protocol ce ireland

8/12/2019 Protocol CE Ireland

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Biomedical Engineering Division, IEI, February, 2003

Proposal for a Protocol for

Professional Formation and Development of

Clinical Engineers in Ireland

February 2003


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Executive Summary

In Ireland, there are currently no specific professional standards for the education, training or

maintenance of competence of Clinical Engineers - graduates or technicians. Clinical Engineers

play a critical role in the hospital environment ensuring appropriate selection, performance,management, maintenance and development of medical devices and equipment. It is vital that

standards of engineering education and training are established and maintained to provide

greater assurance to the public regarding the safe and effective performance of medical

technology in our hospitals and the provision of value for money with respect to its management.

This proposal aims to address the deficit in professional standards for the education, training and

maintenance of competence of Clinical Engineers.

This document provides the background to Clinical Engineering in the Republic of Ireland. It

gives an insight into public sector career grades and pathways through them as well as

opportunities for professional development. It identifies current issues requiring resolution so

that the profession can continue to develop and it notes external factors which must beconsidered. This proposal deals with education, training and professional registration for

engineering graduates and technicians working in Biomedical Engineering and in particular in

Clinical Engineering.

In addition an overview of the current status of Clinical Engineering in a number of countries is

presented, together with likely future developments. Entrants to the profession come from a

diverse range of experiential and educational backgrounds. The breadth of the role of the

Clinical Engineer and the evolution of identifiable sub-disciplines within the field require that

there is a formal approach to the training of new entrants to the profession to ensure a proper

vocational foundation to their careers. The international review highlights the value of

formalised professional structures for Clinical Engineers.

A structured training programme is proposed which integrates the requirements for Professional

Registration with Continuing Professional Development. Curriculum detail for both educational

and experiential learning are provided as guidelines to course providers. The proposal is

developed in such a way as to involve all facets of Biomedical Engineering from those working

in Research and Development in industry to those working in the Clinical Environment. It is

developed to allow a modular approach to education and training, and by providing broad

guidelines and criteria for Training Centres allows geographical breadth of access to Training

while allowing for cross-fertilisation between the sub-disciplines of Biomedical Engineering.

It identifies the current requirement for training posts within the public health sector in Ireland.

Part B provides Guidelines on Syllabi for both the educational and practical components of

Clinical Engineering Training. It is designed to be a resource for Educational providers, to

provide the trainee with an insight into the areas of expertise and competence he or she will be

expected to develop and to be a benchmark for the Clinical Engineering Professional

Development Panel for their work in setting standards for the various aspects of Training.

Part C provides information on currently available Clinical Engineering Education and Training

within the University, Institute of Technology and Hospital Sectors. This will provide

information for educational providers as to where expertise has already been developed in


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specific areas of Clinical Engineering and will provide guidance for Trainees on the most

appropriate training centres for their training needs.

The central objectives of this proposal may be summarised as below:

implementation of professional registration and structured training and development for

Clinical Engineers in the public sector covering graduates and technicians; Government support for the implementation of this scheme as a requirement for progress

through career grades in Clinical Engineering;

the development of a synergistic working relationship between Biomedical Engineers inindustry, the public sector and in academia.

Implementation of this Proposal will lead to increased assurance for the public regarding safety

and performance of medical equipment and increased assurance of value for money for hospital

managers with respect to medical technology.


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Protocol for Professional Formation and Development of Clinical Engineers

Table of Contents

Part A - Overview of Protocol

Executive Summary

1.0 Introduction - page 8

2.0 Background - page 10

2.1 The Medical Device Industry

2.2 The Role of the Professional Bodies and Clinical Engineering

2.3 Conclusion

3.0 Current Situation Analysis - page 14

3.1 Clinical Engineering - Hospital

3.2 Clinical Engineering - Rehabilitation

3.3 Clinical Engineering - IT Specialists/ Decision Support Specialists

3.4 Biomedical Engineering - Biomechanics/Biomaterials Specialists

3.5 The Industry Perspective from a Large Medical Device Manufacturer

3.6 Conclusions

4.0 Professional Registration Scheme for Clinical Engineers - page 24

4.1 Introduction

4.2 Voluntary Professional Registration for Clinical Engineers4.3 Continuing Professional Development

4.4 Conclusions

5.0 Structure of the Biomedical Engineering Training Scheme - page 29

5.1 Introduction

5.2 Proposed Career Paths

5.2.1 Clinical Engineering Professionals Entering from a Background in

Industry or Academia

5.3 Overview of Training

5.4 Management of the Training Scheme

5.5 Education5.6 Basic Training

5.7 Advanced

5.8 Assessment of Training

5.9 Conclusions

6.0 International Perspective for Clinical Engineering and Biomedical Engineering

with respect to Continual Professional Developments: US, UK, Canada, Australia -

page 43

6.1 United Kingdom

6.2 United States

6.2.1 American College of Clinical Engineering6.2.2 American Institute for Medical and Biological Engineering


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6.2.3 Clinical Engineering Education and Training at Third Level

6.3 Canada

6.3.1 The Canadian Medical and Biological Engineering Society

6.3.2 Engineering Institute of Canada

6.3.3 Institute of Biomedical Engineering Technology6.4 Australia

6.5 IEEE Engineering in Medicine and Biology Society

6.6 Conclusions

7.0 Funding - page 55

Part B

Guideline Syllabi and Courses for Educational and Practical Elements of

Professional Formation and Development of Clinical Engineers


2.0 Relating Education and Training to Career Paths -page58

3.0 Outline of Approach to Education - page 59

3.1 Aims of Education

3.2 Modular Approach

3.3 Curriculum Outline

4.0 Educational Component of Training - page 61

4.1 Core Certificate in Clinical Engineering4.2 Major Specialisation Areas

4.3 Core Topic Content Guidelines

4.4 Elective Topics

5.0 Practical Training - page 79

5.1 Common Competencies

5.2 Major Specialisation Competencies

Part C

Clinical Engineering Education and Training within the University, Instituteof Technology and Hospital Sectors in Ireland


1.1 Course development in clinical engineering objective rational

1.2 Working Definitions encompassing clinical and biomedical engineering

2.0 Certificate/Diploma courses currently on offer - page 99

2.1 Cork Institute of Technology

3.0 Degree courses currently on offer - page 1003.1 Existing Degree Programmes


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3.1.1 Dublin City University

3.1.2 University College Galway

3.1.3 University of Limerick

3.2 Further Elective Programs in Biomedical Engineering

3.2.1 University College Dublin

3.2.2 Dublin Institute of Technology3.3 Degree courses on offer in Northern Ireland

3.3.1 University of Ulster

4.0 Taught Postgraduate Degree Courses - page 104

4.1 Combined taught Masters, - University of Trinity College Dublin, University

of Limerick, and University of Ulster (Jordanstown Campus)

4.2 Trinity College Dublin

Postgraduate Diploma / MSc in Health Informatics

4.3 Trinity College Dublin - Faculty of Health Sciences / Haughton Institute

4.4 Dublin Institute of Technology

MEng Biomedical Engineering/Health Informatics/Digital Signal Processing4.5 Trinity College Dublin

Post-graduate Diploma Clinical Engineering (Equipment Management)

5.0 Postgraduate Degrees by Research / Research Centres - page 108

5.1 Overview

5.2 Research Centres

5.2.1 National Centre for Biomedical Engineering Science

National University of Ireland, Galway

5.2.2 Centre for Biomedical Electronics

Department of Electronic and Computer Engineering,

University of Limerick

5.2.3 Biomedical Engineering Research Group, - NUI University College

Dublin, Faculty of Engineering

5.2.4 The Conway Institute of Biomolecular and Biomedical Research,

University College Dublin

5.2.5 Centre for Health Informatics, Trinity College Dublin

5.2.6 Northern Ireland Bio-Engineering Centre

5.2.7 Trinity Centre for Bioengineering, Trinity College

Acknowledgements - page 114

Appendices - page 115

Appendix 1: Summary of current Clinical Engineering Resources in Irish Hospitals.

