Medical Devices Equipment

Medical Devices/Equipment Management
Policy
(Incorporating the Medical Devices
Management Standard)
Document OQR030 Document Quality Function,

reference developed by Office of Quality and
number Risk
Revision 01 Document Senior Management
number approved by Team
Approval 03.11.09 Responsibility All Health sector
date for employees
implementation
Revision date 03.11.10 Responsibility Office of Quality and
for review and Risk
audit
Table of Contents
1.0 Introduction 3
2.0 Policy Statement 4
3.0 Links with other HSE Policies 5
4.0 Purpose 5
5.0 Scope 6
6.0 Definition of a medical device 6
7.0 Policy Objectives 6
8.0 Roles & Responsibilities 7
8.1 The HSE Board 7
8.2 The Risk Committee 7
8.3 CEO 7
8.4 National Directors 7
8.5 Regional Directors of Operations 8
8.6 Hospital Managers/Local Health Managers 8
8.7 All employees 8
8.8 Medical Devices/Equipment Management Committee 9
8.9 Clinical Engineering Lead 9
9.0 Procedural Guidance 10
10.0 Policy Implementation 10
11.0 Evaluation & Audit 10
12.0 Record Keeping 10
13.0 Policy Review 11
14.0 References 11
15.0 Appendices 14
Appendix I Common Categories of medical device 14
Appendix II Statutory Requirements 16
Appendix III HSE Medical Devices & Equipment Standard 22
Appendix IV Members of the Working Group 27
Appendix V Groups who contributed to the consultation process 29
Medical Devices/Equipment Management Policy. Document reference no. OQR030. Revision no. 01.
Approval date 03.11.09
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1.0 INTRODUCTION
An increasing number of medical devices are being used to support the delivery of care
in both Hospital and Primary Care settings. The availability of such devices assists
greatly in the ability of healthcare organizations to effectively monitor, treat and support
the care of service users in the management of their medical conditions. It also allows
for the management of care in a community setting and facilitates self care for patients
in many instances.
The World Health Organisation (WHO) has recognized the importance of having in place
appropriate policies that address all elements related to medical devices which are
supported by a system of compliance monitoring. The Commission on Patient Safety and
Quality Assurance stressed the importance of adopting standards and guidelines as a key
element of effective governance. In the UK it has been identified that 400 people die or
are seriously injured in adverse events involving medical devices each year. Whilst
comparable figures are not available in Ireland, as part of the HSE’s approach to clinical
governance it is critical to ensure that there are systems in place to confirm that medical
devices are managed in a way which complies with the requirements of regulation and
best practice.
Various professions within the health services have direct contact with medical
devices/equipment, such as the Physiotherapist, Occupational Therapist, Medical
Physicists, Lab Scientist, Nurse, Biomedical/Clinical Engineering, Pharmacist, Doctor etc.;
each having varying degrees of responsibility in the care of medical devices/equipment.
It is acknowledged that various professions deal directly with the day to day use and
quality assurance of their particular equipment such as Lab scientists performing quality
assurance for Lab equipment, Occupational Therapists prescribing equipment, Medical
Physics performing quality assurance for ionisation equipment, Physiotherapists
prescribing physiotherapy equipment, nurses and doctors performing user checks etc.
With respect to the management of medical devices/equipment it is acknowledged that
this is the core function of the Biomedical/Clinical Engineering profession.
This policy has been developed by the HSE to ensure compliance with requirements of
legislation and guidance from the European Union (EU), the Health Information and
Quality Authority (HIQA) the Irish Medicines Board, the Health and Safety Authority
(HSA), the National Standards Authority of Ireland (NSAI) and the Electro-Technical
Council of Ireland (ETCI), including the Technical Committee 10 (TC10) of ETCI in
matters related to the management of medical devices / equipment.
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2.0 POLICY STATEMENT
It is the policy of this organisation (HSE) to ensure that a formal system to manage
medical devices is established in the HSE. The HSE is committed to ensuring that
uniform policy, standards and procedural guidance are implemented to support the
development of a system which assures a designated coordinated approach for the
management of Medical Devices / Equipment throughout the organisation. This is
essential to ensure patient safety through clinical and social care governance, risk
management and quality assurance of Medical Devices/Equipment and in achieving Value
For Money (VFM) by way of effective use of resources.
The overall objective of this policy is to provide an organisation wide framework for the
management of Medical Devices/Equipment and that the highest standards of device
safety, risk management and financial efficiency are realised in the management of the
device. The policy aims to minimize related hazards, to ensure that employees are
properly trained and competent in the use of Medical Devices/Equipment, that devices
are maintained in a safe and reliable condition, are quality assured and subjected to
asset management that is inclusive of device history and tracking.
The policy promotes the use of a standards based approach which will instill a safer,
more efficient, and high quality management of all medical devices/equipment. Good
management will involve all aspects of the lifecycle of medical devices/equipment to
include:
Case of Need
Affordability
Case of Need Approval
Prescription/Specification
Trials
Selection
Commissioning and Installation
User Training
Maintenance
Malfunction
Capital Development Projects and Minor Capital
Gifts and Donations
Alert Management
Infection Prevention and Control
Decontamination and Cleaning
Disposal
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3.0 LINKS WITH OTHER HSE POLICIES
Integrated Risk Management Policy

Incident Management Policy and Procedure
Serious Incident Management Policy and Procedure
Corporate Safety Statement
Waste Management Policy
Manual Handling Policy
Procurement Policy
Point of Care Testing
Infection Control Policies
Major Emergency Plan & Policies
IT Security Policy
Decontamination Policy
National Financial Regulations
The policy and management standard should be read in conjunction with the following:
HSE’s Quality and Risk Management Standard

