evices in ractice - dental law & ethics · evices in ractice a guide for professionals in...

evicesin ractice

a guide forprofessionalsin health andsocial care

Safeguarding public health

a guide forprofessionalsin health andsocial care

Medicines and Healthcareproducts Regulatory Agency

Devices in Practice:

1 Introduction 3

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

3 Procuring medical devices 5Checklist: Procuring medical devices

The deviceCosts incurredTraining requirements

4 Using medical devices safely 6Checklist: Using devices safely

Before use: assessmentBefore use: knowledge of deviceAsk yourselfDuring useAfter use

Checklist: Advising service users and carers

5 Record keeping 7Checklist: Record keeping

6 Maintenance and repair 8Checklist: Maintenance and repair

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

8 The importance of reporting 10concerns about devices andadverse incidentsWhat is an adverse incident?

Checklist: If an incident occurs, whatshould I do?

Contents

Medical devices play a crucial role in careand treatment. The number and variety ofmedical devices is vast and professionalshandle a wide range of devices every day intheir practice. As the Agency responsible formaking sure that medical devices are safeand fit for purpose, the Medicines andHealthcare products Regulatory Agency(MHRA) has prepared this booklet whichprovides a practical guide to medical devicesfor all health and social care professionals,and pharmacists working in acute, primarycare, 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), carehomes, care homes with nursing and privatehealthcare systems

• health and social care organisations as theydevelop 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 healthand social care organisations.

It contains a series of practical checklists to helpensure informed procurement and the safe useof medical devices.

Some individuals buy their own medical devicesprivately through pharmacies or other sourcesand, increasingly, on the Internet. In thesecircumstances it is the responsibility of the ownerto ensure that the medical devices areappropriately used, maintained and ultimatelydisposed of.

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1 Introduction

Devices in Practice, MHRA, August 2008

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The term ‘medical device’ covers a wide rangeof healthcare products other than medicinesused 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, alleviationof 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 thedefinition of medical device is provided opposite.

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2 What is a medical device?


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A policy for procuring medical devices should beestablished in consultation with the professionalswho will be prescribing or supplying them andalso with those who will be using the devices.The following factors should be considered indeveloping 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 publicwithout a professional involved in thehandover, for example if supplied by amanufacturer 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 maintenancerequirements and end of lifecyclereplacement/disposal timescales andprocedures

• total cost covering the device’s 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. issomething going to be available shortly thatwill be much better).

If medical devices are purchased from theInternet, care should be taken to purchase onlyfrom recognised sites and purchasers shouldcheck that equipment has been subject toregulatory assessment.

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3 Procuring medical devices


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

6

Professionals in health and social care usemedical 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 carersHealth 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 theirpersonal responsibility to ensure the device isappropriately used and maintained.

Good records are important in effective devicemanagement. Records should provide evidenceof what the device is and where it came from, itsserial or batch number, the maintenance recordof the device and any training carried out on howto use it properly.

Paper-based systems can be used if you haveonly a few devices; a computer-based systemmay be better if you have a number of devices.

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5 Record keeping


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Routine maintenance and planned preventativemaintenance 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 shouldthen 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 careprofessionals


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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 andconditions of use. Sometimes the instructions foruse or labelling are unclear. Sometimes patientsand 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 patientsand/or users. Comprehensive guidance onreporting adverse incidents is contained inDevice Bulletin DB2008/(01) Reporting AdverseIncidents and Disseminating Medical DeviceAlerts. This is published on the MHRA websiteand is updated annually.

