evices in ractice

a guide for professionals in health and social care

Safeguarding public health

 Crown copyright 2008 A fully revised edition of Devices in Practice, published 2001 and prepared by an Expert Working Group

Devices in Practice:
a guide for professionals in health and social care

Medicines and Healthcare products Regulatory Agency

Contents

1 Introduction 2 What is a medical device?

Common types of medical device

3 4

3 Procuring medical devices

Checklist: Procuring medical devices The device Costs incurred Training requirements

4 Using medical devices safely

Checklist: Using devices safely Before use: assessment Before use: knowledge of device Ask yourself During use After use Checklist: Advising service users and carers

5 Record keeping
Checklist: Record keeping

7 8

6 Maintenance and repair

Checklist: Maintenance and repair

7 Training health and social care professionals

Checklist: Content of training programmes

8 The importance of reporting concerns about devices and adverse incidents

What is an adverse incident? Checklist: If an incident occurs, what should I do?

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1 Introduction

Medical devices play a crucial role in care and treatment. The number and variety of medical devices is vast and professionals handle a wide range of devices every day in their practice. As the Agency responsible for making sure that medical devices are safe and fit for purpose, the Medicines and Healthcare products Regulatory Agency (MHRA) has prepared this booklet which provides a practical guide to medical devices for all health and social care professionals, and pharmacists working in acute, primary care, and social care sectors.

This booklet is for:

health and social care professionals working in all areas including acute care, primary care, community care (or care at home), care homes, care homes with nursing and private healthcare systems health and social care organisations as they develop policies and protocols for the use and management of medical devices pharmacists in acute, primary care and social care settings voluntary and charitable organisations who provide devices direct to individuals or health and social care organisations.

It contains a series of practical checklists to help ensure informed procurement and the safe use of medical devices. Some individuals buy their own medical devices privately through pharmacies or other sources and, increasingly, on the Internet. In these circumstances it is the responsibility of the owner to ensure that the medical devices are appropriately used, maintained and ultimately disposed of.

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Devices in Practice, MHRA, August 2008

2 What is a medical device?

The term medical device covers a wide range of healthcare products other than medicines used every day in all healthcare settings. A medical device is any product used in the:

diagnosis, prevention, monitoring and treatment of disease or disability diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap investigation, replacement or modification of the anatomy, or of a physiological process control of conception.

A list of some of the products covered by the definition of medical device is provided opposite.

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Devices in Practice, MHRA, August 2008

3 Procuring medical devices

A policy for procuring medical devices should be established in consultation with the professionals who will be prescribing or supplying them and also with those who will be using the devices. The following factors should be considered in developing a policy:

If medical devices are purchased from the Internet, care should be taken to purchase only from recognised sites and purchasers should check that equipment has been subject to regulatory assessment.

what equipment and accessories need to be provided and why the range of particular devices available to cover requirements purchasing arrangements for bringing in new types of devices suitability for being sold or supplied by the NHS directly to members of the public without a professional involved in the handover, for example if supplied by a manufacturer or a store the tendering process for equipment supply, and, where applicable, maintenance what is included in a procurement package, e.g. device, accessories, consumables, backup, training, servicing and maintenance requirements and end of lifecycle replacement/disposal timescales and procedures total cost covering the devices intended lifecycle compatibility with accessories and other devices if relevant a system of record keeping to include use, maintenance and tracking degree of future proofing of devices (i.e. is something going to be available shortly that will be much better).

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Devices in Practice, MHRA, August 2008

4 Using medical devices safely

Professionals in health and social care use medical devices themselves and also provide devices which are then used by others, such as service users or carers. Professionals in health and social care are personally accountable for their use of devices and therefore must ensure that they have appropriate training. They are also personally accountable for ensuring service users and carers have received appropriate training and know how to use the device that has been provided.
An individual healthcare professional who uses the device in a way not intended, or against manufacturers instructions may be liable for any consequences.

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Service users and carers

Health and social care professionals will often provide medical devices to be used by service users and carers. It is important to make sure that service users and carers have adequate information about the use of the device. Health and social care professionals are personally accountable for ensuring that service users and carers have appropriate training in the use and maintenance of the device provided. Individuals who buy a device over the counter or privately need to be made aware of their personal responsibility to ensure the device is appropriately used and maintained.

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5 Record keeping

Good records are important in effective device management. Records should provide evidence of what the device is and where it came from, its serial or batch number, the maintenance record of the device and any training carried out on how to use it properly. Paper-based systems can be used if you have only a few devices; a computer-based system may be better if you have a number of devices.