Appendix 2: Specific Activities of Clinical Engineers

Appendix 3: Composition of Voluntary Registration Board for Clinical Engineers

Appendix 4: Overview of Bologna Declaration

Appendix 5: Overview of IEI registered title definitions

Appendix 6: Application form for Professional Registration of Clinical Engineers

Appendix 7: Grid of practical Competencies


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Proposal for a Protocol for

Professional Formation and Development of

Clinical Engineers

Part A - Overview of Protocol


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1.0 Introduction

Biomedical Engineers design, develop, use and manage instrumentation for patient monitoring,

diagnosis, treatment or research. Clinical Engineers are Biomedical Engineers based in the

Clinical environment, usually a hospital or rehabilitation unit. They may be responsible for the

design, management and quality assurance of patient-connected equipment in hospitals. Theyprovide operational and technical support to users of clinical equipment. In rehabilitation, they

provide biomechanical assessment, monitoring of patient recovery and the custom manufacture

of aids for individual patients. Clinical Engineers may be employed on a graduate or

technologist scale.

In recognition of the need for a formal structure for the full range of Clinical Engineers working

in Ireland, the work culminating in this document was undertaken. The document proposes a

mechanism for the professional formation and development of the Clinical Engineer. The

proposal is aimed primarily at new entrants to the profession, "grand-fathering" is outside the

scope of this document.

Following a broad invitation to all interested parties, a working group was established to develop

a training scheme for Clinical Engineers which would integrate with statutory requirements for

professional registration and consequently Continuing Professional Development (CPD). The

working group is composed of representatives from the Biomedical Engineering Section of the

Institution of Engineers of Ireland, the Biomedical/Clinical Engineering Association of Ireland

and the Clinical Engineering Professional Vocational Group.

This proposal has been influenced by various issues currently impacting on Clinical

Engineering:

The Bologna Declaration (Appendix 4) in addition to its direct impact on educationalcourses, will have an impact on the entrance qualifications for Clinical Engineers at both

Technician and Graduate level.

The Irish government is currently facilitating a process of benchmarking between

professions. The goal is to manage staff costs particularly in the public sector. Clinical

Engineering is part of this process. The process compares (among other parameters)

education and training requirements for posts. For Clinical Engineering at the technician

end of the grade to maintain its affiliation with paramedical grades, education and

training must be of at least an equivalent standard to other paramedical grades.

Statutory Instrument 1, 1999 sets out the legal requirements for the professionalregistration of all Health Care professionals. In October, 2000, the Department of Health

and Children (DOH&C) published a guidance document, Statutory Registration for

Health and Social Professionals for implementation of the Statutory Instrument in 1999.

Registration is being dealt with in two waves. Clinical Engineering will be in the second

wave. The first wave is currently under-going the final stages of preparation for

Statutory Registration. The profession needs to understand the impact and issues around

registration in advance of the requirement for Statutory Registration.

Part A outlines the Protocol for Professional Formation and Development of Clinical Engineers.


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Part B provides guidelines for educational providers on curriculum details relating to the

different stages of career development and the associated training programmes.

Part C provides information on current opportunities for Biomedical Engineering education in

Ireland. It is hoped this will be a useful reference for everyone in the profession.


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2.0 BackgroundThe evolution of medical technology has led to Engineers, Physicists, Computer Scientists and

others collaborating and competing with one another to provide new methods to see, measure

and treat ailments. As technology develops to meet the theoretical possibilities, there is a need

to manage this new technology and to ensure that there is efficient feedback between technology

designers, manufacturers and users- a role in which the Biomedical Engineer is pivotal.

The medical device industry accounts for approximately 8% of GNP. The sector is a significant

employer of Biomedical Engineers. However the education and training of these Biomedical

Engineers has until now been considered to be independent of that for Biomedical Engineers

working in the Clinical Environment.

Early Clinical Engineering (hospital-based Biomedical Engineering) in Ireland, in common with

many countries around the world was primarily a "technician"-based profession, where the

engineer was primarily responsible for maintenance of equipment. The presence of Medical

Physicists in the hospital environment arose with developments in radiation-based diagnostic

procedures where their input was and is vital to the safe and appropriate use of imaging

technology. The Medical Physics profession was and is primarily a "graduate"-based profession.

With the evolution of technology, technicians working in the hospital environment became

increasingly specialised and no longer belonged in a "maintenance department" where the skills

required, for example, to manage and maintain a building's heating system are inadequate for the

application, management and maintenance of specific items of medical equipment which are

used directly in patient treatment or diagnosis. There was a need for a professional home for

Clinical Engineering.

To accommodate the increasing number of graduate and technician engineers, a 'marriage' ofMedical Physics and Clinical Engineering occurred in some Irish hospitals. Where it did not

happen, Clinical Engineers working at technician level often still belong to maintenance

departments or in recent years have evolved into departments in their own right.

The rate of change of technology in terms of both application and design has required all

professions to evolve. Equipment has become more reliable; electronic repairs are module-

based rather than component-based and increased complexity of equipment has raised the need

for user support on a day-to-day basis. The Clinical Engineering field has evolved to meet the

changing needs as may be observed from the expanding role they play in the healthcare

environment.

2.1 The Medical Device IndustryIreland is the location of choice for healthcare companies seeking to establish a presence in

Europe, to develop and manufacture high end technology medical device products, as well as an

operating base for business support activities such as shared services centres and eBusiness

functions.

Leading medical device companies select Ireland as a base for developing, manufacturing and

marketing a diverse range of products from pacemakers and orthopaedic implants to contact

lenses and stents.


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Eighty companies, including 13 of the world's top 20 medical device companies, have significant

operations in Ireland, making it one of the largest industry sectors, with over 16,000 employees.

These companies export over IR2.5 billion every year.

Ireland is the preferred location for three out of four green-field medical device projects locating

in Europe.

The sub-sectors of the medical device industry in Ireland are:-

- medical equipment

- disposable and support products

- interventional products

- orthopaedics and implants

- vision, dental and hearing products.

It is estimated that 1,600 Biomedical Engineers are employed in this Sector in Ireland.

2.2 The Role of the Professional Bodies and Clinical EngineeringThe following submissions are directly from the professional bodies or are based on their

respective world-wide-web sites.

Biomedical/Clinical Engineering Association of Ireland (BEAI)

In order to meet the needs of the evolving profession of Clinical Engineering in Ireland, the

Biomedical/Clinical Engineering Association of Ireland (BEAI) was established in 1992. At that

time the stated objectives of the founders were to develop communications between those

working in the profession and to develop opportunities for education and learning. More

formally the goals were identified as being:

To encourage and promote the professional development of Bioengineering personnel (i.e. individuals whose principal occupation is in the provision of a Clinical Engineering

service) employed in the Health Care service and support infrastructure.

Advance the science, technology ethics and art of Clinical Engineering throughassociation, education, training, publication and other materials

Facilitate co-operation and understanding among Clinical Engineering personnel andother health care professionals, hospitals, academia, vendors and other organisations with an

interest in Clinical Engineering.

The BEAI continues to focus on these primary goals and has achieved a great deal in the ten

years since its foundation. It is the Irish member of the International Federation of Medical and

Biological Engineering and the European Association of Medical and Biological Engineering

Societies. Members of the BEAI are associated with committees of the IEEE Engineering in

Medicine and Biology Society.

