Medical Device and Equipment Management for Hospital and Community-based Organisations
BULLETIN MDA DB 9801 JANUARY 1998
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ACKNOWLEDGEMENTS We are grateful to everyone who has contributed to and commented on this bulletin, both within MDA and from the NHS, Scottish Healthcare Supplies, the Welsh and Northern Ireland Offices, the community sector, and the medical devices industry. Many organisations made contributions, including ABHI, BAREMA, BSTA and IPEM. Among many others, we thank: Ian Brett, Nigel Cripps, Graham Dymond, Richard Finney, Pat Flanagan, David Head, Kevin Hogan, Kate Kuhn, Michael Mandelstam, Tim Mossman, Richard North, John Reed, Paul Sim, Siân Storey, Chris Quinn, Maggie Winchcombe, Brian Wilson, and Duncan Wilson for notable contributions.
EXECUTIVE SUMMARY This bulletin is written primarily for people responsible for purchasing, deploying, maintaining and repairing medical devices in hospital and in the community. This will include managerial, technical, and clinical staff. Many of the decisions involved have a direct impact both on professionals and patients, and input from these groups is needed during the decisionmaking process. We argue for setting up broad based consultative groups to oversee both purchasing decisions and device management. The two factors with the greatest impact on device safety are training and maintenance. We stress throughout that user knowledge and skills have major implications for safety. Instructions must be clear, concise, and readily available. Training needs to be timely and effective, and include procedures for the routine maintenance of devices by users. Planned preventative maintenance, carried out following manufacturers’ guidance by properly trained technicians, is the other key element in ensuring devices are safe and reliable. Users and technicians need to understand the basic principles on which devices work (generic training) as well as how to use a particular model (specific training). Training programmes should include input from manufacturers. Within the context of a general guide to good practice in the management of medical devices, we have aimed to provide balanced information for groups developing local policy in key areas, including whether: •
to use a central pool or library, or distribute devices among clinical units;
•
to standardise on a single model;
•
to perform extensive acceptance tests on every device delivered;
•
to use a third party maintenance and repair organisation;
•
to impose administrative controls on prescribers.
The medical device industry is now regulated by the Medical Device Regulations, and this change increases the responsibilities of suppliers, especially with regard to the safety of products and the provision of users with adequate information. We cover the likely effects of the legislation,
and summarise other legislation which impinges on the possible liabilities of healthcare organisations. This area is complicated by the growing plurality of arrangements for the supply, ownership and use of devices, which are now frequently lent or leased by suppliers, and used by unsupervised patients at home. We review possible strategies for maintaining control of devices in the community. The role of the MDA is to provide advice on purchasing, investigate adverse incidents, disseminate safety information, and to act as the UK Competent Authority - the regulator for the medical devices industry.
CONTENTS 1 Introduction.................................................................................
A1
1.1 Summary....................................................................
A1
1.2 Scope.........................................................................
A1
1.3 Terminology..............................................................
A2
1.4 Organisations and roles.............................................
A4
1.5 Medical Devices Agency...........................................
A6
1.6 Best practice..............................................................
A7
1.7 England, Scotland, Wales, and Northern Ireland.................................................
A7
2 Strategies for deploying devices.................................................
B1
2.1 Summary....................................................................
B1
2.2 Pros & Cons of equipment stores, pools and libraries...............................................................
B1
2.3 Professional user-centred device management..........
B2
2.4 Risk assessment.........................................................
B3
3 Purchasing...................................................................................
C1
3.1 Summary...................................................................
C1
3.2 Overseeing................................................................
C2
3.3 Legal Liabilities........................................................
C2
3.4 Decision making.......................................................
C2
3.5 The purchasing process............................................
C9
3.6 Other methods of acquisition...................................
C10
4 Instructions.................................................................................
D1
4.1 Summary...................................................................
D1
4.2 Legal requirements...................................................
D1
4.3 Effectiveness of instructions....................................
D2
4.4 Evidence of giving instructions................................
D4
4.5 Providing instruction with loan equipment..............
D5
4.6 Revised instructions..................................................
D5
5 When a new device is delivered.................................................
E1
5.1 Summary...................................................................
E1
5.2 Acceptance checks....................................................
E1
5.3 Storage......................................................................
E4
5.4 Procedure for starting to use a new device...............
E6
6 Prescription.................................................................................
F1
6.1 Summary...................................................................
F1
6.2 Professional prescribing of equipment.....................
F1
6.3 Administrative and technical support for prescribers.
F2
6.4 Prescribing policies and safety.................................
F2
7 Records.......................................................................................
G1
7.1 Summary...................................................................
G1
7.2 Purpose of record keeping........................................
G1
7.3 Computer databases..................................................
G1
7.4 Record-keeping procedure........................................
G2
7.5 Recall of equipment..................................................
G5
8 Maintenance and Repairs...........................................................
H1
8.1 Summary...................................................................
H1
8.2 Division of responsibilities.......................................
H3
8.3 Choice of maintenance and repair organisation.......
H3
8.4 Routine maintenance................................................
H5
8.5 Cleaning and decontamination.................................
H9
8.6 Planned preventative maintenance...........................
H11
8.7 Breakdowns..............................................................
H11
8.8 Replacement criteria.................................................
H12
8.9 Inspection, maintenance and repair of equipment in the community......................................................
H12
9 Training......................................................................................
I1
9.1 Summary...................................................................
I1
9.2 Training for professional users.................................
I1
9.3 The Technical Supervisor's role................................
I2
9.4 Training for End-Users............................................
I2
9.5 Safety training for staff............................................
I2
10 Community issues...................................................................
J1
10.1 Summary. ..............................................................
J1
10.2 Integrated material.................................................
J2
10.3 Delivery and commissioning of loan equipment..
J2
10.4 Collection of equipment when no longer needed.
J2
10.5 Checking and testing of returned equipment........
J3
10.6 Adaptation of equipment.......................................
J3
10.7 Insurance...............................................................
J3
10.8 Device safety for surgeries....................................
J3
Appendix A1 Legislation.............................................................
i
A1.1 Acts of Parliament....................................
i
A1.2 Statutory instruments...............................
iii
A1.3 Selected EU directives.............................
vi
A1.4 CE-marking for purchasers......................
vi
Appendix A2 Bibiliography..........................................................
xv
A2.1 MDA Publications....................................
xv
A2.2 Relevant Health and Safety Executive publications.............................
xvii
A2.3 Relevant Department of Health Circulars
xvii
A2.4 Selected other reports with relevant recommendations....................................
xix
Appendix A3 Preparation of medical devices for return to service departments: infection hazards............................... xxvii Appendix A4 Contact details - arrangements for reporting incidents and ordering publications.......................
xxxi
A4.1 MDA.........................................................
xxxi
A4.2 Scotland, Wales and Northern Ireland......
xxxi
A4.3 Other organisations...................................
xxxii
1 1.1 SUMMARY
INTRODUCTION
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:
1.2 SCOPE
•
suitable for its intended purpose;
•
properly understood by the professional user;
•
maintained in a safe and reliable condition.
This bulletin has been prepared by the Medical Devices Agency after wide consultation. It emphasises the care and maintenance issues directly related to medical devices and offers guidance both for organisations which use devices, and those which supply them to users. Target organisations include community stores, hospitals, and surgeries. We concentrate mainly on devices for which users have to be trained and regular maintenance is needed. The main topics covered are: •
how to purchase the most appropriate device (Section 3);
•
acceptance tests for newly delivered devices (Section 5);
•
adequacy of instructions (Section 4);
•
ensuring a client or patient is prescribed the best device (Section 6);
•
maintenance and servicing (Section 8);
•
record keeping (Section 7);
•
training (Section 9).
A1
Section 10 covers issues peculiar to medical devices in the community. Many topics crop up in several sections, and we have included cross references, using an arrow mark ( ). Fig. 1 illustrates the cyclical process in which devices are prescribed for a given patient, and then prepared for re-use. It shows how different aspects of this process are covered in the various sections of this bulletin.
Fig 1 Prescription,treatments, and re-use
Patient’s clinical need
Devices available for use Section 7.4 Documentation Section 8.6 Maintenance Section 8.4
Prescriber selects device
Check Section 8.5
Section 5.2 Clean Professional user checks Professional user monitors
Application
This bulletin replaces HEI 98, “The management of medical equipment and devices”, which was first published in 1982. We have updated the guidelines in that document following recent changes in legislation, and extended them to take account of the increasing use of medical devices in the community. The two major shifts in emphasis are that manufacturers’responsibilities for safety have been extended under the Medical Devices Regulations, and that Hospital Trusts have responded to the loss of crown immunity by introducing risk management procedures. 1.3 TERMINOLOGY
The following terms have been defined for the purposes of this bulletin: Carer: A lay helper, often unpaid, who looks after an end-user (e.g. patient’s spouse).
A2
Client: Someone who enters the community equipment provision system via a social services department. Clinical supervisor: A clinically trained person responsible for the safe use of a medical device (e.g. ward manager). Community healthcare: Any healthcare provision outside a hospital, including private nursing homes and practices. Device management procedure: A document including policies for purchase, responsibilities for maintenance and training, and actions needed in cases of breakdown or adverse incident. Device provider: An organisation which issues equipment to an end-user (e.g. Disablement Services Centre). Device purchaser: An organisation which buys or leases products from the supplier. End-user: A patient or client who uses a medical device unsupervised at home (e.g. wheelchair user). Medical device: Table A1 gives examples - most healthcare and disability equipment is included. Planned preventative maintenance: servicing operations carried out at fixed intervals by technical staff. Prescriber: A person who decides which is an appropriate device for a given patient or client (e.g. occupational therapist). Professional user: Qualified person using devices as tools (e.g. dentist). Supplier: The manufacturer, or their agents. Routine maintenance: Inspection and device-care operations carried out by end-users and professional users. Technical supervisor: A person in charge of acceptance testing, installation, repair and maintenance (e.g. biomedical engineering department manager). User organisation: A device purchaser which either uses devices (e.g. a hospital trust) or loans them to end-users (e.g. a community store).
A3
Table* A1.Medical devices under the Medical Devices Regulations
*
1.4 ORGANISATIONS AND ROLES
Equipment function
Examples
Diagnosis or treatment of disease
syringes, dressings, catheters, surgical instruments, anaesthetic equipment, implants, scanners, X-ray machines, diagnostic laboratory equipment
Monitoring of patients
ECG, pulse oximeter
Critical care
ventilators, defibrillators, baby incubators
Care of disabled people
orthotic and prosthetic appliances, wheelchairs,hoists, walking aids
Care in the home
urine drainage systems, domiciliary oxygen therapy systems, pressure care equipment
Emergency services
stretchers, trolleys, resuscitators
Tables in this bulletin are primarily checklists - only some of the possibilities listed will be relevant to any given organisation.
We have used standard terms to describe the organisations and people involved, to avoid confusion. The term “user” is a particular problem, with three different meanings: •
manufacturers often refer to purchasers as “users” - this becomes user organisation in this bulletin;
•
the trained and qualified person who operates a device for the benefit of a patient or client is the professional user;
•
the patient or client who uses the device themselves is the end-user.
As well as prescribers, professional users, and end-users, people with technical or managerial roles are often involved. These divide into two groups those with engineering, physics or technical training, and those with a clinical background - technical supervisors and clinical supervisors.
A4
In the simplest cases only one individual performs all the roles - a dentist working in the community buys her or his X-ray machine, supervises maintenance, and is the professional user. Sometimes there are only two people: a prescriber such as an optometrist, and the end-user of the contact lenses they provide. More complicated examples in larger organisations involve up to four people: for example, a patient in hospital has a ventilator prescribed by a doctor, and operated by a nurse. Both the ward manager (clinical supervisor) and the medical engineering department manager (technical supervisor) have supervisory roles. Table A2 lists the many alternative names for medical engineering departments.
Table A2
Medical Engineering department names
Abbreviation
Name
BME
Biomedical Engineering
CE
Clinical Engineering
EBME
Electronic and Biomedical Engineering Electromedical Engineering
EME
*
MEMO
Medical Equipment Maintenance Organisation
MEMS
Medical Equipment Maintenance Service
MP
Medical Physics*
Some medical physics departments are staffed only by physicists and work on metrology, dosimetry, and equipment quality assurance and only undertake limited equipment maintenance - in such cases there will generally be a separate engineering department.
In the community, a client is prescribed a pressure-relieving mattress by an occupational therapist, and lent the mattress by the Community Store (the device provider). The store manager is the technical supervisor, and the client (the end-user), or their carer, operates the mattress. Defining the responsibilities of the various participants and identifying their training needs is one of the main aims of this bulletin. We have found that lack of clarity has led to inadequate patient care, or even harm.
A5
We have distinguished between supervision - the direct day-to-day control of devices, and overseeing - the generation of guidance and policy for supervisors and purchasers. 1.5 MEDICAL DEVICES AGENCY (MDA)
The MDA has been providing advice in this area for over 25 years. Illustrative examples of MDA experience are provided, set in boxes throughout the text of this bulletin. While not intended as guidance, these examples are concrete and varied, and aim to help focus thinking, and to show how people have responded to conflicting pressures, especially financial stringencies. The MDA collates and investigates reports of adverse incidents (hazardous or potentially hazardous occurrences involving medical devices, which have harmed patients, end-users or professional users, or put them at risk), and this activity provides an overview of the causes of problems with medical devices. These include: • • • • • •
inappropriate use; inadequate training; poor quality, obsolete, or worn-out devices (but see Examples A1 and A2); mistakes in servicing or lack of servicing; incompatible ancillary equipment (e.g. leads, probes, infusion sets); poor documentation (e.g. service history or manuals missing).
Example A1 When should defibrillators be scrapped? MDAreceived a query from an Ambulance trust about the possible hazards of using old monitor/defibrillators: “this trust does not have a time-based replacement programme. ..some of our machines have been in service for 10 years.” ( Sections 3.4, 7.4, and 8.8.) Examination of MDA Adverse Incident files showed no evidence of increased failure rates due to age. MDAadvice was that, if manufacturer’s instructions regarding preventative maintenance were followed and if equipment met the tests defined in those instructions, the equipment was safe to use. However staff may not know how to use old-model defibrillators in an emergency, because their training has been on more recent models, and manufacturers may not provide service support for old models.
Our experience is that, unless positive steps are taken, the same adverse incidents happen again and again. We can issue Hazard and Safety Notices, but these are effective only if safetyconscious local management makes sure the information reaches professional users (and end-users where relevant), and is then acted upon. Good device management could in many cases prevent adverse incidents occurring, or reduce their potential for harming people.
Decisions affecting devices should be taken by people with appropriate qualifications and experience who are assigned specific responsibilities. A mistake in the selection of a device at the time of purchase can mean that it will never give satisfactory service. The MDA
A6
runs a programme to evaluate medical devices; and publishes reports with in-depth technical and user information covering single products and comparative reviews of all the products on the market. Specialist technical and other advice is available from the appropriate Evaluation Centre ( Appendix A4.1). Example A2 Worn out pressure-relief mattresses Foam pressure-relief mattresses no longer fulfil their function after long use, and may even cause harm, despite appearing fit for issue from a community store when subjected to a cursory visual inspection. An adequate inspection should include: • a careful check for permanent indentations in the central area of the mattress; • a check for tears in the cover - moisture ingress is known to accelerate loss of core resilience; • if possible, the use of a spring-loaded calliper to compare the thickness under load at a corner (unworn) with the centre of the mattress.
1.6 BEST PRACTICE
Device purchasers and providers should develop and implement a device management procedure. The aim is to ensure that whenever a medical device is used, it should be: •
suitable for its intended purpose;
•
properly understood by the professional user;
•
maintained in a safe and reliable condition.
The device management procedure should include policies for the purchase, acceptance, maintenance, repair, monitoring and replacement of devices, and for the training of users. This is necessary to ensure the safety of professional users, patients, and third parties. This bulletin provides guidance on setting up such policies. Its aim is to provide guidance for optimising the safety, availability and usefulness of medical devices within existing provision and prescribing practice, rather than to examine policy changes. 1.7 ENGLAND, SCOTLAND, WALES AND NORTHERN IRELAND
Although the MDA has a UK-wide role as the Competent Authority (the medical device industry regulator - see Appendix A1.4), the agency is directly responsible for investigating incidents and publishing safety information only in England. 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.
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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 OF EQUIPMENT STORES,POOLS AND LIBRARIES
There are two fundamentally different ways in which devices are deployed: •
•
A central store, pool or library owns the device and is responsible for it. The device is borrowed by the professional user or the end-user when needed. Examples are pressure relief cushions and mattresses issued by community stores, and infusion pumps and ventilators in many hospitals. The device belongs to the professional user, or the user’s unit or department. Examples are fixed installations such as large X-ray machines, and smaller, critical-care devices in some intensive therapy units. Artificial limbs issued to amputees are a community example.
Belonging in this sense is nothing to do with legal ownership - these ways of deploying devices apply equally whether they are sold, lent, or leased by the manufacturer or supplier. There are important issues, mainly concerning liability, to do with leasing or lending - these are covered in section 3. ( Example C1, and Section 3.3.) Where it is practicable, the pool system (e.g. community stores; pools and libraries in hospitals) has big advantages. The return-to-store/re- issue process lends itself to regular inspection and routine maintenance. For example devices with rechargeable batteries can be checked and subjected to a discharge/recharge cycle each time a device returns from use, thus maintaining high standards of reliability in the event of a power failure. ( Example B2)
B1
Table B1
Advantages and dIsadvantages of the pool system
Advantages of the pool system Topic Fewer devices needed for a given level of activity Central purchasing, maintenance and recordkeeping policies Preparation for re-use
Disadvantages Accountability
Notes Local reserve stocks are unnecessary These are easy to implement in a single central store Procedures for cleaning, decontamination, checking and calibration can be implemented centrally Responsibilities are divided between clinical and technical supervisors (see Section 8.2) A pool system needs additional record-keeping to track the current locations of all devices (see Example B1). Out-of-hours access may need to be organised (see Example B1)
Tracking
Access
However pool devices, like cars in a car pool, acquire a characteristically battered look - they are moved around a lot, and there is a perception that people are less careful when the device does not “belong” to them. 2.3 PROFESSIONAL USER-CENTRED DEVICE MANAGEMENT
When the device belongs to the professional user’s unit (e.g. an intensive therapy unit), the person with primary responsibility for device management (the clinical supervisor) is generally someone working in the 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 section 8.4) such as charging for infusion pumps and ventilators. In order that batteries (Example B2). users can acquire a device when the department is closed, there is an open access store. This causes record keeping and tracking problems, and has safety implications since it relies on people using the store knowing which device is appropriate for the patient, and being able to find it. In practice the only way to locate equipment accurately is to check relevant wards daily and note locations of particular devices.
B2
In many hospitals some important aspects of device management, such as record keeping and scheduling servicing, are often controlled outside the unit, and responsibility is split between the clinical and technical supervisors.
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 - PROFESSIONAL USER INPUT
The split in responsibilities between clinical and technical supervisors has some disadvantages which must be addressed if risks to patients are to be controlled. Two elements of the working relationship need particular attention:
Example B2 Infusion pumps failure during patient transfer. Premature battery failure is a common device problem during the transfer of critically ill children by ambulance between specialist units. MDA investigations of 3 infusion pumps which failed showed that average battery capacity had been reduced by 85% due to poor battery maintenance procedures. The capacity of some types of rechargeable battery will only be maintained if they experience regular charge/ discharge cycles. Possible solutions to the problem are regular pump servicing including cycling the batteries, or the regular use of the pump in battery operated mode, rather than on AC mains power.
Example B3 Record keeping for infusion pumps The Scottish Office Home and Health Department document "The management of infusion systems" recommended improvements in record keeping for infusion treatments. A hospital has done this by producing a 2-layer self duplicating form (Fig 2), based on Appendix 7 of the above document. The design was monitored by a project team representing several directorates, and discussed with the trust’s drugs and therapeutics committee. The top layer of the form has an adhesive top edge for attachment to patient notes, and the bottom layer is sticky backed, and wraps round the syringe barrel or the infusion line. Staff gain the security of a visible record of treatment without extra form filling
B3
•
consent - professional users should be consulted about changes and be persuaded of the need for them. They must feel secure and in control when changes are introduced (Example B3).
•
stimulus - someone should be responsible for risk assessment. Their objectives should include: encouraging improvements in working practice which progressively reduce patient risk; communicating the outcome of risk assessments; and stimulating continued improvement (Table B2).
Some hospitals have fostered the consent element by setting up a medical devices group with wide representation of clinical and engineering staff as well as purchasing administrators (Example B4). Similarly some hospitals have appointed an experienced nurse as the medical device coordinator, and allocated tasks including those shown in Table B2. The coordinator needs training in risk assessment techniques.
