good record keeping essential for providers some
way down the supply chain).

i
Consumer Protection Act 1987, s.10. Imposes criminal liability for the
supply of unsafe equipment. Though largely superseded by the
General Product Safety Regulations 1994, nevertheless s.10 of the
1987 Act continues to apply in those circumstances where neither the
1994 Regulations, nor any other specific European Directive and
corresponding UK Regulations apply.
For example, the Medical Devices Regulations 1994 impose liability
on manufacturers - but only imposes it on suppliers in limited
circumstances. Thus, were a supplier to be involved in supplying
unsafe medical devices - but the offence committed were not to fall
under the Regulations - then it might instead be caught by s.10 of the
1987 Act.

Sale of goods: quality etc.


Sale of Goods Act 1979, s.14(2B). Implies various terms into
contracts, with some distinctions between commercial and consumer
contracts. In particular, there is an implied term as to the “satisfactory
quality” of goods. The quality of goods includes “their state and
condition” and aspects of quality include fitness for purpose,
appearance and finish, freedom from minor defects, safety and
durability. Breach of implied terms may give rise to a legal remedy
against the contracting party in breach.

However, it has been established in the law courts that NHS patients
do not enter into a contract with the NHS when they are supplied with
equipment - even if they pay a prescription charge (Pfizer Corporation
v Ministry of Health [1965] AC 512, House of Lords). On the same
principle, it is therefore similarly assumed that users of other statutory
services do not enter into contracts, whether or not a payment is made
- for example, when people are loaned equipment by social services
departments (who might sometimes impose charges).

Supply of Goods and Services Act 1982. Contains similar provisions to


the Sale of Goods Act 1979 (see above) in relation to the hire of
goods.

Supply of Goods (Implied Terms) Act 1973. Contains similar


provisions to the Sale of Goods Act 1979 (see above) in relation to the
hire purchase of goods.

Unfair Contract Terms Act 1977. Contains various provisions


governing the exclusion or restriction of legal liability for breach of
contract.

ii
For example, it absolutely prevents such restriction in relation to
personal injury or death arising from negligence - but allows it, though
subject to a test of unreasonableness, in the case of other harm arising
from negligence. The Act applies in this respect not only to contract
terms but also to “notices” - thus covering non-contractual situations
as well. For instance, the loan of wheelchairs by the NHS to users is
non-contractual; it could not exclude liability for negligent supply
resulting in injury simply by giving the user a notice to that effect. It
also controls attempts at restriction of contractual liability arising from
the sale and supply of goods under Sale of Goods Act 1979 etc.

A1.2 STATUTORY Control of substances hazardous to health


INSTRUMENTS SI 1994/3246. Control of Substances Hazardous to Health
Regulations 1994.

Electrical
SI 1994/3260. Electrical Equipment (Safety) Regulations 1994
Place obligations on both manufacturers - but also on other suppliers
(eg wholesalers, distributors, retailers) to ensure that the equipment
they supply is safe and bears the CE marking. No obligation is
imposed to safety test secondhand equipment, but Department of
Trade and Industry guidance points out that suppliers will want to
ensure that equipment is safe so as to avoid the commission of
an offence.

The Regulations do not apply to items covered, for example, by the


medical devices or machinery directives/regulations.

General product safety


SI 1994/2328. General Product Safety Regulations 1994.
These Regulations apply to products “intended for consumers or likely
to be used by consumers” and which are not already covered by other
specific European Directives (e.g. the Medical Devices Directive).

Basically, “producers” - i.e. manufacturers, importers, own-branders,


and “professionals in the supply chain, insofar as their activities may
affect the safety properties of a product placed on the market” - must
not place unsafe products on the market. Provision of information
about the risks of using products must also be supplied to consumers.

In addition, “distributors” - i.e. professionals in the supply chain whose


activities do not affect the safety properties of products - must a) not
supply products they know, or should have presumed, are dangerous, and
b) must participate in monitoring the safety of products, pass on informa-
tion about risks, and cooperate in action taken to avoid the risks.

iii
Health and safety at work (general)
SI 1989/635. The Electricity at Work Regulations 1989.

SI 1992/2792. Health and Safety (Display Screen Regulations) 1992.

SI 1992/2865. Management of Health and Safety at Work Regulations


1992. Imposes various duties on employers including formal risk
assessments, and planning, organisation, monitoring etc of activities in
the workplace etc.

SI 1992/2932. Provision and Use of Work Equipment Regulations


1992. Places duties on employers to select and maintain suitable
equipment at work.

SI 1992/2966. Personal Protective Equipment at Work Regulations


1992 amended in 1994 SI 1994/2326.

SI 1992/3004. Workplace (Health, Safety and Welfare)


Regulations 1992.

Ionising Radiation
SI 1985/1333. Ionising Radiations Regulations 1985.
Place a range of duties on both employers and employees.

SI 1988/778. Ionising Radiations (Protection of Persons Undergoing


Medical Treatment) Regulations 1988.
Employers must ensure that employees carrying out examinations
involving such radiation are qualified and have an appropriate
certificate, and must keep records of training.

Lasers
SI 1984/958. Nursing Homes (Lasers) Regulations 1984. (No Scottish
equivalent)

Manual handling
SI 1992/2793. Manual Handling Operations Regulations 1992.
Basically, employers must, “so far as is reasonably practicable, avoid
the need for his employees to undertake any manual handling
operations at work which involve a risk of their being injured”. Where
such operations are not avoidable in a reasonably practicable way, the
employer must “make a suitable and sufficient assessment of all such
manual handling operations”, and “take appropriate steps to reduce the
risk of injury” to employees “to the lowest level reasonably practicable”.

iv
Employees, too, must “make full and proper use of any system of
work provided for use by his employer in order to reduce the risk of
injury”.

Machinery
SI 1992/3073. Supply of Machinery (Safety) Regulations 1992
(amended by SI 1994/2063).
These Regulations, rather than the Lift Regulations 1997, cover
stairlifts. See Health and Safety Executive, Field Operations
Directorate, Operational Minute OM 1997/119 (Appendix A4.3).

Medical devices
SI 1994/3017. Medical Devices Regulations 1994. These are explained
more fully in Appendix 1.4.
However, basically, the Regulations state that, from 14th June 1998,
all medical devices placed on the market or put into service must
comply with the essential requirements laid down in the EU Directive
on medical devices. For the most part, devices must carry a CE
Marking (but eg not custom-made devices or some devices intended
for clinical trials). The Regulations apply, in the main, to manufacturers
when they first place a device on the market (eg sell it), and to
anybody who fully refurbishes a product (and thus becomes the
manufacturer of what is effectively a new product).

Exactly what is to be treated as a medical device, and what is not, will


depend on the interpretations and intentions of manufacturers, the
influence of guidance issued by the Commission and the Medical
Devices Agency, and any decisions of the law courts. Both criminal
and civil liability may arise from breach of the Regulations. A defence
of “due diligence” is available.

Pressure systems/transportable gas


SI 1989/2169. Pressure Systems and Transportable Gas Containers
Regulations 1989. Places various duties on both the
manufacturers/suppliers and users of pressure systems - including, for
instance, the requirement of a written scheme providing for periodic
examination by a competent person.

Reporting of injuries etc.


SI 1985/2023. Reporting of Injuries, Diseases and Dangerous
Occurrences Regulations 1985.

Contracts
SI 1993/3228. Public Services Contracts Regulations 1993.
SI 1995/201. Public Services Contracts (Amendment)
Regulations 1993.

v
A1.3 SELECTED EU 85/374/EEC Directive concerning defective products (Consumer Protection
DIRECTIVES Act 1987)
89/392/EEC (as amended) Directive concerning machinery
90/269/EEC Directive concerning manual handling of loads (Manual
Handling Regulations 1992)
90/385/EEC Directive concerning active implantable medical devices
(Active Implantable Medical Devices Regulations 1992 SI 1992 3146; The
Active Implantable Medical Devices (Amendment and Transitional
Provisions) Regulations 1995 SI 1995 1671)
92/59/EEC Directive concerning general product safety (General Product
Safety Regulations 1994)
93/42/EEC Directive concerning medical devices (The Medical Devices
Regulations 1994 SI 1994 3017)

A1.4 CE-MARKING Terminology


FOR
PURCHASERS1 Compliance means showing that a product conforms to the medical device
directives, which lay down “common standards of performance and
safety”8 applying throughout the EU. The Medical Device Directive itself
covers the vast bulk of medical devices - there are also two specialist
directives, for active implantable devices (eg pacemakers) and in vitro diag-
nostic devices (eg AIDS test kits). The latter is still only a draft directive
.
Conformity Assessment route is the process by which a manufacturer
“demonstrates compliance” - i.e. becomes entitled to apply the CE marking
to a medical device. The rigour of the conformity assessment route required
depends on the risk category of the device. MDA Directive Bulletin 4 gives
details, Appendix A2.1.

