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Equipment Management
for Hospital and
Community-based
Organisations
BULLETIN
MDA DB 9801
JANUARY 1998
REGISTRATION
If you want to receive the update sheets for this document as they become
available, please complete the form included.
ACKNOWLEDGEMENTS
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
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.
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.
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.
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).
A3
Table* A1.Medical devices under the Medical
Devices Regulations
* 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:
• 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.
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.
* 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.
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.
• 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).
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).
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.
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.
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
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:
B3
Fig 2 INFUSION IDENTIFICATION LABEL
Diluent Solution:
Total Volume:
Infusion Start Rate:
Device Name & Number:
Route used for infusion
Continuous (C) / Variable (V) Infusion
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.
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
New device
supplied
Section 5.2
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.
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).
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.
C4
Model selection.
Selecting a particular manufacturer and model is the final stage of the
decision-making process.
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” ).
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
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).
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
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.
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
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.
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).
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.
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.
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
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).
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.
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.
Acceptance checks, when equipment is first delivered, aim to ensure that the
correct device has in fact been delivered and satisfies the following criteria:
• the controls are set to standard values for the intended application
(see Example H6).
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).
Acceptance procedures
E3
Table E1 Acceptance checklist
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.
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.
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.
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.
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 .
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.
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:
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.
G2
Table G2 Possible inputs to a device database
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
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.
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.
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);
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.
H3
Similarly, any contract with a third party servicing organisation should
specifically address compliance with manufacturer’s recommendations:
H4
Table H3a Some advantages and disadvantages of doing
maintenance in-house, as compared to using
an outside servicing organisation
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:
H5
Table H3b Comparing third party, and manufacturer’s
servicing organisations
H6
Table H4 Routine maintenance problems
Problems Notes
H7
Table H5 Routine maintenance and device management
for professional user s
When? Action
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 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
• Description of incident
• Were there any deleterious effects in the patient as a result of the incident?
If so, please describe
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.
H9
Fig 6 Fault reporting form
Device Model/Name:
Description of Fault: (Report the last settings of the device and what you think the problem is)
H10
Table H6 Planned preventative maintenance checklist
Heading Notes
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.
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:
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.)
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.
Topic Action
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.
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.
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).
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.
• 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).
9.4 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).
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
When a new device is delivered Acceptance checks for community stores (5.2)
Storage problems (5.3)
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.
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).
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.
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.
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).
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).
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 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.
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:
J6
Appendix A1.Legislation
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.
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.
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).
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.
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.
iii
Health and safety at work (general)
SI 1989/635. The Electricity at Work Regulations 1989.
Ionising Radiation
SI 1985/1333. Ionising Radiations Regulations 1985.
Place a range of duties on both employers and employees.
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).
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)
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.
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.
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.
Measuring devices - must have adequate accuracy and stability, and be easy
to read.
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.
ix
Consumer Protection
x
device classes, but class two is divided into lower (IIa) and higher (IIb) risk
sub-categories, giving four classifications:
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 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.
• 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.
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
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.
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.
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.
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 9602. Guidance on the safe use of lasers in medical and dental practice.
xv
Directive Bulletins
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).
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.
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)
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))
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.
xix
Improve stock control and safety in relation to issue of wheelchairs to
residents of nursing homes.
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.
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.
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.
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.
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.
xxiv
Choosing a supplier, Complying with legislation, Getting the contract
right, Measuring performance and monitoring improvements,
Managing relationships, Partnership works.
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.
xxvi
APPENDIX A3
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.
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.
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.
xxix
Appendix A4
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.”
xxxi
Scotland
Wales
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.
xxxii
National Audit Office 157-197 Buckingham Palace Road, London SW1W
9SP. Tel. 0171 798 7000.
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
WARRANTY
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
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
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
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
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
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
Year 2000 C2 G2 xv
xliv
DISTRIBUTION
TECHNICAL ENQUIRIES
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
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