Fig 2
INFUSION IDENTIFICATION LABEL
Patient / Client Name Record Number: Date: Start Time: (24 hr clock) Drug / Concentration (s):
Diluent Solution: Total Volume: Infusion Start Rate: Device Name & Number: Route used for infusion Continuous (C) / Variable (V) Infusion Completion Time if (C); use 24hr clock Checking Staff Names 1 2
Signatures 1 2
Example B4 Terms of reference of a hospital medical devices group. A hospital has recently set up a medical devices group: an inter-departmental working party for developing procedures for decontamination has been extended and has taken on a wider remit, providing advice on equipment purchase, questioning whether full running, maintenance and consumables costs have been considered when preparing an equipment purchase bid (>Table C1). The group also seeks to
• • • • •
take risk management decisions; increase awareness of training issues; co-ordinate an equipment inventory; draw up guidelines for equipment decontamination; discuss equipment management procedures.
B4
In some cases the medical device coordinator will also act as MDA liaison officer, reporting incidents, receiving copies of all MDA publications, and making sure they reach their intended readers (see Appendix A4.2 for arrangements in Scotland, Wales and N. Ireland). However, when trusts operate on several sites, it may be helpful to have an MDA liaison officer for each site, or for each directorate.
Table B2 -
Checklist for medical device coordinator responsibilities
Area Meetings Training
Information
Risk assessment
User/technical department interface
B5
Task Set up and service medical devices group • Run broad-based training sessions - eg doses, dilutions, syphoning, pressures, for ITU staff. • Organise participation in a suitable training scheme (see Example I1). 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. 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). Improve lines of communication between users and maintenance organisations.
3 3.1 SUMMARY
PURCHASING EQUIPMENT
A broad-based purchasing advisory group can help formulate a purchasing policy which takes into account the needs and preferences of professional and end-users, while remaining consistent and well controlled. We review purchasing decisions of increasing complexity: direct replacement, replacement with a new model, and acquiring a novel type of device. In each case it is important to estimate total costs, including amongst other costs, installation, training, consumables, maintenance, and repair.
Fig 3
The purchasing process YES Has the need changed?
Oversight by purchasing advisory committee
NO YES More of the same?
Negotiate
Re-order
NO
Market survey
Technical specification
Evaluation reports Collect data
Financial data
User experience
Regulatory compliance
Compare cost & features
Negotiate
Order
New device supplied
Section 5.2 Acceptance tests
Log details
Section 9
Section 4.3 Secure supply of any consumables
Provide professional user & technical staff training Device ready for use
C1
Modify instructions if required
The choice of model depends, amongst other factors, on fitness for use, safety, reliability, and ease of maintenance. Relevant information needs to be obtained from the manufacturer before purchase, including standards complied with, manuals available, warranty details, availability of training for users, and maintenance contracts. There is a checklist for drafting orders, and a concluding section covering borrowed equipment, and in-house manufacture. 3.2 OVERSEEING
Many hospitals have found it helpful to set up a purchasing advisory group which includes clinical engineering and finance expertise and informs the purchasing decisions. Figure 3 shows how such a committee can oversee the complex process of making purchasing decisions. In cases when patients are end-users (devices such as artificial limbs or wheelchairs), local groups of users based around Disablement Services Centres can be consulted about purchasing decisions. National groups, such as the Limbless Association may also be able to provide useful information. This results in greater satisfaction of end-users, and also contributes to increased cost-effectiveness of the service. If equipment serves its purpose well, is aesthetically pleasing and comfortable to use, then end-users are likely to take better care of it, leading to reduced maintenance work and improved safety. 3.3 LEGAL LIABILITIES
Employers have duties to their employees: for example purchasers of lifting 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 DECISIONMAKING
The simplest type of purchase involves adding to existing stock or 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 example, 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 purchaser’s negotiating position with the supplier.
C2
For products like wheelchairs and orthoses, different models may best suit the needs of individual end-users. Case for replacing with a new model Technological change may mean that more recently designed models have significant advantages in terms of safety, performance, or value for-money, which outweigh any extra expenditure involved in tendering, training, and maintenance. In some cases new technology reduces running costs to such an extent that replacement of existing devices can be self-financing (see Example C1). Example C1 New anaesthetic machines for old. A hospital needed to replace 15 elderly anaesthetic machines - but the capital cost was over half the total annual equipment budget. The selection of a machine with circle system breathing capabilities enabled projected annual savings on costs of anaesthetic agents sufficient to pay leasing costs on new machines. Possible problems are that all the new machines will be of a single type, increasing vulnerability to a recall. Leasing has complex financial implications, which need expert review. NHS Executive ( Appendix A4.3 for contact details) restrict the permitted financial arrangements and NHS Supplies can advise on what is permissible.
Which product meets our needs? If the decision is taken to replace or add to stock with a new make or model, then we move on to model selection. Case for introducing a novel device.
The introduction of a novel type of device to extend the range of clinical facilities available (such as a thermal imaging system for a hospital, or ambulatory infusion pumps for a community store) is more complicated. The professionals concerned with the use or prescribing of the new device need first to make a case for the new clinical activity in which it will be used, demonstrating that this activity has clear benefits for the patient and/or the organisation, and that it is not possible to match these using existing equipment. Before moving on to model selection criteria, it is important to make a realistic estimate of total costs, (Table C1) including maintenance, training, and running costs, and to make sure that the likely benefits outweigh these costs. This should be done for all short-listed devices. The Audit Commission report “Goods for your health: improving supplies management in NHS trusts” - summarised in Appendix A2.4 - offers useful guidance in this area.
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Table C1
Total Costs checklist. In any given case only some of these will be relevant
Cost Price
Notes In some cases manufacturers will seek to offset low purchase prices with expensive contracts for consumables or servicing. Resources needed to manage and participate in tendering process.
Tendering Risk assessment Installation
Professional user costs
Consumables, accessories
Overheads
Utilities Maintenance Repair Insurance costs Disposal
Special services (power, water, gas, electricity) and minor building works. Environment and safety costs. Local production of procedure manuals, if needed. Training sessions for all relevant staff. Updating store catalogues. Complex devices may need additional staff. 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? Is personal protective equipment (e.g. masks, goggles, film badges) needed? Environmental or health monitoring costs. Operational costs, including electricity, water, laundering and cleaning. Maintenance contracts, spare part costs. Call-out charges - possible need for back-up devices in case of failure ( Section 8.7). Indemnity insurance may be needed. Devices containing radioactive isotopes are expensive to dispose of properly.
Example C2 Compatibility of slings and hoists Using only those combinations of slings and hoists recommended by the manufacturer avoids safety problems caused by incompatible slings. Factors affecting compatibility include: • type of attachment - chain, strap, clip-on attachment; • sling locating arrangement on spreader bars; • dimensions of sling. Using the wrong sling can unbalance the hoist. A risk assessment must be carried out if the use of a third party sling is contemplated, with guidance from both sling and hoist manufacturers, professional judgements of suitability, and advice from insurers.
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Model selection. Selecting a particular manufacturer and model is the final stage of the decision-making process. The Medical Devices Regulations (see Appendix A1.4) will ultimately result in all medical devices carrying a CE marking, which indicates compliance with the Regulations. Thus the CE marking is no help in deciding between models. Price, safety in the intended application (see Example C6), quality, clinical preferences, the preferences of end-users (see Example C3) and the implications of legal requirements are the major considerations. In general, if a device is CE-marked, purchasers will not need to use standards compliance to be sure that it is safe. However standards will sometimes need to be cited in purchase Example C3 Human and financial costs of contracts to make sure a device is fit for short term contracts. the application envisaged - for example to Purchasers who provide artificial limbs must ensure it has compatible connectors. weigh the potential advantages of lower costs resulting from the continual negotiation of shortterm contracts against the costs - financial and human - of disruption to the longstanding relationships between patients and providers of prosthetic services.
Purchasers should always consider the training and maintenance implications of a purchasing decision:
•
Well-maintained equipment used by well-trained staff minimises risks;
•
In the event of an adverse incident, discovery of failures in training or maintenance may lead to a finding of liability by the courts, potentially leading to very large awards of damages (see Section 8.3).
Example C4 Innovative use of tendering process to gain professional input. A community store requested all tenderers to provide a sample device and its instruction manual on short-term loan, as a condition of tender. An open day was held, to which all prescribing professionals were invited. They were asked to examine candidate devices and fill in a questionnaire, which was heavily biassed to safety considerations. Questionnaire analysis was available to the purchasing group when it considered tenders.
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Procedures should be reviewed or introduced to ensure adequate inputs from clinical and professional staff, especially on safety-related topics (see Example C4). Table C2 lists possible factors to take into consideration.
Table C2
Model selection criteria
Factor Life cycle/replacement
Fitness for intended application
Guarantee/warranty Safety
Reliability Service support
Maintenance requirements
Technical advice
Diversity
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Notes 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. 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. Compare terms. Are these negotiable? 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). Have other users experienced problems and failures? Are spares readily available and is service support guaranteed? For how long? Is response time guaranteed? Intervals between service, frequency and complexity of checks and calibrations needed during operation. Does the manufacturer give free access to technical advice, for professional users and technical staff? - is there a 24-hour help-line? Will this choice increase the number of types of the device in use, and could this be to the detriment of safety?
Example C5 A ventilator manufacturer responds to market forces. A manufacturer replaced an existing ventilator model with a version with a wide range of new features, enabling many different ventilating modes to be selected. Users found the new version hard to operate - choosing a given mode was complicated, and there were safety concerns about the possibility of selecting dangerously inappropriate settings. The manufacturer saw the opportunity to produce a simplified version essentially the same ventilator with a new front panel with simplified controls, enabling only a limited range of functions to be selected. Both models are offered for sale, leaving customers to decide which version meets their need.
Information about specific models The MDA can provide a good deal of information needed to choose the most suitable device, either in its publications or from its Evaluation Centres (Appendix A4.1).
However the supplier is generally the main source of information about a given product. NHS Supplies has produced a pre-purchase questionnaire (PPQ Appendix A4.3) which many hospitals send to suppliers to gain information about products. Table C3 is a checklist of possible questions to ask potential suppliers, in order to generate useful information about a proposed device. This list assumes the situation after June 1998, when all new devices placed on the market must be CE-marked under the Medical Devices Regulations. Note that active implantable devices (e.g.pacemakers) and in vitro diagnostic devices are dealt with under separate directives, and that custom-made devices, and devices intended for clinical investigations are special cases ( Appendix A1.4, which includes the definition of “placing on the market” ).
Example C6 - Professionals foresee safety problems. One make of a sliding-turning band (for example for transferring a patient from bed to wheelchair) is cheaper than another. However, the cheaper model has handles at each end, which may have the effect of encouraging professional users or non-paid carers to use the band as a lifting sling - for which it is not designed - to the detriment of their health and safety. Thus, on grounds of safety, the more expensive product should be purchased.
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A useful summary of purchasing issues, including the effects of public procurement law and when you need to publish invitations to tender throughout Europe, is included in “Purchasing medical equipment” a briefing document from the joint NHS Confederation/ NHS Supplies working party. Summaries of this and other documents providing advice on purchasing are in Appendix A2.4.
Table C3
Pre-purchase enquiries for medical devices
Topic CE-marking (establishes that device complies with statutory regulations) Standards (manufacturers are not obliged to comply with standards)
Instructions
Service/repair manuals
Warranty Installation
Training
Maintenance and repairs
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Notes Device class. Notified body involved (where relevant). Details of any quality and safety standards which have been applied either to the device or the manufacturing and inspection processes. Suitable for end-user. Suitable for prescriber or professional user ( Section 4.3). Availability and conditions of supply. Do manuals include: circuit diagrams, preventative maintenance schedules, trouble shooting, repair procedures, parts list, special tools list? Costs? Details of cover. To be carried out by manufacturer /supplier? Details of accommodation and services needed. Is special decontamination equipment needed? (see Section 5) For professional users? For technical staff, to enable them to do all maintenance and repair operations? Costs? 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?
3.5 THE PURCHASING PROCESS
Central Control 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 decisionmaking process can be maintained. This is nullified if individuals can place orders without any checks on the devices selected. Particular problems arise with donations to specified wards or directorates. However centrally controlled purchasing can be slow and bureaucratic, and conflict with delegation and de-layering policies. Tender adjudication Some of the MDA Evaluation Centres offer a tender adjudication service, particularly for complex high-value imaging equipment. The contract The important thing about contracts (which can contain any lawful conditions both seller and purchaser agree to) is that they must be agreed before you commit yourself to a purchase. You will generally not be able to renegotiate after the purchase has been agreed. It is possible to build flexibility into a contract - say to agree a purchase “subject to satisfactory replies to our questionnaire”, if there has been a delay in completing the questionnaire. But this could lead to a lot of very expensive legal clarification of the exact meaning of the word “satisfactory”. Many contractual conditions are only relevant when things go wrong, not when the relationship between seller and purchaser is a smooth one. The order Table C4 contains a checklist for drawing up an order.
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Table C4
Ordering checklist. In any given case, only a subsetof these c hecks are likely to be relev ant
Topic Device details
Notes Type number, software version, power supply details, professional user chosen options, standards complied with - as agreed and where relevant. Professional user manuals, end-user manuals, servicing manuals, other technical literature (parts list, circuit diagrams, cleaning instructions). Specify agreed terms. Leads and connectors, probes and sensors, calibration equipment.
Manuals
Warranty Ancillaries Consumables Installation/commissioning Training
Acceptance procedure Quantity, price, terms, discount Maintenance agreement Any other conditions of supply Delivery date Delivery point
3.6 OTHER METHODS OF ACQUISITION
Any work which the manufacturer or supplier is to do. For users or servicing personnel, including initial training on delivery, and on-going training needs during operation. Details of your acceptance procedure (see Section 5.2). Intervals and response times - level of service required and agreed cost. e.g. a ceiling on future prices for consumables and spare parts. All deliveries should be addressed to a single named department, so devices do not get put into service without checks (see Section 5.2).
Borrowing Hospitals often loan each other devices to avert temporary problems, and manufacturers loan products for evaluation, or as an incentive to purchase. In either case it is important to be clear about where responsibility lies for any problems which arise when you use borrowed devices (see Example C7).
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NHS Supplies has a standard indemnity form which should be used for equipment loans from manufacturers. They have reached global loan agreements with several leading manufacturers, allowing the loaning of equipment to proceed throughout the NHS in England. Similar global agreements exist for Scotland, Wales, and Northern Ireland. Borrowed devices must go through the same acceptance procedure as newly purchased items ( Section 5), and the administration 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.
Example C7 Electric operating table appears. A BME manager was called out to repair an electrically operated operating table after a breakdown. The table proved to be on loan from a manufacturer, the loan having been negotiated by surgical staff without reference to the BME department. Concerns included the lack of electrical safety checks, the non-availability of manuals, possible effects on purchasing decisions, and liability in the event of an adverse incident.
In-house manufacture Many larger BME departments have an excellent tradition of innovative design and construction of medical devices. However the advent of CE marking is an added complication, because they might have to comply with Medical Devices Regulations at the design, manufacturing, and clinical evaluation stages (see Appendix A1.4, and the MDA Directive Bulletin 18a). Custom-made devices - tailored to the Example C8 Home-made spirit levels cause needs of a single patient or client - are a infection special case ( Appendix A1.4). Although A patient in an ITU died, and a number of others they do not need a CE marking, they are were made ill as a result of an outbreak of still subject to the Medical Device multi-resistant Pseudomonas aeruginosa. The Regulations. source of the organism was tap water, and the route by which it reached patients was by a home-made spirit level used for central venous pressure measurements. MDA HN9609 (Appendix A2.1) recommends the use of commercially available items.
Special care is needed to ensure that there is adequate documentation for novel or unusual devices. A manual is essential, including relevant information, such as who holds circuit diagrams and computer programs, where relevant.
Modifying and change of use Modifying existing devices, or using them for purposes not intended by their manufacturer, counts as manufacture of a new device under the Regulations (see Appendix A1.4) and may have safety implications (see Example C8). Once again the modified device can only be used without a
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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 manufacturer 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 necessary be made a condition of purchase. Full refurbishment will normally either be carried out by the manufacturer, or following the manufacturer’s instructions for refurbishment. The key point is that the device is put into use again “as good as new”, under the name of the refurbisher. After 14th June 1998 anyone doing full refurbishment as a business must comply with the Medical Devices Regulations (see Appendix A1.4). This may include third party organisations running community stores for social services or healthcare trusts. The MDA view is that the regulations will not apply if the refurbisher is a healthcare organisation which already owns the device, and intends to use it only for its own patients. In this case the device remains within the same legal entity throughout. Cannibalising Cannibalising is the process of replacing parts which have failed in service with ones taken from other broken devices. At its most pernicious, whole wheelchairs, for instance, are assembled from second-hand parts from many different manufacturers. Cannibalising cannot be recommended: • • •
Using spare parts of unknown quality and suitability could be negligent; Manufacturers will not accept liability in these circumstances; Traceability is impossible in the case of a manufacturer’s recall.
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4 4.1 SUMMARY
INSTRUCTIONS
Good clear instructions have a crucial role in the safe and effective use of medical devices. The Medical Devices Regulations make the manufacturer responsible for supplying appropriate instructions. User organisations must make sure that professional users and end users have access to manufacturers’ instructions, and that, when necessary, the information in the instructions is explained and expanded during training. They may need to consider adding to or replacing manufacturers’ instructions in cases when they are inadequate - either because of the context in which the device is being used, or because users have special problems. Loan equipment may need new sets of instructions each time it is issued, and a procedure should be put in place to ensure that end-users have received instructions and are aware of their importance. Manufacturers sometimes update instructions, and user organisations need to have systems for replacing existing instructions with revised versions, and ensuring that the new versions apply fully to the device in question.
4.2 LEGAL REQUIREMENTS
Manufacturers’ instructions, as well as being practically helpful, make an important contribution: • to patient and professional user safety; • from a legal point of view. Instructions may be either part of the labelling of a device, or a separate manual. The Medical Devices Regulations (Appendix A1.4) have requirements covering the provision of adequate instructions and labels. Paragraph 13 of the Essential Requirements (Annex 1 to the Directive, “Information supplied by the manufacturer”), says “Each device must be accompanied by the information needed to use it safely...taking account of the training and knowledge of potential users....Instructions for use must be included in the packaging for every device.” (There are exceptions for some low and moderate risk devices.) Manufacturers must supply information about “the nature and frequency of the maintenance and calibration needed to ensure that the devices operate properly and safely at all times”. Labels also have to indicate “any special storage or handling conditions”.
D1
4.3 EFFECTIVENESS OF INSTRUCTIONS FOR USE - THE NEED FOR TRAINING
Safety issues do not stop with the device itself. Professional and end users’ awareness of relevant information is a crucial and possibly decisive factor. Professional users should refer to manufacturers’ instructions when prescribing devices. Instructions should give indications for and against the use of a device, including the type of use intended, and categories of patient/client for whom the device is suitable. They should describe risks to the patient and side effects, allowing the prescriber to weigh these against expected benefits. Clear responsibilities should exist for ensuring that essential information is given to professional users and end-users (see Example D1 and Section 5.4). Example D1 Problems with a near-patient testing device A known diabetic was admitted to a hospital Accident & Emergency Department exhibiting signs and symptoms of diabetic ketoacidosis. The patient’s blood glucose was measured at the point of care using a blood glucose meter. A separate sample sent to the hospital laboratory gave a markedly different result. Insulin treatment of diabetic ketoacidosis is titrated against blood glucose concentrations. The hospital reported the inadequate performance of the ward-based meter to MDA. A review of the manufacturer’s instructions for the meter revealed a number of contraindications for use (including ketoacidosis) of which the professional users were unaware. Blood glucose meters may be used for the sole diagnosis and treatment of certain clinical conditions. In all cases professional users should be aware of the manufacturer’s instructions and any contra-indications. Such information should be incorporated into training of all staff involved in extra-laboratory blood glucose measurement this is a case when instructions need supplementing with training.
Special problems arise when an organisation has a stock of superficially similar products with applications which need to be restricted for safety reasons. One solution to this problem is to devise a classification and attach labels to devices indicating their class. Posters at the point of use show which category is suitable for which application (Example D2). Many community stores produce catalogues of all the equipment they supply which contain guidance for prescribers, including contraindications. This information derives from manufacturer’s instructions. In some cases prospective prescribers have to attend a training course before being issued with their catalogue.