Declaration of Conformity is a signed statement by a manufacturer


recording the fact that a product conforms to the essential requirements
listed in the relevant directive. This may be based on an external test or
assessment, or it may be a self-declaration.

The Competent Authority is the national regulator - the MDA acting on


behalf of the Secretary of State in the case of the UK.

1Superscript numbers give the MDADirective Bulletin number, from which a quote is taken. MDD
means a quote from the Medical Devices Directive, which is a European Union document. The Medical
Devices Regulations (SI 1994/3017) is the UK law - a statutory instrument pursuant to the Consumer
Protection Act (1987), implementing the directive. See Appendix A2.1 for Directive Bulletin titles.

vi
A Notified Body is the “third party” - independent of Competent Authority,
manufacturer and user - which actually undertakes the assessment of
conformity. Notified Bodies charge manufacturers for the service they
provide, and are designated and controlled by the Competent Authority.

A Manufacturer can be a company or an individual (legally, a person). If


the manufacturer is based outside the EU, then the manufacturer’s
authorised representative - generally the distributor - can become
responsible for CE-marking if this is administratively more convenient.
The Regulations define the manufacturer as the “person who is responsible
for the design, manufacture, packaging and labelling of a device before it is
placed on the market under his own name, regardless of whether these
operations are carried out by that person himself or on his behalf by a
third party”.

Meaning of CE-marking

At present many medical devices are CE-marked - from June 1998, under
the Medical Devices Regulations (SI 1994/3017), all medical devices
placed on the market (made available for use or distribution even if no
charge is made) must conform to the “essential requirements” - including
safety - required by law, and bear a CE marking as a sign of that
conformity. Although most of the obligations contained in the Regulations
fall on manufacturers, purchasers who are positioned further down the
supply chain may also be liable - for example, for supplying equipment
which does not bear a CE marking or which carries a marking liable to
mislead people (Regulation 18(2) of the Medical Devices Regulations).

Exceptions are:
• In-vitro diagnostic devices - will in due cause be covered by a separate
directive, currently still being prepared.

• Active implants - covered by the Active Implantable Medical Devices


Regulations.

• Devices made specially for an individual patient (“custom made”).

• Devices undergoing clinical investigation.

• Devices made by the organisation (“legal entity”) using them.

The last exception is likely to be interpreted narrowly - an individual hospi-


tal trust, rather than the NHS, is a “legal entity” in this context. Directive
Bulletin 18A gives details.

vii
Another major exception will apply to some devices that are first placed on
the European (including UK) market on or before 14th June 1998. Until
that date, manufacturers have the option of satisfying the requirements of
the Medical Devices Directive and applying a CE marking, or satisfying the
previous legal requirements in each country. In the UK, there were no
specific laws about the marketing of medical devices, so purchasers of
devices not marketed under the terms of the Medical Devices Directive
need to seek other evidence that the devices are safe and will perform
correctly. Appropriate evidence is a certificate of conformity with relevant
standard(s) and/or confirmation that the manufacturer is registered in
MDA’s Manufacturer Registration Scheme.

This situation will continue to apply to some devices even after 14th June
1998, if they have been “placed on the market” by the manufacturer by that
date but have spent some time in the hands of a distributor before reaching
the final customer.

CE-marking means that the “Manufacturer claims his product satisfies the
requirements essential for it to be considered safe and fit for its intended
purpose”2 . In practice, the product has been “assessed in accordance with
Directives”2 and “meets all the relevant provisions of Directives which
apply to it” 2. Annex 1 of the Medical Device Directive lists the essential
requirements which a device must satisfy. Table App1 summarises
the general scope of the requirements, and is in no way exhaustive
or authoritative.

viii
Table App1 A summary of the Essential Requirements of
the Medical Devices Directive

Topic Notes
General A device must not harm patients or users, and any risks
requirements must be outweighed by benefits. Design and construction
must be inherently safe, and if there are residual risks,
users must be informed about them. Devices must per-
form as claimed, and not fail due to the stresses of normal
use. Transport and storage must not have adverse effects.

Design and - must involve the use of suitable materials (low toxicity
construction and flammability, biocompatibility, compatibility with
associated drugs and gases). Devices must not leak, or
allow foreign substances ingress.

Infection and - must be avoided, both by good design, careful


microbial manufacture, the use of validated sterilisation processes,
contamination and adequate packaging.

Mechanical - must be sound, minimising risks to users from physical


construction features, and from any likely environmental impact (eg
electrical interference) or loss of calibration.

Measuring devices - must have adequate accuracy and stability, and be easy
to read.

Exposure to - must be reduced as far as possible, compatible with the


radiation intended purpose of the device. Devices emitting ionizing
radiation must have adequate controls, and enable reliable
monitoring of doses when intended for therapeutic use.

Built-in computer - must be repeatable and reliable. Battery power supplies


systems on which the patient’s safety depends must alarm when
the battery is low. Monitors must alarm when the patient
is in a dangerous state.

Electrical and - must minimise electromagnetic emissions. Devices


electronic design should not give users electric shocks.

Mechanical design - must protect the user from moving parts, vibration, and
high sound levels . Terminals and connectors for linking
devices to mains electricity supplies and gas pipelines
must minimise risks. Accessible parts must not get too hot.

Devices which - must be designed so the flow rate can be set to a


deliver fluids to a suitable level and accurately maintained, to guarantee
patient the patient’s safety. There must be safeguards against
overdoses. Devices which supply energy to the patient
(such as defibrillators) must meet similar criteria.
The function of must be clearly marked.
controls and indicators

ix
Consumer Protection

The Medical Devices Directive clearly provides a very useful measure of


consumer protection, especially as regulators, after taking safeguard action
in their own country, can notify the Commission and other member states,
with the likely result that sales would be banned throughout the EU. The
MDA has various powers under the Consumer Protection Act to issue warn-
ings or remove devices from the market.

The essential requirements cover a wide range of potential problems. For


example portable infusion pump problems typically include:

• failure to meet manufacturer ’s claims for dose control accuracy;


• unexpected battery failure;
• under or over-infusion incidents.

The following essential requirements from the Medical Devices Directive


might be relevant:

3. The device(s) must achieve the performance intended by the manufacturer.


12.2 Devices where the safety of patients depends on an internal power
supply must include an alarm system to signal any power failure.
12.8.1 Devices for supplying the patient with energy or substances must be
designed and constructed in such a way that the flow-rate can be set and
maintained accurately enough to guarantee the safety of the patient and of
the user” MDD

One function of requirements of this sort is to provide regulators with a


clear set of grounds for prohibiting the marketing of a given device.
However, as all devices must conform, there is no possibility of using the
CE marking to select a given model.

The compliance process

The Regulations in several cases provide manufacturers with a choice of


methods for demonstrating that a particular device complies with the
essential requirements. The alternative routes are equivalent - whichever
route is chosen, compliance is ensured. The following summary of the
conformity routes is included here to show how the severity of the confor-
mity testing process is graded to meet the possible risks of using a device,
and to clarify the alternatives available.

The process begins with classification - the extent of involvement of a


notified body and thus severity (and cost) of the conformity route needed
depend on the possible hazards associated with the device. There are three

x
device classes, but class two is divided into lower (IIa) and higher (IIb) risk
sub-categories, giving four classifications:

Class Risk Example

I low Bandage
IIa medium Simple Breast pump
IIb medium Ventilator
III high Intra-aortic balloon

For all devices, the manufacturer begins by setting up quality systems and
preparing a technical file (the design dossier), containing a general
description of the “type” (the actual device), design drawings,
manufacturing methods, standards conformed to (“applied”), design
calculations, risk analysis, and test results, as well as instruction manuals
and labels.

For class I devices all that is needed is a manufacturer’s declaration, backed


up by a risk assessment and appropriate technical documents, that the
device conforms to the essential requirements. If the device is a measuring
instrument, the calibration must be checked by a notified body. If the device
is to be shipped in a sterile condition, the sterility process must be checked
by the notified body.