HSE’s Quality, Safety and Risk Management Framework and Companion
Guide
HSE’s Medical Device/Equipment Procedural Guidance
National Standards for the Prevention and Control of Healthcare

Associated Infections (HIQA)
There are also national and international statutory requirements which must be adhered
to regarding Medical Devices and Equipment (see Appendix II). The policy must also be
implemented with regard to the Health Act 2004 in that implementation must be “within
the limits of resources available”.
4.0 PURPOSE
The purpose of this document is to set out the HSE’s Policy in relation to the
management of medical devices/equipment within its services and within agencies
funded by the HSE and to ensure that medical devices/equipment are managed in a way
which complies with the requirements of regulation and best practice.
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5.0 SCOPE
This policy applies to all HSE services and services funded by the HSE. It also applies to
companies who are contracted by the HSE to provide services in relation to any aspect of
the management of medical devices.
6.0 DEFINITION OF A MEDICAL DEVICE
This refers to any instrument, apparatus, appliance, software, material or other article,
whether used alone or in combination, together with any accessories, including the
software intended by its manufacturer to be used specifically for diagnostic and/or
therapeutic purposes and necessary for its proper application, intended by the
manufacturer to be used for human beings for the purpose of:
— Diagnosis, prevention, monitoring, treatment or alleviation of disease,
— 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
and which does not achieve its principal intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its
function by such means.
(EU definition)
This definition includes devices intended to administer a medicinal product, such as a
syringe driver, or which incorporate a substance defined as a medicinal product, such as
a drug-eluting stent.
A list of some of the products covered by the definition of medical device and prepared
by the Irish Medicines Board is attached (See Appendix I).
7.0 POLICY OBJECTIVES
To minimize the risk of harm, to service users and employees, associated

with the acquisition, use, and ongoing support of Medical
Devices/Equipment
To clearly define and designate the roles and responsibilities for the
management of Medical Devices/Equipment within the HSE.
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To ensure that the HSE complies with all relevant legislative Standards,
Recommendations and Vigilance Systems of the Competent Authority i.e.
the Irish Medicines Board
To set out a statement of standard and supporting criteria based on a

model of internal control for use in managing medical devices/equipment
within the HSE.
8.0 ROLES AND RESPONSIBILITIES
8.1 The HSE Board
The HSE Board will receive and consider the Reports of the Risk Committee and
will hold responsibility for Medical Devices/Equipment Management.
8.2 The Risk Committee
The Risk Committee oversees all risks within the HSE and will incorporate any
issues relating to medical devices/equipment management in its reports to the
Board.
8.3 CEO
The implementation of the Medical Devices/Equipment Policy and management

standard is the responsibility of the CEO and the management team. The CEO can
delegate day-to-day operational management of Medical Devices/Equipment to
the relevant National Director to ensure a national co-ordinated organisation wide
approach.
8.4 National Directors
National Directors are responsible for ensuring that throughout their directorate
that:
Accountability for the management of medical devices/equipment

has been defined and a clear line of accountability has been
described to include roles and responsibilities.
Providing the necessary assurances that the systems, processes

and resources necessary to manage medical devices are in place,
subject to total resources available.
Page 7 of 30
Seek evidence through audit of compliance with this policy and
standard and any relevant legislation and regulation.
8.5 Regional Directors of Operations
Each Regional Director of Operations has overall responsibility to:
Provide assurance to the National Operations Director in relation to

the system for medical device/equipment management. This
assurance will be provided through an audit of compliance with this
policy and standard and any relevant legislation and regulation.
Establish and support an integrated Regional Medical Devices

/Equipment Management Committee (MDEMC).
Designation of sub-regional areas for the integrated management

of medical devices/equipment.
Ensure the establishment of sub-regional Medical

Devices/Equipment Management Committees in the region.
Designate Biomedical/Clinical Engineering leads with delegated

responsibility for the integrated management of medical
devices/equipment within each sub-region.
8.6 Hospital Managers/Local Health Managers
These persons will be responsible for ensuring that there are systems and
processes in place for the local management of Medical Devices / Equipment
within their area of responsibility. This will include supporting the establishment
and operation of a sub-regional Medical Devices/Equipment Management
Committee.
8.7 All Employees
It is the responsibility of each individual employee to ensure that they are

conversant with the content of this policy and are appropriately trained and
competent to use the medical devices which they are required to use as part of
their duties.
All employees have a responsibility with regard to incident reporting and should
follow the Incident Reporting Policy and Procedure in respect of incidents
involving medical devices.
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Under Health and Safety regulations employees must also take reasonable care
for their own health and safety and also of other people who may be affected by
their acts or omissions.
They should report any problem relating to use, maintenance, servicing or

decontamination as contained in this policy to their line manager.
8.8 Medical Devices/Equipment Management Committee
The establishment of Medical Devices/Equipment Management Committees

(MDEMC) are required at local, regional and national levels. This will most likely
be the current “Decontamination Committee” with a few additional members and
additional Terms of Reference. The MDEMC will facilitate implementation, monitor
compliance and provide assurance in relation to this policy and standard as is
relevant to the organisational level at which they exist i.e. sub-regional, regional
or national.
The MDEMC will liaise with the appropriate organisational support services and
specialist committees required to deliver on their objectives. The MDEMC will
arrange for appropriate training: clinical training, appropriate clinical use of
devices and consumables and facilitate “Train the Trainer” programmes with
areas such as Technical Services.
8.9 Clinical Engineering lead
It is the responsibility of Biomedical/Clinical Engineering lead within a sub region:
To provide expert advice on all aspects of the management of medical

devices/equipment
Develop and maintain the systems required to effectively and safely

manage medical devices/equipment
Act as Chairperson for the Medical Device / Equipment Management