Instructions for the end-user Extra care is needed in the case when the end-user is a patient for whom the device has been prescribed. Providers of equipment for end users should be aware of the legal provisions under which they may incur liability, which are outlined in Appendix A1. Prescribers and providers should be aware that a failure to pass on to the end-user the manufacturer’s original instructions on how to use a device may not only compromise the end-user’s ability to use the device safely, but also lay the provider open to legal liability. For example failure to pass on
D2
Example D2 Risk categories for infusion pumps. Some hospitals have devised a strategy for linking infusion pump performance to risk for various therapies. Typically there are three pump categories: neonatal (the highest category); high risk applications; and lower risk applications. Pumps are placed into a category using criteria based on the MDA DB9503 (Appendix A2.1), and a colour-coded N, H, or L label is attached to every pump. A poster at the point of use has two lists of drugs - high risk infusions for which only high risk or neonatal pumps can be used (e.g. morphine, insulin) and lower risk infusions, for which any pump is suitable (e.g. sodium chloride 0.9%, and glucose 5%). There is a warning only to use neonatal category pumps for any infusion given to a neonate. Such systems have been found useful, but there may be some problems: • PCA (patient controlled analgesia) and anaesthetic pumps have different controls and functions, and must never be used instead of a general-purpose infusion pump. Labelling should indicate the type of pump as well as the performance level; • some pumps have settings which can be altered by the user, changing their category; • the infusion risk category depends not only on which drug is being used, but also on the strength of the solution; • there is no universally accepted procedure for assigning a pump or drug to a category; • a complete risk assessment must take the patient into account as well as the drug and the pump - systems should not be so rigid that clinical judgement is fettered.
the manufacturer’s instructions about safe use of a product could be seen to be the cause of an accident - which could lay the authority open to legal liability, under for example,: •
the Consumer Protection Act 1987, s.10 (in the case of a medical device);
•
the General Product Safety Regulations 1994 (in the case of a consumer product not covered by other specific legislation);
•
the common law of negligence.
End-users with particular problems Some users with particular disabilities or medical conditions will need special instructions and training from their prescriber. Basic safety and maintenance information will also need to be supplied to all users by administrative or stores staff. Thus the manufacturer’s instructions about safe use and maintenance of a hoist should be passed on to all endusers. However, in addition, the prescriber may give additional specific information to the user and the carer, in the light of their particular needs and daily routines.
Sometimes the basic information may go beyond aspects of the hardware itself and its basic use, and indicate generally who might or might not use it safely. Suitability of manufacturer’s instructions Prescribers need to be aware that some end-users (for example people who are blind or confused) will not have access to the information in the basic instructions, and will need special training.
D3
In such cases the user organisation may supply its own instructions, though it will need to do so carefully, since “defensive” legal advice might suggest that this invites legal liability. Equally, however, the provider may be inviting liability if it knowingly passes on inadequate instructions supplied by the manufacturer. It may also be necessary to write instructions locally if devices are linked to serve a novel function - for example connecting a blood analyser to a computer system to permit automatic updating of patient records. Table D1 provides a checklist for writing better instructions. In some situations end-users need a telephone advice line as well as written
Table D1
Adequate instructions for end-users
Topic Placement
Content Print size Technical or difficult language Translation from foreign language Translation into other languages
Notes and problems Should instructions be printed on the device itself, or its immediate packaging, or supplied as a leaflet? Instructions must be precise and clear, and should include commonsense advice. Users may have visual impairment. Users may lack technical knowledge instructions must be comprehensible. May not be accurate. End-users must understand the instructions.
instructions (see Example D3). User organisations may wish, when operating a tendering process for purchase of the items of equipment, to impose as a contractual condition that the manufacturer must supply adequate instructions - the adequacy to be determined by the purchaser, who must review the instructions and agree their content. If user organisations do draft their own instructions, they should submit them to the manufacturer for approval. 4.4 EVIDENCE OF GIVING INSTRUCTIONS
User organisations may need - in the event of litigation - to be able to call on evidence that instructions were given to end-users in respect of certain types of equipment. For example, users of equipment could be requested to sign statements to the effect that they have received written or oral instructions - or both.
D4
4.5 PROVIDING INSTRUCTIONS WITH LOAN EQUIPMENT
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, receive instructions, and realise Example D3 Home dialysis. Patients using peritoneal dialysis equipment at that they are important. home need more comprehensive backup than can be provided by written instructions. A 24-hour helpline gives access to expert advice, and home dialysis nurses can be called out to help in the patient’s home.
Even if the manufacturer provided good quality instructions initially, which were passed on to the enduser of the equipment, they will often not be returned with the equipment. Thus, when the provider comes to reissue the equipment following refurbishing there may be no instructions. Providers will
Table D2
Methods of producing instruction for equipment loaned to patients.
Strategy Keep master copy and photocopy* Request additional sets Attach instructions rigidly to device.
Problems May need manufacturer ’s permission. Must be for the relevant model. Some manufacturers screen print onto instrument cases (eg infusion pumps), but attached instructions must survive cleaning and decontamination (see Example D4).
need to adopt one or more of the various options in table D2 to counter this. 4.6 REVISED INSTRUCTIONS
* see Revised Instructions, Section 4.6.
Manufacturers sometimes issue revised instructions, incorporating safer methods of using devices, and clearer Example D4 Attempt to attach instructions guidance. It is important to :
permanently to a device. A community store produced instructions on printed plastic cards which clipped to hoists with a key ring. They were, however, generally missing when hoists were returned. It may be necessary to ask end-users not to remove the instructions, or to make them very hard to remove.
•
make sure that manufacturers keep records of purchasing organisations, and automatically send them copies of revised instructions;
•
check with the manufacturer that revised instructions are actually
appropriate to the products in service - there may have been ware changes;
D5
upgrades or soft-
5 5.1 SUMMARY
WHEN A DEVICE IS DELIVERED
Acceptance checks aim to weed out faulty products and those damaged in transit. Tests to discover whether a device is suitable for its intended application, or whether it complies with standards are inappropriate after delivery - this information must be generated before the device is purchased. Manufacturers are encouraged to include a list of suitable acceptance checks in the manual. Some checks (for example for visible damage, and that the order is complete) can be carried out by storekeepers or secretarial staff. Many functional checks can be carried out by professional users or end-users, given suitable instructions. In general calibrations and safety tests need specially trained staff. Large complex devices (such as sterilizers or imaging systems) need specialists to install and commission them. Poor storage conditions can render devices unserviceable - poor physical conditions, and stock rotation failures are typical examples. When a new device is first put into service, records need updating, staff need training, and planned preventative maintenance put in place. Professional users should be aware when they are the first Example E1 Trolley tests in a community person to use a new device. store
5.2 ACCEPTANCE CHECKS
Rationale for acceptance checks
The swivel castors on a trolley were not properly fixed during refurbishment, and easily dropped out in use. An end-user had an accident at home using a newly refurbished trolley, and was injured. This may result in legal action against the store which loaned the trolley if it can be shown that a reasonably competent provider would have inspected the trolley.
Manufacturers using the CE marking are demonstrating that their products are safe and comply with the Medical 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 without checking it can waste time and resources. Furthermore, an organisation might be found negligent in some situations if harm occurs which could have been prevented by acceptance checking (Example E1).
E1
Acceptance checks are clearly not only good practice with the safety of the end-user in mind, but also a safeguard against litigation. Purchasers report contrasts in quality between different suppliers, and also in relation to different shipments of the same product from the same supplier. Scope of acceptance checks Acceptance checks, when equipment is first delivered, aim to ensure that the correct device has in fact been delivered and satisfies the following criteria: •
it has been delivered complete and is in good condition without visible defects (see Example E2);
•
it is in full working order and performs as expected;
•
it passes standard safety inspections applied to all the equipment in the organisation (for example electrical safety tests);
•
the controls are set to standard values for the intended application (see Example H6).
It is important to distinguish between acceptance checks for newly delivered devices and type-testing or attempting to prove compliance with standards. Typetesting is not recommended or appropriate for products which have been purchased and are to be put into service, because in some instances it has the potential to damage the device under test, and is outside the competence of most BME departments. Appendix A1.4 gives an account of the role of standards compliance in the CE-marking process.
Example E2 Burns from phototherapy device A patient receiving phototherapy treatment suffered burns. The lamp - a newly delivered device - proved to be operating without an essential UV filter, and to be positioned too close to the patient. MDA HN9606 (Appendix A2.1) describes the incident. It is likely that both acceptance checks and staff training for a new device were inadequate.
Acceptance checks serve to weed out faulty product items which have slipped through the manufacturer’s quality assurance process, or have been damaged in transport or storage. They do not aim to test whether a given device model is suitable for its intended use - this must be done before purchase ( Section 3.4).
E2
When an organisation has a technical or engineering department, this can supply the expertise needed to assess safety. Otherwise, non-technical checks can be conducted by clinical or administrative staff, and maintenance organisations must be relied on for technical checks (Table E1). Section 8.4 covers acceptance checks needed after maintenance. Acceptance procedures Complex pieces of equipment which need to be installed and commissioned should have a comprehensive set of prescribed acceptance tests. Steam sterilizers (autoclaves) and X-ray equipment are examples of devices which have special guidelines for installation. For other commissioning regulations and NHS guidelines, see Appendixes A1 and A2. In these cases installation and commissioning will need to be supervised by qualified persons, and might involve independent experts, from MDA evaluation centres, for example (see Example E3). Example E3 - A hospital acquires a new imaging system. A hospital decided to extend its capabilities by acquiring a magnetic resonance imaging system, so that patients could be treated locally, instead of have having to travel long distances. The MDA’s Evaluation Centres were closely involved in the purchasing decision and the installation acceptance procedures: • giving advice on the specification, including maximum resolution capacity, shielding, and manufacturers; •
tender adjudication;
•
advice on installation and acceptance commisioning procedures;
•
For portable equipment, a variety of acceptance testing procedures may be necessary - electrical safety tests for example. Manufacturers may recommend certain forms of acceptance testing in the device manual. All equipment new to an organisation (on loan as well as newly purchased) should be checked before issue to users (see Example E2). A central delivery point for all products helps ensure that this is done.
The situation is complicated when hospitals provide devices for patients to training for radiographers. use at home, after they have been discharged (Example E4). Table E1 provides a checklist for developing an acceptance check protocol.
E3
Table E1
Acceptance checklist
Time Immediately on delivery
During functional and safety tests
Before first use
Possible checks • Check packaging for damage. • Check goods against order - leads, accessories, manuals, consumables. • Check any identification labels against invoice - model numbers, mains voltage. • Check device for obvious defect or damage. • Follow manufacturer’s instructions for setting up and testing device. • Check that device performs within original specification. * • Unless manufacturer's instructions specifically advise against, perform relevant safety tests.* ✝ • Perform the same checks used when a device is returned to use after maintenance (see Tables H5 and H6).* • Recheck suitability of device for intended application - see Section 6.*
* checks needing technical or clinical training. † for example the hoist load tests needed for insurance purposes, and electrical safety tests.
People carrying out checks should be adequately trained (see Section 9). 5.3 STORAGE
Inappropriate storage of items affects their subsequent safe use (see Example E5). Manufacturer’s information and instructions both on storage conditions and shelf life should be followed. Table E2 is a storage checklist.
Example E4 Acceptance testing of loan enteral feeding pumps for community use. A dietetics unit provides clinical support for patients using enteral feeding pumps in the community. Patients are trained to use their pump before discharge from hospital, and are usually lent a pump from a stock which the hospital maintains for this purpose. Sometimes the pump is supplied directly by the manufacturer. The manufacturer owns all the pumps, and is responsible for technical support and maintenance once the patient is back home, replacing faulty pumps when necessary. Problems arise if the hospital BME department takes a long time to do acceptance tests on pumps going into stock, or if they insist that all replacement pumps must be tested in hospital before issue to patients. The manufacturer is addressing these difficulties by improving documentation: • Instructions for professional users include a full functional check, and pump care procedures; • Instructions for end-users (supplied with a training video) include a checklist headed “Before using the pump”, with a freephone helpline number. In addition, clinical staff who are trained in the use of the device should check the pump when visiting the patient's home to monitor treatment. Hospitals could decide that professional and end-user tests constitute adequate acceptance checks for these devices, and that they do not need to pass through the BME Department for acceptance testing.
E4
Table E2
Storage issues
Topic Physical conditions
Storage system
Separation of equipment needing decontamination and repair from equipment ready to issue (see Appendix A3) Shelf life and stock rotation
Problems • dirty or wet conditions; • inappropriate temperature or humidity labels on packaging should indicate appropriate storage conditions. • stacks too high; • fragile equipment stored too far off the ground, likely to be damaged by falling from shelves. • inadequate space for demarcated areas for quarantine etc; • inadequate labelling of zones; • inadequate packaging and labelling of refurbished equipment. • no stock handling procedures, so earliest deliveries are not issued first; • inventory system does not identify outof-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 usefully addressed by a quality assurance system. 5.4 PROCEDURE FOR STARTING TO USE A NEW DEVICE
Table E3 lists topics which may need inclusion in this procedure. These are primarily the technical supervisor’s responsibility, but training will need liaison with the clinical supervisor.
Table E3
Example E5 Poor storage causes problems with endotracheal tubes A series of incidents occurred in a hospital when endotracheal tubes failed to retain their connectors, resulting in the loss of ventilation during anaesthesia. Investigation showed that the tubing had suffered an irreversible loss of resilience due to poor storage conditions - tubes had been stored in an unheated basement office where temperatures fell below freezing.
New device checklist
Topic Record keeping Training
Planned preventative maintenance
Labels and documentation
E6
Action Enter new item into inventory ( Section 7.4) Attach label with local serial number. 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. • Inform users about day-to-day checks and operations. • Note which servicing organisation is to be used. • Work out date for first service, enter in record keeping system. • File maintenance manuals. 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.
Example E6 Hourly and Daily rates. Two infusion pumps made by the same manufacturer have identical front panels, except that one pump is calibrated in mm/hour and the other in mm/day. After several adverse incidents (including fatal overinfusions) in which rates 24 times too slow or too fast were inadvertently administered (by choosing the wrong pump) the manufacturer supplied new stick-on labels to cover the front panels, colour coded and with very prominent 1hr and 24hr legends. See MDA HN9506 (Appendix A2.1) for more details. Despite these changes, MDA is still receiving similar adverse incident reports.
E7
You should treat all devices coming into your organisation the same way, whether they are bought, leased or rented, borrowed or on trial. Standard procedures for testing newly serviced devices ( Tables H5 and H6) before they are returned to use should be applied to all devices which are brand new or new to your organisation.
6 6.1 SUMMARY
PRESCRIPTION OF DEVICES
User organisations are responsible for making sure that prescribing decisions are made by staff with appropriate professional qualifications and suitable experience. They may wish to limit the range of devices a given professional group are allowed to prescribe. Prescribers need administrative and technical support, including ready access to technical information and advice, and to safety information. In some situations a technician can usefully share the decision as to which device is best for a given patient or client. Safety must always be an over-riding consideration for prescribers, but user organisations should beware of totally inflexible regulations, which can sometimes result in end-users being denied the best device.
6.2 PROFESSIONAL PRESCRIBING OF EQUIPMENT
The prescription of equipment is the responsibility of the prescribing professionals, and user organisations will need to introduce and manage procedures and policies which ensure that the prescription of different types of equipment is undertaken by suitably qualified and experienced staff (see Example F1). In addition, where joint working arrangements are in place and involve the “crossing of professional boundaries” in prescribing, providers will wish to clarify where professional and legal responsibility for prescription lies. For example, some health authorities in England and Wales have drawn up joint arrangements with social services departments to allow NHS district nurses to provide equipment normally the province of social services occupational therapists (e.g. bath boards), and vice versa (e.g. OTs may issue commodes). Providers will need to be clear about where professional responsibility for the issue of equipment lies, where continuing responsibility lies to monitor the equipment and the condition of the end-user, and thus where legal liability, in case of mishap, falls.
Example F1 Support Seating for severely disabled children The prescription of equipment for severely disabled children is a sensitive issue: the wrong equipment can have permanently detrimental effects on the child, causing or exacerbating postural problems, skeletal deformity etc. Recognising this, a social services department which does not employ specialist paediatric occupational therapists has requested NHS paediatric therapists to carry out assessments on its behalf.
Organisations can adopt policies limiting which equipment certain professionals may prescribe. Social service departments may restrict the prescribing powers of, for example, occupational therapists both in terms of
F1
devices and client groups. Any contraventions of such policies may not only put the end-user of equipment at risk, but - should an accident occur - put the provider on the legal defensive, because its own policy had been contravened. Example F2 illustrates the potential problems which can arise if non-professionals are allowed to make prescribing decisions. 6.3 ADMINISTRATIVE AND TECHNICAL SUPPORT FOR PRESCRIBERS
Administrative and technical support can help prescribers avoid hazards. Computer databases (see Example F3, Section 7.3) can build in certain safeguards in relation to safety, based on the information about the equipment supplied by the manufacturers.
Example F2 Stores Officer denies patient crutches Some years ago, the health service ombudsman found maladministration when a person leaving hospital was denied crutches - not on the basis of a clinical decision, but of an administrative one, made by a Stores Officer who was running out of crutches (because they were not being returned).
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 the responsibility for choosing the most capacity of hoists or commodes on the computer record of particular types of equipment. When a appropriate device. (Example F4). request is input by the prescribing professional (directly or via an administrative officer) for such an item of equipment, the computer requires the inputting of the proposed user’s weight. The request may then not be accepted by the system if the weight of the user exceeds the upper stated weight-bearing capacity of the equipment.
6.4 PRESCRIBING POLICIES AND SAFETY
Providers, and their professional prescribing staff, necessarily develop policies on safety. These should be based on reliable, up-to-date information - and, whilst a premium must be placed on safety issues, such policies should not lapse into rigidity which in some cases may be based more on administrative convenience than on safety.
F2
Example F4 Therapist and technician jointly decide on the best chair raiser. The therapist recommends chair raising blocks for somebody assessed in a day centre. However, she has not visited the person’s home - so she does not specify the particular make of block. It is the experienced driver/technician who visits (with two or three different types of block) who makes the decision about exactly which make of block can be used safely with the particular chair in question.
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 .
Example F5 User denied an appropriate hoist sling. An experienced carer - a woman caring for her disabled husband - requested a two piece sling for use with the hoist already in the home. The social services department staff told her that this was impossible because of “European regulations”. This was misinformation: in fact what they should have referred to was an MDA Hazard Notice. MDA issued the Hazard Notice following an incident in which a patient fell from a two-piece sling and died two days later. The notice did not advise against the use of two-piece slings, but pointed out that they should be used carefully and selectively, in accordance with instructions - and that carers and users should receive full instruction. The notice also referred to the fact that most suppliers of band slings advise that they are not suitable for certain people: those with extensor spasm, flaccid stroke subjects, confused people or those with painful shoulders (Hazard(94)18 Appendix A2.1).
F3
For instance many social services departments have guidelines indicating that people with conditions such as multiple sclerosis or severe epilepsy may be unable to use stairlifts safely. However, on occasion such guidelines might become so rigid that prescribers cease to take any notice of individual circumstances, diagnosis and prognosis. Were this to occur, then particular end users who could in fact use the stairlift safely might be unfairly denied. In addition, the ombudsman - and even the law courts (in judicial review) - might in some circumstances find against the social services department, on the grounds that it had “fettered its discretion” - i.e. that it had not properly exercised its discretion in coming to a decision.
7 7.1 SUMMARY
RECORD KEEPING
Accurate and accessible records are a key factor in effective device management. The primary functions of records include identifying the stock of devices currently available for use, and ensuring prompt planned preventative maintenance and rapid repairs. Secondary functions include providing an inventory, logging service histories, and generating management information about running costs. Computer databases are potentially an effective and flexible way of keeping records, but problems can arise through lack of protection against hardware failures, and inadequate database maintenance, leading to inaccuracies. In some cases it is convenient to have separate, cross-linked, databases serving the inventory and maintenance functions.
7.2 PURPOSE OF RECORD KEEPING
Accurate and consistent record keeping is central to good equipment management. Clear records should be kept from the outset, enabling the organisation to trace individual products (e.g. by serial number), or at least particular types or batches of devices throughout their whole life. Information available should include: • • • •
the current location of a given item; its history - supplier, purchase date, service history; how many items are available for use (or loan); how many are undergoing repair or servicing.
Furthermore this will enable organisations to take appropriate action following a manufacturer’s recall, and to satisfy various legal concerns. For example, under the Consumer Protection Act 1987, civil liability which would normally be attributed to the manufacturer for a defective product transfers to the provider if the manufacturer cannot be identified. Consumers must bring an action for harm caused by defective products within 10 years. Department of Health guidance states that in respect of products supplied, records should be kept for 11 years (HC(89)20) Appendix A2.3. 7.3 COMPUTER DATABASES
The principles of record keeping are the same whether the information is 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 Accuracy
Notes • 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. Databases should contain sufficient but not excessive data. • 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. • 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) 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
Content Flexibility
Reliability
Stability
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 KEEPING PROCEDURE
Inputs Table G2 summarises possible inputs to a device database. Simpler databases are easier to maintain, so the minimum number of categories should be used. A record-keeping system should be able to generate the following outputs: •
When a device needs planned maintenance or calibration;
•
When a device needs checks or tests;
•
Overdue reminders for the above at intervals;
•
When a device reaches the end of its planned life.
G2
Table G2
Possible inputs to a device database
When a new device arrives
• • • • •
• • • • When a device is issued
• •
When a device is returned to BME dept./store When an engineer/technician is called out
When device is in the workshop
• • • • • • • • • •
When a device is disposed of
Example G1 - Bar codes for local serial numbers. A community store attached pre-printed bar code strips to equipment to identify it during its life. These facilitated stock-taking and servicing record keeping, but usage and regular cleaning posed a threat to such strips: user organisations 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 equipment (to discourage people from peeling them off and to provide additional physical protection).