For all other devices there are the two main routes:
i) If a Full Quality Assurance system is in place, and passes the notified
body audit, this is sufficient for any class II device. Class III devices
additionally need an audit of their design dossier, which contains
detailed information about all aspects of the design.

ii) If the Type-examination route is chosen, conformity involves two


components, except for class IIa devices which only need the
manufacturer’s declaration of conformity (as above for class I devices)
and the second component:

• FIRST COMPONENT:
Type Examination itself: the notified body audits the technical file and
carries out tests on a sample of the device, checking that it conforms
to relevant standards which the manufacturer claims to have applied.
• SECOND COMPONENT:
One of the following three procedures, applied by the notified body:
• product quality assurance audit;
• production quality assurance audit;
• verification by product examination - either of every product, or a
statistical sample from batches.

xi
For class III devices only the last two possibilities are allowed.
In general terms, active implantable devices are treated, under their
directive, in a similar way to class III devices.
MDA Directives Bulletin 4 includes flow charts for conformity assessment
procedures.

All that a manufacturer must make public about the process is actually
printed on the device - the CE-marking itself, and a code number for the
notified body if one has been involved. There is, of course, nothing to
prevent purchasers asking for more details, if they think it relevant to do so.

Selling second-hand equipment

The regulations for CE-marking all relate to the first time a product is
brought to market (i.e. sold, leased, or lent), so they should cause no
problems to anyone wanting to dispose of redundant equipment carrying a
CE marking by selling it as second-hand. The regulations do, however,
apply to refurbishers.

Role of standards

A standard is a “document, established by consensus and approved by a


recognised body, that provides, for common and repeated use, rules,
guidelines or characteristics for activities or their results, aimed at the
achievement of the optimum degree of order in a given context”.

Standardisation takes place at international, regional and national levels.


National standards bodies such as the British Standards Institution can
decide whether or not to adopt international standards, but are obliged to
publish European Standards as national standards.

Standards are prepared for various reasons and many uses.

Relevance of standards for medical device purchasers

The main reason for device purchasers to be concerned about standards is


for the assurance that they can provide that a device will be safe and will
perform as intended. For this purpose, two kinds of standards are mainly
relevant.

A product standard specifies one or more aspects of a particular kind of


product or a range of products. For example EN 60601-2-19 specifies
safety requirements for baby incubators (including aspects of performance
directly relevant to the well-being of the baby), and EN 556 specifies
requirements for many kinds of medical devices to be labelled “Sterile”.

xii
A management system standard specifies requirements for the way an
organisation is run to achieve a desired purpose. In particular the ISO 9000
series standards specify requirements for quality management systems by
which manufacturers ensure that their products will be as intended.

In the past, reference to standards in purchasing has made a major


contribution to ensuring device safety and quality, but the introduction of
CE-marking for medical devices has changed the significance of standards.
For manufacturers they have become even more important, because they
provide a means of demonstrating that the legal requirements have been
met. Device purchasers, however, should no longer need to refer to
standards in most purchase contracts, because the CE marking will
constitute reasonable assurance that a device will be safe and will perform
as intended: either the manufacturer will in fact have made the device in
accordance with relevant standard(s) or he will have ensured safety and
quality in some other effective way.

Even devices that are not CE-marked (viz those that are custom made or
intended for clinical investigations) must still, by law, be safe and perform
as described by their manufacturers. Purchasers should therefore still not
need to call for conformity with standards. (See above regarding devices
first placed on the market by 14th June 1997, though possibly not reaching
the final device purchaser until some time after that date.) Device
purchasers will however sometimes need to refer to standards in order to
identify devices that are suitable for a particular use; for example where
devices are supplied in various sizes or grades, such as support hosiery, or
where they need to be compatible with other devices or systems already in
use which could comply with either an old national standard or a newer
European standard.

“A review of Standards Applying to Technical Medical Equipment”


(Dräger) provides a useful brief summary of the relevant standards.
(Appendix A2.4).

How manufacturers will use standards - relationship to CE–marking

Since the Directives cover a wide range of medical devices, involving many
levels and types of technology, the Essential Requirements can only provide
a broad approach in setting the targets that manufacturers must meet. The
European Commission, therefore, has mandated the European standards
organisations to prepare European standards to address the Essential
Requirements. These standards assist manufacturers by setting out
generally agreed specifications of what the essential requirements mean for
particular products, and practical objective means to show that products
comply with the Essential Requirements, for example by the application of
standard test methods.

xiii
Conformity with a relevant Harmonised Standard provides a presumption
that the device conforms to the Essential Requirements. In many cases a
manufacturer will need to refer to more than one standard in order to
address all the relevant Essential Requirements for a given medical device.
With few exceptions, however, application of standards by manufacturers
and other organisations is voluntary.

How regulators/MDA will use standards

If MDA needs to form an opinion as to whether or not a particular medical


device conforms to the Essential Requirements of the relevant Directive, we
will often refer to relevant standard(s).

xiv
Appendix A2.Bibliograph y

This contains documents referred to in the main body of the bulletin, and
selected other documents which offer background information relevant to
the the topics we discuss.

A2.1 MDA A list of all current MDA publications can be found on our web site:
PUBLICATIONS http://www.medical-devices.gov.uk

DB 9501. Reuse of medical devices supplied for single use only


Deals with the reuse of medical devices labelled by the
manufacturer as being for single use only. Looks at the
regulation of medical devices through the Medical Devices
directive, legal issues, technical issues and economic issues.
Gives examples of use of equipment in the community,
including plastic syringes for insulin injection and urethral
catheters.

DB 9503. Infusion Systems

DB9504. The management of infusion systems: a report by the Scottish


Office Home and Health Department.

DB 9606. Wheelchair and vehicle passenger lifts: safe working practices.

DB 9605. Purchase, operation and maintenance of benchtop steam


sterilisers.

Deals with a range of issues: advice and personnel,


Regulations, purchase, installation and validation, periodic
testing, maintenance, technical aspects and safety, legal and
insurance considerations.

Clearly relevant to community settings, where these relatively


small sterilisers may be in use.

DB 9602. Guidance on the safe use of lasers in medical and dental practice.

DB 9704. Medical Devices and the Year 2000.

xv
Directive Bulletins

8. Information about the EC Medical Devices Directives


2. The CE Marking
3. The Vigilance System
4. Conformity Assessment Procedures
5. Pre-clinical Assessment Routes
6. The Notified Body
7. The Competent Authority
9. The Citizens Charter and a Code for Enforcement
10. The Classification Rules
11. CE and EFTA member states (EEAAgreement)
12. Sale and Supply of In Vitro Diagnostic Medical Devices
13. Standards
14. Compliance Cost Assessments
15. The Medical Devices, Electromagnetic Compatibility and Low Voltage
Directives
16. Information about the Packaging and Packaging Waste Directive
17. Medical Devices and Medicinal Products
18A.The Medical Devices Regulations: Implications on Healthcare and
other Related Establishments
19. Own Brand Labelling and Rented Products

TRS89 (1989). NHS procurement directorate technical requirements for


the supply and installation of equipment for diagnostic imaging and
radiotherapy.

MDA (1996). Sterilisation, disinfection and cleaning of medical equipment:


guidance on decontamination from the Microbiology Advisory to
Department of Health, Medical Devices Agency.

Looseleaf publication outlining recommendations of good


practice and dealing with different methods of sterilisation,
disinfection and cleaning. Also contains many references to
further publications. The publication appears primarily to
be aimed at issues of “hospital associated infection”, but the
introduction refers also to “other health care settings” and
to General Practice settings.

MDA (1995). The report of the expert working group on alarms on


clinical monitors, in reponse to Recommendation 11 of the
Clothier Report: The Allitt inquiry. (C.M. Clothier, 1994,
HMSO, London).

xvi
Hazard(94)18. MDA Hazard Notice 1994 Patient hoists using band slings -
risk of serious or fatal injury. (HAZ(1994)012 in Scotland,
WHSN(94)18 in Wales).

HN9506. MDA Hazard notice 1995 Graseby Medical MS16A and


MS26 ambulatory syringe drivers: repeat warning: risk of
incorrect rate settings due to confusion between two
models. (HAZ(SC)96/01 in Scotland, WHSN(96)4
in Wales).

HN9606. MDA Hazard Notice 1996 Phototherapy devices for the


treatment of neonates and infants (WHSN(96)8 in Wales).

HN9609. MDA Hazard Notice 1996 In-house manufactured spirit


level used in central venous pressure (CVP) measurement
(WHSN(96)12 in Wales).

SAB(89)14. 1989 Safety Action Bulletin Patient lifting devices: sling,


harness and strap failures.

SAB(91)46. 1991 Resuscitators: regular testing and inspection.

A2.2 RELEVANT Health and Safety Commission (1993). Getting to grips with handling
HEALTH AND problems: worked examples of assessment and reduction of risk in the
SAFETY health services. HSE Books.
EXECUTIVE
PUBLICATIONS HSE (1992). Manual handling: guidance on regulations: Manual
Handling Operations Regulations 1992. HSE Books.