Committees (MDEMC). Carry out an ongoing programme of monitoring
to provide assurance in relation to the effectiveness of the systems in
place for the safe management of medical devices/equipment.
To advise on the compliance requirements of relevant legislation
Page 9 of 30
To provide guidance to managers and employees with regard to the
implementation of best practice guidance
Keep up to date professionally in order to maintain an appropriate level

of competence.
9.0 PROCEDURAL GUIDANCE
Detailed procedural guidance to support the successful implementation of this policy and
compliance with the standard has been developed.
10.0 POLICY IMPLEMENTATION
Each National Director is responsible for the effective communication and

implementation of this policy as it relates to his/her directorate.
11.0 EVALUATION AND AUDIT
In order to establish the effectiveness of this policy services will be required to conduct
an assessment of their system in relation to compliance with the HSE’s Medical Device/
Equipment Management Standard (see Appendix II) and to put in place improvement
plans where required.
Services will also be required to agree, implement and monitor relevant performance
indicators at an operational and national level, and that these will be the subject of
monitoring by the relevant Directorate. When monitoring has identified
underperformance quality improvement plans (QIPs) will be developed and systems put
in place to ensure variances are addressed.
12.0 RECORD KEEPING
Good record keeping is essential for the safe management of all Medical
Devices/Equipment. A standardised computerised medical device/equipment
management system should be in place throughout the organisation to capture all
aspects pertaining to the device history throughout the management cycle and must be
capable of providing a complete audit trail.
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13.0 POLICY REVIEW
This Policy will be reviewed in October 2010.
14.0 REFERENCES
• HSE Code of Practice for Decontamination of Reusable Invasive Medical

Devices
http://www.hse.ie/eng/Publications/services/Hospitals/HSE_Publications/Co
de_of_Practice_for_Decontamination_of_Reuable_Invasive_Medical_Devices_1
.pdf
• National Finance Regulations
http://hsenet.hse.ie/HSE_Central/finance_Transformation_Projects/Financial
%20Regulations/NFR_1_Purchase_to_Pay.pdf
• HSE Procurement
http://hsenet.hse.ie/HSE_Central/Commercial_and_Support_Services/Procure
ment/Policies_Procedures/HSE_Procurement_Policy.pdf
• HSE Quality and Risk Management Standard
http://hsenet.hse.ie/HSE_Central/Office_of_the_CEO/Quality_and_Risk/Docu
ments/OQR009_Quality_Risk_Management_Standard.pdf
• HSE Quality, Safety and Risk Framework
ments/HSE_quality_safety_and_risk_framework_V1_Jan_2009.pdf
• HSE Quality, Safety and Risk Framework Companion Guide
ments/HSE_companion_guide_V1_Feb_2009_.pdf
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• HSE Incident Management Policy and Procedure
ments/OQR006_Incident_Management_Policy_Procedure.pdf
• HSE Serious Incident Management Policy and Procedure
ments/SIMT_01_Part_2_Serious_Incident_Management_Policy_and_Procedur
e.pdf
• HSE Medical Devices/Equipment Management – Compliance with the

HSE’s Medical Devices and Equipment Management Standard – Guidance
for Service Areas
ments/OQR031_HSE_Medical_Devices_Equipment_Management;_Best_Practic
e_Guidance.pdf
• Framework for the Corporate and Financial Governance of the Health

Service Executive. HSE Integrated Risk Management Policy
ments/OQR023_HSE_Integrated_Risk_Management_Policy_Doc_2_4_.pdf
• HSE Corporate Safety Statement
http://hsenet.hse.ie/Intranet/Library/HSE_Publications/?importUrl=http://lo
calhost:82/eng/Publications/corporate/HSE_Corporate_Safety_Policy_and_Co
rporate_Safety_Statement.pdf
• A Framework for Major Emergency Management
http://www.mem.ie/memdocuments/a%20framework%20for%20major%20e
mergency%20management.pdf
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• HSE Infection Control Policies
http://hsenet.hse.ie/HSE_Central/Population_Health/Health_Protection/Healt
h_Care_Associated_Infection/HCAI_publications/Local_Implementation_Team
_Action_Plan.pdf
• HSE Information Technology Acceptable Usage Policy
http://hsenet.hse.ie/HSE_Central/Commercial_and_Support_Services/ICT/Pol
icies_and_Procedures/Policies/HSE_Information_Technology_Acceptable_Use
_Policy.pdf
• National Standards for the Prevention and Control of Healthcare

Associated Infections (HIQA)
http://www.hiqa.ie/media/pdfs/National_Standards_Prevention_Control_Infe
ctions.pdf
• Health Act 2004
http://www.irishstatutebook.ie/2004/en/act/pub/0042/index.html
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15.0 Appendices
APPENDIX I
COMMON CATEGORIES OF MEDICAL DEVICE
Note: This list is not exhaustive. It provides examples of medical devices.
Equipment used in the diagnosis or treatment of disease, or monitoring of patients, such

as:
Dental instruments, equipment and materials.

