03 Devices in Practice

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evicesin ractice

a guide for

professionalsin health andsocial care

Safeguarding public health


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Crown copyright 2008A fully revised edition of Devices in Practice,

published 2001 and prepared by anExpert Working Group


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a guide for

professionalsin health andsocial care

Medicines and Healthcare

products Regulatory Agency

Devices in Practice:


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1 Introduction 3

2 What is a medical device? 4Common types of medical device

3 Procuring medical devices 5

Checklist: Procuring medical devicesThe device

Costs incurred

Training requirements

4 Using medical devices safely 6

Checklist: Using devices safely

Before use: assessment

Before use: knowledge of device

Ask yourself

During useAfter use

Checklist: Advising service users and carers

5 Record keeping 7

Checklist: Record keeping

6 Maintenance and repair 8

Checklist: Maintenance and repair

7 Training health and social 9care professionalsChecklist: Content of training programmes

8 The importance of reporting 10concerns about devices and

adverse incidentsWhat is an adverse incident?

Checklist: If an incident occurs, what

should I do?

Contents


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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 whichprovides 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 workingin 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 useand management of medical devices

pharmacists in acute, primary care and socialcare settings

voluntary and charitable organisations whoprovide 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 useof 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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1 Introduction

Devices in Practice, MHRA, August 2008

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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 andtreatment of disease or disability

diagnosis, monitoring, treatment, alleviation

of or compensation for an injury or handicap

investigation, replacement or modification ofthe 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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2 What is a medical device?


Go to list


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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:

what equipment and accessories need to beprovided and why

the range of particular devices available tocover requirements

purchasing arrangements for bringing in newtypes of devices

suitability for being sold or supplied by theNHS 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 intendedlifecycle

compatibility with accessories and otherdevices 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 thatwill be much better).

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.

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3 Procuring medical devices


Go to Checklist


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An individual healthcare professional who uses thedevice in a way not intended, or against manufacturersinstructions may be liable for any consequences.

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Professionals in health and social care use

medical devices themselves and also providedevices which are then used by others, such asservice users or carers. Professionals in healthand social care are personally accountable fortheir use of devices and therefore must ensurethat they have appropriate training. They are alsopersonally accountable for ensuring service usersand carers have received appropriate training andknow how to use the device that has beenprovided.

4 Using medical devices safely


Go to Checklist

Go to Checklist

Service users and carers

Health and social care professionals will oftenprovide medical devices to be used by serviceusers and carers. It is important to make surethat service users and carers have adequateinformation about the use of the device. Healthand social care professionals are personallyaccountable for ensuring that service users andcarers have appropriate training in the use andmaintenance of the device provided.

Individuals who buy a device over the counter orprivately need to be made aware of their

personal responsibility to ensure the device isappropriately used and maintained.


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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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5 Record keeping


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Routine maintenance and planned preventative

maintenance should make sure that yourequipment will work safely when you need to useit, and should keep it operating safely throughoutits working life. Lack of maintenance could leadto premature failure of the device in use.

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6 Maintenance and repair


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All practices and organisations in the public,

independent and voluntary sectors must provideadequate arrangements for training in the safeuse of medical devices. This also includesagencies providing staff to the care sector.Employers are responsible for ensuring that staffwho use medical devices have appropriate training.Equally, all healthcare professionals and supportworkers have a personal responsibility andaccountability to ensure that they are trained in thesafe use of the medical devices they need to use.

Assessment of training needs

An assessment of training needs should be under-taken for individual staff and should address bothclinical and technical matters. Training should

then be planned to meet the identified needs.This should include whether individual staff:

understand the principles underlying the useof devices

are familiar with the practical aspects of thedevices they are likely to encounter

have had their competence assessed inrelation to the safe use of devices.

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7 Training health and social care

professionals


Go to Checklist


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What is an adverse incident?