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Devices in Practice, MHRA, August 2008

6 Maintenance and repair

Routine maintenance and planned preventative maintenance should make sure that your equipment will work safely when you need to use it, and should keep it operating safely throughout its working life. Lack of maintenance could lead to premature failure of the device in use.

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Devices in Practice, MHRA, August 2008

7 Training health and social care professionals

All practices and organisations in the public, independent and voluntary sectors must provide adequate arrangements for training in the safe use of medical devices. This also includes agencies providing staff to the care sector. Employers are responsible for ensuring that staff who use medical devices have appropriate training. Equally, all healthcare professionals and support workers have a personal responsibility and accountability to ensure that they are trained in the safe use of the medical devices they need to use.

Assessment of training needs

An assessment of training needs should be undertaken for individual staff and should address both clinical and technical matters. Training should then be planned to meet the identified needs. This should include whether individual staff: understand the principles underlying the use of devices

are familiar with the practical aspects of the devices they are likely to encounter have had their competence assessed in relation to the safe use of devices.

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Devices in Practice, MHRA, August 2008

8 The importance of reporting concerns about devices and adverse incidents

What is an adverse incident?

A device-related adverse incident is an event which can produce, or has the potential to produce, unwanted effects involving the safety of patients, users or other people. An adverse incident can arise from shortcomings in the device, its accessories, its operating instructions, user practice, servicing and maintenance and conditions of use. Sometimes the instructions for use or labelling are unclear. Sometimes patients and practitioners do not use a device in the way in which the manufacturer intended. Adverse incidents can also be the result of user error. It is important to report all device-related adverse incidents so that these can then be investigated thoroughly and action taken as appropriate to improve the device and protect other patients and/or users. Comprehensive guidance on reporting adverse incidents is contained in Device Bulletin DB2008/(01) Reporting Adverse Incidents and Disseminating Medical Device Alerts. This is published on the MHRA website and is updated annually. The preferred incident reporting route is via the online reporting system on the MHRA website: www.mhra.gov.uk Additionally advice on reporting may be obtained from the Adverse Incident Centre: Telephone: 020 7084 3080 Email: aic@mhra.gsi.gov.uk Medical device safety warnings and advice are issued through Medical Device Alerts from the Medicines and Healthcare products Regulatory Agency. You can subscribe to receive these via the website at: www.mhra.gov.uk

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Common types of medical device

This list is not comprehensive but gives a sense of the range of products that are medical devices

Devices used in the diagnosis or treatment of disease, or monitoring of patients, such as:
I I I I I I I I I I I I I I I I I I Anaesthetic machine Blood glucose measuring devices Chiropody and podiatry equipment CT scanner Dental instruments, equipment and materials Dressings Endoscopes Examination gloves Intravenous (IV) administration sets and pumps Nebulisers Ophthalmic equipment Pacemakers Peak flow meters Surgical instruments Suction equipment Syringes and needles Ultrasound dopplers Urinary catheters

Devices used in care, such as:

I Adjustable beds I Lifting poles I Patient hoists and other transfer equipment I Pressure relief equipment I Stoma care equipment

Equipment used by people with disabilities, such as:

I Bathing equipment I Commodes I Communication aids I External prostheses and orthoses I Hearing aids I Incontinence aids I Prescribable footwear I Standing frames I Telecare (environmental controls and alarms) I Urine drainage systems I Walking aids I Wheelchairs and special support seating

Devices used in life support, such as:

I I I I Defibrillators Patient monitors Pulse oximeters Ventilators

Devices supplied by pharmacists

I Condoms I Contact lens care products I Chlamydia test kits I Cholesterol test kits I Pregnancy test kits I Sphygmomanometers I Thermometers I Stoma equipment I Urine test strips

In vitro diagnostic medical devices and their accessories, such as:

I I I I Blood glucose measuring devices Cholesterol test kits Pregnancy test kits Urine test strips

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Checklist: Procuring medical devices

This checklist will help in making a decision about procuring the most appropriate device

The device
I What functions must the device perform?
Consider its fitness and suitability for purpose. If the device is being purchased for a specific individual, consider if his/her clinical or physical condition contraindicates its use

I Where can unbiased information on the range of available devices be obtained?

consult documents, e.g. Centre for Evidencebased Purchasing, Guidelines and Audit Implementation Network (GAIN), Disabled Living Foundation reports consult National Association of Equipment Providers, servicing contractors, hospital supplies departments, hospital specialists seek advice from colleagues, professional associations, experts in the field

I What similar devices do we already have?

Keep range of any type of device limited

I What is the evidence for the choice of this device?