Institution of Engineers of Ireland (IEI)The Institution of Engineers of Ireland (IEI) was founded in 1835 and under the Charter

Amendment Act, 1969 is empowered to define and protect its registered titles. Within Ireland the

IEI is the authoritative voice of the engineering professional and currently represents the

interests of in excess of 19,000 engineering professionals.


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The fundamental aims of the institution are:

To promote knowledge of engineering and of engineering science

To establish and maintain standards of engineering education and training

To promote and provide continuous professional development

To maintain standards of professional ethics and conduct

To ensure that registered Professional titles of the Institution are assigned only toappropriately qualified engineers and technicians

The membership of the IEI is open to all Biomedical engineering personnel.

The IEI registered titles are:

Chartered Engineer

Associate Engineer

Engineering Technician

In 1998 a group of Biomedical Engineers approached the Institution of Engineers of Ireland

(IEI) with a view to setting up a Biomedical Engineering Division within the Institution. TheIEI is the body with statutory responsibility for accreditation of engineers, that is they are the

only body in Ireland who may award Chartered Engineer Status. The Biomedical Engineers

recognised the need for direct involvement with the Institution as well as the value to be gained

by interaction between all the facets of Biomedical Engineering (including those based in

hospitals, rehabilitation, industry and education). The Biomedical Engineering Division of the

IEI was established and has provided a platform for debate and learning across all sectors of

Biomedical Engineering. It has spearheaded the working group which developed this Proposal.

Clinical Engineering Professional Vocational Group

The Clinical Engineering Professional Vocational Group currently represents Clinical Engineers

at trade union level. This is a Trade Union body.

The Healthcare Informatics Society of Ireland and the Healthcare Informatics Section of

the Royal Academy of Medicine in IrelandOver the past thirty years, Healthcare Informatics has developed from a narrow cross-

disciplinary interest to a discipline in its own right. In Ireland we have a growing number of

full-time Healthcare Informatics professionals, in hospitals, in health boards, in universities and

in service companies.

From 1976 to 1996, Healthcare Informatics interests in the Republic of Ireland were represented

by the Health Care Specialist Group of the Irish Computer Society. This group represented

Ireland at the European Federation for Medical Informatics (EFMI) and the InternationalMedical Informatics Association (IMIA). It hosted the European Medical Informatics

conference, MIE 82, and was associated with the IMIA Working Group 8 international

symposium on Nursing Informatics held in Dublin in 1988.

In May 1996 the members of the Health Care Specialist Group formed a new society, the

Healthcare Informatics Society of Ireland (Cumann Romheolais Slinte), in order to broaden the

base of membership and increase the range of services offered. By formal agreement with the

Irish Computer Society, the Health Care Specialist Group was disbanded, and its functions,

assets and liabilities transferred to the new Society, which then became affiliated to the Irish

Computer Society.


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The Healthcare Informatics Society of Ireland was inaugurated formally at its First Annual

Conference in the Burlington Hotel, Dublin, on Thursday 10th October 1996. The society

incorporates the Healthcare Informatics section of the Royal Academy of Medicine in Ireland.

Thus the Healthcare Informatics Society is in a position to build bridges between computer

professionals interested in health care, and health care professionals interested in computing,

while supporting and embracing the new professionals of health care informatics. There arecurrently some 200 members, drawn from information technology, clinical engineering,

medicine, nursing, other professions allied to medicine, education, government and industry.

The objectives, as set out in the Constitution,are:

1. To develop and disseminate knowledge of the use of informatics in health care.

2. To promote research and education in health care informatics.

3. To participate internationally with bodies of similar interests.

In pursuit of the third objective, the Healthcare Informatics Society of Ireland has been accepted

as a member of the European Federation for Medical Informatics, and the International Medical

Informatics Association

Royal Academy of Medicine in Ireland, Bioengineering Section

The Section of Bioengineering was founded in 1994 to facilitate collaboration between medical

doctors, engineers and scientists. It runs the Bioengineering Design Forum three times each year,

where problems are discussed informally and interdisciplinary research projects initiated.

Research papers are presented at its annual conference "Bioengineering...in Ireland" where an

invited speaker delivers the Samuel Haughton Lecture for which the Academy Silver Medal is

awarded.

The Council of Chairmen of Medical Engineering OrganisationsIn 2000, The Council of Chairmen of Medical Engineering organisations was established to

acknowledge the value in developing co-operation, collaboration and communications between

the individual organisations.

The organisations represented are:

Biomedical/Clinical Engineering Association of Ireland

Healthcare Informatics Society of Ireland/Royal Academy of Medicine in Ireland, HealthInformatics Section

Institution of Engineers of Ireland, Biomedical Engineering Division

Irish Medical and Surgical Trade Association

Royal Academy of Medicine in Ireland, Bioengineering Section

2.3 ConclusionClinical Engineering is a strong and developing profession in Ireland which has been

establishing itself as an individual entity only in the last ten years. The profession has identified

internal issues which must be addressed while at the same time reacting to national and

international factors with direct and indirect impact on Clinical Engineering.
http://members/rules.htmhttp://members/rules.htm


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3.0 Current Situation AnalysisThe Biomedical Engineer is an individual competent to practice independently within one or

more of the sub-specialities of Biomedical Engineering. Five broad sub-specialities of

Biomedical Engineering are described below and the core responsibilities and activities

identified. Biomedical Engineers working in the clinical environment are known as Clinical

Engineers".

3.1 Clinical Engineering - HospitalClinical Engineering has been practised in Ireland for many decades. Over this time, it has been

known as Medical Engineering, Electronic Engineering, Biomedical Engineering and Medical

Electronics. Clinical Engineering is the branch of engineering that uses engineering,

management and technology concepts to improve health care delivery systems in hospitals.

The Clinical Engineering function includes primary responsibility for all electrical-medical

assets. This broad-spectrum of assets include all therapeutic, diagnostic and analytical

equipment. Clinical Engineering is responsible for ensuring that the highest levels of equipment

safety, user application and financial efficiency are realised in the support and management of

this critical application equipment. This is achieved through prudent management of clinical

engineering services for optimum benefit of patient care.

An institutional benefit of the Clinical Engineering presence is the provision of a scientific

sounding board and technical support for the application, adaptation and development of medical

devices and equipment within a Legislative Standards and Directives framework. This allows

clinicians to solve specific clinical problems and develop new techniques and devices through

liaison with manufacturers and their agents.

Profile of Clinical Engineering Presence across Hospitals in the Republic of IrelandTo date, no internationally accepted guidelines for the Clinical Engineering presence per head of

population or any other unit has been identified. Nor is there any clarity around department of

Clinical Engineering Department Structures on an international level. Appendix 1 provides detail

of the current Clinical Engineering presence in Ireland.

Evolving medical technology fulfils a very necessary and crucial role in todays healthcare and a

highly dependent relationship has developed between clinicians and the performance of this

technology. It is difficult to identify a single diagnosis that can be confirmed without the use of

this diagnostic/analytical technology, or similarly, a single surgical procedure which could be

safely undertaken, without utilising the currently available monitoring and therapeutic facilities.

To ensure the safe and optimum utilisation of this technology, the clinical engineering function

is employed. The critical nature of clinical engineering demands an uncompromising,

competent, and conscientious attitude to all aspects of work. These kernel attributes must be

clearly reflected in all personnel that contribute to clinical engineering.