The preferred incident reporting route is viathe online reporting system on the MHRAwebsite: www.mhra.gov.uk

Additionally advice on reporting may beobtained from the Adverse Incident Centre:Telephone: 020 7084 3080020 3080 7080Email: [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 concernsabout devices and adverse incidents


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

� 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 life support, such as:

� Defibrillators

� Patient monitors

� Pulse oximeters

� Ventilators

In vitro diagnostic medical devicesand their accessories, such as:

� Blood glucose measuring devices

� Cholesterol test kits

� Pregnancy test kits

� Urine test strips

Devices used in care, such as:

� Adjustable beds

� Lifting poles

� Patient hoists and other transfer equipment

� Pressure relief equipment

� Stoma care equipment

Equipment used by people withdisabilities, such as:

� Bathing equipment

� Commodes

� Communication aids

� External prostheses and orthoses

� Hearing aids

� Incontinence aids

� Prescribable footwear

� Standing frames

� Telecare (environmental controls and alarms)

� Urine drainage systems

� Walking aids

� Wheelchairs and special support seating

Devices supplied by pharmacists

� Condoms

� Contact lens care products

� Chlamydia test kits

� Cholesterol test kits

� Pregnancy test kits

� Sphygmomanometers

� Thermometers

� Stoma equipment

� Urine test strips

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

12 Devices in Practice, MHRA, August 2008

The device

�� 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

�� What similar devices do we already have?Keep range of any type of device limited

�� What is the evidence for the choice of this device?Consider whether any research on effectiveness has been carried out

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

�� What is the life expectancy of the device?

�� Does it have multifunctionality, i.e. can it replace several not just one device

�� Is a single-use or a multiple-use device most appropriate?

�� Has the device a CE marking?See note below

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

�� Where is the device to be used?Consider location, e.g. health centre, care home or user’s home

�� Are infection control or decontamination processes required and are facilities available?Consider whether any infection control or decontamination measures are needed

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

• consult documents, e.g. Centre for Evidence-based 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

Costs incurred

�� What is the cost of the device and installation, if applicable?

�� What maintenance is required and what is thecost?

�� Are maintenance and servicing costs included in the price?

�� What are the purchase, lease and finance options?

�� Is servicing insurance cover available and at what cost?

�� What is the cost of consumables?

�� Does the device represent value for money?

�� What is the cost of disposal?

Training requirements

�� Are special clinical and technical training requirements necessary?

�� Are initial and updating training programmes provided by the manufacturer and have these been validated?

�� Does the end user/patient require training before 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

�� What are the patient’s or client’s clinical andsocial needs?

�� Which of the medical devices available bestmeets those needs?

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

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

�� If the medical device is to be used by patientsand/or carers, have the following been takeninto account:• physical capabilities – e.g. manual dexterity• sensory capabilities – e.g. vision, hearingability to understand and remember

• previous experience with the medical device• the patient’s or client’s expectations• the environment in which device will be used

Before use: knowledge of device

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

�� What are the limitations and contra-indicationsfor use?

�� Has the device been maintained in line withthe manufacturer’s instructions?

�� Has the device been checked/calibrated aftermaintenance?

�� Is the device within its expiry or use-by date?

�� Who is able to carry out pre-use checks?

�� Are there any signs of wear, damage or faults?

�� Where can a replacement device be obtained?

Ask yourself:

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

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

�� Have I been trained in its use?

�� How was my competency in relation to this device assessed?

�� Do I know how this device should perform and the monitoring that needs to be done to check its performance?

�� Am I using the correct additional equipment, e.g.disposable infusion sets for an infusion pump?

�� Do I know how to recognise whether the device has failed?

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

�� Do I know how and to whom to report a device-related adverse incident?

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

�� In 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

�� Does checking the medical device indicate itis functioning correctly and to themanufacturer’s specifications?

�� What action should be taken if the device isnot functioning properly?

�� Has this been documented?

�� Is there up-to-date documentation to recordregular checking of the device?

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

�� Is the equipment still appropriate in the light ofthe patient or client’s changing needs?

After use�� What cleaning and/or decontamination is

required?

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

�� Is any servicing, maintenance or repairrequired?

�� Were there any problems in using this devicewhich should be noted and could be rectifiedfor the future? E.g. was any informationmissing from the patient/carer guidance whichwould have been useful?

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



�� Has the service user or carer been trained inthe use of the device?