Consider whether any research on effectiveness has been carried out

I How easy is the device to use and maintain?

Previous experience, feedback from users

Costs incurred
I What is the cost of the device and installation, if applicable? I What maintenance is required and what is the cost? I Are maintenance and servicing costs included in the price? I What are the purchase, lease and finance options? I Is servicing insurance cover available and at what cost? I What is the cost of consumables? I Does the device represent value for money? I What is the cost of disposal?

I What is the life expectancy of the device? I Does it have multifunctionality, i.e. can it replace several not just one device I Is a single-use or a multiple-use device most appropriate? I Has the device a CE marking?
See note below

I What accessories are necessary for the intended function of the device?
Consider whether they are easy to obtain and compatible with existing device

I Where is the device to be used?

Consider location, e.g. health centre, care home or users home

I Are infection control or decontamination processes required and are facilities available?
Consider whether any infection control or decontamination measures are needed
CE marking means that the device meets the relevant regulatory requirements, performs as intended, complies with the necessary requirement covering safety and performance and is acceptably safe. In general, a medical device cannot be marketed in Europe without carrying a CE marking. Custom-made devices and those under clinical investigation do not require CE marking.

Training requirements
I Are special clinical and technical training requirements necessary? I Are initial and updating training programmes provided by the manufacturer and have these been validated? I Does the end user/patient require training before the device is used?

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Checklist: Using devices safely

Use this checklist to ensure that you use medical devices safely

Before use: assessment

I What are the patients or clients clinical and social needs? I Which of the medical devices available best meets those needs? I Has a risk assessment been undertaken? Are the risks associated with this device acceptable and can they be minimised? I If the device has been bought privately is the patient or client aware of their personal responsibility? I If the medical device is to be used by patients and/or carers, have the following been taken into account: physical capabilities e.g. manual dexterity sensory capabilities e.g. vision, hearing ability to understand and remember previous experience with the medical device the patients or clients expectations the environment in which device will be used

I Do I know how this device should perform and the monitoring that needs to be done to check its performance? I Am I using the correct additional equipment, e.g. disposable infusion sets for an infusion pump? I Do I know how to recognise whether the device has failed? I Do I know what to do if the device fails? I Do I know how and to whom to report a device-related adverse incident? I Has the device been modified, if so, has liability been checked with the manufacturer? I In the case of devices purchased over the counter, have I advised the user to register with the manufacturer for ease of contact in case of urgent upgrades or recalls?

During use
I Does checking the medical device indicate it is functioning correctly and to the manufacturers specifications? I What action should be taken if the device is not functioning properly? I Has this been documented? I Is there up-to-date documentation to record regular checking of the device? I Have you documented the details (name and serial number) of the device being used? I Is the equipment still appropriate in the light of the patient or clients changing needs?

Before use: knowledge of device

I Is the device to be used in the way intended by the manufacturer? I What are the limitations and contra-indications for use? I Has the device been maintained in line with the manufacturers instructions? I Has the device been checked/calibrated after maintenance? I Is the device within its expiry or use-by date? I Who is able to carry out pre-use checks? I Are there any signs of wear, damage or faults? I Where can a replacement device be obtained?

After use
I What cleaning and/or decontamination is required? I Does the medical device show any signs of wear, damage or faults that should be reported? I Is any servicing, maintenance or repair required? I Were there any problems in using this device which should be noted and could be rectified for the future? E.g. was any information missing from the patient/carer guidance which would have been useful? I If used in the home, how will the medical device be returned to the owner, disposed of, or safely stored?

Ask yourself:
I Do I know how to set up and use this device? I Have I read the user instructions, and are they attached to the device [if this is possible]? I Have I been trained in its use? I How was my competency in relation to this device assessed?

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Devices in Practice, MHRA, August 2008

Checklist: Advising service users and carers

Use this checklist to make sure that service users and carers are fully aware of their responsibility for medical devices

I Has the service user or carer been trained in the use of the device? I Have they been given written guidance to support the use of the device and covers:
the name of the device the operation of the device and, where

fitted, accessories
their responsibility for checking the device

while in use the maintenance required and its frequency

recognition of device failure and fault action to be taken in the event of a device

failure or fault
their responsibility for reporting an untoward

event to the supplier of the equipment

telephone numbers of contact points in an

emergency, including out of hours

their responsibilities if they have bought the

device themselves

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Checklist: Record keeping

Use this checklist to ensure your record keeping is adequate

Ensure that your records provide evidence of: I a unique identification of the device, and its location where appropriate I an appropriate history of the lifecycle of the device, including date of purchase and installation I meeting any legal requirements concerning the use of the device
I I

proper installation routine maintenance

Your records should show that the end user: I knows how to use the device safely I can carry out day-to-day checks and routine maintenance I has been trained and had relevant refresher training