A device-related adverse incident is an eventwhich can produce, or has the potential toproduce, unwanted effects involving the safetyof patients, users or other people. An adverseincident can arise from shortcomings in thedevice, its accessories, its operating instructions,user practice, servicing and maintenance and

conditions of use. Sometimes the instructions foruse or labelling are unclear. Sometimes patients

and practitioners do not use a device in the wayin which the manufacturer intended. Adverseincidents can also be the result of user error.

It is important to report all device-related adverseincidents so that these can then be investigatedthoroughly and action taken as appropriate toimprove the device and protect other patients

and/or users. Comprehensive guidance onreporting adverse incidents is contained in

Device Bulletin DB2008/(01) Reporting AdverseIncidents and Disseminating Medical Device

Alerts. This is published on the MHRA websiteand 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 beobtained from the Adverse Incident Centre:

Telephone: 020 7084 3080

Email: [email protected]

Medical device safety warnings and advice areissued through Medical Device Alerts from theMedicines and Healthcare products RegulatoryAgency. You can subscribe to receive these viathe website at: www.mhra.gov.uk

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8 The importance of reporting concerns

about devices and adverse incidents


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Devices used in the diagnosis ortreatment of disease, or monitoringof patients, such as:

I Anaesthetic machine

I Blood glucose measuring devices

I Chiropody and podiatry equipment

I CT scanner

I Dental instruments, equipment and materials

I Dressings

I Endoscopes

I Examination gloves

I Intravenous (IV) administration sets and pumps

I Nebulisers

I Ophthalmic equipment

I Pacemakers

I Peak flow metersI Surgical instruments

I Suction equipment

I Syringes and needles

I Ultrasound dopplers

I Urinary catheters

Devices used in life support, such as:

I

DefibrillatorsI Patient monitors

I Pulse oximeters

I Ventilators

In vitrodiagnostic medical devicesand their accessories, such as:

I Blood glucose measuring devices

I Cholesterol test kits

I Pregnancy test kits

I Urine test strips

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 withdisabilities, 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 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

Common types of medical deviceThis list is not comprehensive but gives a sense of the range of products

that are medical devices


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Checklist: Procuring medical devicesThis checklist will help in making a decision about procuring the most appropriate device

CE marking means that the device meets the relevantregulatory requirements, performs as intended,

complies with the necessary requirement covering safety andperformance and is acceptably safe. In general, a medicaldevice cannot be marketed in Europe without carrying a CEmarking. Custom-made devices and those under clinicalinvestigation do not require CE marking.

2 Devices in Practice, MHRA, August 2008

The device

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

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 thisdevice?Consider whether any research on effectivenesshas been carried out

I How easy is the device to use and maintain?Previous experience, feedback from users

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 mostappropriate?

I Has the device a CE marking?See note below

I What accessories are necessary for theintended function of the device?Consider whether they are easy to obtain andcompatible with existing device

I Where is the device to be used?Consider location, e.g. health centre, care home orusers home

I Are infection control or decontaminationprocesses required and are facilities available?Consider whether any infection control ordecontamination measures are needed

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

consult documents, e.g. Centre for Evidence-based Purchasing, Guidelines and AuditImplementation Network (GAIN), Disabled Living

Foundation reports

consult National Association of Equipment

Providers, servicing contractors, hospital suppliesdepartments, hospital specialists

seek advice from colleagues, professionalassociations, experts in the field

Costs incurred

I What is the cost of the device andinstallation, 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 financeoptions?

I Is servicing insurance cover available and atwhat cost?

I What is the cost of consumables?

I Does the device represent value for money?

I What is the cost of disposal?

Training requirements

I Are special clinical and technical trainingrequirements necessary?

I Are initial and updating training programmesprovided by the manufacturer and have thesebeen validated?

I Does the end user/patient require trainingbefore the device is used?



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Checklist: Using devices safelyUse this checklist to ensure that you use medical devices safely

Before use: assessment

I What are the patients or clients clinical andsocial needs?