G3
• • • •
Order number; Date of purchase; Local serial number (see Example G1); Supplier; Manufacturer, model, manufacturer’s serial number, serial numbers of component modules; Results of acceptance tests; Warranty details; Date of first service; Information about application, e.g. pump category, hoist safe working load. Location (in a hospital); End-user’s address (devices on loan in the community); Issue date. Reason for return; Date of return. Nature of problem; Location; Action taken; Date. Servicing and calibration (see Table G3) details (including parts replaced); Results of safety/functional tests; Any modifications, including software updates; Location on return to service; Relevant dates. Copy details from active database to archive; Record disposal details on archive.
Other useful outputs include running costs and reliability information. These can both be relevant to future purchasing decisions. If a high level of breakdowns occurs with a given model, then users should contact the Medical Devices Agency, which will investigate the cause. Cross-referencing between databases It is sometimes administratively convenient to split the inventory/tracking function and the maintenance/repair function into two
Fig 4
Records from tw o linked databases
Code Type Maker Nodel SN Location RepCost AcqDate Supp1ier OrderNo AssocEquipment AssoCode PCost Entered RepCostDate
: : : : : : : : : : : : : : :
02305 SO2MON XXXXXX 3800 FBFZ00769 OCH_ITU £1,650 1997/02/06 xxxxxx DBA10010 N N £1,650 18-Feb-97 18-Feb-97
JOB CODE DATE IN DATE OUT DTIME FAULT
: : : : : :
WORK DONE
:
MHOURS ENG STEST MATCOST LABCOST TOTCOST
: : : : : :
04203 00029 28/04/97 28/04/97 1 MONITOR NOTRUNNING ON BATT. DEFIB OK. REPBAT (COMPAT LP6-1000 FROM STOCK. FUNCTTEST. 1.0 DT Y £60.00 £15.00 £75.00
Inventory record
Maintenance/ repair record
separate databases. Some necessary information may only be available from a third database holding the patient/client records. It is vital to be able to cross-reference these databases - for instance to obtain the service history of a device which has failed. This can be achieved by using the same local serial number for a given device in all the databases. Fig. 4 gives examples of typical records from a linked inventory and service/repair database - the code records the local serial number of the device in each case. The inventory record shows the entry on the database for a pulse oximeter - the service record is for a single job, repairing a defibrillator. Table G3 is a checklist of possible inputs for a maintenance database.
G4
Table G3
Inputs to maintenance database ( Table H6)
Heading Date taken out of service Reason Faults detected or reported
Date on which work commenced Parts fitted Calibration and performance checks. Safety tests Time taken Date on which returned service Date for next service.
7.5 RECALL OF EQUIPMENT
Notes Planned maintenance or fault. Use fault codes to facilitate analysis develop lists of codes for each type of device. Serial numbers, costs. Log data. Record which tests performed and their results. Costing purposes. Down time data generation.
When a product Example G2 Using a computer data base to recall loan 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. It was thus possible to identify quickly and reliably the location a risk to profesof 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 8.1 SUMMARY
MAINTENANCE AND REPAIR
Keeping medical devices safe and effective needs both routine maintenance procedures supervised by professional users, and planned preventative maintenance carried out by suitably trained technicians. Management needs to take decisions about the most appropriate strategy for repairs and planned preventative maintenance: to use an in-house engineering department, a third party servicing organisation, or manufacturers’ servicing facilities. Any servicing organisation must have properly trained staff, the correct manuals and tools, access to spare parts approved by the manufacturer, and adequate quality control. Professional users and end-users are responsible for routine maintenance the regular cleaning, preparation for use, and checking of devices. Cleaning and decontamination have safety implications, and Appendix A3 covers this area in detail. Planned preventative maintenance should follow manufacturers’ guidance on procedures and staff training - if this, for any reason, is not practicable, proposed changes should be approved by the manufacturer, preferably before purchase. Devices which need maintenance work must be cleaned and, where relevant, decontaminated before release. Example H1 Total quality assurance in a hospital biomedical engineering department. A hospital BME department has introduced an ISO9002 based Total Quality Assurance system. The quality manual defines the management system, and provides an index to quality procedure documents, which cover all the department’s working practices. Although the system has overhead costs (mainly activity recording and quality audits) it is effective, and well-liked by staff. A similar department in a different hospital had to abandon ISO9002 because the overheads could not be supported, possibly because their system was too complicated and over-prescriptive.
Breakdowns can be dealt with either by substituting an equivalent device, or by rapid repair. In both case planning is needed - to be sure that suitable replacement devices are available in the first case, and that maintenance contracts specify adequately short response times and maximum down times in the second.
Devices and equipment used in the community present special difficulties: routine maintenance depends on the enduser, who needs adequate instructions and training. Planned preventative maintenance is complicated by the need to locate devices and pick them up from end-users’ homes.
H1
Breakdowns must be reported by end-users, who need to know when a device is failing, and how to report defects. Finally, a system is needed for deciding when to replace both hospital and community devices. Criteria suggested include unacceptable levels of wear and damage, chronic unreliability, and obsolescence.
Table H1
Hospital /facility management
Responsibilities for maintenance
• • • •
Technical Supervision
• • • • • • • •
Clinical Supervision
• • • •
•
• • • • *see Table H2
Procedures for placing maintenance contracts. Ensuring recalls and safety-related modifications take place. Deciding when to use in-house, manufacturer, or third party maintenance and repair organisations*. Setting training budgets which allow adequate training in device use, safety, and maintenance. Authorising staff to do jobs, based on their training and experience*. Organising manuals, ensuring spares, tools, and test equipment are available. Monitoring quality control of devices following maintenance and repair work. Supervising contractor’s staff. Overseeing record keeping,✝ scheduling services. Keeping in touch with professionals users. Taking overall responsibility for safety. Giving advice to management on: technical content of repair and maintenance agreements, what to do in a major crisis. Supervising routine maintenance. Attending commissioning of new equipment. Organising staff training for using new and existing equipment. Overseeing planned maintenance - negotiating schedules; dealing with necessary interruptions to maintenance schedules. Overseeing handing over and receiving back devices, making sure devices are decontaminated before release ( Section 8.5, Appendix A3). Checking records to see that maintenance intervals are not exceeded. Making sure maintenance engineers have suitable working conditions. Planning fallbacks in case of equipment failure. Giving advice on user interests in maintenance and repair.
✝ see Tables G2, G3 and H4.
H2
8.2 DIVISION OF RESPONSIBILITIES
Keeping a device working reliably and safely needs : •
a clear division of responsibilities between: senior management, technical supervision, and, in hospitals, clinical supervision (see Table H1);
•
good communications between these elements, and free access to information by all;
•
a routine maintenance policy - professional users and end-users need to know their responsibilities, and may need training;
•
well-organised planned preventative maintenance.
Table H1 makes some proposals for a possible distribution of responsibilities for servicing equipment. 8.3 CHOICE OF MAINTENANCE AND REPAIR ORGANISATION
Table H2 lists prerequisites which apply equally whether maintenance and repair work is undertaken in-house, by the manufacturer, or by a third party maintenance organisation. If a third party maintenance organisation subcontracts work, each of the subcontractors must fulfil the criteria in Table H2. Table H3 is a checklist of possible advantages and disadvantages of the three methods. The training of technical staff is a key element in safe and effective maintenance work. We have distinguished between the generic staff training, which teaches the principles on which medical devices work, and specific training relating to a given model of a given device. Both are generally necessary - it is certainly dangerous for people without adequate generic training to work on medical devices. Both engineering/technical staff and professional users need training. Manufacturer’s guidance on maintenance should always be followed, especially when a manufacturer says a given component should not be repaired. Section 3.6 covers refurbishment, as distinct from maintenance. If the purchasing organisation’s intention is not to return devices to the manufacturer for maintenance or repair, it is important to include arrangements for maintenance staff training, availability of spares, and approval of any proposed use of third party servicing organisations (see Table H3) in the original purchase contract. It may not be possible to resolve these issues after purchase (see Section 3.4).
H3
Similarly, any contract with a third party servicing organisation should specifically address compliance with manufacturer’s recommendations: •
by the third party agreeing to follow the manufacturer’s recommendations, or
•
by including evidence that the manufacturer approves the revised procedure, or
•
by the third party accepting full liability for inadequate maintenance, and maintenance-induced faults.
Maintenance organisations sometimes take the view that a fully qualified maintenance engineer’s training is already adequate to deal with simple devices, and that additional training such as a manufacturer’s training course is not necessary. The manufacturer’s views should be sought before purchase.
Table H2
Personnel
Hardware
Documentation
Quality control
Requirements for effective planned preventative maintenance and repair • Adequate generic training (engineering and technical qualifications); • Specific training for the given device (if required by the manufacturer) - training records should be available, including certificates of attendance from manufacturer’s training courses; • Ability to work in demanding environments - in treatment facilities in hospitals, and client’s homes. • Adequate provision of general workshop tools and facilities; • Special tools may be needed for a particular device; • Test and calibration equipment, calibrations should be traceable and kept up to date, as required by ISO9001/2; • Spare parts - parts needing regular replacement should be in stock. • User manuals; • Repair/Maintenance manuals including any revisions; • Circuit diagrams/engineering drawings; • Maintenance schedule.* • Inspection and tests before return to use to demonstrate the device is working within the manufacturer’s specification; • Record keeping;✝ • Quality assurance.
*see Table H5 for routine maintenance ✝ see Table G3
H4
Table H3a
Some advantages and disadvantages of doing maintenance in-house, as compared to using an outside servicing organisation
Maintenance/ repair organisation
Advantages
Disadvantages
Outside organisations
• •
•
•
Predictable costs; Possible to specify response times; Possible to specify equipment down times.
•
•
In-house
• •
• •
•
Fast response possible for breakdowns; Technical staff can work closely with professional users; On site repairs can lead to short down times; May generate revenue, taking in work from other organisations; Often less costly than an outside organisation for a given level of service.
• •
•
•
•
Increases routine maintenance workload; Harder to maintain cover for critical care breakdowns; Equipment may need to be sent to distant locations for repair and servicing. Fixed overheads; Hard to maintain adequate stocks of spare parts across a wide range of devices; Special tools and test equipment may not be available; Training costs high manufacturers sometimes reluctant to provide training; In-house staff are typically generalist rather than specialist.
Any departure from manufacturer ’s recommendations will inevitably carry a risk of increased liability in the event of an adverse incident. 8.4 ROUTINE MAINTENANCE
This includes inspection and device care operations performed by end-users and professional users, as distinct from planned preventative maintenance operations, carried out by engineers or technicians. End-users in the community will need to perform a limited set of operations such as: • • •
simple equipment care, including cleaning; noting when malfunctions or obvious damage has occurred, and stopping using the device; contacting the servicing organisation. (see Table H4).
H5
Table H3b
Comparing third party, and manufacturer’s servicing organisations
Maintenance/ repair organisation Manufacturer
Advantages
•
• •
• •
Same build standard as original device, with modifications and updates incorporated. Assured access to spares. Remote diagnostics via computer network sometimes available. No problems with warranty/liability. Availability of training for professional users.
Disadvantages
•
•
• •
•
Third party
• •
•
Contracts with many separate manufacturers need to be negotiated and updated. Staff needed to administer the maintenance system, despatching, and receiving devices. Quality control must be monitored. Response times may be long, depending on the contract. Clinical staff need long lists of help-line numbers.
Often cheaper than • May only be available for manufacturer. certain devices -“unpopular” Possible to have an on-site devices and very small engineer to cope with numbers of devices are breakdowns. often excluded. Fewer external • Manufacturers may be organisations to deal reluctant to train personnel. with. • Possible liability problems.
End-users should receive appropriate training. For example, for devices whose batteries need removing before recharging, they should be shown how to remove and insert batteries, told how long to charge them for (see Example H2), and warned of the dangers of substituting different battery types. For devices with moving parts such as orthoses, they should be shown the areas in which wear first becomes evident, and warned of the signs of incipient failure, for example cracks developing around screw holes. Table H4 covers problems which arise when users are not equipped to carry out these tasks.
H6
Table H4
Routine maintenance problems
Problems
Notes
Failure to note emergent defects
Worst case physical, mental and perceptual capacities of user must be taken into account. Some defects are intrinsically hard to detect, e.g. loss of effectiveness in pressure relief products ( Example A2).
Failure to report defects.
Motivation of end-user and quality of service: • access to contact details; • quality of response to enquiries; • effectiveness of repair/replacement service.
Difficulties with maintenance tasks
Instructions may need to be detailed, lengthy, and difficult to perform. (see Example H2).
End-user’s condition changes.
• Decline in physical condition can render existing equipment unsafe. • Cognitive problems may increase likelihood that faults will not be reported.
Example H2 Typical instructions for charging lead-acid wheelchair batteries. • Keep naked flame (including lighted cigarettes and matches) away from battery. • Use the specific charger supplied with the wheelchair. • Avoid body contact with the acid which will burn. • Charge the battery regularly as per manufacturer’s instructions even when the wheelchair is not in use. • Keep the battery terminals clean and covered with petroleum jelly. • There should be ventilation wherever the charging is done, but the charger should not be used out-of-doors. • Contact the provider if there are any difficulties or problems.
H7
Table H5 provides a checklist for routine maintenance operations which professional users can undertake. In a hospital context, an effective routine maintenance system can greatly reduce the workload of a technical servicing organisation. Professional users who have received some basic training may be expected to sort out simple faults (eg no mains power, device needs resetting by switching off and on again), and will be able to give technical staff useful information about the nature of more complicated problems.
Table H5
Routine maintenance and device management for professional user s
When?
Action
Device malfunctions
• • •
Obtain technical advice; Withdraw from service if necessary (Example H3); Note problems and action.
Before use
•
•
Check leads, probes, ancillary pipework in good order and properly assembled (Example H4); Check reassembly if device has been dismantled for cleaning and decontamination; Do relevant functional and calibration checks, noting results; Check settings of controls.
At specified intervals (daily, weekly)
• • •
Inspect, checking known problem areas; Note results; Remove from service if tests failed.
After use (and before releasing for servicing)
• • •
Clean; Decontaminate (see next section); Safely discard single use devices or other accessories which cannot be reused.
When sending a device to be repaired or serviced
•
Include all the probes and leads needed to operate device; Enclose as full an account as possible of any problems (see Example H3).
• •
•
When a device has undergone maintenance
In addition to standard “before use” checks: • check output levels where relevant (eg defibrillators); • check that appropriate programs have been selected (eg ventilators) (see Example H6).
When a serious adverse incident has occurred (e.g. when a patient or staff member has been injured or put at serious risk)
First, take steps necessary for the well-being of the patient and/or staff, then: • avoid altering settings, switching off equipment, or removing patient leads, infusion sets, ventilator tubing etc from any device; • leave any fluids in device; • note details of all medical equipment connected to the patient - device type, make, model, and serial 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 dismantling the equipment (see Example H5 and Fig.5).
H8
Fig 5
Adverse incident repor ting form CRITICAL INCIDENT ANALYSIS
• Description of incident
• Action taken to avoid harm
• Were there any deleterious effects in the patient as a result of the incident? If so, please describe
• What, if any, were the factors contributing to this incident occurring?
• Date of incident
•
Title and grade of person reporting
• Time occurred (24hr clock please) • Staffing levels (fill in as appropriate) Nursing: (No. of nurses on duty and their grades) or Medical: (No. of juniors and seniors)
8.5 CLEANING AND DECONTAMINATION
These operations are vital both in the hospital context when equipment is returned for servicing and repair, and for community equipment providers, when loan equipment is returned to their store. A failure to have effective procedures in place will not only put staff and the end-users of equipment at risk, but also create a danger of legal liability being incurred if for example unsafe equipment is supplied to community end-users (eg variously under s.10 of the Consumer Protection Act 1987, the General Product Safety Regulations 1994, and the common law of neglience).
Example H3 Professional user report forms. In response to BME department complaints about equipment returned with only a scrap of paper towel labelled U/S attached, a hospital has introduced a user report form (Fig 6), which is filled in by the user who discovers the malfunction, and returned to the workshop with the device.
H9
Fig 6
Fault reporting form Electronic Medical Device - fault reporting form Please attach this form to faulty equipment when sending to EME dept.
Date & Time Fault Identified: Device Model/Name: Device ‘ZE’Number:
(can be found on the red badge attached to device)
Description of Fault: (Report the last settings of the device and what you think the problem is)
Name of person reporting the fault: (print name as well as signing) Contact Point and Telephone Number: (Ward / Dept Name)
Example H4 Checking anaesthetic machines The Association of Anaesthetists has published a checklist for anaesthetic apparatus, giving a list of simple checks to be carried out at the beginning of each operating session (Appendix A2.5). These cover the correct assembly of the anaesthetic machine and the ventilator, the correct function of monitors, and the correct setting of alarms. The booklet notes “These checks are the responsibility of the anaesthetist and must not be delegated to other personnel”, suggests that a record be kept in a log book attached to the anaesthetic machine, and says “The ‘first-user’ check after servicing is especially important and must be recorded as such.”
The Department of Health has issued various guidance including HSG(93)26, “Decontamination of equipment prior to inspection, service or repair”. Further advice is given in the Microbiological Advisory Committee manual (Sterilization, disinfection and cleaning of medical equipment Appendix A3). Providers should also look to manufacturers’instructions - which should legally, in some circumstances, carry “information about the appropriate processes to allow reuse, including cleaning, disinfection, packaging and, where appropriate, the method of sterilization of the device.” (Medical Devices Regulations). Appendix A3 gives guidance on setting up local procedures in this area.
Example H5 A difficult incident investigation. In a recent incident a patient died while connected to an external pacemaker and a monitor. The monitor had apparently failed to alarm. The incident was reported to MDA36 hours later, by which time the electronic internal record of the monitor setting had been lost (it is maintained for 3 hours after switch off). The monitor returned to its default settings when power was restored, and no fault could be discovered. Furthermore no one knew which pacemaker had been involved. The cause of the problem was thus impossible to determine.
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Table H6
Planned preventative maintenance checklist
Heading
Notes
Service interval
Should allow for average unavoidable delays in removing equipment from service.
Initial inspection
• • •
Parts replaced Calibration Performance Functional/safety tests
Methods for fitting parts and reassembling device. Values to be set, with tolerances. Acceptable limits. Electrical safety tests where relevant. Test, e.g. brakes on wheelchairs, kneelocks on artificial limbs.
Return-to-use checklist
• • • •
8.6 PLANNNED PREVENTATIVE MAINTENANCE
Is the device clean? - has it been decontaminated? Likely problems - areas to check for wear. Note settings of controls.
Input details to maintenance database (see Table G2). Check device is complete with leads and probes where appropriate, and is properly assembled. Return controls either to zero or to the settings noted at initial inspection (see Example H6). Stick on a “JUST SERVICED/ date” label, and a note of any alterations in control settings.
Manufacturer’s guidance should be followed concerning the frequency of planned preventative maintenance, and the checks and operations to be carried out. Table H6 provides a checklist for planning and carrying out preventative maintenance.
8.7 BREAKDOWNS
An efficient servicing organisation aims at rapid recovery from breakdowns. The simplest method is often to substitute a similar device in working order, though this requires increased stock levels, and is not always possible (e.g. large X-ray machines in hospitals; artificial limbs and specially adapted wheelchairs in the
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Example H6 Overinfusion incident following maintenance. A patient suffered overinfusion while using an infusion pump at home. The pump came from a special stock maintained for domicilary applications, all of which were set to a single, standard, infusion rate. The pump in question was returned, following maintenance, set to its highest rate, and issued without the rate being reset. Maintenance organisations should reset controls before returning devices, all newly serviced devices should be checked carefully before reissue, and have a label attached with the date on which maintenance was carried out.
community). Increased stock levels can be set against the likely costs of, for instance, paying a third party servicing organisation for 24-hour fast response cover, or manufacturer’s call-out fees for engineers. The next option is rapid repair; in-house servicing organisations have a major advantage here, with qualified personnel and spares immediately available. Repairs should be carried out with the resources and systems listed in Table H2 in place. Wherever possible temporary repairs should be avoided. If some temporary expedient is needed to keep a critical device running (say during surgery), the device should be withdrawn from service and properly repaired before it is used again. 8.8 REPLACEMENT CRITERIA
For both hospital and community devices, a stage is reached at which replacement must be considered. Informed purchasing decisions (see Table C2) involve making an estimate of the likely length of life of each device. This estimate should be held in the inventory record, and a possible procedure for determining when a device should be decommissioned is to inspect it when the estimated length of life has elapsed. If any of the following six criteria apply, the device is no longer serviceable: • • • • • •
Worn out beyond economic repair; Damaged beyond economic repair; Unreliable (check service history); Clinically or technically obsolete; Spare parts no longer Example H7 - Do wheelchairs need an available; odometer? More cost-effective or Many NHS wheelchair services need to have a clinically effective policy on maintaining wheelchairs on loan to people in the community. Recommended devices have become periodic servicing and testing will not only vary available.