Dressings
Endoscopes
Examination gloves
Gastrostomy tubes
Intravenous (IV) administration sets and pumps
Nebulisers
Ophthalmic equipment
Peak flow meters
Podiatry and Podiatric Surgery equipment
Sphygmomanometers
Suction equipment
Surgical instruments
Syringes and needles
Thermometers
Ultrasound Doppler’s
Urinary catheters
Equipment used in life support such as:
Blood glucose measuring devices

Cholesterol test kits
Defibrillators
Domiciliary oxygen therapy systems
In vitro diagnostic medical devices and their accessories
Intensive Care ventilators
Insulin injectors
Pregnancy test kits
Pulse oximeters
Specimen collection tubes
Urine test strips
Ventilators used in the home

Page 14 of 30
Vital Signs monitoring
Equipment used in care, such as:
Adjustable beds
Lifting poles
Patient hoists
Pressure relief equipment
Stoma care equipment
Equipment used by people with disabilities, such as:
Bathing equipment
Commodes
Communication aids
External prostheses and orthoses
Hearing aids
Prescribable footwear
Standing frames
Urine drainage systems
Walking aids
Wheelchairs and special support seating
Items stocked by Pharmacy Departments with CEs
Interactive Wound Dressings
Bone Cements
Viscoelastic Opthalmic Injections
Inhaled Drug Delivery Devices
Page 15 of 30
APPENDIX II
Statutory Requirements:
Directives:
European directives are passed into legislation by the co-decision procedure of the EU
council and the EU parliament. Directives are applicable in Members states and are
implemented in National Law. The relevant directives that apply to the Medical Devices
are:
• Directive 2007/47/EC of the European Parliament and of the Council of 5

September 2007 amending Council Directive 90/385/EEC on the approximation of
the laws of the Member States relating to active implantable medical devices.
• Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC
concerning the placing of biocidal products on the market.
Directive 2007/47EEC - OJ L247/ 21.9.07
• Active Implantable Medical Devices (AIMDD) - consolidated version

11/10/2007
- Directive 90/385/EEC - OJ L189/ 20.7.90
• Medical Devices Directive (MDD) - consolidated version 11/10/2007

- Directive 93/42/EEC - OJ 169/ 12.7.93
• In Vitro Diagnostic Directive (IVDD)

- Directive 98/79/EC - OJ331/ 7.12.98 - consolidated version 20/11/2003
EC Implementing Legislation
• Reclassification of breast implants:
- Directive 2003/12/EC - OJ L028/ 4.02.2003
• Common Technical Specification on IVD:

- Commission Decision 2002/364/EC - OJ L131/ 16.05.2002
• MD manufactured utilising tissues of animal origin:

- Directive 2003/32/EC - OJ L105/18- 26.04.2003
• MD incorporating stable derivates of human blood or human plasma:

- Directive 2000/70/EC - OJ L 313 , 13/12/2000
• MD incorporating stable derivates of human blood or human plasma:

- Directive 2001/104/EC - OJ L 6/50 , 10/01/2002
• Reclassification of hip, knee and shoulder joint replacements:

- Directive 2005/50/EC - OJ L 210 , 12/08/2005
In addition in relation to Medical Exposure from ionising radiation, the following

apply:
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Medical Exposure Directive 97/43/EURATOM
Council Directive of 30 June 1997 on health protection of individuals against the dangers
of ionizing radiation in relation to medical exposure, and repealing Directive
84/466/EURATOM.
(OJ L-180 of 09/07/97 page 22)
In addition it is necessary to take into account the following environmental directives:
WEEE Directive
Council Directive 2002/96/EC[4] on waste electrical and electronic equipment as
amended by Council Directive 2003/108/
Regulations
European Community Directives are transposed into Irish law by Statutory Instrument
under the European Communities Act 1972. The following are the relevant Irish
Legislation for Medical Devices
S.I. No. 252/1994: European Communities (Medical Devices)

Regulations, 1994.
S.I. No. 253/1994: European Communities (Active Implantable Medical Devices)
Regulations,
1994.
S.I. No. 304 of 2001 European Communities (In Vitro Diagnostic Medical Devices)
Regulations, 2001)
S.I. No. 444 of 2001 European Communities (Medical devices) (Amendment)
Regulations, 2001
S.I. No. 576 of 2002 European Communities (Medical Devices) (Amendment)
Regulations, 2002 (Blood Products)
S.I. No. 358 of 2003 European Communities (Medical Devices) (Reclassification of

Breast Implants)
(Amendment) Regulations, 2003
S.I. No. 554 of 2003 European Communities (Medical Devices) (Tissues of Animal Origin)
Regulations, 2003
S.I. No 92 of 2007 European Communities (Medical Devices) (Reclassification of Hip,

Knee and Shoulder Joint Replacements)(Amendment) Regulations
2007 ;
The relevant Statutory Instruments that apply to the Medical Exposures of Patients are:
Amendment SI 303 (2007) SI 478 /2002, European Communities (Medical Ionising Radiation
Protection) Regulations 2002
SI 125/ 2000, Radiological Protection Act, 1991 (Ionising Radiation) Order, 2000
Environmental Statutory Instruments
SI 340 Waste Management (Waste Electrical and Electronic
Equipment) Regulations 2005:
SI 290 Waste Management (Electrical and Electronic Equipment)
Regulations 2005:
S.I. No. 375 of 2008 Waste Management (Waste Electrical and Electronic
Equipment) (Amendment) Regulations 2008
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S.I. No. 268 of 2008 Waste Management (Batteries and Accumulators)
Regulations 2008
GUIDANCE:
EU Medical Devices MEDDEV’S –
The guidelines aim at promoting a common approach by manufacturers and Notified

Bodies involved in the conformity assessment procedures according to the relevant
annexes of the Directives, and by the Competent Authorities charged with safeguarding
Public Health.
They have been carefully drafted through a process of consultation with various
interested parties during which intermediate drafts were circulated and comments were
taken up in the documents. Therefore, they reflect positions taken in particular by
representatives of Competent Authorities and Commission Services, Notified Bodies,
industry and other interested parties in the medical devices sector.
The guidelines are not legally binding. It is recognised that under given circumstances,
for example, as a result of scientific developments, an alternative approach may be
possible or appropriate to comply with the legal requirements.
Due to the participation of the aforementioned interested parties and of experts from
Competent Authorities, it is anticipated that the guidelines will be followed within the
Member States and, therefore, ensure uniform application of relevant Directive
provisions. Guidelines are subject of a regular updating process.
MEDDEV’s are available at:
<http://ec.europa.eu/enterprise/medical_devices/meddev/meddev_index_en.htm>
and include the following relevant guidelines:
• Clinical investigation, clinical evaluation