Since the origins of clinical engineering in Ireland, the benefits of this essential support role have

been acknowledged, and as a consequence has propagated clinical engineering expertise in most

major Irish healthcare institutions. Clinical engineering currently employs in excess of over one

hundred engineers and technicians across 19 separate healthcare institutions. These engineering

personnel have developed and enhanced their expertise through dedicated healthcare support,

and as a consequence have accumulated in-depth knowledge of the applied principles,equipment design, equipment use and relevant hazards associated with this equipment


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(Appendix 1). In many of these applications, the expertise and services of these same personnel

are used to support several individual hospitals. This consolidation of resources ensures that

optimum efficiency (financial and operational) is realised, with a minimum of staff and

resources. This exemplifies the current clinical engineering trend and is presently the support

model employed in the Southern Health Board, Midland Health Board and Mid-Western Health

Board.

Currently Clinical Engineering Professionals are employed in one of the following structures:

1. Clinical Engineering Technicians who are members of a Maintenance or

Technical Services Department;

2. Clinical Engineering Technicians who are the sole professional group in a

Clinical Engineering Department;

3. Clinical Engineers - graduates and technicians who are members of a joint

Clinical Engineering and Medical Physics and Clinical Engineering Department;

4. Clinical Engineers - technicians and graduates who are the sole professional

group in a Clinical Engineering Department.

Core Roles and ResponsibilitiesDifferent types of hospitals have differing Clinical Engineering needs and each hospital offers a

unique profile of clinical specialisation. There is not a strict demarcation between the actual

roles performed between various grades of Clinical Engineering personnel. The Clinical

Engineering Department realises its objectives through professional managerial practice and

employs both in-house clinical engineering personnel and external service contractors.

Appendix 2 identifies many clinical engineering roles and notes the overlap between those of the

graduate and technician. Some of the core roles of the Clinical Engineer are identified below:

Qualified appraisal of equipment support and safety requirements. This ensures that eachasset is adequately supported, in an optimally cost effective manner and eliminates the

potential of under / over supporting. Previously this consideration was a function of the

vested enthusiasm of the respective equipment supplier;

Clinical Engineers have been involved in Project Management within the Health Service formany years. Projects such as the recent Adelaide and Meath Hospital Incorporating the

National Childrens Hospital have had a substantial Clinical Engineering input. Project

Management at Electromedical equipment level is now a normal part of the Clinical

Engineer professional role;

The management of service contracts and the supervision and control of external equipmentservice suppliers, where it is not feasible for this same support to be directly provided by theClinical Engineering Department;

Financial management and accountability for all medical equipment assets supported byClinical Engineering Department regarding costs and service;

Provision of technical advice and equipment training for clinical users;

Technical investigation of injury / death incidents where medical equipment is implicated;

Documenting and filing of all records pertaining to the support of this equipment, withintegration to the hospital asset register. This facilitates the extraction of statistical data and

preserves full service records relating to each item of equipment;

Provide and implement an extensive preventative maintenance program for clinical,pathology, radiology and radiotherapy assets;


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Implementation of Risk Management and Health and Safety policies for medical equipmentassets which address the health service obligations and reduces the potential for patient

injury;

Provision of financial projections and reports concerning the support of the variouscategories of medical equipment;

Provision of advice to hospital administration regarding the purchase, application,commissioning, support and eventual decommissioning of all Clinical Engineering

equipment;

Preparation of equipment technical specifications for tender purposes and the subsequentevaluation of prospective equipment as part of the standard purchasing tender procedure;

Continuous development of service / support initiatives within the department that pertain tomedical equipment management and will enhance the facilities provided by the hospital in

the context of user / patient satisfaction and financial efficiency;

Liasing with medical staff, service suppliers and device manufacturers to develop or enhancemedical devices or establish new protocols for the optimum use of technology from a clinical

perspective; To contribute to Research & Education programmes in the hospital environment;

To be a source of advice on Standards and Legislation impacting on medical technology;

Contribution to Industry and Commerce through co-ordination of for example, Beta testsites.

Current Career Paths for Hospital Based Clinical EngineersWithin Irish hospitals there is currently one grade of Clinical Engineer: Technician. Technicians

may be employed at basic, senior, principal or chief grade. However there are a number of

graduates employed to undertake a Clinical Engineering function. These are employed as

Medical Physicists. The following issues have acted as catalysts for this proposal for the

Professional Formation and Development of the Clinical Engineer:

The Clinical Engineering Technician has an entry requirement at Diploma level, no

structured training is currently required to progress through the employment grades. The

employment grades are: Basic Grade, Senior Grade, Principal and Chief. Criteria for

progress is based on post availability and years of experience. It should be noted that

many personnel employed at Clinical Engineering Technician level hold Bachelor or

Masters degrees.

The Clinical Engineer has an entry requirement at primary level (or equivalent), no

structured training is currently required to progress through the employment grades. The

employment grades are: Basic Grade, Senior Grade, Principal and Chief (these areMedical Physicist Grades). Criteria for progress is based on post availability and years

of experience.

There is no formal route for movement from Technician to Graduate grades, despite the

profile of continuing education and professional development that is evident in the

Technician group.

In the hospital environment, external service contractors are used to complement hospital

Clinical Engineering services. These contractors are employed in situations when it is not

viable or cost effective to use in-house clinical engineering expertise. It is a reasonable

expectation that such personnel should be trained to the same level as in-house personnel.


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This document will act as a basis for addressing the issues raised above.

3.2 Clinical Engineering - RehabilitationClinical Engineering in a rehabilitation setting is the clinical application of engineering

principles and technology with the aim of restoring or improving the physical, mental and socialfunction and well-being of a disabled person to his/her maximum potential. It is an important

element of a comprehensive rehabilitation service, and includes the following activities, services

and subjects of research, design, development, production and marketing:

Patient assessment

Wheelchair and special vehicles

Specialised prosthetics

Gait analysis

Specialised orthotics

Seating Communication systems

Environmental Control

Assistive devices

Functional Electrical stimulation

Below is an outline of the core responsibilities and activities of a Clinical Engineer working in

Rehabilitation

Core Roles and Responsibilities:

Contribute at a professional level to clinical teams; Define and prioritise the functional implications of the main disabling conditions;

Match residual body movements, posture and sensory abilities to appropriate switchesand other transducers for the operation of Communication and Environmental Control

Equipment;

Confirm forces, precision and actuation time for switch operation of such equipment;

Obtain and interpret the movement patterns, loads and contact forces during use of aProsthesis or Orthosis, including operation of gait analysis measurement equipment;

propose adjustment requirement to optimise comfort and function;

Recommend socket contact interfaces or body postures to ensure comfort, function and

avoidance of tissue damage in use of Prostheses, Orthoses and Seating; Recommend Wheelchair requirements for an individual patient, via clinical team

discussion and personal patient assessment;

Evaluate the function to be stimulated using Electrical stimulation and the likely level ofenhancement possible;

Identify for individual patients the criteria to be used as indicators or contra - indicatorsof Electrical stimulation usage, with particular reference to all aspects of safety;

Agree with the patient the needs for, and realistic expectations of assistive equipment;

Identify indicators for any non- standard Bioengineering requirement;

Evaluate equipment which is in use, for its effectiveness, safety and suitability;

Create, maintain and use records of technical audit in regard to individual patienttechnical provision;


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Maintain technical performance records for the solutions provided;

Innovate, and develop, design for non-standard equipment, and oversee its manufacturetesting, and commissioning;

Identify and prioritise technical solutions in respect to benefit to the patient, technicalcomplexity, availability and cost;

Produce technical specifications for equipment which is not commercially available; Design devices and produce technical drawings and/or circuit diagrams to meet the

technical specification above, demonstrating application of appropriate safety standards;

Produce appropriate documentation for such equipment;

Interpret and explain current technical Standards and Legislation affecting theengineering performance of assistive devices;

Evaluate technical drawings for manufacture of custom devices, and evaluate technicalspecifications of commercial equipment to be obtained;

Monitor the manufacturing process and authorise modifications to meet localmanufacturing capability;

Describe relevant safety legislation and interpret its application to specific designs andtheir uses;

Commission and evaluate new equipment ensuring appropriate performance and safetytests are carried out;

Set up equipment to meet the specified user requirements;

Introduce the equipment to the patient ensuring appropriate fitting and mounting;

Train and familiarise the patient in the use of the equipment;

Prepare Ethical approval submissions;

Carry out follow up assessment of the patient and equipment supplied;

Critically appraise the appropriateness of equipment provided to the patient;

Investigate the cause of equipment failure; Analyse records to identify problems and shortcomings in supplied equipment anddefine areas where new products techniques or materials Research and Development are

indicated;

Maintain data to enable evaluation of cost benefit and patient benefit of different devicesand technological approaches;

Define appropriate quality standards to apply and interpret their meaning;

Initiate informed action following failure of equipment, and negotiate with suppliers/producers etc. regarding technical aspects of its failure;

Be aware when legal implications may derive from equipment failure and alert theappropriate staff member;

Survey current equipment in the department and use this to organise and / or monitor itsuse with respect to effective and safe practices.