HSE (1998). Guidance Note PM77: Fitness of equipment used for


medical exposure to ionising radiation.

HS(G)115. Manual handling: solutions you can handle.

HS(G)107. Maintaining portable and transportable electrical


equipment (1994).

HS(G)104. Health and safety in residential homes (1993).

A2.3 RELEVANT HSG(93)13. Reporting adverse incidents and reactions, and defective
DEPARTMENT products relating to medical and non-medical equipment
OF HEALTH and supplies, food, buildings and plant, and medicinal
CIRCULARS products. (MEL(1995)74 in Scotland, PEL(93)36 in
Northern Ireland, WHC(97)28 in Wales)
Sets out procedures for adverse incident reporting.

xvii
HSG(93)26. Decontamination of equipment prior to inspection, service
or repair.
Refers to the need for safe systems of work to protect
against transmission of infection from medical devices or
other equipment which comes into contact with patients or
their body fluids. Highlights legal requirements, features of
an appropriate system of work and the necessary
documentation. (No equivalent in Scotland, WHC(93)56
in Wales)

HSG(95)18. Hospital laundry arrangements for used and infected linen.


(MEL(1993)7 in Scotland, DGM(96)130 in Wales)
Refers to some aspects of equipment: e.g. in relation when
to use, when not to use and how to use washer extractor
machines and batch continuous washing machines.

HSG(95)47. Contracting for orthotics services.


Acknowledges the criticisms levelled at the orthotics
services and a checklist of issues for purchasers and
providers, including, for instance, checking for specification
and quality, advice about correct use and maintenance of
the orthosis etc. (No equivalent in Scotland, DGM(95)163
in Wales).

HSG(96)34. Powered indoor/outdoor wheelchairs for severely disabled


people. (MEL(1992)67 in Scotland, not issued in Wales).
In relation to the NHS supply of powered wheelchairs, this
Circular includes reference to issue of third party insurance
in case of accident in a public place, and the need for clear
explanation of arrangements for maintenance, servicing
and repair.

HSG(96)53. Wheelchair voucher scheme.


Explains the “independent” option, through which the user
of the wheelchair takes responsibility for maintenance and
repairs; and the “partnership” option which leaves such
responsibility with the NHS. (No equivalent in Scotland)

HC(88)3 and Procurement:Product Liability. (In Scotland:


HC(FP)(88)5. SHHD/DGM(1988)6 Consumer Protection Act 1987 -
General Guidance on Product Liability and
SHHD/DGM(1988)20 Consumer Protection Act 1987 -
Product Liability: Medicinal Products and Medical
Supplies.)

xviii
HC(89)20. Preservation, retention and destruction of records. (In
Scotland: MEL(1993)152 “Guidance for retention and
destruction of Health Records”, and in Wales: WHC(89)60
and WHC(94)59))

LASSL(95)7. Notification by the Department of Health of hazard and


safety information which may affect the personal social
services.
Announces the introduction of a new system for dissemi-
nating safety information affecting personal social services
to local authorities, voluntary organisations and registered
voluntary and private residential care homes. (Not thought
to apply in Scotland, not issued in Wales)

Department of Health (1992). Equipped for independence?


Meeting the needs of disabled people. London: DH.
Highlights - through examples of good practice - the need
for information for service users about what is available,
involvement of users in service planning to help eliminate
wasteful provision, and innovative use of the independent
sector to improve services including value for money.

Department of Health (1997). Community Care (Direct


Payments) Act 1996: Policy and Practice guidance. (cover-
ing letter: LAC(97)11).

A2.4 SELECTED Aldersea, P (1996). National prosthetic & wheelchair services report 1993
OTHER REPORTS 1996. London: College of Occupational Therapists.
WITH RELEVANT Comprehensive and in-depth report.
RECOMMEND- 1. Prosthetic services. Contracts: short-term 3 or 5 year contracts can
ATIONS disrupt services for clients and reduce the morale of prosthetists,
whilst accepting the lowest financial bid can be at the cost of ignoring
both quality and research findings. Expertise: there is sometimes
absence of appropriate expertise to prescribe prostheses (e.g. for
children); whilst the value of consultants in rehabilitation medicine is
not always realised. Maintenance: e.g. safety and legal issues involved
in giving instruction to clients to make their own adjustments to
prostheses. User consultative committees: should be consulted to assist
with planning of services.

2. Wheelchairs. Purchase: issues of design of wheelchairs: e.g. weight


of chair, foldability, manoeuvrability in relation to carer ’s ability.
Safety: e.g. NHS wheelchairs in nursing homes with punctures,
without tyres, unstable for bilateral amputees, split seats and back
canvases, without brakes, without footplates, without safety straps.

xix
Improve stock control and safety in relation to issue of wheelchairs to
residents of nursing homes.

Equipment standards and safety: suggests annual inspection of all


powered wheelchairs: part of contract with repairer. Suggests three
year maintenance check for non-powered wheelchairs, but one year
check not cost-effective. Discusses manufacturers’ recommendations
about when maintenance should be carried out (e.g. time of ownership
is less relevant than level of use over any given period of time).
Suggests users should always be provided with the name of the
contract repairer, have it explained that they are responsible for
cleaning and keeping the wheelchair in good working order, and be
given information on general maintenance.
Wheelchair user groups: can provide valuable advice on contract
matters and contribute to effective purchasing and service planning.

Amputee Medical Rehabilitation Society (1992). Amputee rehabilitation:


recommended standards and guidelines. London: AMRS.

Chapter on contracts. Amongst its recommendations on contracts it


points out the adverse effects short term contracts can have, given the
long term periods of patient care required and the importance of the
development of confidence and trust - by patients and families - in
staff. Appropriate stocks of items - eg socks, gloves - must be kept in
stock, and their supply should be part of normal service delivery.
Disablement Services Centres must be committed to ongoing research
- including the development and evaluation of new prosthetic materials.

Association of Anaesthetists Checklist for anaesthetic apparatus 2 (1997).


This booklet lists checks to be carried out by the anaesthetist at the
beginning of each operating theatre session, covering: anaesthetic
machine, oxygen analyzer, medical gas supplies, vaporizers, breathing
system, ventilator, scavenging, ancillary equipment, and monitoring.

Audit Commission (1991). NHS Occasional Papers. Value for money in


NHS sterile services. London: HMSO.
Makes a number of recommendations in relation to Sterile Services
Departments including a unified management responsibility - with
adequate business, administrative and information systems - for all
sterile products used by patients, the pricing of packs and trays so that
users are aware of the costs involved, user groups to review products
against full costs, phasing out of in-house single-use packs in favour
of limited range of commercially supplied packs.

xx
Audit Commission (1995). Improving your image: how to manage
radiology services more effectively. London: HMSO.
Makes a number of observations in each chapter, followed by
recommendations at the end. For instance, it notes that value for
money is difficult to assess when different suppliers of equipment shift
costs onto the maintenance contract or offer package details; the
“whole-life” cost of equipment is often ignored; second-hand
equipment offers opportunities but purchasing it raises the question of
who is responsible for its proper commissioning; the appropriate
expertise is required for purchasing decisions - and so on.

Audit Commission (1996). Goods for your health: improving supplies


management in NHS Trusts. London: HMSO.
Deals with a variety of issues and contains short recommendations at
the end of each chapter:
• Equipment selection. Points out that excessive diversity can be
expensive: standardisation on items of common use can make savings.
• Evaluation. Proper evaluation is needed to ensure that purchases are
justified.
Users need access to adequate information: randomised clinical trials
are the best way of assessing the effectiveness of medical devices.
• Procurement. Suggests reducing the number of low-value orders,
reviewing number and location of receipt points to ensure better
planned and coordinated delivery of items to the point of use. Also
consolidation of deliveries: eg through single carrier. Examine
payment systems and invoice checking.
• Prices. Use competition whenever appropriate, aggregate demand for
products over time, establish longer term contracts with suppliers,
maximise early payment discounts, avoid end-of-year poor
procurement practice, but allow reasonable budgetary flexibility.
• Stocks. Discusses need to avoid excessive stock which may become
obsolete, is expensive to store, and vulnerable to damage, loss or theft.
Suggests reviewing and setting target stock levels, based on suppliers’
delivery capability, price, handling costs etc. Also contractual
arrangements to reduce on-site stocks. Introduce and extend “materials
management” system of stock management. Monitor high value stocks
in high-spending departments regularly. Improve security, whilst
balancing risk and process costs.
• Usage. Has a big effect on expense. Recommends examination of the
causes of significant variations in usage. Work with suppliers to
benchmark and manage usage patterns. Define guidelines for the use
of consumables and equipment. Increase equipment usage through
pooling. Ensure equipment is fit for the use for which it is intended.

xxi
• Management. Link supplies strategy to overall objectives. Looks at
three main models of supplies service: in-house, NHS Supplies,
independent agency. Information technology can be effective
particularly for: requisitioning, ordering, stock management, receipt,
invoice matching and payment. Electronic data interchange: computer
to computer of standard business forms between two organisations.
Accountability: an executive director responsible for supplies should
be appointed. The Trust should have adequate procurement expertise:
something many Trusts are thought not to have.
• Relationships. Establish effective business relationships with NHS
Supplies. Establish partnerships with other strategically important
suppliers: e.g. longer term contracts, close cooperation to reduce sup-
ply costs, improved communication including electronic ordering and
payment, prompt payment, experimenting with nominated carrier
arrangements, logistics partnerships and partnership sourcing
arrangements. Pursue partnership with other Trusts.