• Medical devices vigilance system
• Classification of MD
The relevant European Commission DG for the medical exposure directive is Directorate-General for
Energy and Transport. Since 1976 the Radiation Protection unit has been responsible for publishing
information covering a wide range of issues relating to ionizing radiation and radiation protection and
are available on the net at :
(http://ec.europa.eu/energy/nuclear/radioprotection/publication_en.htm).
Page 18 of 30
GUIDANCE IMB:
Examples of IMB guidance published in 2008 is illustrated below, full details on web site
<http://www.imb.ie/EN/Publications/Publications.aspx?pagecategoryid=202
The following are the primary guidance documents issued by the IMB with respect to
Medical Devices / Equipment Management:-
SN2003(08) Equipment Management: Guidance for the Maintenance and

Timely Replacement of Medical Equipment
SN2003(09) Equipment Management: Some basic Principles of Equipment

Management.
SN2006(03) The Procurement and Commissioning of Medical Equipment in

Hospitals.
SN2007(06) Medical Devices Recommended by Healthcare Institutions for use

in a Community Setting
Guide for Class I Manufacturers on compliance with European Communities (Medical

Devices) Regulations, 1994
Guide for custom-made Medical Device Manufacturers on compliance with European

Communities (Medical Devices) Regulations, 1994
Guide to Applications for Certificates of Free Sale for Medical Devices
Guide to Drug-Device Consultations
Guidelines for Safe and Effective Management and Use of Point of Care Testing
Guide for Ethics Committees on Clinical Investigation of Medical Devices
Categories: Medical Device-Guidance
STANDARDS
"Harmonised standards" are European standards, adopted by CEN, CENELEC or ETSI,

following a mandate issued by the European Commission after consultation of Member
States. They are developed through an open and transparent process, built on consensus
between all interested parties.
Compliance with harmonised standards, of which the reference numbers have been
published in the Official Journal and which have been transposed into national standards,
provides presumption of conformity to the corresponding essential requirements of the
EC directives. Compliance with harmonised standards remains voluntary, and
manufacturers are free to choose any other technical solution that provides compliance
with the essential requirements. In a number of cases compliance with harmonised
standards also increases the options for conformity assessment procedures.
Where the Commission or the Member States consider that harmonised standards
present shortcomings with respect to the essential requirements, the publication of the
reference in the Official Journal can, in conformity with the procedures laid down in the
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directives, be withdrawn by the Commission. In such cases, the harmonised standard
will cease to provide a presumption of conformity.
An overview of the references of harmonised standards can be found in the "List

references of harmonised standards" . Although it is updated regularly, it may not be
complete, and only publication in the Official Journal produces legal affect.
High Level Standards would be:
EN ISO 13485:2003 Medical devices - Quality management systems -

Requirements for regulatory purposes (ISO 13485:2003).
EN ISO 14971:2007 Medical devices - Application of risk management to medical

devices (ISO 14971:2007)
EN 60601-1-1:2001 Medical electrical equipment - Part 1-1: General

requirements for safety - Collateral standard: Safety
requirements for medical electrical systems
EN 60601-2-xx ( XXX) Series Medical electrical equipment - Part 2-XX: Particular

requirements for the safety of XXX
ISO 9001:2008 Quality Management Series
CE-marking
The essential objective of a conformity assessment procedure is to enable the public
authorities to ensure that products placed on the market conform to the requirements
expressed in the provisions of the directives, in particular with regard to the health and
safety of users and consumers.
CE-marking is the only marking which indicates that products conform to the relevant
EC directives. The CE-marking affixed to products also provides a witness that the
natural or legal person having affixed or been responsible for the affixing of the CE-
marking has verified that the product conforms to all relevant EC directives which
require the CE-marking applying to it, and has been the subject of the appropriate
conformity evaluation procedures.
NSAI aims to inspire consumer confidence and protect industry interests through setting
standards and issuing certification in the quality and safety of goods and services. The
NSAI benchmarks these standards against international best practice and is therefore a
key facilitator of fair trade both in Ireland and in global markets. More information, such
as the NSAI mission statement and its policies with regard to privacy, quality, and
customers is available in strategy and policies on the NSAI website www.nsai.ie.
The NSAI provides knowledge-based services and technical support to the government,
consumers and industry, through:
Consultation on standards to assist manufacturers and suppliers in meeting safety

and consumer requirements;
Independent certification of products, processes and services;
Certification specific to the construction industry, known as ‘agrément’;
Regulatory control in the area of measures, or metrology;
Maintenance and development of the national measurement standards.
As well as domestic activities, the NSAI also represents Ireland in European and
international standards bodies, whose aim is to harmonise standards and remove
technical barriers to trade.
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The Electro-Technical Council of Ireland Limited (ETCI) is a voluntary body of twenty-
three organisations representative of all aspects of electro-technology in the Republic of
Ireland. Formally constituted in 1972, the Council is the national body responsible for the
harmonisation of standards in the electrotechnical field in collaboration with the National
Standards Authority of Ireland
Objectives of the ETCI
1. To promote and co-ordinate standardisation in all branches of electro-technology

in harmony with international agreements and in collaboration with the National
Standards Authority of Ireland (NSAI).
2. To establish liaison with similar bodies in other countries and with international
bodies.
3. To promote safety in electrical equipment and installations and to encourage an
awareness of electrical safety among the general public
4. To advise and make recommendations on any matter pertaining to
electrotechnology, subject to the statutory powers, duties and functions of other
bodies.
Additional information can be obtained on www.etci.ie
Information is also available from:

IMB website at www.imb.ie
MHRA website at < http://www.mhra.gov.uk/index.htm >
FDA website at < http://www.fda.gov/CDRH/ >
TGA website at < http://www.tga.gov.au/devices/devices.htm >
Page 21 of 30
APPENDIX III
HSE MEDICAL DEVICES AND EQUIPMENT STANDARD
1.0 Introduction
This document sets out a framework for implementation of an integrated medical devices
and equipment management system within the HSE. Robust standards for the
management of medical devices and equipment are required to ensure
• High quality safe care for service users
• Safety of employees
• Improved performance and effectiveness
• Less likelihood of unexpected events
• Better decision making at all levels
• Better resource planning and utilisation
• Compliance with legislation
• Assurance to Risk and Audit Committees and thereby assurance to the HSE
Board and all stakeholders.
What follows in this document is a framework for an integrated medical devices and
equipment management system, comprising a statement of overall standard together
with supporting criteria. HSE guidance in relation to the criteria is available to support
the achievement of the standard Reference. Each criterion reflects the elements of a
higher level management model describing a ‘system of internal control’ for a healthcare
organisation. This standard is aligned to the HSE’s Quality and Risk Management
Standard and the NHO and PCCC’s Integrated Quality, Safety and Risk Framework.
Figure 1 – Internal Control Model
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The model (see above) sits within an overarching Governance approach and
influences, and is influenced by, the Organisational Culture. The model specifies a
generic approach to providing assurances to stakeholders that a healthcare organisation
is meeting its various objectives and providing the right ‘outcomes’. In this case the
objective (or ‘standard’) is to ensure implementation of an integrated medical devices
and equipment management system within the HSE. Various criteria, including outcomes
criteria, have been devised in line with the elements of the model as follows:
• The principal Objective is to ensure that “There is a system in place which

ensures that all risks associated with acquisition and use of Medical Devices
and Equipment are minimized. ”This is known as the ‘Statement of Standard.’
• Stakeholders should be identified and there should be proper

Communication and Consultation with all relevant stakeholders within and
outside the organisation.
• An appropriate Accountability framework to meet the objective should be

developed by relevant Directorates, encompassing suitable management
structures and practices (leadership, committees, reporting arrangements,
policies and strategies, etc.) at all levels in the Directorate.
• The Core Processes and Programmes required to produce the desired

outcomes should be in place – these include a range of quality and risk
management processes.
• The organisation (or department, etc.) should have the necessary Capability
(leadership, knowledgeable and skilled staff, adequate financial and physical
resources, etc.) to ensure the entire system works effectively.
• Management should receive sufficient objective Independent assurance as

to the robustness of the system defined by the model.
• Management should continuously Monitor, review, learn and improve all

aspects of the system defined by the model. Such monitoring etc. will
necessarily include taking on-board any independent assurances received.
Overall, this process will ensure that the medical devices and equipment
management system is properly configured and working effectively to achieve
the desired outcomes and overall objective(s).
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2.0 STANDARD
2.1 Statement of Standard

“There is a system in place which ensures that all risks associated with
acquisition and use of Medical Devices and Equipment are minimized.”
2.2 Assessment of Compliance with the Standard
A self assessment tool will accompany this Standard. All Service Areas are required to
conduct a self assessment against this standard on an annual basis. The outcome of this
self assessment will determine the areas requiring improvement. These areas will be the
focus of quality improvement plan development, the implementation of such plans will
be the subject of monitoring and review.
3.0 CRITERIA
There are 26 criteria incorporated within this standard divided in line with the internal
control model above as described on page 13 of this document.
In order to comply with the standard, it is necessary to comply with each of the criteria.
3.1 Communication and Consultation

1 Appropriate and effective mechanisms are in place for communication and
consultation on medical devices and equipment management matters within and
outside the HSE.
3.2 Accountability
2 Individual responsibility for Medical Devices and Equipment management is clearly
defined and there are clear lines of accountability for medical devices and equipment
leading up to the most senior manager or director.
3.3 Core Processes and Programmes

3. There are broad-based Medical Devices and Equipment groups established in
accordance with the recommendations of the IMB safety notice SN2006(03) at
local, regional and national levels.
4. There are procedures, based on best available evidence, implemented throughout

the HSE for all aspects of Medical Devices and Equipment Management which are
governed by a formal document control process.
5. All Medical Devices and Equipment are selected and acquired in accordance with
the HSE’S Procurement Policy
6. All Medical Device and Equipment developments, modifications and trials are
conducted in accordance with relevant legislation and guidance.
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7. Delivery and pre-use checks are carried out on all newly delivered Medical
Devices/Equipment
8. All newly delivered Medical Devices and Equipment are properly stored after
acceptance.
9. The manufacturer is responsible for issuing clear, accurate instructions.