The Clinical Engineer working in rehabilitation is usually either:

A qualified engineer who has undertaken a postgraduate qualification in medical engineering in

order to gain a basic undertaking of anatomy, physiology and biomechanics;

or

Someone qualified in a life science who has undertaken a postgraduate qualification in medical

engineering in order to obtain a basic understanding of applied engineering.

The Clinical Engineer therefore helps to bridge the gap between the clinical and engineering

professions. The Clinical Engineer is an important part of a multi-disciplinary team where the


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Clinical Engineer and the therapist can offer an effective combination of skills in the clinic, and

link up with the appropriate medical and technical backup. The distinction between the therapist

and Clinical Engineer however, is perhaps more blurred as they both gain experience in the

particular Rehabilitation setting. Between them they will:

identify the problems and potential problems identify with the client the specific aims and objectives

decide on an appropriate approach to achieve these objectives;

define the appropriate equipment and materials to achieve the above;

determine the appropriate configuration, training etc.

It is obviously preferable to have a full team approach. When it is necessary to work

independently however, the Clinical Engineer can take responsibility for both technical and

clinical actions.

Often it will be necessary to custom build a device (seating / aid for daily living). It will be

essential to specify the configuration and material to achieve the desired objectives. The design

work and manufacture of the devices should be undertaken by or under the direction of a

qualified engineer. Consideration will need to be given to product liability, risk assessment and

the various regulations associated with Assistive technology devices and aids for daily living

Where there is a standard piece of equipment that will meet the needs of an individual it may be

necessary to fit it, and modify it if necessary. This requires some basic technical skills but also

an understanding of the materials and integrity of the modified structure. Responsibility for

these items is assumed by the provider once they are modified.

The Clinical Engineer with a suitable background should be able to offer the chance to enhance

the service through helping to undertake research and development. He or she should be able toidentify, design (if necessary), install equipment. Examples of equipment in the area of seating

would include positioning jigs or equipment for measuring variables such as pressure

distribution, EMG activity, or back shape. If appropriate, attempts should be made to attract

funding for further research and development which would raise the profile of the organisation.

The Clinical Engineer should also have basic skills in management of technical service in a

health care environment. He or she should be able to communicate with, and understand the

needs of users, therapists, clinicians, technicians and wheelchair service employees.

Current Career PathsIn Ireland there are three main organisations that could employ Clinical Engineers to work in

areas associated with Rehabilitation: Enable Ireland, Central Remedial Clinic and NationalRehabilitation Hospital. Currently Engineers are employed in Enable Ireland and the Central

Remedial Clinic, in these institutions they are not employed directly on the Department ofHealth and Children grading structure, however, most staff are employed on a parallel structure.

The issues identified above impacting on hospital-based engineers also pertain to rehabilitation-

based engineers.

Clinical Engineering- Assistive Technology TechniciansAssistive Technology Technicians assess and match the needs of people with disabilities to

appropriate assistive technologies. They make design recommendations and manage the

provision of services as part of a team of professionals. They provide operational and technical

support to users of Assistive Technologies.


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Assistive technology technicians require knowledge of:

1. Assistive Technologies Communication, Mobility and Seating, Sensory, Environmental

2. Introduction to computers basic networking and applications.

3. Knowledge of disabling conditions and functional implications.

4. Knowledge of human biomechanics and activity analysis

5. Knowledge of Human Factors in Assistive Technology6. Knowledge of psychosocial factors

7. Knowledge of service delivery

Assistive Technology Technicians currently undertake a Certificate or Diploma in Assistive

Technology (Central Remedial Clinic/UCD).

3.3 Healthcare Information and Communication Technology ProfessionalsThere are professionals from a broad range of backgrounds working in this sector. There are no

formal career structures in place and those providing user and technical support as well as those

involved in systems analysis, system development and high level management posts are

generally employed on clerical grades.

3.4 Biomedical Engineering - Biomechanics/Biomaterials

Biomaterials include both living tissue and artificial materials used for implantation.

Understanding the properties and behaviour of living material is vital in the design of implant

materials. The selection of an appropriate material to place in the human body may be one of the

most difficult tasks faced by the biomedical engineer. Certain metal alloys, ceramics, polymers,

and composites have been used as implantable materials. Biomaterials must be non-toxic, non-

carcinogenic, chemically inert, stable, and mechanically strong enough to withstand the repeated

forces of a lifetime. Newer biomaterials even incorporate living cells in order to provide a true

biological and mechanical match for the living tissue.

Biomechanics applies classical mechanics (statics, dynamics, fluids, solids, thermodynamics,

and continuum mechanics) to biological or medical problems. It includes the study of motion,

material deformation, flow within the body and in devices, and transport of chemical constituents

across biological and synthetic media and membranes. Progress in biomechanics has led to the

development of the artificial heart and heart valves, artificial joint replacements, as well as a

better understanding of the function of the heart and lung, blood vessels and capillaries, and

bone, cartilage, intervertebral discs, ligaments and tendons of the musculoskeletal systems.

Cellular, Tissue and Genetic Engineering involve more recent attempts to attack biomedical

problems at the microscopic level. These areas utilise the anatomy, biochemistry and mechanics

of cellular and sub-cellular structures in order to understand disease processes and to be able tointervene at very specific sites. With these capabilities, miniature devices deliver compounds that

can stimulate or inhibit cellular processes at precise target locations to promote healing or inhibit

disease formation and progression.

Orthopaedic Bioengineering is the speciality where methods of engineering and computational

mechanics have been applied for the understanding of the function of bones, joints and muscles,

and for the design of artificial joint replacements.

Orthopaedic bioengineers analyse the friction, lubrication and wear characteristics of natural and

artificial joints; they perform stress analysis of the musculo-skeletal system; and they develop

artificial biomaterials (biologic and synthetic) for replacement of bones, cartilages, ligaments,tendons, meniscus and inter-vertebral discs. They often perform gait and motion analyses for

sports performance and patient outcome following surgical procedures. Orthopaedic


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bioengineers also pursue fundamental studies on cellular function, and mechano-signal

transduction.

Current Career Path, Core Roles and ResponsibilitiesThe majority of those with expertise in Biomechanics and Biomaterials will take up careers in

the device manufacturing industry or in academia. Career paths have some parallels withhospital-based Clinical Engineers, but structures are not as rigid. Roles and responsibilities are

based on opportunity and suitability.

3.5 The Industry Perspective from a Large Medical Device Manufacturer

Overview of TrainingThe ultimate responsibility of ensuring that an employee undergoes all the necessary training

programmes lies with the employees immediate Supervisor/Manager.

It is the responsibility of each employee to ensure successful completion of training and to

maintain and update their training files.

It is the responsibility of the immediate manager to ensure a training file is opened for new hires.