Beresford, B (1995). Expert opinions: a national survey of parents caring


for a severely disabled child. York: Joseph Rowntree Foundation.
Expresses concern about the stress placed on the growing numbers of
parents who look after “technologically dependent” babies at home -
and the need for support from professionals.

Bowker P, Rocca L, Arnell P, Powell E (1992). Study of the organisation of


the orthotic services in England and Wales. Salford: Salford Health
Authority Physiotherapy Service; University of Salford, Department of
Orthopaedic Mechanics; North Western Orthotic Unit.
Found a service which is uncoordinated and rudderless with little
informed management, service audit or strategic planning. Makes
various recommendations about the role of different members of the
multi-disciplinary team, training etc. Criticises the making of contracts
- e.g. Lack of involvement of appropriate staff, lack of good practice
guidelines - resulting in “wastefully generous”, but also “punitively
frugal” services. The supply process might not be monitored properly -
with resulting mispayments (eg pay twice for one orthosis), no
monitoring of the work being undertaken by independent orthotists, no
checking of adherence to prescription etc.

British Society of Rehabilitation Medicine (1995). Seating needs for


complex disabilities: a working party report of the British Society of
Rehabilitation Medicine. London: BSRM.
Contains a chapter on legal implications, including clinical
responsibilities for, and reporting of, adverse occurrences; product lia-
bility, insurance, maintenance etc.

xxii
Cameron, I et al (1995). Leeds wheelchair project: an investigation into
face to face assessment of all non-permanent users of wheelchairs,
September 1995. United Leeds Teaching Hospitals NHS Trust; Nuffield
Institute for Health.
In the control (i.e. the “normal”) control group of wheelchair users,
only 21.3% had received verbal instruction in use of the wheelchair.
Users who were assessed face-to-face were ten times more likely to
use their wheelchair in a safe way. These users would also be more
likely to receive relevant information about use, and to use the chair
more frequently.

Dräger (1997) A review of Standards Applying to Technical Medical


Equipment (Drägerwerk Aktiengesellschaft, Moislinger Allee 53-55, D-
23542 Lübeck, Germany)

Easton, J (1995). Thirteenth annual report of the Assistive Communication


Aid Centre, Frenchay Hospital, Bristol. Bristol: Frenchay Hospital.
Points out the cost-effectiveness of loan banks, and the recycling, of
communication aids. Also that budget holders have to consider
“on-costs” beyond the actual hardware: e.g. maintenance, modifica-
tion, insurance and training of users.

ICE Ergonomics (1992). Aids and equipment for elderly people (Home and
Leisure Accident Research). London: Department of Trade and Industry.
Found that although most aids were reasonably safe, many items
lacked adequate instructions.

Initiative on communication aids for children (1994). Communication aids


for children: a briefing for purchasers and managers. London: ICAC.
Points out huge range of prices of communication aids: from £10 to
£7000. Argues that provision of an aid without support and user
training is false economy, because the aid is abandoned. Identifies
technical support and maintenance as a key issue.

Leonard Cheshire Foundation (1990). Report on the wheelchair and seating


project carried out in residential homes of the Leonard Cheshire
Foundation for physically disabled people. London: LCF.
Concluded that inadequate prescription of wheelchairs and seating
caused imbalance, instability and high pressure - causing pain, spasm,
spasticity, deformity, contractures and often pressure sores.

Mandelstam, M Going to Market. Equipment and Products for disabled and


older people - an overview. The Disabled Living Centres Council 1996.

xxiii
National Audit Office (1996). Health and safety in NHS Acute Hospital
Trusts in England. London: HMSO.
75% of accidents recorded involved patients or visitors, and 80% of
these involved slips, trips and falls. For staff, the main types of
accident stemmed from needle stick injuries, manual handling, slips,
trips and falls - and patient assaults. 1% of accident were considered
serious enough to report to HSE. The report clearly points to the need
for managers to provide appropriate equipment for lifting and to
ensure that it is used by providing information, training and
supervision.

NHS Confederation; NHS Supplies (1997). Purchasing medical equipment:


the third boardroom briefing document from the Joint Working Party.
Small booklet set out in the form of checklists under the headings
Forward planning, Who needs to be involved in the purchase?, Expert
guidance and assistance, Assessing the options, Planning for
post-purchase requirements.

NHS Estates Hospital Technical Memoranda series, including HTM 2010


Sterilization and HTM 2020 Electrical safety

NHS Executive (1993). Risk management in the NHS.


NHS Executive (1996). Renal purchasing guidelines.
Refers to geographical location, demography, main renal units,
satellite units, minimal care units, contribution by the private sector -
when planning services. Contracts should address the need for
infection control. Contracts should contain clear quality standards.
Contracts may be made with multiple providers, so that a “portfolio of
contracts” makes up the total care package. However, arrangements
should be flexible enough to allow seamless service for patients.
Contracts should be monitored and be assessed.

National Radiological Protection Board Dental Monitoring Services.


A leaflet describing the services offered to dentists, for calibration,
dose record keeping, and personal monitoring.

Owens, J (1996). Strategic procurement for the NHS: working with


suppliers. Birmingham: National Association of Health Authorities
and Trusts.
Explains that it is intended primarily for NHS Trusts to use strategic
procurement to outsource high cost services for which there are few
adequate suppliers; but that the process involved may also be useful in
relation to the purchase of health care generally. Contains many useful
checklists for purchasers, under the chapter headings: Procurement in
the NHS, Setting the strategy for procurement, Analysis and planning,
Specifications based on outcomes, Pre-qualification of suppliers,

xxiv
Choosing a supplier, Complying with legislation, Getting the contract
right, Measuring performance and monitoring improvements,
Managing relationships, Partnership works.

Poswillo, D.E. (1990). General anaesthesia, sedation and resuscitation in


dentistry - report of an expert working party. Department of Health
Standing Dental Advisory Committee, 160 Great Portland Street, London
W1N 5DT.

Ross, F, Campbell, F (1992). “If it wasn’t for this wheelchair, I might as


well be dead”: a study of equipment and aids for daily living in the commu -
nity, a district nurse and consumer perspective. London: St George’s
Hospital Medical School.
Found chaotic equipment delivery systems, and even worse equipment
collection systems, as well as confusion about who was responsible for
ensuring that aids were serviced.

Royal College of Physicians (1992). Domiciliary oxygen therapy for


children. London: RCP.
Points out that parents must be taught how to use the equipment, and
that prescription should be decided on grounds of safety, ease of use,
convenience and cost. Provision of an oxygen concentrator may affect
domestic insurance cover and insurance companies should be
informed - though this will not necessarily affect the premium.

Royal College of Physicians (1995). Provision of wheelchairs and special


seating. London: RCP.
Points out that inadequate wheelchair prescription causes health
problems in both users and carers, as well as placing a greater eventual
burden on statutory services.

Scottish Health Management Efficiency Group, Clinical Resource & Audit


Group. Final report SCOTMEG project 41: incontinence services in the
community. Edinburgh: SCOTMEG.
Found that pads were delivered direct to patients by van, picked up by
patients or relatives, or delivered by district nurses. This last route was
questioned as possible poor use of resources. Laundry services were
found to be patchy, and where they did exist, there were several
different models. The report recommended that computer systems used
for management of the supplies service should be capable of linking to
patient records. Most health boards used CSA national contracts,
whilst making separate arrangements for specialist supplies. It pointed
out that anecdotal evidence about wastage, inappropriate supplies,
stockpiling and onward selling could not be investigated in the
absence of good information systems.

xxv
Scottish Health Management Efficiency Group, Clinical Resource & Audit
Group (1996). SCOTMEG report on patient equipment in the community.
Edinburgh: SCOTMEG.
Contains various recommendations relating to, for example: a)
clarification of responsibilities of different statutory services (e.g.
social/health care divide); b) centralisation of stores, joint working
between statutory services, or running of the service by a third party;
c) appropriately qualified people to manage budget, to run the stores
service, to select the equipment; d) clear requisitioning arrangements;
e) clear transport/delivery systems; f) maintenance and technical
back-up systems; g) training of professional and support staff (eg
health and safety); h) training of users/carers.