9.1
All professional users and end-users have access to manufacturer's instructions and
all users sign statements to the effect that they have received instructions on the
safe use of Medical Devices or Equipment
9.2
Where Medical Device/Equipment manufacturers automatically send copies of
revised instructions to a named recipient, these are appropriately dealt with.
9.3
All instructions supplied by HSE services are evaluated for their adequacy.
10. Medical Devices/Equipment designated for single use are not reused under any
circumstances
11. All necessary information required to properly manage HSE Service’s range of
Medical Devices/Equipment is recorded on a suitable system.
12. All Medical Devices/Equipment are properly maintained and repaired.
13. All Medical devices/Equipment returned for servicing and repair are properly
decontaminated.
14. Medical Devices/Equipment are replaced in accordance with an agreed policy.
15. All loaned Medical Devices/Equipment are collected when no longer needed.
16. All adverse incidents involving Medical Devices and Equipment are managed in
accordance with the requirements of the HSE’s Incident and Serious Incident
Management Policies and the Irish Medicines Board
17. A complete record of guidance issued by the Irish Medicines Board is maintained;
warning notices are distributed to the appropriate people in the organisation; and
recommendations contained in the notices are implemented.
18. The risk management process contained within the HSE’s Quality and Risk
Standard is applied to the management of Medical Devices and Equipment risk.
3.4 Capability
20. Employees are made aware of and, where necessary, trained in incident
management (reporting and investigation) for the management of adverse
19. All Medical
incidents DevicesMedical
involving and Equipment prescribing
Devices and decisions are made by employees
Equipment.
with appropriate professional qualifications and suitable experience, backed by
21. All professional users and technical supervisors are trained in the safe operation of
appropriate administrative and technical support.
Page 25 of 30
Medical Devices and Equipment.
22. All end-users (employees and service users) are where relevant given appropriate
training in the safe and effective use of Medical Devices and Equipment.
3.5 Outcomes
23. There is demonstrable improvement in key performance indicators relating to
Medical Device and Equipment Management
24. The organisation participates in benchmarking its management of Medical

Devices/Equipment.
3.6 Monitoring and Review

25. All aspects of the system in place for Medical Devices and Equipment Management
are monitored and reviewed by management for the purposes of learning and
improvement.
3.7 Independent Assurance

26. Senior Management receives independent assurance(s) that an appropriate and
effective system of managing Medical Devices and Equipment is in place and that
the necessary level of controls and monitoring are being implemented.
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APPENDIX IV
Members of Working Group:
Name Address
Marie Kehoe Quality and Risk Dept, Room 76
Area GM, Q&R HSE South Eye, Ear and Throat Hospital
Lead for Quality Function, Western Road, Cork
HSE Office of Quality and Risk Office
(Chairperson)
Theo Neijenhuizen Waterford Regional Hospital

Lead for Systems and Processes Waterford
Office of Quality and Risk
Miriam Rourke Portfolio & Category Management
HSE Procurement St. Canice’s Hospital Complex, Dublin
Road,
Kilkenny.
Wilf Higgins HSE Estates

Principal Engineering Adviser 2/3 Parnell Square
Dublin1
Ronnie McDermott Cavan / Monaghan Hospital

Clinical Engineering, Cavan
Brendan White HSE Procurement

Assistant Head of Portfolio & Category Management St. Canice’s Hospital Complex, Dublin
Road,
Kilkenny.
Yvonne O'Neill HSE

Assistant National Director – VFM Oak House, Millennium Park
Naas
Co. Kildare
James Gorman Finance Manager

Health Centre
Arden Road
Tullamore
Cornelia Stuart Quality & Risk Department

Area Quality & Risk Manager, HSE Dublin North East
Lead for Risk Management Function Office of Q&R Navan Road
Kells
Co Meath
Denise McCarthy, Quality and Risk,

Researcher Health Service Executive South,
Eye Ear and Throat Hospital,
Western Road,
Cork.
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Name Address
Finola Cashman HSE Dublin North East
SEO – Risk Management Navan Road
Kells
Co Meath
Ger Flynn Cork University Hospital

Head of Clinical Engineering Cork
CUH
Siobhan McEvoy Community Asset Management Service,

Project Manager St Dympna’s Hospital, Carlow
Fionnuala Duffy Mill Lane, Palmerstown, Dublin 20

Assistant National Director; Planning and
Development
Sandra Phelan LHO Dublin North Central
Occupational Therapy Manager Ballymun Civic Centre
Main Street, Ballymun, Dublin 9
Dr. John Keogh Cork University Hospital

Consultant Anaesthetist Cork
Cork University Hospital
Page 28 of 30
APPENDIX V
Acknowledgements:
The Working Group would like to thank the following individuals/groups who participated
in the consultation process.
Location Name
1 Abbott Laboratories
2 Bio Medical/Clinical Engineering Department, Waterford Seamus Guiry
Regional Hospital
3 Engineers Ireland (EI)) Dr Michael Walsh
4 Cavan Monaghan Hospital Group
5 Clinical Engineering Professional Vocational Group (CEPVG)
6 Clinical Engineering, Rotunda Hospital, Dublin
7 Clinical Indemnity Scheme (CIS) Dr. Ailis Quinlan
8 Community OT Dept, Barrack Street, Sligo Bernie Convey
9 Community Rehabilitation Services Longford/Westmeath Elizabeth Moore
10 Dental Office, Ballymun Healthcare Facility, Dublin Anne M O’Neill
11 Dept Medical Physics and Bioengineering, University Hospital Prof. W. van der
Galway Putten
12 Dept of Medical Physics and Clinical Engineering, AMNCH, Dr Barry McMahon
Tallaght, Dublin
13 Dietician Manager, Portiuncula Hospital, Ballinasloe, Co Galway Maeve Doherty
14 DON, St Camillus Hospital, Shelbourne Road, Limerick Majella Cussen
15 DON, St Josephs Hospital Ardee Eileen Dullaghan
16 Dublin Hospitals Group Risk Management Liam Duffy
17 Dublin Mid Leinster Occupational Therapists Managers Dublin, Mary O’Kelly
Wicklow, Kildare
18 Engineering Manger, Children’s University Hospital, Temple Shane Kelly
Street, Dublin
19 Fresenius Kabi Ltd. Olive Nolan
20 General Hospital, High road, Letterkenny, Co. Donegal Paddy McGowan
21 Health Protection Surveillance Centre Shelia Donlon
22 HSE MA, Clinical Engineering Dept, Tullamore, Co. Offaly Liam Hackett
23 Health Information Quality Authority (HIQA) Jon Billings
Eric Koornneef
24 Infection Prevention and Control Nurse, Beacon Hospital, Dublin Lenora Leonard
25 Irish Medication Safety Network (IMSN) Ciaran Meegan
26 Irish Medical and Surgical Trade Association (IMSTA) Justin Carty
27 Irish Medicines Board (IMB) Ann O’Connor
Andrea Hanson
28 Local Health Manager, North Dublin Pat Dunne/Mary
Ormsby
29 Markievicz House, Sligo Muireann Toibin
30 Markievicz House, Sligo, Community Medicine Paula Gilvarry
31 Mid Western Regional Hospital, Nenagh, Co. Tipperary Frank Keane
32 Naas General Hospital, Co. Kildare Peter Grainger
33 Occupational Therapist Manager, Donegal Community Services Anne Flannery
34 Occupational Therapy Department, Portiuncula Hospital, Eileen Davis
Ballinasloe, Co Galway
35 Our Lady’s Hospital, Navan & Louth County Hosp, Dundalk Aileen Maguire
36 Our Lady of Lourdes Hospital Drogheda Mairead Twohig
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37 Our Lady of Lourdes Hospital Drogheda – Clinical Engineering Patrick Healy
Dept.
38 PCCC Physiotherapy, Acorn Unit, Cherry orchard Hospital Rosemary Fenton
39 Risk Management, HSE Dublin Mid Leinster Annette Macken
40 Roscommon PCCC Fiona Garvey
41 Senior Clinical Engineer, Enable Ireland Disability Services John Tiernan
42 Senior Manager, Environmental Health, Population Health Ciara Norton
43 St Josephs Hospital, Trim, Co. Meath Karl Brogan
44 St Vincent’s University Hospital, Dublin Margaret Boland
45 St Vincents Hospital, Dungarvan Co Waterford Paula French
46 St. James Hospital Neil O Hare
Fran Hegarty
Sharon Glynn
Miriam Kenny
Betty Murphy
Gail Melanophy
Page 30 of 30