Training needs are identified by reviewing annual performance appraisals and identifying

common training needs. A training calendar is then published which offers a range of training

interventions for each level of the organisation. Training programs are generally carried out

through in-house training and use of external organisations. Each time a company employee is

trained on a particular job or procedure, the training is documented on the relevant training

record per Department Operating Procedures. These training records are retained in a centralisedlocation within each department.

The overall effectiveness of the training applied is evaluated at employees scheduled

Performance Review.

Course reports and feedback from participants and Management allow for evaluation of training

success.

Orientation

When an engineer joins the organisation it is required that they attend Orientation which

comprises of a one-day induction to the company. The areas covered during this training are:

Company Background / General Information on Company

Human Resources Department

Quality Systems

Chemical training

Security

Product Training

GMP and Dress Code Training

Tour of Facilities

QSR training

Fire Evacuation / First Aid training

Manual Handling


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Supervisor/Manager facilitates the orientation of new employees to the Company or to the

Department (new hires, transfers, promotions, change in position) to provide training in their

area of responsibility. The responsibility for ensuring that these programmes are documented

and Department specific Orientation Programs are also developed by the completed belongs

jointly with the department Supervisor/Manager and the employee.

The Department Operating Procedure training guideline is maintained by the Quality Systems

Department. Training on all procedures that are essential to a job function must be completed

within six months of joining the company. Then as necessary/required training is completed on

the other procedures specified on the matrix.

Executive/Management Training

When it is proposed that an employee move into a management role, appropriate training

programs are designed and conducted which will provide a full understanding of, and enhance

the executive Management participation. Individual and specific requirements are catered for

through the utilisation of internal and external courses.

Supervisor Training

When it is proposed that an employee should move into a supervisory role training programs are

designed and conducted which will develop the skills necessary for the supervisor to carry out

his/her tasks efficiently. Emphasis is placed on problem solving skills, presentation skills,

personal development, communication skills and interpersonal relationships. Particular training

in Statistical Techniques is given where applicable.

Clinical Training

All engineers should attend clinical training within 6 months of joining the company/moving

into an engineering role. This training should consist of attendance at procedures in the clinical

environment and attendance at lectures/seminars by leading clinicians.

Proposed Career PathsThe academic requirements for progression are as follows:

Junior Technician: Employee should be in process of studying a Certificate course in arelevant science/engineering discipline.

Technician: Employee should have a Certificate or Diploma in a relevantscience/engineering discipline.

Associate engineer: Employee should have a Diploma in relevant discipline plus 5 yearsminimum experience.

Level 1 engineer: Employee should have a Degree in a relevant science/engineeringbackground plus a minimum of 1 year experience.

Level 2etc.: Progression is based on experience/achievements.

The company has worked with the local IT college to formulate a Medical Device Engineering

course that runs from Certificate level to Degree level. The company sponsors 8 people approx.

each year to participate on this course. These people are selected based on performance and arigorous selection process that includes psychometric testing and interviews.


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3.6 ConclusionsOpportunities in Biomedical Engineering are diverse. Careers in Clinical Engineering in

particular are based around a formal career structure. It is the support of this career structure in

terms of training, education, professional registration and Continuing Professional Development

that provides the framework for this document. However, since all the branches of BiomedicalEngineering have a common route, the principles and structures proposed in this document can

be applied to all the branches of Biomedical Engineering.


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4.0 Professional Registration Scheme for Clinical Engineers

4.1 IntroductionThe background for the requirement for Professional Registration of Clinical Engineers and a

protocol for its implementation is set out below. This section is written in consideration of the

imminent Statutory Registration for Health and Social Professionals.

The European Communities Directive 89/48 deals with regulation of the professions within the

European Community. SI number 1 of 1991 sets out the Irish Statutory Instrument dealing with

the European communitys general system for the recognition of higher education diplomas

regulations as laid out in the EC Directive. This Statutory Instrument must be adopted by the

Irish Government and they have produced a document titled Statutory Registration for Health

and Social Professional. This document proposes the way forward, it deals with the first wave

of groups being registered, and the issues, which surround registration. This first group includes

Laboratory Technicians, Psychologists, Radiographers, Chiropodists etc. It also states that

registration also will include Physicists, Cardiac Catheterisation Technicians, ECG Technicians,

Public Analysts, Analytical Chemists and Clinical Engineering. While the time-scale is not clear

it is expected that registration will be implemented in the next two years. There will be a lead -

in time before all members will have to have attained the appropriate level of registration, this is

to allow arrangements made under the grandfather clause to be adhered to.

Within the Health Care professions this SI will apply to any Health Care staff who are Public,

Private or Industry based, and who have the potential to cause harm to patients. This clearly

applies to the Clinical Engineering profession.

It is incumbent upon the Clinical Engineers to put in place the structures to allow voluntary

registration of Clinical Engineers, thereby allowing as much time as possible for those currentlypractising to regularise their position and ensure that all those who are currently being recruited

will be in a position to register.

The philosophy underlying the issue of professional registration is that the public needs to be

protected and have confidence in those professionals in whom they place their trust. The

Clinical Engineering profession established a Voluntary Registration Scheme in 2001. The

Scheme is set out below.

4.2 Voluntary Professional Registration for Clinical EngineersProfessional Registration is a system whereby each individual member of a profession is

recognised by a specified body as competent to practice within that profession under a formalmechanism.

The scheme was initially developed by members of the profession and handed over to a

Registration Board on 18thFebruary, 2002. The structure of the scheme was developed in

cognisance of the Department of Health and Children document, "Statutory Registration for

Health and Social Professionals", 2001.

ScopeClinical Engineering describes the profession of those working at technician and graduate

engineer level in the clinical environment (in particular in hospitals and rehabilitation centres)

providing design, modification, research and development, management, user support and

maintenance of medical technology in the hospital environment. However it is designed to


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accommodate those working in Clinical Engineering in the broader sense, including those

working for medical equipment service providers.

This scheme is aimed at those professionals working as Clinical Engineers at both Technician

and Graduate levels.

Registration BoardThe composition of the Registration Board is based on the categories of members as set out in

the Department of Health Guidelines on Statutory Registration. The composition of the

Registration Board set out in Appendix 3.

Role of Voluntary Registration BoardWith time it is expected that this role will develop, however in the first instance it is set out as

below:

Code of Conduct and EthicsThe Code of Conduct of the Institution of Engineers of Ireland is adopted.

Maintain a Register of all persons deemed eligible to practice

The register is held in Microsoft Excel format and on a paper printout by the register

administrator. A copy (software and paper copy) is held and updated 6-monthly by the

Chairman of Registration Committee.

Application forms for registration are included in Appendix 6. Following agreement by

the Registration Board that candidates meet the criteria for Registration, their registration

will be confirmed in writing and their names included on the register.

Determination of the Criteria for RegistrationCriteria for Registration are:

attainment of appropriate professional standing, this will be based on theregistered titles of the Institution of Engineers of Ireland (IEI), that is, Engineering

Technician; Associate Engineer; Chartered Engineer.

undertaking of a relevant CPD programme

on-going professional activity within the parameters of the Code of Ethics

Term of Office, Registration Boards

The term of office for members of the Registration Board was agreed as being four years,

however for the purposes of continuity, up to half the members would step down after

two years.

Meeting Schedule, Registration Boards

Meetings are held every six months.

Professional Registration requires a Continuing Professional Development scheme to ensure that

the standard achieved at the time of registration is maintained. A suitable Continuing

Professional Development scheme is proposed.


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4.3 Continuing Professional DevelopmentA direct consequence of Professional Registration is Continuing Professional Development

(CPD).