Scunthorpe Community Health Care NHS Trust; Nuffield Institute for


Health (1994). Yorkshire wheelchair services: approved prescribers
competencies. Leeds: Nuffield Institute.
Approved prescribers’s competencies - including instruction to clients
and carers bout the safe use of equipment, in relation to e.g. pushing,
brakes, kerbs, uneven ground, stability, transfers, folding/storage,
loading into car, cleaning and maintenance, life span of cushion and its
correct use, safety precautions.

Social Services Inspectorate, Department of Health (Shipley C, Raw D)


(1991). Managing aids to daily living.
Points out that equipment is big volume business accounting for up to
50% of referrals of older people, it is relatively inexpensive since it
consumes less than 5% of social services resources, it does help
restore independence, there is ample scope for significant
improvement in how services are delivered.

Touche Ross (1994). Department of Health reimbursement and remunera -


tion of appliances report.
Looks at the system of remuneration, in relation to services provided
and the prescriptions dispensed, for pharmacists and dispensing appli-
ance centres (DACs) in relation to ostomy products continence prod-
ucts, dressings and other appliances. Recommends changes so that the
value of remuneration fluctuates with services provided, not the value
of the prescription being dispensed.

xxvi
APPENDIX A3

Preparation of Medical Devices,


Equipment and Materials to be
returned to, or handled locally by,
Service Departments,Manufacturer s,
or their represenatives: Infection
Hazards

Medical devices and equipment to be inspected, serviced or repaired should


be in a condition which is safe to be handled by all personnel who may
come into contact with them during transit and subsequent handling. The
device should not only be mechanically and electrically safe, but also the
risk of causing an infection should be minimised. The Department of
Health published HSG (93) 26 Decontamination of equipment prior to
inspection, service or repair to highlight the legal requirements, appropri-
ate systems of work and the necessary documentation for this activity. The
document should be consulted prior to the establishment of a decontamina-
tion regime. Failure to comply with the legislative requirements could leave
a healthcare establishment open to prosecution.

The Department of Health agrees with the view that all engineers,
technicians and service personnel have the right to expect that articles
handled by them have been properly treated to remove any such risks.
It should also be emphasised that medical devices and equipment loaned,
rented or leased to a patient for use in the community environment, must be
treated with the same level of caution and preparation. Those devices which
have been used for demonstration purposes must also present no risk to
subsequent users.

The following information should be brought to the attention of those


who have responsibility for medical equipment maintenance and
decontamination. It may be of particular interest to personnel in the
following units; operating theatres, endoscopy, sterile service, supplies,
EBME & EME departments and to Control of Infection staff &
Consultant Microbiologists.

Devices and equipment to be repaired or serviced on site, at the


manufacturer’s or agent’s premises, and those devices being returned from
an episode of use within the community healthcare setting, should have
been decontaminated appropriately, by trained personnel. Depending upon

xxvii
how the device or equipment is used will dictate whether it should be
cleaned and either disinfected or sterilized. For those devices which do not
come into contact with bodily fluids, cleaning only may be sufficient.
Decontamination should be carried out in accordance with the
manufacturer’s instructions.

Decontamination agents must be compatible with the article to ensure that


decontamination does not change the properties or damage the item.
Manufacturer’s guidance should be sought if there is no reprocessing
information available with the product. After cleaning, the item may be
disinfected or sterilized. Items compatible with the high temperatures and
pressures comprising a steam sterilization cycle should be sterilized in an
appropriate autoclave. For items where exposure to high temperature is
detrimental to the device, it may be possible to sterilize using ethylene
oxide gas. The manufacturer must be consulted before either method of
sterilization is used. Those items which cannot be sterilized may be
disinfected using either low temperature steam or immersion in liquid
chemical disinfectants. Consideration should be given to the requirements
for the safe use of chemicals such as glutaraldehyde and peracetic acid.
Other decontamination processes may be used provided they are validated
and it is demonstrated that they are not detrimental to the medical device or
equipment.

Further guidance on suitable decontamination regimes can be found in the


following Department of Health publications:

HC (91) 33 Decontamination of equipment, linen or other surfaces


contaminated with Hepatitis B and/or Human Immunodeficiency Viruses .

Sterilization, Disinfection and Cleaning of Medical Equipment: Guidance


on Decontamination from Microbiology Advisory Committee to the
Department of Health Medical Devices Agency (MAC Manual) Part 1
Principals (published 1993), Part 2 Protocols (published 1996).

MDA Device Bulletin DB9605 The purchase, operation and maintenance


of bench top steam sterilizers.

MDA Device Bulletin DB9607 Decontamination of Endoscopes.

MDA Safety Notice SN9701 Reporting adverse incidents relating to


medical devices.

xxviii
A local policy may be established for the decontamination of medical
devices, drawing on technical input from the following:

• Manufacturer’s instructions;
• Control of Infection staff;
• Consultant Microbiologist;
• Risk Assessment Officer;
• Advice from the appropriate Government body responsible for health
matters e.g. MDA;
• Advice from appropriate professional bodies e.g. BMA.

Devices to be inspected, serviced or repaired and those being returned from


use in the community should be accompanied by a certificate identifying
their contamination status. An example may be found in HSG (93) 26 or the
MAC manual.

Technical enquiries regarding the content of this appendix should be


addressed to:

Mr N Moore Miss N Thomas


Medical Devices Agency Medical Devices Agency
Hannibal House Hannibal House
Elephant & Castle Elephant & Castle
London London
SE1 6TQ SE1 6TQ
Tel. 0171 972 8066 Tel. 0171 972 8263
Fax. 0171 972 8106

xxix
Appendix A4

Contact details - arrangements for


reporting incidents and ordering
publications

A4.1 MDA “A guide to contacts” August 1997 lists all the MDA contact details.
For copies ring 0171 972 8136, or fax 0171 972 8136.
Our main switchboard number is 0171 972 8000.
For reporting adverse incidents, ring 0171 972 8080. For details on how to
report adverse incidents, see MDA SN9801 “Reporting adverse incidents
relating to medical devices.”

MDA publications are listed in:


• Device Evaluation and Publications Catalogue (Oct 1997 - fax 0171
972 8105 or ring 0171 972 8181 for a copy), for evaluation reports.
• Adverse Incident Reports 1997 (Jan 1998 - fax 0171 972 8124 or ring
0171 972 8188 for a copy), for Device Bulletins, Hazard Notices,
Safety Notices and Pacemaker Technical Notes.

The MDA web site: http://www.medical-devices.gov.uk has up-to-date


publication lists.

• Medical Devices Directives : MDA Guidance Documents (June 1997 -


fax 0171 972 8112, tel. 0171 972 8300 - European and Regulatory
Affairs Helpline) for Directives Bulletins and Competent Authority
publications giving guidance on the Medical Devices Directives.

A4.2 SCOTLAND, Northern Ireland


WALES,AND
NORTHERN Adverse incidents involving medical devices in Northern Ireland should be
IRELAND reported to:
The Northern Ireland Defect and Investigation Centre, Health Estates -
Estate Policy, 14 Stoney Rd, Dundonald, Belfast BT16 0US. Tel. 01232
523714 Fax 01232 523900.

For details on how to report incidents, see “Reporting adverse incidents..”


PEL(93)36 - copies from above address.

xxxi
Scotland

Adverse Incidents involving medical devices in Scotland are reported to:


Scottish Healthcare Supplies, Trinity Park House, Edinburgh EH5 3SH.
Telephone 0131 551 8333 (emergencies: 0131 552 6380)
Fax. 0131 552 6535.

For details on how to report adverse incidents in Scotland, see “Reporting


of adverse incidents and defective equipment” NHS MEL (1995)74 - copies
from NHS in Scotland, The Scottish Office, Room 278, St. Andrew’s House
Edinburgh EH1 3DG. Tel. 0131 244 4049.

Wales

Adverse incidents involving medical devices in Wales are reported to


Health Strategy Division 2, Welsh Office Health Department, Cathays Park,
Cardiff CF1 3NQ. Tel. 01222 825111, Fax. 01222 825479.