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Medical Devices/Equipment Management

Document OQR030 Document Quality Function,

2.0 Policy Statement 4

3.0 Links with other HSE Policies 5

6.0 Definition of a medical device 6

7.0 Policy Objectives 6

8.0 Roles & Responsibilities 7

8.1 The HSE Board 7

8.2 The Risk Committee 7

8.4 National Directors 7

8.5 Regional Directors of Operations 8

8.6 Hospital Managers/Local Health Managers 8

8.7 All employees 8

8.8 Medical Devices/Equipment Management Committee 9

8.9 Clinical Engineering Lead 9

9.0 Procedural Guidance 10

10.0 Policy Implementation 10

11.0 Evaluation & Audit 10

12.0 Record Keeping 10

13.0 Policy Review 11

 Integrated Risk Management Policy

 HSE’s Quality and Risk Management Standard

 HSE’s Medical Device/Equipment Procedural Guidance

 National Standards for the Prevention and Control of Healthcare

6.0 DEFINITION OF A MEDICAL DEVICE

7.0 POLICY OBJECTIVES

 To minimize the risk of harm, to service users and employees, associated

 To set out a statement of standard and supporting criteria based on a

8.0 ROLES AND RESPONSIBILITIES

8.1 The HSE Board

8.2 The Risk Committee

The implementation of the Medical Devices/Equipment Policy and management

8.4 National Directors

 Accountability for the management of medical devices/equipment

 Providing the necessary assurances that the systems, processes

8.5 Regional Directors of Operations

Each Regional Director of Operations has overall responsibility to:

 Provide assurance to the National Operations Director in relation to

 Establish and support an integrated Regional Medical Devices

 Designation of sub-regional areas for the integrated management

 Ensure the establishment of sub-regional Medical

 Designate Biomedical/Clinical Engineering leads with delegated

8.6 Hospital Managers/Local Health Managers

8.7 All Employees

It is the responsibility of each individual employee to ensure that they are

They should report any problem relating to use, maintenance, servicing or

8.8 Medical Devices/Equipment Management Committee

The establishment of Medical Devices/Equipment Management Committees

8.9 Clinical Engineering lead

It is the responsibility of Biomedical/Clinical Engineering lead within a sub region:

 To provide expert advice on all aspects of the management of medical

 Develop and maintain the systems required to effectively and safely

 Act as Chairperson for the Medical Device / Equipment Management

 To advise on the compliance requirements of relevant legislation

 Keep up to date professionally in order to maintain an appropriate level

9.0 PROCEDURAL GUIDANCE

10.0 POLICY IMPLEMENTATION

Each National Director is responsible for the effective communication and

11.0 EVALUATION AND AUDIT

12.0 RECORD KEEPING

Integrated Risk Management Policy

HSE’s Quality and Risk Management Standard

HSE’s Medical Device/Equipment Procedural Guidance

National Standards for the Prevention and Control of Healthcare

To minimize the risk of harm, to service users and employees, associated

To set out a statement of standard and supporting criteria based on a

Accountability for the management of medical devices/equipment

Providing the necessary assurances that the systems, processes

Provide assurance to the National Operations Director in relation to

Establish and support an integrated Regional Medical Devices

Designation of sub-regional areas for the integrated management

Ensure the establishment of sub-regional Medical

Designate Biomedical/Clinical Engineering leads with delegated

To provide expert advice on all aspects of the management of medical

Develop and maintain the systems required to effectively and safely

Act as Chairperson for the Medical Device / Equipment Management

To advise on the compliance requirements of relevant legislation

Keep up to date professionally in order to maintain an appropriate level

Dental instruments, equipment and materials.

Blood glucose measuring devices

Ventilators used in the home

Interactive Wound Dressings

Viscoelastic Opthalmic Injections

Inhaled Drug Delivery Devices