Continuous Professional development can be defined as:

The systematic maintenance, enhancement and development of Knowledge and skill, and the

development of personal qualities necessary for the execution of professional and technical

duties throughout the practising engineering professionals career.

or

The Planned acquisition of knowledge, experience and skills required for professional practice

throughout ones working life.

CPD encompasses a large range of processes aimed at ensuring that professionals maintain and

update their skills and experience in their chosen field and that they keep fully abreast of

developments. CPD can comprise formal training, part-time off-site training and other

structured methods of maintaining and updating skills. It may or may not be formally examined.

CPD is normally recorded officially, whether by a professional body or the professional

him/herself, or both. It can be accredited by the professional body and can include a point system

whereby professionals aim to accumulate a specified number of points per period of time.

CPD and Statutory RegistrationCPD is now of critical importance in the context of Statutory Registration because of a growing

concern about the need continually to retain competence within a profession rather than merely

to attain competence at the beginning of ones professional life. CPD has become to be seen as

essential to any successful registration scheme. There is a danger that without CPD there would

be no formal requirement on the practitioner to keep abreast of developments in the professionand to upgrade and maintain their skills. Registration will provide a legislative framework for

the appraisal and approval of education and training courses, examinations, qualifications and

institutions, thus ensuring the proper development of education and training across the

professions. Registration will also provide a more widely informed and participative forum for

the administration and implementation of the EU directive on the Mutual Recognition of Third

level Qualifications in EU member states. The role of CPD in relation to statutory registration is

therefore an important one.

The Department of Health and Children in the Statutory Registration for Health and social

Professionals - Proposal for the Way Forward has indicated to the professional bodies that it is

prepared in principle to support financially an agreed system of CPD for health and social care

professions in the specific context of introducing a system of statutory registration.

The commitment of the Institution of Engineers of Ireland (IEI) to continuing Professional

Development (CPD) is reflected in it mission statement:

To promote the highest standard of professional engineering practice in order to serve

the needs of modern society.

More specifically, its goal is:

To set up and maintain professional standards of general formation, competence and

ethics for admission to and retention of membership of the Institution and for use of itsChartered Engineer, Associate Engineer and Engineering Technician registration titles.


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The role envisaged for the IEI in CPD is to champion the importance of CPD for engineering

professionals through the following undertakings:

Highlighting the importance of CPD;

Providing advice on CPD options; Providing a Help line;

Identification of CPD partners;

Development of awareness;

Undertaking quality assurance;

Promoting Best Practice CPD methodologies;

Providing a database of CPD programmes;

Publish regular CPD-related articles in the Journal.

The IEI fully supports the Continuous Professional Development of Technicians and Engineers

working in the Health Service and Medical Industries in Ireland.

The FrameworkFollowing an in-depth review of the models of Continuous Professional Development that are in

operation internationally by Engineering Organisations and Health Care Services it was decided

that it would be important to develop a CPD framework that could be approved and supported by

the International Association for continuing Education and Training (IACET) an internationally

recognised organisation for standards and certification for continuing education and training. I is

recommended that such a framework is adopted.

Registration

Each individual will register with his/ her Professional Registration Board. He/ she will start aLog Book to record the CPD activities carry out.

The Log Book will be made available to the registration board for review. Such a record will

verify the level CPD activities achieved by an individual over a period of time.

CPD recommendations made by the Registration Board following a review of the Log book shall

be facilitated by the employer.

CPD TargetContinuing Education Units CEU will be used to measure Continuous professional development.

One CEU is equivalent to ten contact hours of participation in an organised continuing education

experience. Each individual should have a minimum of 150 hours of CPD over threeyears.

This target should be comprise of an even balance of training in:Technical Development, ( 75 hours)

Managerial Development ( 45 hours)

Engineering in Society. ( 30 hours)

CPD Activities

The types of activities that constitute CPD include:

Type A:

Distance education, short courses, higher degrees

Type B:

Books, journals, manuals; on-the-job learning; private study

Type C:

Conferences, symposia, technical inspections and meetings


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Type D:

Preparation and presentation of courses, conferences, seminars and symposia; promoting

awareness of engineering; technical papers

Type E:

Providing professional Development of others, committee work

Type F:Industry involvement for those in academic positions

CPD activities may be organised by recognised professional organisations where the content or

the focus of the activity contributes to the Clinical Engineering knowledge base. Such

organisations include The Biomedical Engineering Association of Ireland, Health Informatics

Society of Ireland, Association of Physical Scientists in Medicine, Institution of Engineers of

Ireland etc.

The allocation of CEUs for specific activities is to be defined by the professional registration

board.

4.4 ConclusionsThere is a need for Clinical Engineers to be professionally registered and there must be a

mechanism in place for the maintenance of registration. To ensure Registered Clinical

Engineers are appropriately educated and trained a formalised training and education scheme is

proposed.


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5.0 Structure of the Biomedical Engineering Training Scheme

5.1 Introduction

Since the Department of Health and Children requirement for Statutory Registration impactsprimarily on those working in the hospital and rehabilitation environment, this proposal

describes different levels of training to various clinical engineering career grades in the hospital

and rehabilitation environment. The work carried out for this proposal identified the need for a

review of career grades to ensure that:

entrance requirements take into account the changing profile of those applying fortechnician grade posts as well as the likely changes in education provision based on the

Bologna Declaration;

there is a formalised career path across the grades;

that the Clinical Engineering professional is acknowledged in his or her own right, by titleat all levels.

Since Professional Registration is based on the Institution of Engineers of Ireland registered

titles as per the Charter Amendment Act of 1969, it is also reasonable to associate career

progression with attainment of professional standing as per the registered titles.

This Section outlines the structure of a Training and Education Programme specifically designed

for Clinical Engineers. It is based on the experience of those currently working in the field,

international developments regarding Clinical Engineering, current and proposed professional

structures and benchmarking across the international approaches to the professional formationand development of Clinical Engineers as outlined in Section 6. The detail of the curriculum

and an overview of currently available Biomedical Engineering courses in Ireland are presented

separately in Part B.

5.2 Proposed Career PathsAs outlined above, no structured training is currently required for progress through current

grades for either Clinical Engineering Technicians or graduate Clinical Engineers. It is proposed

that regulated, structured training will become a requirement for progress through the

employment grades. It is also proposed that this training should be in accordance with the

professional structures which have already statutory recognition relevant to Clinical

Engineering, that is through the Institution of Engineers of Ireland (IEI). One of thefundamental aims of the Institution of Engineers of Ireland is "to establish and maintain

standards of engineering education and training". This proposal establishes standards for

Clinical Engineering Education and Training and promotes the maintenance of those standards.

The development of this proposal was carried out with the specific support of the Clinical

Engineering Professional Vocational Group. This group worked to promote the integration of

the recommendations of the proposal for "Professional Formation and Development of Clinical

Engineers in Ireland" into a proposal for "Professional Development of Clinical Engineering

within the Irish Health Service". (Thisdocument is available fr om John Mahady, Secretary,

Cli ni cal Engineering Professional Vocational Group. John may be contacted as foll ows:

John M ahady, Chief Cl in ical Engineer ing Technician, Adelaide, Meath and National

Chil dren's Hospital, Tall aght, Dublin 24 ([email protected])). Issues such as specific


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salary scales, terms and conditions of employment are negotiated by trade union vocational

groups, however, vocational groups look to and reference the relevant professional bodies for the

identification of standards for education and training.

This Proposal for Professional Formation and Development of the Clinical Engineer focuses on

achievement of practical and educational competency based on the Guidelines on CurriculumDetail set out in Part B.

Reference is made to the proposed Career Grades, however until they are implemented career

development may be mapped to the current grades. Entry level and progress through these

grades is dictated by education and training as laid out below. Figures 1 and 2 summarise the

relationship between career grades and education and training requirements.