For details on how to report incidents, see “Reporting of adverse incidents,


reactions and defective products relating to medical and non-medical
equipment, supplies, food, building and plant, and medicinal products.”
WHC(97)28, available from the address above.

A4.3 OTHER Audit Commission 1 Vincent Square London SW1P 2PN. Tel. 0171 828 1212.
ORGANISATIONS
Association of Anaesthetists of Great Britain and Ireland, 9 Bedford Square,
London WC1B 3RA. Tel. 0171 631 1650.

Disabled Living Centres Council, Winchester House, 11 Cranmer Rd.


Kennington, London SW9 6EJ. Tel. 0171 820 0567.

Finger on the Button Training, Scitech Educational Ltd, Units 15-17 St


John Business Centre, St Peter’s Rd Margate CT9 1TE. Tel. 01843 231494.

Institute of Healthcare Engineering and Estate Management. 2 Abingdon


House, Cumberland Business Centre, Northumberland Road, Portsmouth,
Hants PO5 1DS. Tel. 01705 823186.

Health and Safety Executive, Field Operations Directorate, 14 Cardiff Road


Luton LU1 1PP. Tel. 01582 444200.

Limbless Association (formerly NALD) 31 The Mall Ealing London W5


2PX. Tel. 0181 579 1758.

xxxii
National Audit Office 157-197 Buckingham Palace Road, London SW1W
9SP. Tel. 0171 798 7000.

National Radiological Protection Board, Dental Monitoring service,


Hospital Lane, Cookridge, Leeds LS16 6RW. Tel. 0113 267 9041.

NHS Estates, Department of Health, 1 Trevelyan Square, Boar Lane, Leeds


LS1 6AE.
NHS Estates publications are listed in “Publications List, Summer 1997”
(for copies fax 0113 254 7299, or ring 0113 254 7201). This list includes
Health Guidance Notes and Health Technical Memoranda series.

NHS Executive, Quarry House, Quarry Hill, Leeds LS2 7UE. Tel. 0113 254
5000.

NHS Supplies, Apex Plaza, Forbury Road, Reading RG1 1AX. Tel. 0118
980 8600.

For medical and surgical supplies, contact 01244 586700 (80 Lightfoot St.
Chester CH2 3AD); for rehabilitation services, contact 01189 808800
(Clipper House, 62-66 London St. Reading RG1 4SQ), for diagnostic and
medical equipment, contact 01275 512800 (Ham Green House, Ham Green
Bristol BS20 0LH).

NHS Supplies have produced standard terms and conditions, against which
the majority of purchases are made. Where appropriate, these have been
discussed with the ABHI and other relevant trade associations and industry
representatives. They also publish the PPQ form for use by NHS trusts.
An extract from the text of the form follows:

xxxiii
PRE-PURCHASE QUESTIONNAIRE SAFETY STANDARDS

This form is intended to supply prospective 5. For devices not CE marked to 1b) i) or ii)
purchasers with information about equipment being above, with which safety standard(s) does the
considered for purchase. It is intended principally equipment comply?(Standard, Test House,
for pre-purchase information on electrical medical, Certificate, Date)
dental, ophthalmic and laboratory equipment. The
form may also be used for other products, including SERVICE / SPARES / INSTALLATION
non-electrical items, and to give information prior
to equipment being supplied on loan, in which case 6. Is service/repair information/manual available?
not all the questions will be relevant. Please ensure If YES, please state current price and indicate
all relevant questions are answered. contents below: (Full circuit diagrams, Fault
finding procedures, Preventive maintenance,
CE MARKING Repair information, Spare parts listing, List of
special tools/test equipment/etc.)
1. a) Does the product carry the CE marking? 7. a) In addition to the service/repair inform
b) If YES, which EC Directive(s): tion/manual, will training be required before
i) Active Implantable Medical Device the purchaser’s technical personnel can
Directive (90/385/EEC) provide (First line maintenance, Calibration,
ii) Medical Device Directive (93/42/EEC) Planned preventive-maintenance, Repair.)
If YES, state classification of device: b) For those indicated by YES above, is the
Identification No of Notified Body, if supplier able to provide training for the
applicable: purchaser’s technical personnel?
iii) EMC Directive (89/336/EEC) If YES, will this be free of charge,or
iv) Low Voltage Directive (73/23/EEC) chargeable?
v) Other (please specify) If NO, please indicate if details of an
If YES to i) or ii) above, go to question 6. organisation which is able to provide this
2. a) Is the product a “custom-made device”? training are available on request: (Company,
b) Or a “device intended for clinical Location)
investigations”? 8. a) Is the supplier able to provide an “as
If YES, does it comply with the UK Medical required” repair/maintenance service in
Devices Regulations? the UK?
b) Is the supplier able to provide a contract
QUALITYASSURANCE repair/maintenance service?
If YES, please confirm that details of
3. Is the manufacturer currently registered under repair/maintenance contracts are provided on
the DH Manufacturer Registration Scheme for a separate sheet.
this product? c) i) Will repairs normally be performed on the
If YES, please give Registration Number: purchaser’s site?
4. Is the manufacturer currently registered to any ii) If repairs are performed off-site, where
other GMP/quality system standard for this will these be carried out? (Company,
product? Location.)
If YES, please state standard:

xxxiv
9. Is the supplier’s maintenance organisation
currently registered to a quality system
standard?
If YES, please state standard:
10. Please indicate when the item was first put
on the market:
11. For how many years from the date of last
manufacture is the supply of spare parts
guaranteed?
12. Please indicate if spare parts will be made
available to the purchaser:
13. Is installation necessary?
If YES, please confirm that details of all
services required are given on a separate sheet:

DECONTAMINATION

14. Does decontamination require the use of


specific equipment?
If YES, please state equipment type and
parameters of operation (eg. temperature,
pressure, etc).

WARRANTY

15. Please confirm that a copy of the warranty is


provided on a separate sheet.

xxxv
INDEX
Acceptance testing E2 E3 E4
Accuracy ix
Accident xxiv
Active implantable
medical devices directive vi vii xxxiv
Adverse incident H8 xxxi
— reporting xvii xxxxii
Alarm xvi
Archive G3
Aids to daily living xxvi
Ambulance A6
Ambulatory infusion pump I2
Ambulatory syringe driver xvii
Anaesthesia xxv
Anaesthetic machine C3 H9 J4 xx
Artificial limbs B1 C5 H11
Audit Commission C3
Authorised person J5
Autoclave xxviii

Backrest J3
Bath board F1 H14
Band sling xvii
Bank nurse I2
Bar code G3
Battery B3 E5 H6 H7 xi
Benchtop steam sterilizer xv
Biocompatibility ix
Biomedical engineering (BME) A5 B3 C11 G3 H9
Blood glucose meter D2
Bolus delivery I2
Breakdowns H1 H5 H11
Build standard H6

Carer A2
Calibration D1 G3 xxxiv
Callout fee C4 H12
Cannibalising C12
Capnograph J4
Cardiotocograph I2
Care manager H15
Care of disabled people A4

xxxvi
CE marking A1 C5 C11 C12 H14 vii
viii xvi xxxiv
Change of use C11
Chair raising blocks F2
Chiropodist J3
Class (device) xi xii
Cleaning H1 H9 H10
Client A2
Clinical supervisor A3 A4 B2 I2 H2
Clinical engineering A5
Clinical investigation vii
Clinical monitors xvi
Collection J2
Community store A2 A5 B1 C5 G5
Community Care (direct
payments) Act H14
Community healthcare A3
Commisioning H2
Communication aids xxiii
Competent authority A7 vi xxxi
Compliance vi x
Commode F1 H13
Computer F2 G2 xxii xxv
Computer database G1 G5
Computer discs G2
Computer drives G2
Computer systems ix
Conformity assessment vi
Consultative committee xix
Consumer Protection Act G1 H9 J3 ii
Contamination xxix
Contract C9 ii
Contractor H12
Control of infection xxvii xxix
Control of substances
hazardous to health iii
Controls E2 H10 H8 ix
Cost effective devices H11
Critical care A4
Cross infection J2
Crutch E5 F2

Database G2
Declaration of conformity vi
Decommision H11

xxxvii
Decontamination B4 E5 H1 H9 H10 xviii xxvii
xxviii xxxv
Defect reporting H13
Defibrillator A6 H8 G4 J4 ix
Delivery J2
Dentist xxiv xxv
Dental X-ray J5
Device bulletin xxviii
Device management procedure A3
Device Provider A3
Device purchaser A3
Diagnostic imaging xvi
Dialysis D5
Disabled people xix
Disablement service centre xx
District nurse F1
Domiciliary oxygen xxv