�� Have they been given written guidance tosupport 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 untowardevent 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 theirresponsibility 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:

�� a unique identification of the device, and itslocation where appropriate

�� an appropriate history of the lifecycle of thedevice, including date of purchase andinstallation

�� meeting any legal requirements concerning theuse of the device

�� proper installation

�� routine maintenance

Your records should show that the end user:

�� knows how to use the device safely

�� can carry out day-to-day checks and routinemaintenance

�� has been trained and had relevant refreshertraining



Checklist: Maintenance and repairUse this checklist to ensure that your maintenance and repair systems are appropriate

�� 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

�� Procedures for routine maintenance shouldensure that:

• instructions are documented and available

• the user knows the decontamination process for the device after use

• devices are stored safely in accordance withthe manufacturer’s instructions

�� Planned preventative maintenance:

• should follow the device manufacturer’s guidance

• is usually done by the manufacturer, supplieror agent

• may be done by third party repairers, provided the work of the sub-contractor is ofa sufficiently high standard, is audited and reviewed regularly

�� 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 manufacturer’s 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

�� Back-up equipment should be available if thedevice is defective or requires servicing ormaintenance

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



Checklist: Content of training programmesUse this checklist to ensure that the key issues have been covered when receiving ordeveloping training programmes

Programmes addressing general principlesconcerning medical devices should include:

�� relevant regulations

�� the purpose intended by the manufacturer

�� performance specifications

�� frequency of maintenance and servicing

�� checks required following maintenance andservicing

�� importance of complying with themanufacturer’s instructions for use

�� setting up a device

�� pre-use checks

�� monitoring and checking during use

�� procedures (including local procedures) forreporting an adverse incident

�� importance of cleaning and decontamination

�� the importance of consulting the manufacturerin the exceptional event of considering usingor processing the medical device in any waynot covered by the manufacturer's instructions

�� the importance of removing devices from useat the end of their lifecycle

�� the importance of disposing of devicesappropriately

Programmes addressing the use of specificdevices should include:

�� purpose of the device

�� principles of how it operates

�� device specifications

�� setting up the device

�� safety features and the rationale for them

�� reliance to be placed on the device

�� reliance to be placed on results obtained fromthe device

�� reliance to be placed on the safety features ofthe device

�� importance of ‘double checking’ by observingthe patient and device

�� use of any relevant alarms

�� difficulties in the use of the specific deviceand any likely causes of failure

�� monitoring and checking of device

�� recognising when the device has failed

�� common faults in the use of the device

�� importance of the user consulting themanufacturer’s instructions

�� cleaning and decontamination

�� assessing competence in the safe use of thedevice



�� Check and take steps necessary for thewellbeing of the patient

�� Take device(s) involved out of action, togetherwith other material evidence, e.g. packaging ifavailable. Label the affected device. If this isnot possible the state of the device at the timeof incident should be recorded

�� Record:

• date and time of the incident• device settings if relevant• details of incident (how it happened and anyoutcomes for the person affected)

• details of device affected and any others (type, make, model and serial numbers)• details of any error message or failures

�� 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 products Regulatory AgencyMarket Towers151 Buckingham Palace Road1 Nine Elms LaneLondonLondon, SW8 5NQSW1W 9SZTel: 020 7084 3080Tel: 020 3080 7080Fax: 020 7084 3109Fax: 020 3118 9814E-mail: [email protected] online: www.mhra.gov.uk

Northern IrelandNorthern Ireland Adverse Incident Centre (NIAIC)Room A7Health EstatesEstate Policy DirectorateStoney RoadDundonaldBelfast, BT16 1USTel: 02890 523714Fax: 02890 523900E-mail: [email protected] Web: www.dhsspsni.gov.uk

ScotlandIncident Reporting and Investigation Centre (IRIC)Health Facilities ScotlandNHS National Services ScotlandGyle Square 1 South Gyle CrescentEdinburgh, EH12 9EBTel: 0131 275 7575Fax: 0131 314 0722E-mail [email protected]: www.shs.scot.nhs.uk

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



Safeguarding public health

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

© Medicines and Healthcare products Regulatory AgencyAugust 20082011 website version. First published 2001, revised 2008Chlorine free paper

First published August 2008

This publication is available atwww.mhra.gov.uk

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