Notes on Figure 1:

Mapping to the new grades involves Transition and Equivalency. Transition refers tothe period when a technician is undergoing further training and education to meeting the

requirements of engineer status.

Progress through the career grades will be based on education and training progress.

It is expected that after a period of time when all Clinical Engineering professionals willhave undertaken or be in the process of undertaking formal and structured training, that there

will not be a need for the transition titles.

5.2.1 Clinical Engineering Professionals Entering from a Background in Industry or

Academia

Inference of equivalence to years of training and education may be made for those entering the

Clinical Engineering profession from a relevant industrial or academic background. However,

recognition of professional standing (via relevant IEI grades as set out in Figure 2) will be

required and the Core Certificate in Clinical Engineering (Part B, Section 4 and 4.1) will also be

required. A period of grace may be allowed to achieve these requirements.


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Mapping

Current Grades Proposed Grades

Figure 1:

Mapping of Current Clinical Engineering Grades to Proposed Clinical Engineering CareerGrades

Basic Grade

Clinical Engineering

Technician

Senior Grade


Technician

Principal


Technician

Chief


Technician

Basic Grade

Physicist (those

working as Clinical

Engineers only)

Senior Grade

Physicist (those

working as Clinical

Engineers only)

Principal

Physicist(those

working as Clinical

Engineers only)

Chief

Physicist (Clinical

Engineering only)


Operative (New

Grade)

Prin/Chief CET

(transition) /

Senior Clinical

Engineer

Principal

Clinical Engineer

Chief

Clinical Engineer


Technician

(CET)(transition)/Trainee Clinical

Sen CET (transition)

/

Clinical Engineer

Equivalent

Equivalent

Equivalent

Equivalent

Transition

Transition

Transition

Transition


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Figure 2 provides an outline of training and education requirements for career progression

through proposed career grades. As outlined in the re-structuring Proposal in Appendix 4, the

detail below applies primarily to new entrants to the profession. A period of grace will be

negotiated to allow for procedures to be put in place to transfer those on the current career

grades to the proposed career grades. The Training referred to in Figure 2 primarily refers to

structured training as set out in the remainder of this Section with curriculum detail based on theguidelines in Part B. Persons with experience in Biomedical Engineering outside of the Public

Sector career grades who wish to do so, may have their experience judged as being equivalent to

the structured training as set out below; however the educational qualifications as set out below

and achievement of registered titles must be attained.

Career Grade Title Entrance Qualification


Operative

Certificate


Technician/Trainee

Clinical Engineer

3 year diploma in Biomedical, Computer, Electrical,

Electronic or Mechanical Engineering or equivalent

Senior Clinical


3 year diploma in Biomedical, Computer, Electrical,


+ 2 years training with associated education

Clinical Engineer 4/5 year degree in Biomedical, Computer, Electrical,


Principal Clinical


Chief Clinical


Senior Clinical

Engineer

3 year diploma + 4 years training + Core Clinical

Engineering Certificate + Associate Engineer, IEI

-------------------------------

4/5 year degree in Biomedical, Computer, Electrical,

Electronic or Mechanical Engineering or equivalent+ 4 years training with associated education + Core

Clinical Engineering Certificate

-------------------------------

MSc in Biomedical, Computer, Electrical, Electronic

or Mechanical Engineering or equivalent + Core

Clinical Engineering Certificate + 2 years training +MIEI

Principal Clinical

Engineer

MSc in Biomedical, Computer, Electrical, Electronic


Clinical Engineering Certificate + 4 years training

and Chartered Engineer StatusChief Clinical Engineer MSc in Biomedical, Computer, Electrical, Electronic


Clinical Engineering Certificate + 4 years and

Chartered Engineer Status

Figure 2: Outline of training and education requirements for career progression through

proposed career grades.


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5.3 Overview of TrainingA Trainee will normally be employed in the Training Centre. He or she will undergo a 4 year

training period including education, supervision and experiential training. He or she will select

two of the Specialisation Subjects. They will follow an associated course of study to a level

dependent on their entrance qualifications. Education is composed of the Core Clinical

Engineering Certificate and course work associated with the selected Specialisation Subjects.The curriculum guidelines are presented in Part B. During the training period which has a total

duration of four years, the trainee will follow a plan of supervised experiential training for

achievement of the competencies as set out in Part B. The training plan will be developed by the

Training Co-ordinator. The first two years of training are referred to as Basic Training and

during this time the trainee will always be supervised. During the following two years, the

Advanced Training period, some limited, clearly identified unsupervised work may be

performed. A log-book will be maintained throughout training and practical skills will be tested,

the Trainee will be interviewed at the end of each of the periods of Training to ensure that a

reasonable standard of competency has been achieved.

Overall responsibility for accreditation of various aspects of the training scheme will be held by

the Clinical Engineering Professional Development Panel which will be appointed by the

Executive Committee of the Biomedical Engineering Division of the Institution of Engineers of

Ireland which already has significant experience in this area.

The Specialisation Subjects are listed below:

Medical Electronics and Equipment Management

Information Management and Technology

Rehabilitation Engineering

Radiotherapy Technology

Diagnostic Imaging Technology Expert Systems/Decision Support Systems

Biomaterials

Biomechanics

Figure 3 below provides an overview of the Training Scheme.


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34

*

Trainee

Educational

Institution(s)

Industry - Manufacturer

Hospital/Rehab Centre

Industry - Supplier 2 Specialisation

Areas

Basic

Training

(2 years)

Core Clinical

Engineering

Certificate

Figure 3: Overview of Training Scheme

Training Centre

Experiential

Edu


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5.4 Management of the Training Scheme

Management of the Training Scheme will involve significant interaction with the Institution of

Engineers of Ireland, and it will require a commitment from the employers to support those

acting at various levels in the management of the Training Scheme.

Figure 4 provides an overview of the Training Scheme Management Structure.


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36

Board of Examiners, IEI

Clinical Engineering Professional

Development Panel

Exec Committee of Biomedical

Engineering Division, IEI

Educational Institutions

Biomedical Industry

Manufacturers

Medical Equipment

Su liers


Professionals

Training Moderator

- Moderates whole Training Scheme

Training Co-ordinator

(1 per Training Centre)

Training Supervisor

(1 for each Trainee)

Trainee

Figure 4: Overview of Management Structure for Training Scheme

Employer

RepresentativesBoard of

Examiners, IEI


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37

Ownership/Accrediting BodyA Clinical Engineering Professional Development Panel will be appointed by the executive

committee of the Biomedical Engineering Division of the Institution of Engineers of Ireland.

The panel will be composed of members of the profession, representatives of the employers,

educational providers and representatives from various bodies representing Clinical Engineers.

The term of office for members of the Clinical Engineering Accreditation Panel will be fouryears, however for the purposes of continuity, in the first instance up to half the members would

step down after two years.

The role of the Clinical Engineering Professional Development Panel will be:

To accredit educational modules

To appoint the Training Moderator

To accredit the Training Co-ordinators and Supervisors

To assess trainees at the end of the Advanced Training Period

To ensure a high standard of training and practical education is maintained

To liaise with trainees via the Training Moderator.

Appointment to the Clinical Engineering Professional Development Panel will be by nomination

from representative bodies. Each member will have a nominee who will take their place should

they need to retire from the panel. The panel will convene once in each of the academic

quarters.

The Training ModeratorThe role of the Training Moderator is to manage the Training Scheme on a national level and to

liaise with the Clinical Engineering Professional Development Panel, the Training Co-ordinators

and Training Supervisors. He or she shall also assess some aspects of the trainees practical skillsat the end of the Basic and Advanced Training Periods.

The Training Mod

protocol ce ireland

Documents