EBME department xxvii


ECG J4
Electrical safety test H10
Electrical equipment (safety)
regulations iii
Electric shock ix
Electromagnetic emissions ix
Employers' Liability Act i
End-user A3 A4 D3
End-user preferences C5
End-user training I2
End-user (vulnerable) H13
Endotracheal tube E6
Engineer G2
Equipment for disabled people xxiii
Equipment in the community H12
Equipment pool B2
Equipment selection xxi
Essential requirements ix x
Evaluation C10 xxi xxxi
Evaluation centre A7 C7 C9 I2 I3
External pacemaker H10

Fault reporting H9
Film badge C4
Finger on the button I2
Full refurbishment C12

xxxviii
General product safety directive vi
General product safety
regulations H9 ii iii
Glutaraldehyde xxviii

Handling technique H15


Hazard notice A6
Health and safety H15 I2
Health and safety at work i iv
HEI 98 A1 A2
Hoist C4 D5 H13 xvii
Hoist sling F3
Hoist instructions D5

Imaging system E3
Incident investigation H10
Incontinence pad xxv
Infusion pump B3 D3 E7 H11 I2
Infusion system xv
In-house manufacture C11
In-house maintenance H5
In-house servicing H11
Injury v
Insurance xxii
Instructions J1 H7 xxiii
Instructions for end-user D2 D4
Instructions for loan equipment D5
Instructions (revised) D5
Inventory B4 G2 G4
In vitro diagnostic device vii
ISO 9000 xii
ISO 9002 H1 H4

Joint HS/SS stores J2


Judicial review F3

Label D1 E6
Label (bar code) G3
Label (infusion identication) B4
Label (just serviced) H10
Laundry C4 xviii
Laser iv xv
Leads and probes A6 C10 E4 H8 H10
Legal entity vii
Liability H6

xxxix
Liability (employers') i
Liability (legal) D4 H9 iii
Lifting and handling H14
Lifting devices xvii
Loan C10
Loan equipment D1 G5 H13 H14 H15
Lumen J5

Maintenance contract xxxiv


Maintenance database G5
Maintenance instructions D1
Maintenance intervals H2
Maintenance (routine) H8
Maintaining portable
equipment xvii
Maintaining simple equipment H13
Manual C8 C10 H2 H4 xxxiv
Manual Handling operations
directive vi
Manual Handling operations
regulations C2 H14 I2 iv xvii
Manufacturer vi vii xiii
Manufacturers' instructions D3 D4 H13
Manufacturers' registration
scheme viii xxxiv
Market survey C2
Mattress (electric) H13
MDA A1 A6 A7 v xxxxi
MDA liaison officer B4
Medical device A4
Medical device coordinator B3
Medical device directive vi vii xxxi
Medical device group B1
Medical device regulations C2 C5 C7 D1 J3 vii
Medical physics A5
Microbiologist xxvii
Monitor A4 H10 ix
MRI scanner E3

Near patient testing D2


Nebuliser J4
Negligence H15
NHS vii
NHS Executive C3
NHS guidelines E3

xl
NHS Supplies C11
NHS wheelchair services H12
Northern Ireland A1 A7 C6 C12 I3
Notified body vi xxxiv
Nursing home xix

Obsolete A6 H11
Obsolescence H2
Occupational therapist F1 H13
Ombudsman F2 F3
On-site maintenance C8
Operating table C11
Optometrist A5
Orthosis C3 C12 H6 H15 xxii
Orthotic srvice xviii
Ostomy products xxvi
Out-of-box failure E1
Overinfusion H11 xi
Overseeing A6
Oxygen cylinder J6

Packaging E4 H8 ix
Personal prtective equipment C4
Phototherapy lamp E2 xvii
Physiotherapist H13 J3
Place on market viii
Planned prevetative
maintenance A3 H1 H5
Pool B1 B2
Poswillo report J4
PPQ form C7 xxxiii xxxiv

Prescriber A2 A3 J1 xxvi
Prescribing mistake F2
Pressure relief mattress A7 H13
Pressure relief product H7
Pressure system v
Pressure system and transportable
gas regulations J5
Procurement xviii xxi
Product examination xi
Product liability xviii xxii
Product safety i
Professional user H8
Professional user report forms H9

xli
Prosthetist F2
Prosthetic xix xx
Protective equipment iv
Pulse oximeter G4
Purchasing decisions H11

Quality system xxxv


Quality asurance audit xi
Quality control H6

Radiation iv ix
Radiology xxi
Recall G5
Record keeping B3 G1 G2 H4 J1
Record preservation xix
Refurbishment C12
Regulator xiv
Repair (on-site) H15
Repair (temporary) H11
Replacement C6
Reliability C6
Remote diagnostics H6
Renal purchasing xxiv
Residential homes xvii
Response time H6
Resuscitation xxv
Resuscitator J2 J6 xvii
Re-use xv
Risk assessment B5 xxix
Routine maintenance A3 H7
Rubber component J6

Safety notice A6
Safety test G5
Sale of Goods Act ii
Scotland A1 A7 C6 C11 xxxii
Scottish Healthcare Supplies A7
Seating xxii
Secondhand equipment xii
Senior management H3
Serial number E6 G1 G5
Service interval H10
Servicing organisation H1
Single-use device H8
Sliding-turning band C7

xlii
Sling C4 F3 H13 xvii
Sling (two piece) F3
Social services xxvi
Software update C4 G3
Spares C6 H5 xxxv
Spares no longer available H11
Stairlift F3 H14 v
Standard C2
Standard compliance E2
Standard (harmonised) xiv
Standard (product) xii
Standard terms and conditions xxxiii
Steam sterilizers E3 J5 xxviii
Sterile services xx xxvii
Sterilization xvi xxiv xxviii
Stock rotation E5
Storage E6 ix
Storage system E5
Store B1 G3
Stores officer F2
Strategic procurement xxiv
Supervision A6
Supplies xxii
Support seating F1
Surgery J2
Syphoning I2
Syringe xv

Technical supervisor A3 A4 E6 H3 I2
Tender C5 C7 C9
Test person (sterilizers) J5
Test equipment H5
Third party J3 H4
Third party servicing
organisation H1 H2 H3 H6 H12
Total costs C3
Total quality assurance H1
Tools (special) H5
Tracking B2
Training E6 H2 I1 I2 J1
Training availability H6
Training costs H5
Training for carer H15
Training scheme B5
Trolley E1

xliii
Turning band C7
Type examination xi
Type testing E2

User group xx
User organisation A3

Ventilator C5 C7 E5 H8

Wales A1 A7 C6 C11 F1 xxxii


Walking frame H13
Warranty C6 G3 xxxv
Website xv xxxi
Wheelchair C3 C12 H12 J3 xx xxiii xxv
xxvi
Wheelchair battery H7
Wheelchair (hospital) H12
Wheelchair lift xv
Wheelchair loan iii
Wheelchair (powered) J3 xviii
Wheelchair (specially adapted) H11
Wheelchair safety xix
Wheelchair voucher xviii

X-ray machine E3 H11 J5

Year 2000 C2 G2 xv

xliv
DISTRIBUTION

This device bulletin should be brought to the attention of medical device


coordinators, medical engineering and medical physics staff, IT staff,
medical and nursing directorate managers, general practitioners, dental
practitioners, pathology laboratory managers and staff responsible for
medical equipment used in the community.

TECHNICAL ENQUIRIES

Enquiries regarding the content of this Device Bulletin should be addressed


to Dr Stephen Young, Medical Devices Agency, Hannibal House, Elephant
and Castle, London SE1 6TQ.
Tel: 0171 972 8310
Fax: 0171 972 8113

Mr Clive Bray, Medical Devices Agency, Hannibal House, Elephant and


Castle, London SE1 6TQ.
Tel: 0171 972 8274
Fax: 0171 972 8010

HOW TO OBTAIN COPIES

2500 copies of this bulletin have been distributed free of charge to health-
care providers. Further copies Price £49.50, may be obtained from:

MDA/DTS Orders
Business Services Level 9
Hannibal House
Elephant and Castle
London SE1 6TQ
or fax to 0171 972 8124
or phone your order to 0171 972 8360

© CROWN COPYRIGHT 1999

Addressees may take copies for distribution within their own organisations
Medical Devices Agency
An Executive Agency of the Department of Health.
1. INTRODUCTION
2. STRATEGIES FOR
DEPLOYING DEVICES
3. PURCHASING
4.INSTRUCTIONS
5. WHEN A NEW
DEVICE IS DELIVERED
6. PRESCRIPTION
7. RECORDS
8. MAINTENANCE AND
REPAIRS
9. TRAINING
10. COMMUNITY
ISSUES
APPENDICES