If the device survives this test, a date should be set for retesting - say, in a year ’s time. 8.9 INSPECTION, MAINTENANCE, AND REPAIR OF EQUIPMENT IN THE COMMUNITY
The maintenance of equipment in the community presents added problems. Community equipment, in terms both of the state of the hardware and of its safe use by particular end-users, is
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between different types of wheelchair (eg manual or electric), but also on the type of usage and the user. Thus, manufacturers’ recommendations that a wheelchair be checked after a certain period of time are of limited use. The provision of a distance-travelled meter could be considered, but the information would need careful interpretation - some users spend 18 hours a day in their wheelchair, but only ever move a short distance. For providers the difficulty lies in deciding between frequent checks, and a regime of less frequent checks which appears to contradict the manufacturer’s recommendations and hence may put the provider at increased risk in case of litigation.
less amenable to the monitoring and inspection possible in a hospital. (However evidence over a number of years about the condition of hospital wheelchairs suggests that difficulties remain even within institutions relating to the safety of basic, widely-used equipment.) Manufacturer’s guidelines on the frequency and nature of servicing operations should be followed (see Section 4). Providers should put procedures in place which enable those clients most likely to be put at risk by a device failure to be identified and appropriately monitored. Regular planned maintenance of major items of equipment When supplying major items of equipment such as hoists or stairlifts, providers will normally put in place regular maintenance and servicing procedures, either operated by the provider or contracted out. Such procedures may range from periodic brief visual inspection to periodic full testing.
Table H7
Checklist for inspection and repair priorities in the community
Topic
Action
Equipment returned from loan
ALWAYS clean, inspect, and service if necessary.
Potentially hazardous equipment (e.g. chairs, lifts, and mattresses which are electrically powered)
Inspect regularly, e.g. twice a year for hoists, slings and harnesses (SAB(89) 14, Appendix A2.1)
Equipment loaned to vulnerable end-users (see Table H4)
• •
maintain register of vulnerable end-users - visit regularly; get professionals to identify endusers whose condition is rapidly changing, possibly rendering prescribed devices inappropriate, and to set date for inspection.
Encouraging defect reporting by professional visitors (eg district nurses, occupational therapists, physiotherapists)
• • •
remind them to inspect devices in the home; encourage immediate reporting; provide a helpline for reporting faults and giving advice on action.
Encouraging defect reporting by end-users
•
keep in touch at 3-monthly intervals by phone or letter; always ask about any device problems; remind end-users how to report problems.
• •
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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 or defect in the equipment. stair lifts. Some housing authorities provide disabled facilities grants for people to install stairlifts which belong to the grant applicant not to the authority. The authority may advise the applicant about maintenance and servicing arrangements, but the responsibility for these clearly lies with the applicant. However, this position becomes confused if, as happens in some areas of the country, social services departments pay for maintenance and servicing for people on income support.
Maintenance and servicing of simpler items of equipment. Different problems arise with simpler devices which lack obvious hazards. Manufacturers may provide insufficiently detailed recommendations on servicing for items which clearly require it.
Where manufacturer’s instructions are absent or inadequate, and useful information cannot be obtained from the manufacturer, providers may need to categorise different types of equipment in terms of risk and on that basis arrive at reasonable maintenance and servicing schedules (see Example H7). The provision of Example H9 Disabled people become employers and adequate instructions is maintenance managers. Under the new Community Care (Direct Payments) Act 1996, local an essential requireauthorities are empowered to make payments direct to certain groups ment for devices CEof people (basically, disabled people between the ages of 18 and 65) marked under the - so that they can purchase their own community care services, Medical Devices including disability equipment. The responsibility for arranging maintenance and servicing will lie with end-users. However, social Regulations and the services departments making such payments should consider advis- MDA should be ing people fully about their responsibilities as employers or owners informed about nonof equipment, how to go about fulfilling them, and to include with- compliances.
in the payment essential elements (e.g. for training of a carer). The guidance also advises that local authorities “will need to bear in mind the specialist expertise that may be needed to ensure that equipment purchased is safe and appropriate, and the question of whether making a direct payment is a cost-effective way of purchasing such equipment” Authorities would also need to clarify, with the user, the ownership of any equipment, and where responsibility lies for its ongoing care and maintenance. For these reasons the Department considers that direct payments are unlikely to be appropriate for purchasing complex and expensive pieces of equipment, although they may well make sense for smaller, less specialised items (see Department of Health guidance 1997, Appendix A2.3).
Many items such as commodes, walking frames or bath boards may be issued on longterm loan to end-users, whose “active” file is in practice closed (eg after six months) although the equipment remains on loan. Providers such as local authority social services departments have to balance the difficulty
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Example H10 Training for a carer. In respect of one particular severely disabled patient, the carer was specifically asked by his manager to report any change in the person’s 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 training sessions he had received, began to use unsafe handling techniques. As a consequence 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.
of keeping checks on up to 50000 items of equipment on loan at any one time with the need to ensure that safety remains a high priority. Table H7 provides a checklist for inspection and maintenance priorities for equipment in use in the community.
Responsibilities for maintaining equipment. Some of the responsibility for maintaining equipment and reporting defects clearly lies with the end-user ( Section 8.4). If equipment is on loan, the provider retains a greater responsibility than if it simply transferred into the ownership of the end-user (Example H8). In some cases the end-user does become legally responsible for maintenance (Example H9). Example H11. An accident with a faulty orthotic device. The user of a lower limb orthotic device reported that it was showing signs of wear, and was offered an appointment several weeks in the future. She had no choice but to continue using the device: a week later fatigue caused the side strut to snap and injure her leg.
Responsibilities of staff.
Under health and safety legislation, staff have a duty to look after their own health and safety and that of others who may come into contact with equipment they are using. For example, under the Health and Safety at Work etc. Act 1974 (Appendix A1.1), an employee must take reasonable care for their own health and safety, and under the Manual Handling Operations Regulations 1992, an employee “must make full and proper use of any system of work provided for his use by his employer”.
A provider of equipment for use by an unpaid carer is in a position somewhat analogous to an employer, and should consider providing training for the home carer in lifting and handling techniques (including the use of hoists and hoist slings), and of health and safety generally (see Example H10). The training should make clear that the carer has a responsibility to take care of their own health and safety. Unpaid carers should be monitored and supported by their care manager, who should decide when refresher courses are needed.
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Repair of equipment whilst still in use. This section concerns the actions taken by providers to deal with faulty items of loan equipment( Section 8.7 and Table H7). Providers should ensure that (written) instructions are given to users, informing them about whom to contact in case equipment appears to be in need of repair. This may apply not only to major items of equipment such as hoists or stairlifts, but also smaller items, such as bath seats with, for example, missing screws or exposed metal. Providers should also adopt particular policies on repair - to ensure least disruption to the user, efficient use of repair resources, and appropriate response times, taking account of the patient’s level of dependency on the equipment. In some circumstances failure to respond promptly to requests for repair could lead to litigation if an accident were to occur as a result of continued - and perhaps unavoidable - use of the faulty equipment (see Example H11). Stipulated response times may vary from “immediate” in case of emergency situations (eg malfunctioning oxygen concentrator), to very high priority in urgent cases involving the total loss of independence (malfunctioning hoist preventing a person getting out of bed), to lower priority for less urgent situations. It may be preferable for both user and provider to have a general policy of not attempting major repairs to portable equipment in the user’s home, but instead supplying a replacement and repairing the faulty item off-site. Such a policy means that stock levels must be adequate to provide replacement devices ( Section 8.7). Where replacement is not possible, on-site repair might need to be considered if the user’s independence is at risk. In addition, removal of the equipment with no replacement might entail increased costs of caring for the person by other means.
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9 9.1 SUMMARY
TRAINING
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 equipment for lifting and handling, user organisations have statutory duties.
9.2 TRAINING FOR PROFESSIONAL USERS
Professional users need to understand the normal operation of the device. Where relevant they should: • • • • •
be aware of differences between models of a given device, where these affect safety or device function; be able to assemble the device if it needs disassembly for cleaning, and fit relevant accessories; be able to set the controls appropriately; be able to link the device to a patient effectively, causing a minimum of discomfort; be able to show the patient or client how to use a device.
If the device malfunctions, they should be able to: • •
recognise malfunctions; correct them, or withdraw device from service.
When the device is removed from service, professional users should know how to clean it and to organise decontamination.
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Example I1 Finger on the Button training This is a proprietary training system combining open learning, study days, skills training, and competence assessment. The open learning element reduces problems for the shift-worker, and the training and assessment day tests competence to defined standards. Training is currently available for infusion pumps and cardiotocograph monitors. Contact details are in Appendix A4.3.
The MDA perception is that many adverse incidents in hospitals occur during the early hours of the morning, and that sometimes the staff involved (night staff and bank nurses especially) have not been able to complete relevant training. Clinical supervisors should audit training records, and ensure that all professional users are properly trained.
The MDA Evaluation Centres offer training for professional users for certain devices (see Appendix A4.1 for contact details). 9.3 THE TECHNICAL SUPERVISOR’S ROLE
The technical supervisor should: • • • •
9.4 TRAINING FOR END-USERS
Clinical supervisors need to make sure that training for end-users enables them to use a device safely and effectively, and to perform routine maintenance (see Section 8.2). For example, end-users of ambulatory infusion pumps should be aware of: • •
9.5 SAFETY TRAINING FOR STAFF
organise training for professional users when necessary (see Example I1); ensure technical staff attend relevant courses; check the quality of courses; directly supervise people working with new devices.
how their device works, including special features such as bolus delivery; the risks of syphoning if a syringe is removed from a driver.
Safe use of equipment by staff often requires training (see Example I2). Safety training for staff is often undertaken in response to Health and Safety Regulations - in the case of training for lifting and handling, the Manual Handling Operations Regulations (see Appendix A1.2). Organisations should be discouraged from taking a limited view of their responsibilities, and where possible, should provide the same standards of equipment and training for end-users as they do for staff. Some providers - concerned with their duty under the Regulations - adopt a policy of providing lifting equipment for their own staff to use in people’s own homes - but not for end-users or their carers to use themselves.
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Example I2 Staff training forusing lifting and handling equipment Some NHS and social services departments (in Northern Ireland the Health Department has sole responsibility) have both instituted training in lifting and handling techniques, and purchased - and trained staff to use - lifting, handling and training equipment. Such equipment includes, for example, hoists, bath lifts, turntable discs, non-slip (“one way”) sheets, turning bands etc. Specialist trainers can be used to ensure that all staff involved in manual handling receive training, with refresher sessions to keep up-to-date with manual handling/lifting techniques. A discrete budget devoted to staff safety can help identify and cost safety activities.
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One reason for this policy is that the Regulations place a duty on employers towards their own employees, and not towards anyone else. Apart from the fact that this practice may have unfortunate consequences for the safety of users and carers, providers should bear in mind that, given the greatly raised awareness of the dangers of back injuries from lifting, legal liability could arise (for example in negligence) in respect of end-users and carers injured.
10 COMMUNITY ISSUES 10.1 SUMMARY
Community equipment needs to be delivered to and picked up from end-users’homes - these processes must include checks that: the correct equipment has been delivered in good order, the end-user has received training - or has been told not to use the device until trained, and that the delivery and collection process does not risk cross-contamination. Procedures are necessary to make sure that equipment is picked up as soon
Table J1
Community topics in main body of bulletin
Area
Topics covered (Section)
Purchasing
End-users in purchasing groups (3.2) Sling and hoist compatibility (3.4) Tendering for stores (3.4) Adapting orthoses and prostheses (3.6) Refurbishing/cannibalising wheelchairs (3.6)
Instructions
Instructions for the end-user (4.3) End-users with particular problems (4.3) Evidence of giving instructions (4.4) Instructions for loan equipment (4.5)
When a new device is delivered
Acceptance checks for community stores (5.2) Storage problems (5.3)
Prescribing
Prescribing in the community (6.2) Support seating (6.2) Crossing SS/HS boundaries (6.2) Patient denied crutches (6.2) Prescribing mistake detected by database (6.3) Best chair-raiser (6.3) Stair lifts for MS patients (6.4)
Record Keeping
Bar codes in a community store (7.4) Recall of loan equipment (7.5)
Maintenance and repair
End-user maintenance (8.4) End-users with limited capabilities (8.4) Charging wheelchair batteries (8.4) Cleaning and decontamination for stores (8.5) Major items: hoists and lifts (8.9) Choosing service intervals for wheelchairs (8.9) Repair of equipment still in use (8.9) Maintenance priorities (8.9)
Training
Training for end-users (9.4) Training for staff (9.5)
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as it is no longer needed and that it is adequately prepared for re-issue on return to the store. Device selection, user training, maintenance and safety are issues which must be addressed for devices used in surgeries. The procedures proposed for hospital devices are unnecessarily complicated for small surgeries, but a proper allocation of responsibilities is needed. Three problem areas are covered - sterilization, dental X-ray equipment, and resuscitators. 10.2 INTEGRATED MATERIAL
The premise on which this bulletin is based is that good device management is the same for hospitals and for the community. At every stage we have included community examples and covered issues relating to endusers (Table J1). This section deals with some remaining issues.
10.3 DELIVERY AND COMMISSIONING OF LOAN EQUIPMENT
Procedures for the delivery of equipment should pay attention to safety issues in terms, for example, of avoidance of cross-infection (see Example J1), delivery of the correct item, and commissioning (Table J2). 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 collection the next (or afternoon only) of whether it is simple, requires 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 EQUIPMENT WHEN NO LONGER NEEDED
From the point of view of both economics and safety, providers will wish to have systems in place which ensure the appropriate collection of equipment when it is no longer needed by users. In some instances team budgets are credited as equipment is returned to store, putting pressure on prescribers to monitor returns. Collection systems may involve regular or semi-regular postal communications (e.g. postcards) with users, providing with them with a contact point should they no longer require equipment. End-users may often not know, or remember, where to return the equipment. Clearly marked equipment may help. Joint health and social
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services stores (run either by the statutory services themselves or on their behalf by an independent third party) can make efficient collection of equipment easier - because there is locally one obvious place for return of equipment. When loan equipment is withdrawn because it is faulty, the provider may have to meet the short-term needs of the user by supplying extra personal care, until an equivalent Example J2 Destabilising a wheelchair replacement product is found. If A provider may inadvertantly destabilise a there is no equivalent suitable wheelchair by changing the frame structure product immediately available, to accommodate a reclined backrest angle without considering stability effects, or then longer term alternatives consulting the manufacturer. In so doing it may have to be considered. 10.5 CHECKING AND TESTING OF RETURNED EQUIPMENT
10.6 ADAPTATION OF EQUIPMENT
10.7 INSURANCE
will have affected the safety properties of the wheelchair, and thus probably invalidated the CE marking which the manufacturer placed on the wheelchair as a sign that it conformed to the essential requirements of the Medical Devices Regulations 1994 (Appendix A1.4). It is possible that in some circumstances the provider will have also become, for the purposes of Part 1 of the Consumer Protection Act 1987 (Appendix A1.1), “the producer” of a new product, and incur civil liability in the event of a subsequent accident.
Authorities need to have in place well-organised and understood procedures for cleaning, decontaminating (see Section 8.5 and Appendix A3), then checking, testing and preparing for re-issue ( Section 8.9) returned equipment before it is returned into store for reissue. Where possible, manufacturer’s instructions or recommendations on checking and refurbishing should be followed. Staff undertaking such checking and testing should have the appropriate expertise.
Providers must ensure that if they adapt equipment, the product remains safe (see Example J2). They should also be aware that there are particular legal implications arising from such activities (see section 3.6). Equipment loaned by the NHS or social services departments normally remains the property of those statutory services, and users cannot be required to insure it. However, where end-users are using equipment in public places (e.g. powered wheelchairs), it may be advisable for them to consider third party insurance against personal liability in case of accident (see e.g. HSG(96)34 (Appendix A2.3) concerning powered wheelchairs).
10.8 DEVICE SAFETY FOR SURGERIES
Most doctor’s and dentist’s surgeries own and use substantial numbers of medical devices, as do chiropodists and physiotherapists. But the actual amount of equipment in any given surgery is not generally enough to warrant setting up procedures for device management of the sort advocated elsewhere in this bulletin (but see Example J3).
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Example J3 Device management in a large general practice A 9-partner GP surgery has 2 autoclaves, 4 nebulisers, 2 ECG machines, and several glucose and cholesterol measuring devices. A member of staff responsible for estates and equipment fulfils the technical supervisor role, and organises servicing of equipment. There is a third party servicing contract with the local hospital’s BME department, and various arrangements for external checks on the calibration of diagnostic equipment.
However the key issues: device selection, user training, and device maintenance and safety testing, still all need to be addressed, if devices are to perform effectively and safely. Device selection Practitioners should be aware of the MDA evaluation reports (see Appendix A2.2), which offer guidance on which model to choose. 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 necessary training. Because all servicing will by “the practitioner with the greatest interest in the area, but the purchase is authorised by generally be done by the manufacturer, cost the partners”. It was noted that the selection and availability of servicing is going to be an usually involved a trawl of the literature, but important factor in the selection decision. that reference was often made to someone at the local hospital with expertise in the particular area.
In the case of dental anaesthetic equipment, the Poswillo report establishes the principle that the anaesthetic and resuscitation equipment available when someone is given a general anaesthetic in a dentist’s surgery must not fall below the standard of hospital provision (see Example J5). Maintenance and safety testing
Example J5 The Poswillo report on general anaesthesia, sedation and resuscitation in dentists surgeries The report specifies particular equipment for anaesthetic monitoring: An electrocardiograph, a pulse oximeter, and a blood pressure monitor. A capnograph is also specified when tracheal anaesthesia is used. A defibrillator must be available. “Equipment conforming to recognised standards should be purchased and installed, regulary serviced and maintained in accordance with manufacturers’ instructions”.
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Particular care is needed when devices are reissued to different patients. Nebulisers are a typical example. Reusable parts should be thoroughly cleaned and serviced following the manufacturer’s instructions, and any parts (e.g. face masks) which are designated for single patient use should be discarded on return and replaced before reissue. We have identified three areas in which regular testing and maintenance has important safety implication, and where current practice may not be adequate.
i) Sterilizers. Sterilizers contain a large amount of energy when operating, so they must comply the Pressure Systems and Transportable Gas Containers Regulations 1989 (Appendix A1.2). These require the sterilizer chamber to be tested at minimum 14 month intervals by a competent person (pressure vessels). This may be undertaken by the insurer of the sterilizer as part of their annual risk assessment. Insurance cover for sterilizer must be with a specialist insurer: risks to staff must be covered. Users must be clear that the pressure vessel check does not test the efficiency of the sterilization process and it does not check any other safety aspects of the sterilizer, or its safety features such as door interlocks. The Health Technical Memorandum 2010 (published by HMSO, see Appendix A2.5) provides comprehensive advice from NHS Estates (Dept. of Health) on sterilization. The MDA Device Bulletin DB9605 “The purchase, operation and maintenance of benchtop steam sterilizers” (Appendix A2.1) provides guidance specific to benchtop steam sterilizers which are not equipped with a vacuum cycle; it is a useful guide to best practice. It notes that “failure to carry out periodic tests and maintenance tasks could compromise safety and may have legal and insurance implications for the user and owner of the sterilizer.” The tests of safety and effectiveness include a daily and weekly test to show that the sterilizing cycle is operating correctly, weekly safety checks, and more searching quarterly and annual checks - some of which must be carried out by someone qualified to test sterilizers, known as a Test Person (sterilizers). Quarterly and annual tests are often included in maintenance contracts, and the maintenance engineers should be qualified Test Persons. Instruments which are wrapped or placed in pouches, or instruments with lumens, can only be sterilized in properly validated sterilizers equipped with a vacuum stage. An Authorised Person (sterilizers) is an independent expert who will provide advice on all aspects of sterilizers and sterilization processes. A list of AP(s)s is maintained by the Institute of Healthcare Engineers and Estates Managers ( Appendix A4.3). ii) Dental X-ray equipment. Tests of small X-ray machines tend to be limited to 3-yearly postal tests, when films provided by the National Radiological Protection Board (Appendix A4.3) are exposed and returned for processing and checking.
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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 proExample J6 A resuscitator failed when gressively more demanding if sedation or needed. general anaesthesia is used. A rubber resuscitation bag in a long-stay psychiatric hospital was found to have perished when an emergency resuscitation became necessary. MDA issued a Safety Notice SAB91(46) Appendix A2.1, recommending regular checks of valves and rubber components of bags kept for use in rare emergencies. Legal action against the hospital ensued.
• • • •
The problem is to maintain equipment and training for devices which are almost never used (see Example J6). Best practice is to check emergency resuscitation equipment daily, including:
pressure in oxygen cylinder; bag working - rubber components and valves in good order; any drugs still in date; any sterile materials in date, and packaging undamaged.