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Devices in Practice, MHRA, August 2008

Checklist: Maintenance and repair

Use this checklist to ensure that your maintenance and repair systems are appropriate

I Routine maintenance will include:

regular cleaning of the device

preparation of the device for use checking and calibrating the device before and during periods of use I Procedures for routine maintenance should ensure that: instructions are documented and available the user knows the decontamination process for the device after use devices are stored safely in accordance with the manufacturers instructions I Planned preventative maintenance: should follow the device manufacturers guidance is usually done by the manufacturer, supplier or agent may be done by third party repairers, provided the work of the sub-contractor is of a sufficiently high standard, is audited and reviewed regularly
Collection, storage, cleaning and decontamination of devices have safety implications not only for patients and users, but also for servicing and maintenance personnel.

I Procedures for planned preventative maintenance should ensure that:

there is a contract which sets out

responsibilities and repair and maintenance requirements there is evidence to show that the service organisation is competent to maintain the device to the manufacturer's specification any changes to the manufacturers maintenance recommendations have been agreed and documented following maintenance or servicing, the device is checked for safe function before it is used there is a planned replacement policy times for preventative maintenance on individual devices are brought to users attention regularly and automatically there is a system to display the date of the last and the next service, if this is appropriate I Back-up equipment should be available if the device is defective or requires servicing or maintenance

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Devices in Practice, MHRA, August 2008

Checklist: Content of training programmes

Use this checklist to ensure that the key issues have been covered when receiving or developing training programmes

Programmes addressing general principles concerning medical devices should include: I relevant regulations I the purpose intended by the manufacturer I performance specifications I frequency of maintenance and servicing I checks required following maintenance and servicing I importance of complying with the manufacturers instructions for use I setting up a device I pre-use checks I monitoring and checking during use I procedures (including local procedures) for reporting an adverse incident I importance of cleaning and decontamination I the importance of consulting the manufacturer in the exceptional event of considering using or processing the medical device in any way not covered by the manufacturer's instructions I the importance of removing devices from use at the end of their lifecycle I the importance of disposing of devices appropriately

Programmes addressing the use of specific devices should include: I purpose of the device I principles of how it operates I device specifications I setting up the device I safety features and the rationale for them I reliance to be placed on the device I reliance to be placed on results obtained from the device I reliance to be placed on the safety features of the device I importance of double checking by observing the patient and device I use of any relevant alarms I difficulties in the use of the specific device and any likely causes of failure I monitoring and checking of device I recognising when the device has failed I common faults in the use of the device I importance of the user consulting the manufacturers instructions I cleaning and decontamination I assessing competence in the safe use of the device

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Devices in Practice, MHRA, August 2008

Checklist: If an incident occurs, what should I do?

I Check and take steps necessary for the wellbeing of the patient I Take device(s) involved out of action, together with other material evidence, e.g. packaging if available. Label the affected device. If this is not possible the state of the device at the time of incident should be recorded I Record:
date and time of the incident device settings if relevant details of incident (how it happened and any

I Report incident to relevant manager and to the incident centre in your country or listed below England and Wales report to: Adverse Incident Centre Medicines and Healthcare products Regulatory Agency Market Towers 1 Nine Elms Lane London, SW8 5NQ Tel: 020 7084 3080 Fax: 020 7084 3109 E-mail: aic@mhra.gsi.gov.uk Report online: www.mhra.gov.uk Northern Ireland Northern Ireland Adverse Incident Centre (NIAIC) Room A7 Health Estates Estate Policy Directorate Stoney Road Dundonald Belfast, BT16 1US Tel: 02890 523714 Fax: 02890 523900 E-mail: niaic@dhsspsni.gov.uk Web: www.dhsspsni.gov.uk Scotland Incident Reporting and Investigation Centre (IRIC) Health Facilities Scotland NHS National Services Scotland Gyle Square 1 South Gyle Crescent Edinburgh, EH12 9EB Tel: 0131 275 7575 Fax: 0131 314 0722 E-mail iric@shs.csa.scot.nhs.uk Web: www.shs.scot.nhs.uk

outcomes for the person affected) details of device affected and any others (type, make, model and serial numbers) details of any error message or failures

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Devices in Practice, MHRA, August 2008

Safeguarding public health

Devices in Practice: A guide for professionals in health and social care Medicines and Healthcare products Regulatory Agency August 2008 Chlorine free paper

First published August 2008 This publication is available at www.mhra.gov.uk