I Which of the medical devices available bestmeets those needs?

I Has a risk assessment been undertaken? Arethe risks associated with this deviceacceptable and can they be minimised?

I If the device has been bought privately is thepatient or client aware of their personalresponsibility?

I If the medical device is to be used by patients

and/or carers, have the following been takeninto 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

Before use: knowledge of device

I Is the device to be used in the way intendedby the manufacturer?

I What are the limitations and contra-indicationsfor use?

I Has the device been maintained in line withthe manufacturers instructions?

I Has the device been checked/calibrated aftermaintenance?

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?

Ask yourself:

I Do I know how to set up and use this device?

I Have I read the user instructions, and are theyattached to the device [if this is possible]?

IHave I been trained in its use?

I How was my competency in relation to thisdevice assessed?

I Do I know how this device should performand the monitoring that needs to be done tocheck 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 thedevice has failed?

I Do I know what to do if the device fails?

I Do I know how and to whom to report adevice-related adverse incident?

I Has the device been modified, if so, hasliability been checked with the manufacturer?

IIn the case of devices purchased over thecounter, have I advised the user to register withthe manufacturer for ease of contact in case ofurgent upgrades or recalls?

During use

I Does checking the medical device indicate itis functioning correctly and to themanufacturers 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 recordregular checking of the device?

I Have you documented the details (name andserial number) of the device being used?

I Is the equipment still appropriate in the light ofthe patient or clients changing needs?

After use

I What cleaning and/or decontamination isrequired?

I Does the medical device show any signs ofwear, damage or faults that should be reported?

I Is any servicing, maintenance or repairrequired?

I Were there any problems in using this devicewhich should be noted and could be rectifiedfor the future? E.g. was any information

missing from the patient/carer guidance whichwould have been useful?

I If used in the home, how will the medicaldevice be returned to the owner, disposed of,or safely stored?




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I Has the service user or carer been trained inthe 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

Checklist:Advising service users and carersUse this checklist to make sure that service users and carers are fully aware of their

responsibility for medical devices


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Checklist: Record keepingUse 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 proper installation

I 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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Checklist: Maintenance and repairUse 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 manufacturersguidance

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

I Procedures for planned preventative

maintenance should ensure that:

there is a contract which sets outresponsibilities 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 usersattention 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

Collection, storage, cleaning and decontamination ofdevices have safety implications not only for patientsand users, but also for servicing and maintenancepersonnel.




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Checklist: Content of training programmesUse 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

Ichecks required following maintenance andservicing

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 incidentI 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

devicesshould include:

I purpose of the device

I principles of how it operates

I device specifications

I setting up the device

Isafety 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

Iuse 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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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

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

I Report incident to relevant manager and to

the incident centre in your country or listed

below

England and Wales report to:Adverse Incident CentreMedicines and Healthcare productsRegulatory AgencyMarket Towers1 Nine Elms LaneLondon, SW8 5NQTel: 020 7084 3080Fax: 020 7084 3109E-mail: [email protected]

Report online: www.mhra.gov.uk

Northern Ireland

Northern Ireland Adverse Incident Centre(NIAIC)Room A7Health EstatesEstate Policy DirectorateStoney RoadDundonaldBelfast, BT16 1US

Tel: 02890 523714Fax: 02890 523900E-mail: [email protected]: www.dhsspsni.gov.uk

Scotland

Incident Reporting and Investigation Centre(IRIC)

Health Facilities ScotlandNHS National Services ScotlandGyle Square1 South Gyle CrescentEdinburgh, EH12 9EBTel: 0131 275 7575

Fax: 0131 314 0722E-mail [email protected]: www.shs.scot.nhs.uk

Checklist: If an incident occurs, what should

I do?




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Safeguarding public health

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

Medicines and Healthcare products Regulatory AgencyAugust 2008Chlorine free paper

First published August 2008

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03 Devices in Practice

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