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Appendix A1.Legislation The following selective references to legislation are accompanied by a number of summaries. When making policies or engaging in disputes, the original legislation (as amended) should be consulted and professional advice sought. A1.1 ACTS OF PARLIAMENT (except where stated, Acts and Statutory Instruments apply in Scotland)
Defective equipment at work Employers’Liability (Defective Equipment) Act 1969 Imposes strict liability on employers for injuries caused to employees by defective equipment - where the defect is wholly or in part the manufacturer’s fault. This includes where the defect is wholly or partly the fault of a third party, not necessarily the manufacturer. (Therefore, the employer needs to have a contractual indemnity against manufacturers). Health and safety at work Health and Safety at Work etc. Act 1974. Employers must ensure, so far as reasonably practicable, the health, safety and welfare at work of employees. This covers eg plant and systems of work; handling/storage of articles and substances; information, instruction, training, supervision; any place of work under the employer’s control; working environment. The employer must also ensure, so far as is reasonably practicable, that non-employees who may be affected are not exposed to risks to their health or safety. Employees must take reasonable care for the health and safety of themselves, and also of other people who may be affected by the employees’ acts or omissions. Product Safety Consumer Protection Act 1987, Part 1. Imposes civil liability on manufacturers (“producers”) who supply defective products which cause harm or damage to somebody. However, there are various defences, including the state of knowledge at the time the product was supplied by the manufacturer: a defence sometimes known as the “development risks defence”. Actions can be brought up to 10 years after the product was supplied: hence the recommendation, by the Department of Health, to keep records for at least 11 years. Suppliers, too, may incur liability, if they are unable, within a reasonable time, to identify the person who supplied them with the product. (This makes good record keeping essential for providers some way down the supply chain).
i
Consumer Protection Act 1987, s.10. Imposes criminal liability for the supply of unsafe equipment. Though largely superseded by the General Product Safety Regulations 1994, nevertheless s.10 of the 1987 Act continues to apply in those circumstances where neither the 1994 Regulations, nor any other specific European Directive and corresponding UK Regulations apply. For example, the Medical Devices Regulations 1994 impose liability on manufacturers - but only imposes it on suppliers in limited circumstances. Thus, were a supplier to be involved in supplying unsafe medical devices - but the offence committed were not to fall under the Regulations - then it might instead be caught by s.10 of the 1987 Act. Sale of goods: quality etc. Sale of Goods Act 1979, s.14(2B). Implies various terms into contracts, with some distinctions between commercial and consumer contracts. In particular, there is an implied term as to the “satisfactory quality” of goods. The quality of goods includes “their state and condition” and aspects of quality include fitness for purpose, appearance and finish, freedom from minor defects, safety and durability. Breach of implied terms may give rise to a legal remedy against the contracting party in breach. However, it has been established in the law courts that NHS patients do not enter into a contract with the NHS when they are supplied with equipment - even if they pay a prescription charge (Pfizer Corporation v Ministry of Health [1965] AC 512, House of Lords). On the same principle, it is therefore similarly assumed that users of other statutory services do not enter into contracts, whether or not a payment is made - for example, when people are loaned equipment by social services departments (who might sometimes impose charges). Supply of Goods and Services Act 1982. Contains similar provisions to the Sale of Goods Act 1979 (see above) in relation to the hire of goods. Supply of Goods (Implied Terms) Act 1973. Contains similar provisions to the Sale of Goods Act 1979 (see above) in relation to the hire purchase of goods. Unfair Contract Terms Act 1977. Contains various provisions governing the exclusion or restriction of legal liability for breach of contract.
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For example, it absolutely prevents such restriction in relation to personal injury or death arising from negligence - but allows it, though subject to a test of unreasonableness, in the case of other harm arising from negligence. The Act applies in this respect not only to contract terms but also to “notices” - thus covering non-contractual situations as well. For instance, the loan of wheelchairs by the NHS to users is non-contractual; it could not exclude liability for negligent supply resulting in injury simply by giving the user a notice to that effect. It also controls attempts at restriction of contractual liability arising from the sale and supply of goods under Sale of Goods Act 1979 etc. A1.2 STATUTORY INSTRUMENTS
Control of substances hazardous to health SI 1994/3246. Control of Substances Hazardous to Health Regulations 1994. Electrical SI 1994/3260. Electrical Equipment (Safety) Regulations 1994 Place obligations on both manufacturers - but also on other suppliers (eg wholesalers, distributors, retailers) to ensure that the equipment they supply is safe and bears the CE marking. No obligation is imposed to safety test secondhand equipment, but Department of Trade and Industry guidance points out that suppliers will want to ensure that equipment is safe so as to avoid the commission of an offence. The Regulations do not apply to items covered, for example, by the medical devices or machinery directives/regulations. General product safety SI 1994/2328. General Product Safety Regulations 1994. These Regulations apply to products “intended for consumers or likely to be used by consumers” and which are not already covered by other specific European Directives (e.g. the Medical Devices Directive). Basically, “producers” - i.e. manufacturers, importers, own-branders, and “professionals in the supply chain, insofar as their activities may affect the safety properties of a product placed on the market” - must not place unsafe products on the market. Provision of information about the risks of using products must also be supplied to consumers. In addition, “distributors” - i.e. professionals in the supply chain whose activities do not affect the safety properties of products - must a) not supply products they know, or should have presumed, are dangerous, and b) must participate in monitoring the safety of products, pass on information about risks, and cooperate in action taken to avoid the risks.
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Health and safety at work (general) SI 1989/635. The Electricity at Work Regulations 1989. SI 1992/2792. Health and Safety (Display Screen Regulations) 1992. SI 1992/2865. Management of Health and Safety at Work Regulations 1992. Imposes various duties on employers including formal risk assessments, and planning, organisation, monitoring etc of activities in the workplace etc. SI 1992/2932. Provision and Use of Work Equipment Regulations 1992. Places duties on employers to select and maintain suitable equipment at work. SI 1992/2966. Personal Protective Equipment at Work Regulations 1992 amended in 1994 SI 1994/2326. SI 1992/3004. Workplace (Health, Safety and Welfare) Regulations 1992. Ionising Radiation SI 1985/1333. Ionising Radiations Regulations 1985. Place a range of duties on both employers and employees. SI 1988/778. Ionising Radiations (Protection of Persons Undergoing Medical Treatment) Regulations 1988. Employers must ensure that employees carrying out examinations involving such radiation are qualified and have an appropriate certificate, and must keep records of training. Lasers SI 1984/958. Nursing Homes (Lasers) Regulations 1984. (No Scottish equivalent) Manual handling SI 1992/2793. Manual Handling Operations Regulations 1992. Basically, employers must, “so far as is reasonably practicable, avoid the need for his employees to undertake any manual handling operations at work which involve a risk of their being injured”. Where such operations are not avoidable in a reasonably practicable way, the employer must “make a suitable and sufficient assessment of all such manual handling operations”, and “take appropriate steps to reduce the risk of injury” to employees “to the lowest level reasonably practicable”.
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Employees, too, must “make full and proper use of any system of work provided for use by his employer in order to reduce the risk of injury”. Machinery SI 1992/3073. Supply of Machinery (Safety) Regulations 1992 (amended by SI 1994/2063). These Regulations, rather than the Lift Regulations 1997, cover stairlifts. See Health and Safety Executive, Field Operations Directorate, Operational Minute OM 1997/119 (Appendix A4.3). Medical devices SI 1994/3017. Medical Devices Regulations 1994. These are explained more fully in Appendix 1.4. However, basically, the Regulations state that, from 14th June 1998, all medical devices placed on the market or put into service must comply with the essential requirements laid down in the EU Directive on medical devices. For the most part, devices must carry a CE Marking (but eg not custom-made devices or some devices intended for clinical trials). The Regulations apply, in the main, to manufacturers when they first place a device on the market (eg sell it), and to anybody who fully refurbishes a product (and thus becomes the manufacturer of what is effectively a new product). Exactly what is to be treated as a medical device, and what is not, will depend on the interpretations and intentions of manufacturers, the influence of guidance issued by the Commission and the Medical Devices Agency, and any decisions of the law courts. Both criminal and civil liability may arise from breach of the Regulations. A defence of “due diligence” is available. Pressure systems/transportable gas SI 1989/2169. Pressure Systems and Transportable Gas Containers Regulations 1989. Places various duties on both the manufacturers/suppliers and users of pressure systems - including, for instance, the requirement of a written scheme providing for periodic examination by a competent person. Reporting of injuries etc. SI 1985/2023. Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1985. Contracts SI 1993/3228. Public Services Contracts Regulations 1993. SI 1995/201. Public Services Contracts (Amendment) Regulations 1993.
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A1.3 SELECTED EU DIRECTIVES
85/374/EEC Directive concerning defective products (Consumer Protection Act 1987) 89/392/EEC (as amended) Directive concerning machinery 90/269/EEC Directive concerning manual handling of loads (Manual Handling Regulations 1992) 90/385/EEC Directive concerning active implantable medical devices (Active Implantable Medical Devices Regulations 1992 SI 1992 3146; The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995 SI 1995 1671) 92/59/EEC Directive concerning general product safety (General Product Safety Regulations 1994) 93/42/EEC Directive concerning medical devices (The Medical Devices Regulations 1994 SI 1994 3017)
A1.4 CE-MARKING FOR PURCHASERS1
Terminology Compliance means showing that a product conforms to the medical device directives, which lay down “common standards of performance and safety”8 applying throughout the EU. The Medical Device Directive itself covers the vast bulk of medical devices - there are also two specialist directives, for active implantable devices (eg pacemakers) and in vitro diagnostic devices (eg AIDS test kits). The latter is still only a draft directive . Conformity Assessment route is the process by which a manufacturer “demonstrates compliance” - i.e. becomes entitled to apply the CE marking to a medical device. The rigour of the conformity assessment route required depends on the risk category of the device. MDA Directive Bulletin 4 gives details, Appendix A2.1. Declaration of Conformity is a signed statement by a manufacturer recording the fact that a product conforms to the essential requirements listed in the relevant directive. This may be based on an external test or assessment, or it may be a self-declaration. The Competent Authority is the national regulator - the MDA acting on behalf of the Secretary of State in the case of the UK.
1
Superscript 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.
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A Notified Body is the “third party” - independent of Competent Authority, manufacturer and user - which actually undertakes the assessment of conformity. Notified Bodies charge manufacturers for the service they provide, and are designated and controlled by the Competent Authority. A Manufacturer can be a company or an individual (legally, a person). If the manufacturer is based outside the EU, then the manufacturer’s authorised representative - generally the distributor - can become responsible for CE-marking if this is administratively more convenient. The Regulations define the manufacturer as the “person who is responsible for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party”. Meaning of CE-marking At present many medical devices are CE-marked - from June 1998, under the Medical Devices Regulations (SI 1994/3017), all medical devices placed on the market (made available for use or distribution even if no charge is made) must conform to the “essential requirements” - including safety - required by law, and bear a CE marking as a sign of that conformity. Although most of the obligations contained in the Regulations fall on manufacturers, purchasers who are positioned further down the supply chain may also be liable - for example, for supplying equipment which does not bear a CE marking or which carries a marking liable to mislead people (Regulation 18(2) of the Medical Devices Regulations). Exceptions are: • In-vitro diagnostic devices - will in due cause be covered by a separate directive, currently still being prepared. •
Active implants - covered by the Active Implantable Medical Devices Regulations.
•
Devices made specially for an individual patient (“custom made”).
•
Devices undergoing clinical investigation.
•
Devices made by the organisation (“legal entity”) using them.
The last exception is likely to be interpreted narrowly - an individual hospital trust, rather than the NHS, is a “legal entity” in this context. Directive Bulletin 18A gives details.
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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.
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Table App1 A summary of the Essential Requirements of the Medical Devices Directive Topic
Notes
General requirements
A device must not harm patients or users, and any risks 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 perform as claimed, and not fail due to the stresses of normal use. Transport and storage must not have adverse effects.
Design and construction
- must involve the use of suitable materials (low toxicity and flammability, biocompatibility, compatibility with associated drugs and gases). Devices must not leak, or allow foreign substances ingress.
Infection and microbial contamination
- must be avoided, both by good design, careful manufacture, the use of validated sterilisation processes, and adequate packaging.
Mechanical construction
- must be sound, minimising risks to users from physical features, and from any likely environmental impact (eg electrical interference) or loss of calibration.
Measuring devices
- must have adequate accuracy and stability, and be easy to read.
Exposure to radiation
- must be reduced as far as possible, compatible with the intended purpose of the device. Devices emitting ionizing radiation must have adequate controls, and enable reliable monitoring of doses when intended for therapeutic use.
Built-in computer systems
- must be repeatable and reliable. Battery power supplies on which the patient’s safety depends must alarm when the battery is low. Monitors must alarm when the patient is in a dangerous state.
Electrical and electronic design
- must minimise electromagnetic emissions. Devices should not give users electric shocks.
Mechanical design
- must protect the user from moving parts, vibration, and high sound levels . Terminals and connectors for linking devices to mains electricity supplies and gas pipelines must minimise risks. Accessible parts must not get too hot.
Devices which deliver fluids to a patient
- must be designed so the flow rate can be set to a suitable level and accurately maintained, to guarantee the patient’s safety. There must be safeguards against overdoses. Devices which supply energy to the patient (such as defibrillators) must meet similar criteria.
The function of controls and indicators
must be clearly marked.
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Consumer Protection The Medical Devices Directive clearly provides a very useful measure of consumer protection, especially as regulators, after taking safeguard action in their own country, can notify the Commission and other member states, with the likely result that sales would be banned throughout the EU. The MDA has various powers under the Consumer Protection Act to issue warnings or remove devices from the market. The essential requirements cover a wide range of potential problems. For example portable infusion pump problems typically include: • • •
failure to meet manufacturer ’s claims for dose control accuracy; unexpected battery failure; under or over-infusion incidents.
The following essential requirements from the Medical Devices Directive might be relevant: 3. The device(s) must achieve the performance intended by the manufacturer. 12.2 Devices where the safety of patients depends on an internal power supply must include an alarm system to signal any power failure. 12.8.1 Devices for supplying the patient with energy or substances must be designed and constructed in such a way that the flow-rate can be set and maintained accurately enough to guarantee the safety of the patient and of the user” MDD One function of requirements of this sort is to provide regulators with a clear set of grounds for prohibiting the marketing of a given device. However, as all devices must conform, there is no possibility of using the CE marking to select a given model. The compliance process The Regulations in several cases provide manufacturers with a choice of methods for demonstrating that a particular device complies with the essential requirements. The alternative routes are equivalent - whichever route is chosen, compliance is ensured. The following summary of the conformity routes is included here to show how the severity of the conformity testing process is graded to meet the possible risks of using a device, and to clarify the alternatives available. The process begins with classification - the extent of involvement of a notified body and thus severity (and cost) of the conformity route needed depend on the possible hazards associated with the device. There are three
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device classes, but class two is divided into lower (IIa) and higher (IIb) risk sub-categories, giving four classifications: Class
Risk
Example
I IIa IIb III
low medium medium high
Bandage Simple Breast pump Ventilator Intra-aortic balloon
For all devices, the manufacturer begins by setting up quality systems and preparing a technical file (the design dossier), containing a general description of the “type” (the actual device), design drawings, manufacturing methods, standards conformed to (“applied”), design calculations, risk analysis, and test results, as well as instruction manuals and labels. For class I devices all that is needed is a manufacturer’s declaration, backed up by a risk assessment and appropriate technical documents, that the device conforms to the essential requirements. If the device is a measuring instrument, the calibration must be checked by a notified body. If the device is to be shipped in a sterile condition, the sterility process must be checked by the notified body. For all other devices there are the two main routes: i) If a Full Quality Assurance system is in place, and passes the notified body audit, this is sufficient for any class II device. Class III devices additionally need an audit of their design dossier, which contains detailed information about all aspects of the design. ii)
If the Type-examination route is chosen, conformity involves two components, except for class IIa devices which only need the manufacturer’s declaration of conformity (as above for class I devices) and the second component:
•
FIRST COMPONENT: Type Examination itself: the notified body audits the technical file and carries out tests on a sample of the device, checking that it conforms to relevant standards which the manufacturer claims to have applied. SECOND COMPONENT: One of the following three procedures, applied by the notified body: • product quality assurance audit; • production quality assurance audit; • verification by product examination - either of every product, or a statistical sample from batches.
•
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For class III devices only the last two possibilities are allowed. In general terms, active implantable devices are treated, under their directive, in a similar way to class III devices. MDA Directives Bulletin 4 includes flow charts for conformity assessment procedures. All that a manufacturer must make public about the process is actually printed on the device - the CE-marking itself, and a code number for the notified body if one has been involved. There is, of course, nothing to prevent purchasers asking for more details, if they think it relevant to do so. Selling second-hand equipment The regulations for CE-marking all relate to the first time a product is brought to market (i.e. sold, leased, or lent), so they should cause no problems to anyone wanting to dispose of redundant equipment carrying a CE marking by selling it as second-hand. The regulations do, however, apply to refurbishers. Role of standards A standard is a “document, established by consensus and approved by a recognised body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context”. Standardisation takes place at international, regional and national levels. National standards bodies such as the British Standards Institution can decide whether or not to adopt international standards, but are obliged to publish European Standards as national standards. Standards are prepared for various reasons and many uses. Relevance of standards for medical device purchasers The main reason for device purchasers to be concerned about standards is for the assurance that they can provide that a device will be safe and will perform as intended. For this purpose, two kinds of standards are mainly relevant. A product standard specifies one or more aspects of a particular kind of product or a range of products. For example EN 60601-2-19 specifies safety requirements for baby incubators (including aspects of performance directly relevant to the well-being of the baby), and EN 556 specifies requirements for many kinds of medical devices to be labelled “Sterile”.
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A management system standard specifies requirements for the way an organisation is run to achieve a desired purpose. In particular the ISO 9000 series standards specify requirements for quality management systems by which manufacturers ensure that their products will be as intended. In the past, reference to standards in purchasing has made a major contribution to ensuring device safety and quality, but the introduction of CE-marking for medical devices has changed the significance of standards. For manufacturers they have become even more important, because they provide a means of demonstrating that the legal requirements have been met. Device purchasers, however, should no longer need to refer to standards in most purchase contracts, because the CE marking will constitute reasonable assurance that a device will be safe and will perform as intended: either the manufacturer will in fact have made the device in accordance with relevant standard(s) or he will have ensured safety and quality in some other effective way. Even devices that are not CE-marked (viz those that are custom made or intended for clinical investigations) must still, by law, be safe and perform as described by their manufacturers. Purchasers should therefore still not need to call for conformity with standards. (See above regarding devices first placed on the market by 14th June 1997, though possibly not reaching the final device purchaser until some time after that date.) Device purchasers will however sometimes need to refer to standards in order to identify devices that are suitable for a particular use; for example where devices are supplied in various sizes or grades, such as support hosiery, or where they need to be compatible with other devices or systems already in use which could comply with either an old national standard or a newer European standard. “A review of Standards Applying to Technical Medical Equipment” (Dräger) provides a useful brief summary of the relevant standards. (Appendix A2.4). How manufacturers will use standards - relationship to CE–marking Since the Directives cover a wide range of medical devices, involving many levels and types of technology, the Essential Requirements can only provide a broad approach in setting the targets that manufacturers must meet. The European Commission, therefore, has mandated the European standards organisations to prepare European standards to address the Essential Requirements. These standards assist manufacturers by setting out generally agreed specifications of what the essential requirements mean for particular products, and practical objective means to show that products comply with the Essential Requirements, for example by the application of standard test methods.
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Conformity with a relevant Harmonised Standard provides a presumption that the device conforms to the Essential Requirements. In many cases a manufacturer will need to refer to more than one standard in order to address all the relevant Essential Requirements for a given medical device. With few exceptions, however, application of standards by manufacturers and other organisations is voluntary. How regulators/MDA will use standards If MDA needs to form an opinion as to whether or not a particular medical device conforms to the Essential Requirements of the relevant Directive, we will often refer to relevant standard(s).
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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 PUBLICATIONS
A list of all current MDA publications can be found on our web site: http://www.medical-devices.gov.uk DB 9501.
Reuse of medical devices supplied for single use only Deals with the reuse of medical devices labelled by the manufacturer as being for single use only. Looks at the regulation of medical devices through the Medical Devices directive, legal issues, technical issues and economic issues. Gives examples of use of equipment in the community, including plastic syringes for insulin injection and urethral catheters.
DB 9503.
Infusion Systems
DB9504.
The management of infusion systems: a report by the Scottish Office Home and Health Department.
DB 9606.
Wheelchair and vehicle passenger lifts: safe working practices.
DB 9605.
Purchase, operation and maintenance of benchtop steam sterilisers. Deals with a range of issues: advice and personnel, Regulations, purchase, installation and validation, periodic testing, maintenance, technical aspects and safety, legal and insurance considerations. Clearly relevant to community settings, where these relatively small sterilisers may be in use.
DB 9602.
Guidance on the safe use of lasers in medical and dental practice.
DB 9704.
Medical Devices and the Year 2000.
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Directive Bulletins 8. 2. 3. 4. 5. 6. 7. 9. 10. 11. 12. 13. 14. 15.
Information about the EC Medical Devices Directives The CE Marking The Vigilance System Conformity Assessment Procedures Pre-clinical Assessment Routes The Notified Body The Competent Authority The Citizens Charter and a Code for Enforcement The Classification Rules CE and EFTA member states (EEAAgreement) Sale and Supply of In Vitro Diagnostic Medical Devices Standards Compliance Cost Assessments The Medical Devices, Electromagnetic Compatibility and Low Voltage Directives 16. Information about the Packaging and Packaging Waste Directive 17. Medical Devices and Medicinal Products 18A.The Medical Devices Regulations: Implications on Healthcare and other Related Establishments 19. Own Brand Labelling and Rented Products TRS89 (1989). NHS procurement directorate technical requirements for the supply and installation of equipment for diagnostic imaging and radiotherapy. MDA (1996). Sterilisation, disinfection and cleaning of medical equipment: guidance on decontamination from the Microbiology Advisory to Department of Health, Medical Devices Agency. Looseleaf publication outlining recommendations of good practice and dealing with different methods of sterilisation, disinfection and cleaning. Also contains many references to further publications. The publication appears primarily to be aimed at issues of “hospital associated infection”, but the introduction refers also to “other health care settings” and to General Practice settings. MDA (1995). The report of the expert working group on alarms on clinical monitors, in reponse to Recommendation 11 of the Clothier Report: The Allitt inquiry. (C.M. Clothier, 1994, HMSO, London).
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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 EXECUTIVE PUBLICATIONS
A2.3 RELEVANT DEPARTMENT OF HEALTH CIRCULARS
HN9506.
MDA Hazard notice 1995 Graseby Medical MS16A and MS26 ambulatory syringe drivers: repeat warning: risk of incorrect rate settings due to confusion between two models. (HAZ(SC)96/01 in Scotland, WHSN(96)4 in Wales).
HN9606.
MDA Hazard Notice 1996 Phototherapy devices for the treatment of neonates and infants (WHSN(96)8 in Wales).
HN9609.
MDA Hazard Notice 1996 In-house manufactured spirit level used in central venous pressure (CVP) measurement (WHSN(96)12 in Wales).
SAB(89)14.
1989 Safety Action Bulletin Patient lifting devices: sling, harness and strap failures.
SAB(91)46.
1991 Resuscitators: regular testing and inspection.
Health and Safety Commission (1993). Getting to grips with handling problems: worked examples of assessment and reduction of risk in the health services. HSE Books. HSE (1992).
Manual handling: guidance on regulations: Manual Handling Operations Regulations 1992. HSE Books.
HSE (1998).
Guidance Note PM77: Fitness of equipment used for medical exposure to ionising radiation.
HS(G)115.
Manual handling: solutions you can handle.
HS(G)107.
Maintaining portable and transportable electrical equipment (1994).
HS(G)104.
Health and safety in residential homes (1993).
HSG(93)13.
Reporting adverse incidents and reactions, and defective products relating to medical and non-medical equipment and supplies, food, buildings and plant, and medicinal products. (MEL(1995)74 in Scotland, PEL(93)36 in Northern Ireland, WHC(97)28 in Wales) Sets out procedures for adverse incident reporting.
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HSG(93)26.
Decontamination of equipment prior to inspection, service or repair. Refers to the need for safe systems of work to protect against transmission of infection from medical devices or other equipment which comes into contact with patients or their body fluids. Highlights legal requirements, features of an appropriate system of work and the necessary documentation. (No equivalent in Scotland, WHC(93)56 in Wales)
HSG(95)18.
Hospital laundry arrangements for used and infected linen. (MEL(1993)7 in Scotland, DGM(96)130 in Wales) Refers to some aspects of equipment: e.g. in relation when to use, when not to use and how to use washer extractor machines and batch continuous washing machines.
HSG(95)47.
Contracting for orthotics services. Acknowledges the criticisms levelled at the orthotics services and a checklist of issues for purchasers and providers, including, for instance, checking for specification and quality, advice about correct use and maintenance of the orthosis etc. (No equivalent in Scotland, DGM(95)163 in Wales).
HSG(96)34.
Powered indoor/outdoor wheelchairs for severely disabled people. (MEL(1992)67 in Scotland, not issued in Wales). In relation to the NHS supply of powered wheelchairs, this Circular includes reference to issue of third party insurance in case of accident in a public place, and the need for clear explanation of arrangements for maintenance, servicing and repair.
HSG(96)53.
Wheelchair voucher scheme. Explains the “independent” option, through which the user of the wheelchair takes responsibility for maintenance and repairs; and the “partnership” option which leaves such responsibility with the NHS. (No equivalent in Scotland)
HC(88)3 and Procurement:Product Liability. (In Scotland: HC(FP)(88)5. SHHD/DGM(1988)6 Consumer Protection Act 1987 General Guidance on Product Liability and SHHD/DGM(1988)20 Consumer Protection Act 1987 Product Liability: Medicinal Products and Medical Supplies.)
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HC(89)20.
Preservation, retention and destruction of records. (In Scotland: MEL(1993)152 “Guidance for retention and destruction of Health Records”, and in Wales: WHC(89)60 and WHC(94)59))
LASSL(95)7. Notification by the Department of Health of hazard and safety information which may affect the personal social services. Announces the introduction of a new system for disseminating safety information affecting personal social services to local authorities, voluntary organisations and registered voluntary and private residential care homes. (Not thought to apply in Scotland, not issued in Wales) Department of Health (1992). Equipped for independence? Meeting the needs of disabled people. London: DH. Highlights - through examples of good practice - the need for information for service users about what is available, involvement of users in service planning to help eliminate wasteful provision, and innovative use of the independent sector to improve services including value for money. Department of Health (1997). Community Care (Direct Payments) Act 1996: Policy and Practice guidance. (covering letter: LAC(97)11). A2.4 SELECTED OTHER REPORTS WITH RELEVANT RECOMMENDATIONS
Aldersea, P (1996). National prosthetic & wheelchair services report 1993 1996. London: College of Occupational Therapists. Comprehensive and in-depth report. 1. Prosthetic services. Contracts: short-term 3 or 5 year contracts can disrupt services for clients and reduce the morale of prosthetists, whilst accepting the lowest financial bid can be at the cost of ignoring both quality and research findings. Expertise: there is sometimes absence of appropriate expertise to prescribe prostheses (e.g. for children); whilst the value of consultants in rehabilitation medicine is not always realised. Maintenance: e.g. safety and legal issues involved in giving instruction to clients to make their own adjustments to prostheses. User consultative committees: should be consulted to assist with planning of services. 2.
Wheelchairs. Purchase: issues of design of wheelchairs: e.g. weight of chair, foldability, manoeuvrability in relation to carer ’s ability. Safety: e.g. NHS wheelchairs in nursing homes with punctures, without tyres, unstable for bilateral amputees, split seats and back canvases, without brakes, without footplates, without safety straps.
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Improve stock control and safety in relation to issue of wheelchairs to residents of nursing homes. Equipment standards and safety: suggests annual inspection of all powered wheelchairs: part of contract with repairer. Suggests three year maintenance check for non-powered wheelchairs, but one year check not cost-effective. Discusses manufacturers’ recommendations about when maintenance should be carried out (e.g. time of ownership is less relevant than level of use over any given period of time). Suggests users should always be provided with the name of the contract repairer, have it explained that they are responsible for cleaning and keeping the wheelchair in good working order, and be given information on general maintenance. Wheelchair user groups: can provide valuable advice on contract matters and contribute to effective purchasing and service planning. Amputee Medical Rehabilitation Society (1992). Amputee rehabilitation: recommended standards and guidelines. London: AMRS. Chapter on contracts. Amongst its recommendations on contracts it points out the adverse effects short term contracts can have, given the long term periods of patient care required and the importance of the development of confidence and trust - by patients and families - in staff. Appropriate stocks of items - eg socks, gloves - must be kept in stock, and their supply should be part of normal service delivery. Disablement Services Centres must be committed to ongoing research - including the development and evaluation of new prosthetic materials. Association of Anaesthetists Checklist for anaesthetic apparatus 2 (1997). This booklet lists checks to be carried out by the anaesthetist at the beginning of each operating theatre session, covering: anaesthetic machine, oxygen analyzer, medical gas supplies, vaporizers, breathing system, ventilator, scavenging, ancillary equipment, and monitoring. Audit Commission (1991). NHS Occasional Papers. Value for money in NHS sterile services. London: HMSO. Makes a number of recommendations in relation to Sterile Services Departments including a unified management responsibility - with adequate business, administrative and information systems - for all sterile products used by patients, the pricing of packs and trays so that users are aware of the costs involved, user groups to review products against full costs, phasing out of in-house single-use packs in favour of limited range of commercially supplied packs.
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Audit Commission (1995). Improving your image: how to manage radiology services more effectively. London: HMSO. Makes a number of observations in each chapter, followed by recommendations at the end. For instance, it notes that value for money is difficult to assess when different suppliers of equipment shift costs onto the maintenance contract or offer package details; the “whole-life” cost of equipment is often ignored; second-hand equipment offers opportunities but purchasing it raises the question of who is responsible for its proper commissioning; the appropriate expertise is required for purchasing decisions - and so on. Audit Commission (1996). Goods for your health: improving supplies management in NHS Trusts. London: HMSO. Deals with a variety of issues and contains short recommendations at the end of each chapter: • Equipment selection. Points out that excessive diversity can be expensive: standardisation on items of common use can make savings. • Evaluation. Proper evaluation is needed to ensure that purchases are justified. Users need access to adequate information: randomised clinical trials are the best way of assessing the effectiveness of medical devices. • Procurement. Suggests reducing the number of low-value orders, reviewing number and location of receipt points to ensure better planned and coordinated delivery of items to the point of use. Also consolidation of deliveries: eg through single carrier. Examine payment systems and invoice checking. • Prices. Use competition whenever appropriate, aggregate demand for products over time, establish longer term contracts with suppliers, maximise early payment discounts, avoid end-of-year poor procurement practice, but allow reasonable budgetary flexibility. • Stocks. Discusses need to avoid excessive stock which may become obsolete, is expensive to store, and vulnerable to damage, loss or theft. Suggests reviewing and setting target stock levels, based on suppliers’ delivery capability, price, handling costs etc. Also contractual arrangements to reduce on-site stocks. Introduce and extend “materials management” system of stock management. Monitor high value stocks in high-spending departments regularly. Improve security, whilst balancing risk and process costs. • Usage. Has a big effect on expense. Recommends examination of the causes of significant variations in usage. Work with suppliers to benchmark and manage usage patterns. Define guidelines for the use of consumables and equipment. Increase equipment usage through pooling. Ensure equipment is fit for the use for which it is intended.
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•
•
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 supply costs, improved communication including electronic ordering and payment, prompt payment, experimenting with nominated carrier arrangements, logistics partnerships and partnership sourcing arrangements. Pursue partnership with other Trusts.
Beresford, B (1995). Expert opinions: a national survey of parents caring for a severely disabled child. York: Joseph Rowntree Foundation. Expresses concern about the stress placed on the growing numbers of parents who look after “technologically dependent” babies at home and the need for support from professionals. Bowker P, Rocca L, Arnell P, Powell E (1992). Study of the organisation of the orthotic services in England and Wales. Salford: Salford Health Authority Physiotherapy Service; University of Salford, Department of Orthopaedic Mechanics; North Western Orthotic Unit. Found a service which is uncoordinated and rudderless with little informed management, service audit or strategic planning. Makes various recommendations about the role of different members of the multi-disciplinary team, training etc. Criticises the making of contracts - e.g. Lack of involvement of appropriate staff, lack of good practice guidelines - resulting in “wastefully generous”, but also “punitively frugal” services. The supply process might not be monitored properly with resulting mispayments (eg pay twice for one orthosis), no monitoring of the work being undertaken by independent orthotists, no checking of adherence to prescription etc. British Society of Rehabilitation Medicine (1995). Seating needs for complex disabilities: a working party report of the British Society of Rehabilitation Medicine. London: BSRM. Contains a chapter on legal implications, including clinical responsibilities for, and reporting of, adverse occurrences; product liability, insurance, maintenance etc.
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Cameron, I et al (1995). Leeds wheelchair project: an investigation into face to face assessment of all non-permanent users of wheelchairs, September 1995. United Leeds Teaching Hospitals NHS Trust; Nuffield Institute for Health. In the control (i.e. the “normal”) control group of wheelchair users, only 21.3% had received verbal instruction in use of the wheelchair. Users who were assessed face-to-face were ten times more likely to use their wheelchair in a safe way. These users would also be more likely to receive relevant information about use, and to use the chair more frequently. Dräger (1997) A review of Standards Applying to Technical Medical Equipment (Drägerwerk Aktiengesellschaft, Moislinger Allee 53-55, D23542 Lübeck, Germany) Easton, J (1995). Thirteenth annual report of the Assistive Communication Aid Centre, Frenchay Hospital, Bristol. Bristol: Frenchay Hospital. Points out the cost-effectiveness of loan banks, and the recycling, of communication aids. Also that budget holders have to consider “on-costs” beyond the actual hardware: e.g. maintenance, modification, insurance and training of users. ICE Ergonomics (1992). Aids and equipment for elderly people (Home and Leisure Accident Research). London: Department of Trade and Industry. Found that although most aids were reasonably safe, many items lacked adequate instructions. Initiative on communication aids for children (1994). Communication aids for children: a briefing for purchasers and managers. London: ICAC. Points out huge range of prices of communication aids: from £10 to £7000. Argues that provision of an aid without support and user training is false economy, because the aid is abandoned. Identifies technical support and maintenance as a key issue. Leonard Cheshire Foundation (1990). Report on the wheelchair and seating project carried out in residential homes of the Leonard Cheshire Foundation for physically disabled people. London: LCF. Concluded that inadequate prescription of wheelchairs and seating caused imbalance, instability and high pressure - causing pain, spasm, spasticity, deformity, contractures and often pressure sores. Mandelstam, M Going to Market. Equipment and Products for disabled and older people - an overview. The Disabled Living Centres Council 1996.
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National Audit Office (1996). Health and safety in NHS Acute Hospital Trusts in England. London: HMSO. 75% of accidents recorded involved patients or visitors, and 80% of these involved slips, trips and falls. For staff, the main types of accident stemmed from needle stick injuries, manual handling, slips, trips and falls - and patient assaults. 1% of accident were considered serious enough to report to HSE. The report clearly points to the need for managers to provide appropriate equipment for lifting and to ensure that it is used by providing information, training and supervision. NHS Confederation; NHS Supplies (1997). Purchasing medical equipment: the third boardroom briefing document from the Joint Working Party. Small booklet set out in the form of checklists under the headings Forward planning, Who needs to be involved in the purchase?, Expert guidance and assistance, Assessing the options, Planning for post-purchase requirements. NHS Estates Hospital Technical Memoranda series, including HTM 2010 Sterilization and HTM 2020 Electrical safety NHS Executive (1993). Risk management in the NHS. NHS Executive (1996). Renal purchasing guidelines. Refers to geographical location, demography, main renal units, satellite units, minimal care units, contribution by the private sector when planning services. Contracts should address the need for infection control. Contracts should contain clear quality standards. Contracts may be made with multiple providers, so that a “portfolio of contracts” makes up the total care package. However, arrangements should be flexible enough to allow seamless service for patients. Contracts should be monitored and be assessed. National Radiological Protection Board Dental Monitoring Services. A leaflet describing the services offered to dentists, for calibration, dose record keeping, and personal monitoring. Owens, J (1996). Strategic procurement for the NHS: working with suppliers. Birmingham: National Association of Health Authorities and Trusts. Explains that it is intended primarily for NHS Trusts to use strategic procurement to outsource high cost services for which there are few adequate suppliers; but that the process involved may also be useful in relation to the purchase of health care generally. Contains many useful checklists for purchasers, under the chapter headings: Procurement in the NHS, Setting the strategy for procurement, Analysis and planning, Specifications based on outcomes, Pre-qualification of suppliers,
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Choosing a supplier, Complying with legislation, Getting the contract right, Measuring performance and monitoring improvements, Managing relationships, Partnership works. Poswillo, D.E. (1990). General anaesthesia, sedation and resuscitation in dentistry - report of an expert working party. Department of Health Standing Dental Advisory Committee, 160 Great Portland Street, London W1N 5DT. Ross, F, Campbell, F (1992). “If it wasn’t for this wheelchair, I might as well be dead”: a study of equipment and aids for daily living in the commu nity, a district nurse and consumer perspective. London: St George’s Hospital Medical School. Found chaotic equipment delivery systems, and even worse equipment collection systems, as well as confusion about who was responsible for ensuring that aids were serviced. Royal College of Physicians (1992). Domiciliary oxygen therapy for children. London: RCP. Points out that parents must be taught how to use the equipment, and that prescription should be decided on grounds of safety, ease of use, convenience and cost. Provision of an oxygen concentrator may affect domestic insurance cover and insurance companies should be informed - though this will not necessarily affect the premium. Royal College of Physicians (1995). Provision of wheelchairs and special seating. London: RCP. Points out that inadequate wheelchair prescription causes health problems in both users and carers, as well as placing a greater eventual burden on statutory services. Scottish Health Management Efficiency Group, Clinical Resource & Audit Group. Final report SCOTMEG project 41: incontinence services in the community. Edinburgh: SCOTMEG. Found that pads were delivered direct to patients by van, picked up by patients or relatives, or delivered by district nurses. This last route was questioned as possible poor use of resources. Laundry services were found to be patchy, and where they did exist, there were several different models. The report recommended that computer systems used for management of the supplies service should be capable of linking to patient records. Most health boards used CSA national contracts, whilst making separate arrangements for specialist supplies. It pointed out that anecdotal evidence about wastage, inappropriate supplies, stockpiling and onward selling could not be investigated in the absence of good information systems.
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Scottish Health Management Efficiency Group, Clinical Resource & Audit Group (1996). SCOTMEG report on patient equipment in the community. Edinburgh: SCOTMEG. Contains various recommendations relating to, for example: a) clarification of responsibilities of different statutory services (e.g. social/health care divide); b) centralisation of stores, joint working between statutory services, or running of the service by a third party; c) appropriately qualified people to manage budget, to run the stores service, to select the equipment; d) clear requisitioning arrangements; e) clear transport/delivery systems; f) maintenance and technical back-up systems; g) training of professional and support staff (eg health and safety); h) training of users/carers. Scunthorpe Community Health Care NHS Trust; Nuffield Institute for Health (1994). Yorkshire wheelchair services: approved prescribers competencies. Leeds: Nuffield Institute. Approved prescribers’s competencies - including instruction to clients and carers bout the safe use of equipment, in relation to e.g. pushing, brakes, kerbs, uneven ground, stability, transfers, folding/storage, loading into car, cleaning and maintenance, life span of cushion and its correct use, safety precautions. Social Services Inspectorate, Department of Health (Shipley C, Raw D) (1991). Managing aids to daily living. Points out that equipment is big volume business accounting for up to 50% of referrals of older people, it is relatively inexpensive since it consumes less than 5% of social services resources, it does help restore independence, there is ample scope for significant improvement in how services are delivered.
Touche Ross (1994). Department of Health reimbursement and remunera tion of appliances report. Looks at the system of remuneration, in relation to services provided and the prescriptions dispensed, for pharmacists and dispensing appliance centres (DACs) in relation to ostomy products continence products, dressings and other appliances. Recommends changes so that the value of remuneration fluctuates with services provided, not the value of the prescription being dispensed.
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APPENDIX A3 Preparation of Medical Devices, Equipment and Materials to be returned to, or handled locally by, Service Departments,Manufacturer s, or their represenatives: Infection Hazards Medical devices and equipment to be inspected, serviced or repaired should be in a condition which is safe to be handled by all personnel who may come into contact with them during transit and subsequent handling. The device should not only be mechanically and electrically safe, but also the risk of causing an infection should be minimised. The Department of Health published HSG (93) 26 Decontamination of equipment prior to inspection, service or repair to highlight the legal requirements, appropriate systems of work and the necessary documentation for this activity. The document should be consulted prior to the establishment of a decontamination regime. Failure to comply with the legislative requirements could leave a healthcare establishment open to prosecution. The Department of Health agrees with the view that all engineers, technicians and service personnel have the right to expect that articles handled by them have been properly treated to remove any such risks. It should also be emphasised that medical devices and equipment loaned, rented or leased to a patient for use in the community environment, must be treated with the same level of caution and preparation. Those devices which have been used for demonstration purposes must also present no risk to subsequent users. The following information should be brought to the attention of those who have responsibility for medical equipment maintenance and decontamination. It may be of particular interest to personnel in the following units; operating theatres, endoscopy, sterile service, supplies, EBME & EME departments and to Control of Infection staff & Consultant Microbiologists. Devices and equipment to be repaired or serviced on site, at the manufacturer’s or agent’s premises, and those devices being returned from an episode of use within the community healthcare setting, should have been decontaminated appropriately, by trained personnel. Depending upon
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how the device or equipment is used will dictate whether it should be cleaned and either disinfected or sterilized. For those devices which do not come into contact with bodily fluids, cleaning only may be sufficient. Decontamination should be carried out in accordance with the manufacturer’s instructions. Decontamination agents must be compatible with the article to ensure that decontamination does not change the properties or damage the item. Manufacturer’s guidance should be sought if there is no reprocessing information available with the product. After cleaning, the item may be disinfected or sterilized. Items compatible with the high temperatures and pressures comprising a steam sterilization cycle should be sterilized in an appropriate autoclave. For items where exposure to high temperature is detrimental to the device, it may be possible to sterilize using ethylene oxide gas. The manufacturer must be consulted before either method of sterilization is used. Those items which cannot be sterilized may be disinfected using either low temperature steam or immersion in liquid chemical disinfectants. Consideration should be given to the requirements for the safe use of chemicals such as glutaraldehyde and peracetic acid. Other decontamination processes may be used provided they are validated and it is demonstrated that they are not detrimental to the medical device or equipment. Further guidance on suitable decontamination regimes can be found in the following Department of Health publications: HC (91) 33 Decontamination of equipment, linen or other surfaces contaminated with Hepatitis B and/or Human Immunodeficiency Viruses . Sterilization, Disinfection and Cleaning of Medical Equipment: Guidance on Decontamination from Microbiology Advisory Committee to the Department of Health Medical Devices Agency (MAC Manual) Part 1 Principals (published 1993), Part 2 Protocols (published 1996). MDA Device Bulletin DB9605 The purchase, operation and maintenance of bench top steam sterilizers. MDA Device Bulletin DB9607 Decontamination of Endoscopes. MDA Safety Notice SN9701 Reporting adverse incidents relating to medical devices.
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A local policy may be established for the decontamination of medical devices, drawing on technical input from the following: • • • • • •
Manufacturer’s instructions; Control of Infection staff; Consultant Microbiologist; Risk Assessment Officer; Advice from the appropriate Government body responsible for health matters e.g. MDA; Advice from appropriate professional bodies e.g. BMA.
Devices to be inspected, serviced or repaired and those being returned from use in the community should be accompanied by a certificate identifying their contamination status. An example may be found in HSG (93) 26 or the MAC manual. Technical enquiries regarding the content of this appendix should be addressed to: Mr N Moore Medical Devices Agency Hannibal House Elephant & Castle London SE1 6TQ Tel. 0171 972 8066 Fax. 0171 972 8106
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Miss N Thomas Medical Devices Agency Hannibal House Elephant & Castle London SE1 6TQ Tel. 0171 972 8263
Appendix A4 Contact details - arrangements for reporting incidents and ordering publications A4.1 MDA
“A guide to contacts” August 1997 lists all the MDA contact details. For copies ring 0171 972 8136, or fax 0171 972 8136. Our main switchboard number is 0171 972 8000. For reporting adverse incidents, ring 0171 972 8080. For details on how to report adverse incidents, see MDA SN9801 “Reporting adverse incidents relating to medical devices.” MDA publications are listed in: • Device Evaluation and Publications Catalogue (Oct 1997 - fax 0171 972 8105 or ring 0171 972 8181 for a copy), for evaluation reports. • Adverse Incident Reports 1997 (Jan 1998 - fax 0171 972 8124 or ring 0171 972 8188 for a copy), for Device Bulletins, Hazard Notices, Safety Notices and Pacemaker Technical Notes. The MDA web site: http://www.medical-devices.gov.uk has up-to-date publication lists. •
A4.2 SCOTLAND, WALES,AND NORTHERN IRELAND
Medical Devices Directives : MDA Guidance Documents (June 1997 fax 0171 972 8112, tel. 0171 972 8300 - European and Regulatory Affairs Helpline) for Directives Bulletins and Competent Authority publications giving guidance on the Medical Devices Directives.
Northern Ireland Adverse incidents involving medical devices in Northern Ireland should be reported to: The Northern Ireland Defect and Investigation Centre, Health Estates Estate Policy, 14 Stoney Rd, Dundonald, Belfast BT16 0US. Tel. 01232 523714 Fax 01232 523900. For details on how to report incidents, see “Reporting adverse incidents..” PEL(93)36 - copies from above address.
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Scotland Adverse Incidents involving medical devices in Scotland are reported to: Scottish Healthcare Supplies, Trinity Park House, Edinburgh EH5 3SH. Telephone 0131 551 8333 (emergencies: 0131 552 6380) Fax. 0131 552 6535. For details on how to report adverse incidents in Scotland, see “Reporting of adverse incidents and defective equipment” NHS MEL (1995)74 - copies from NHS in Scotland, The Scottish Office, Room 278, St. Andrew’s House Edinburgh EH1 3DG. Tel. 0131 244 4049. Wales Adverse incidents involving medical devices in Wales are reported to Health Strategy Division 2, Welsh Office Health Department, Cathays Park, Cardiff CF1 3NQ. Tel. 01222 825111, Fax. 01222 825479. For details on how to report incidents, see “Reporting of adverse incidents, reactions and defective products relating to medical and non-medical equipment, supplies, food, building and plant, and medicinal products.” WHC(97)28, available from the address above. A4.3 OTHER ORGANISATIONS
Audit Commission 1 Vincent Square London SW1P 2PN. Tel. 0171 828 1212. Association of Anaesthetists of Great Britain and Ireland, 9 Bedford Square, London WC1B 3RA. Tel. 0171 631 1650. Disabled Living Centres Council, Winchester House, 11 Cranmer Rd. Kennington, London SW9 6EJ. Tel. 0171 820 0567. Finger on the Button Training, Scitech Educational Ltd, Units 15-17 St John Business Centre, St Peter’s Rd Margate CT9 1TE. Tel. 01843 231494. Institute of Healthcare Engineering and Estate Management. 2 Abingdon House, Cumberland Business Centre, Northumberland Road, Portsmouth, Hants PO5 1DS. Tel. 01705 823186. Health and Safety Executive, Field Operations Directorate, 14 Cardiff Road Luton LU1 1PP. Tel. 01582 444200. Limbless Association (formerly NALD) 31 The Mall Ealing London W5 2PX. Tel. 0181 579 1758.
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National Audit Office 157-197 Buckingham Palace Road, London SW1W 9SP. Tel. 0171 798 7000. National Radiological Protection Board, Dental Monitoring service, Hospital Lane, Cookridge, Leeds LS16 6RW. Tel. 0113 267 9041. NHS Estates, Department of Health, 1 Trevelyan Square, Boar Lane, Leeds LS1 6AE. NHS Estates publications are listed in “Publications List, Summer 1997” (for copies fax 0113 254 7299, or ring 0113 254 7201). This list includes Health Guidance Notes and Health Technical Memoranda series. NHS Executive, Quarry House, Quarry Hill, Leeds LS2 7UE. Tel. 0113 254 5000. NHS Supplies, Apex Plaza, Forbury Road, Reading RG1 1AX. Tel. 0118 980 8600. For medical and surgical supplies, contact 01244 586700 (80 Lightfoot St. Chester CH2 3AD); for rehabilitation services, contact 01189 808800 (Clipper House, 62-66 London St. Reading RG1 4SQ), for diagnostic and medical equipment, contact 01275 512800 (Ham Green House, Ham Green Bristol BS20 0LH). NHS Supplies have produced standard terms and conditions, against which the majority of purchases are made. Where appropriate, these have been discussed with the ABHI and other relevant trade associations and industry representatives. They also publish the PPQ form for use by NHS trusts. An extract from the text of the form follows:
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PRE-PURCHASE QUESTIONNAIRE
SAFETY STANDARDS
This form is intended to supply prospective purchasers with information about equipment being considered for purchase. It is intended principally for pre-purchase information on electrical medical, dental, ophthalmic and laboratory equipment. The form may also be used for other products, including non-electrical items, and to give information prior to equipment being supplied on loan, in which case not all the questions will be relevant. Please ensure all relevant questions are answered.
5. For devices not CE marked to 1b) i) or ii) above, with which safety standard(s) does the equipment comply?(Standard, Test House, Certificate, Date)
CE MARKING 1. a) Does the product carry the CE marking? b) If YES, which EC Directive(s): i) Active Implantable Medical Device Directive (90/385/EEC) ii) Medical Device Directive (93/42/EEC) If YES, state classification of device: Identification No of Notified Body, if applicable: iii) EMC Directive (89/336/EEC) iv) Low Voltage Directive (73/23/EEC) v) Other (please specify) If YES to i) or ii) above, go to question 6. 2. a) Is the product a “custom-made device”? b) Or a “device intended for clinical investigations”? If YES, does it comply with the UK Medical Devices Regulations? QUALITYASSURANCE 3. Is the manufacturer currently registered under the DH Manufacturer Registration Scheme for this product? If YES, please give Registration Number: 4. Is the manufacturer currently registered to any other GMP/quality system standard for this product? If YES, please state standard:
SERVICE / SPARES / INSTALLATION 6. Is service/repair information/manual available? If YES, please state current price and indicate contents below: (Full circuit diagrams, Fault finding procedures, Preventive maintenance, Repair information, Spare parts listing, List of special tools/test equipment/etc.) 7. a) In addition to the service/repair inform tion/manual, will training be required before the purchaser’s technical personnel can provide (First line maintenance, Calibration, Planned preventive-maintenance, Repair.) b) For those indicated by YES above, is the supplier able to provide training for the purchaser’s technical personnel? If YES, will this be free of charge,or chargeable? If NO, please indicate if details of an organisation which is able to provide this training are available on request: (Company, Location) 8. a) Is the supplier able to provide an “as required” repair/maintenance service in the UK? b) Is the supplier able to provide a contract repair/maintenance service? If YES, please confirm that details of repair/maintenance contracts are provided on a separate sheet. c) i) Will repairs normally be performed on the purchaser’s site? ii) If repairs are performed off-site, where will these be carried out? (Company, Location.)
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9. Is the supplier’s maintenance organisation currently registered to a quality system standard? If YES, please state standard: 10. Please indicate when the item was first put on the market: 11. For how many years from the date of last manufacture is the supply of spare parts guaranteed? 12. Please indicate if spare parts will be made available to the purchaser: 13. Is installation necessary? If YES, please confirm that details of all services required are given on a separate sheet: DECONTAMINATION 14. Does decontamination require the use of specific equipment? If YES, please state equipment type and parameters of operation (eg. temperature, pressure, etc). WARRANTY 15. Please confirm that a copy of the warranty is provided on a separate sheet.
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INDEX Acceptance testing Accuracy Accident Active implantable medical devices directive Adverse incident — reporting Alarm Archive Aids to daily living Ambulance Ambulatory infusion pump Ambulatory syringe driver Anaesthesia Anaesthetic machine Artificial limbs Audit Commission Authorised person Autoclave
E2 E3 E4 ix xxiv
Backrest Bath board Band sling Bank nurse Bar code Battery Benchtop steam sterilizer Biocompatibility Biomedical engineering (BME) Blood glucose meter Bolus delivery Breakdowns Build standard
J3 F1 H14 xvii I2 G3 B3 E5 H6 H7 xi xv ix A5 B3 C11 G3 H9 D2 I2 H1 H5 H11 H6
Carer Calibration Callout fee Cannibalising Capnograph Cardiotocograph Care manager Care of disabled people
A2 D1 G3 xxxiv C4 H12 C12 J4 I2 H15 A4
xxxvi
vi vii xxxiv H8 xxxi xvii xxxxii xvi G3 xxvi A6 I2 xvii xxv C3 H9 J4 xx B1 C5 H11 C3 J5 xxviii
CE marking Change of use Chair raising blocks Chiropodist Class (device) Cleaning Client Clinical supervisor Clinical engineering Clinical investigation Clinical monitors Collection Community store Community Care (direct payments) Act Community healthcare Commisioning Communication aids Competent authority Compliance Commode Computer Computer database Computer discs Computer drives Computer systems Conformity assessment Consultative committee Consumer Protection Act Contamination Contract Contractor Control of infection Control of substances hazardous to health Controls Cost effective devices Critical care Cross infection Crutch Database Declaration of conformity Decommision
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A1 C5 C11 C12 H14 vii viii xvi xxxiv C11 F2 J3 xi xii H1 H9 H10 A2 A3 A4 B2 I2 H2 A5 vii xvi J2 A2 A5 B1 C5 G5 H14 A3 H2 xxiii A7 vi xxxi vi x F1 H13 F2 G2 xxii xxv G1 G5 G2 G2 ix vi xix G1 H9 J3 ii xxix C9 ii H12 xxvii xxix iii E2 H10 H8 ix H11 A4 J2 E5 F2 G2 vi H11
Decontamination Defect reporting Defibrillator Delivery Dentist Dental X-ray Device bulletin Device management procedure Device Provider Device purchaser Diagnostic imaging Dialysis Disabled people Disablement service centre District nurse Domiciliary oxygen
B4 E5 H1 H9 H10 xviii xxvii xxviii xxxv H13 A6 H8 G4 J4 ix J2 xxiv xxv J5 xxviii A3 A3 A3 xvi D5 xix xx F1 xxv
EBME department ECG Electrical safety test Electrical equipment (safety) regulations Electric shock Electromagnetic emissions Employers' Liability Act End-user End-user preferences End-user training End-user (vulnerable) Endotracheal tube Engineer Equipment for disabled people Equipment in the community Equipment pool Equipment selection Essential requirements Evaluation Evaluation centre External pacemaker
iii ix ix i A3 A4 D3 C5 I2 H13 E6 G2 xxiii H12 B2 xxi ix x C10 xxi xxxi A7 C7 C9 I2 I3 H10
Fault reporting Film badge Finger on the button Full refurbishment
H9 C4 I2 C12
xxxviii
xxvii J4 H10
General product safety directive General product safety regulations Glutaraldehyde
H9 ii iii xxviii
Handling technique Hazard notice Health and safety Health and safety at work HEI 98 Hoist Hoist sling Hoist instructions
H15 A6 H15 I2 i iv A1 A2 C4 D5 H13 xvii F3 D5
Imaging system Incident investigation Incontinence pad Infusion pump Infusion system In-house manufacture In-house maintenance In-house servicing Injury Insurance Instructions Instructions for end-user Instructions for loan equipment Instructions (revised) Inventory In vitro diagnostic device ISO 9000 ISO 9002
E3 H10 xxv B3 D3 E7 H11 I2 xv C11 H5 H11 v xxii J1 H7 xxiii D2 D4 D5 D5 B4 G2 G4 vii xii H1 H4
Joint HS/SS stores Judicial review
J2 F3
Label Label (bar code) Label (infusion identication) Label (just serviced) Laundry Laser Leads and probes Legal entity Liability
D1 E6 G3 B4 H10 C4 xviii iv xv A6 C10 E4 H8 H10 vii H6
xxxix
vi
Liability (employers') Liability (legal) Lifting and handling Lifting devices Loan Loan equipment Lumen
i D4 H9 iii H14 xvii C10 D1 G5 H13 H14 H15 J5
Maintenance contract Maintenance database Maintenance instructions Maintenance intervals Maintenance (routine) Maintaining portable equipment Maintaining simple equipment Manual Manual Handling operations directive Manual Handling operations regulations Manufacturer Manufacturers' instructions Manufacturers' registration scheme Market survey Mattress (electric) MDA MDA liaison officer Medical device Medical device coordinator Medical device directive Medical device group Medical device regulations Medical physics Microbiologist Monitor MRI scanner
xxxiv G5 D1 H2 H8
Near patient testing Nebuliser Negligence NHS NHS Executive NHS guidelines
xvii H13 C8 C10 H2 H4 xxxiv vi C2 H14 I2 iv xvii vi vii xiii D3 D4 H13 viii xxxiv C2 H13 A1 A6 A7 v xxxxi B4 A4 B3 vi vii xxxi B1 C2 C5 C7 D1 J3 vii A5 xxvii A4 H10 ix E3 D2 J4 H15 vii C3 E3
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NHS Supplies NHS wheelchair services Northern Ireland Notified body Nursing home
C11 H12 A1 A7 C6 C12 I3 vi xxxiv xix
Obsolete Obsolescence Occupational therapist Ombudsman On-site maintenance Operating table Optometrist Orthosis Orthotic srvice Ostomy products Out-of-box failure Overinfusion Overseeing Oxygen cylinder
A6 H11 H2 F1 H13 F2 F3 C8 C11 A5 C3 C12 H6 H15 xxii xviii xxvi E1 H11 xi A6 J6
Packaging Personal prtective equipment Phototherapy lamp Physiotherapist Place on market Planned prevetative maintenance Pool Poswillo report PPQ form
E4 H8 ix C4 E2 xvii H13 J3 viii
Prescriber Prescribing mistake Pressure relief mattress Pressure relief product Pressure system Pressure system and transportable gas regulations Procurement Product examination Product liability Product safety Professional user Professional user report forms
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A3 H1 H5 B1 B2 J4 C7 xxxiii xxxiv A2 A3 J1 xxvi F2 A7 H13 H7 v J5 xviii xxi xi xviii xxii i H8 H9
Prosthetist Prosthetic Protective equipment Pulse oximeter Purchasing decisions
F2 xix xx iv G4 H11
Quality system Quality asurance audit Quality control
xxxv xi H6
Radiation Radiology Recall Record keeping Record preservation Refurbishment Regulator Repair (on-site) Repair (temporary) Replacement Reliability Remote diagnostics Renal purchasing Residential homes Response time Resuscitation Resuscitator Re-use Risk assessment Routine maintenance Rubber component
iv ix xxi G5 B3 G1 G2 H4 J1 xix C12 xiv H15 H11 C6 C6 H6 xxiv xvii H6 xxv J2 J6 xvii xv B5 xxix A3 H7 J6
Safety notice Safety test Sale of Goods Act Scotland Scottish Healthcare Supplies Seating Secondhand equipment Senior management Serial number Service interval Servicing organisation Single-use device Sliding-turning band
A6 G5 ii A1 A7 C6 C11 xxxii A7 xxii xii H3 E6 G1 G5 H10 H1 H8 C7
xlii
Sling Sling (two piece) Social services Software update Spares Spares no longer available Stairlift Standard Standard compliance Standard (harmonised) Standard (product) Standard terms and conditions Steam sterilizers Sterile services Sterilization Stock rotation Storage Storage system Store Stores officer Strategic procurement Supervision Supplies Support seating Surgery Syphoning Syringe
C4 F3 H13 xvii F3 xxvi C4 G3 C6 H5 xxxv H11 F3 H14 v C2 E2 xiv xii xxxiii E3 J5 xxviii xx xxvii xvi xxiv xxviii E5 E6 ix E5 B1 G3 F2 xxiv A6 xxii F1 J2 I2 xv
Technical supervisor Tender Test person (sterilizers) Test equipment Third party Third party servicing organisation Total costs Total quality assurance Tools (special) Tracking Training Training availability Training costs Training for carer Training scheme Trolley
A3 A4 E6 H3 I2 C5 C7 C9 J5 H5 J3 H4
xliii
H1 H2 H3 H6 H12 C3 H1 H5 B2 E6 H2 I1 I2 J1 H6 H5 H15 B5 E1
Turning band Type examination Type testing
C7 xi E2
User group User organisation
xx A3
Ventilator
C5 C7 E5 H8
Wales Walking frame Warranty Website Wheelchair Wheelchair battery Wheelchair (hospital) Wheelchair lift Wheelchair loan Wheelchair (powered) Wheelchair (specially adapted) Wheelchair safety Wheelchair voucher
A1 A7 C6 C11 F1 xxxii H13 C6 G3 xxxv xv xxxi C3 C12 H12 J3 xx xxiii xxv xxvi H7 H12 xv iii J3 xviii H11 xix xviii
X-ray machine
E3 H11 J5
Year 2000
C2 G2 xv
xliv
DISTRIBUTION This device bulletin should be brought to the attention of medical device coordinators, medical engineering and medical physics staff, IT staff, medical and nursing directorate managers, general practitioners, dental practitioners, pathology laboratory managers and staff responsible for medical equipment used in the community.
TECHNICAL ENQUIRIES Enquiries regarding the content of this Device Bulletin should be addressed to Dr Stephen Young, Medical Devices Agency, Hannibal House, Elephant and Castle, London SE1 6TQ. Tel: 0171 972 8310 Fax: 0171 972 8113 Mr Clive Bray, Medical Devices Agency, Hannibal House, Elephant and Castle, London SE1 6TQ. Tel: 0171 972 8274 Fax: 0171 972 8010
HOW TO OBTAIN COPIES 2500 copies of this bulletin have been distributed free of charge to healthcare providers. Further copies Price £49.50, may be obtained from: MDA/DTS Orders Business Services Level 9 Hannibal House Elephant and Castle London SE1 6TQ or fax to 0171 972 8124 or phone your order to 0171 972 8360 © CROWN COPYRIGHT 1999 Addressees may take copies for distribution within their own organisations Medical Devices Agency An Executive Agency of the Department of Health.
1. INTRODUCTION
2. STRATEGIES FOR DEPLOYING DEVICES
3. PURCHASING
4.INSTRUCTIONS
5. WHEN A NEW DEVICE IS DELIVERED
6. PRESCRIPTION
7. RECORDS
8. MAINTENANCE AND REPAIRS
9. TRAINING
10. COMMUNITY ISSUES
APPENDICES
