Questionnaire 4:

Biomedical/Clinical Engineering Training

The goal of this part of BIOMEDEA is to gather the information necessary to write a survey on
BME/CE Training in Europe and to establish guidelines for the minimum requirements for the
training of Clinical Engineers in Europe.
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. They provide
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 (a
definition of the Biomedical Engineering Division, The Institution of Engineers of Ireland).
The American College of Clinical Engineering (ACCE) defines clinical engineering as: “A Clinical
Engineer is a professional who supports and advances patient care by applying engineering and
managerial skills to healthcare technology.” Clinical engineers generally have backgrounds in
engineering applied to the healthcare industry. They have completed a period of defined education in
engineering or related disciplines, in addition to defined experience as practicing clinical engineers
leading to mastery of a defined core of knowledge.
In recognition of the need for a formal structure for the full range of Clinical Engineers working in
Europe, guidelines for the professional formation and development of the Clinical Engineer need to be
developed. The guidelines need to contain a Protocol for Professional Formation and Development of
Clinical Engineers, guidelines for educational providers on curriculum details relating to the different
stages of career development and the associated training programmes.
Also, information shall be provided on current opportunities for Clinical Engineering training in
Europe.
This questionnaire aims at collecting data about the minimum requirements for training that you feel
each Clinical Engineer should at least have before being allowed to work independently in a hospital
environment and on possible structures for the harmonization of training throughout Europe.
In the UK, there are 3 grades of training:
Grade A is the initial training grade, and for clinical engineers it involves two years in-service training,
incorporating an accredited MSc and leading to the Institute of Physics and Engineering in Medicine
(IPEM) Diploma.
Upon completing Grade A training, the engineer can apply for a post at Grade B, which is the main
professional grade.
The clinical engineer will then be able to develop his/her job, take on more responsibility or move to
another department to widen his/her experience. By following IPEM's Programme of Advanced
Training and Responsibility (PATR) for a further four years, the engineer may achieve IPEM
Corporate Membership, the professional qualification, and will then be eligible for a Senior Grade B
post.
All senior scientists working in the new NHS must be state registered and will be eligible for
registration following two years of initial training and the first two years of PATR.
Having relevant qualifications and experience the CE may be able to enter at Grade B, but will need
specific clinical training and experience to become state registered and to qualify for more senior posts.
Grade C is the consultant level and the CE could be promoted to this because of his/her individual
ability or experience, or because he/she is taking on wider responsibilities, such as managing a
department.

1. Do you think that this model is suited to be adopted as the European model for Clinical
Engineering Training?
Yes: ….. No: X…..
Other European countries have another structure in health care system and other tradition in
qualifications. It would be interesting to learn about the procedures/requirements of the private
health sector in UK . Trend in Germany is towards privatization of hospitals!
2. Which modifications do you suggest for the future European model for Clinical Engineering
Training?
Is there any common European model from the past?
3. Which entrance requirements do you consider sufficient for the Clinical Engineering training
program?
Without details about such a training program we cannot discuss about entrance requirements.

1. Bachelor of Science in physics or any engineering discipline: Yes: …. No: ….

2. Bachelor (of Science) in Biomedical Engineering: Yes: …. No: ….X
3. Master of Science in physics or any engineering discipline: Yes: …. No: ….
4. Master (of Science) in Biomedical Engineering: Yes: …. No: ….
5. Additional requirements? Yes: …. No: ….
Please specify: ……….
According to the Biomedical Engineering Division of The Institution of Engineers of Ireland, Clinical
Engineers are employed at various grades within the Health Care System. In various circumstances
depending on personnel levels and patient load, there is no strict demarcation between the specific roles
carried out by the different grades, however the activities at the top of the chart below are weighted
towards the "graduate" or Chartered Engineer while those at the bottom are weighted towards the
"technician" or Associate Engineer.
Chartered Engineer
1. Specifically assist hospital personnel in defining their problems and needs in
connection with biomedical instrumentation and its management
2. Provide and actively part-take in strategic planning with regard to a hospital's
complement of medical equipment
3. Fulfill a risk management role with regard to medical equipment
4. Design and supervise the construction and testing of special-purpose electronic
equipment when requirements cannot be met by commercially available apparatus
5. Conduct continuing study and research in contemporary developments, design, and
construction methods as applied to medical and health care
6. Develop methods for calibrating and performance-checking biomedical
instrumentation, maintaining a set of fundamental electrical standards and
instruments adequate for this work
7. Supply background in physics, chemistry, mechanical engineering, control theory,
and mathematics provide informal instruction in theory and practice to
instrumentation section specialists for improved understanding of current
developments
8. Supply background knowledge in national and international standards and
guidelines pertaining to the application of medical devices and instruments
9. Provide fiscal analysis of technical issues relating to medical equipment
10. Act as a consultant and adviser to research and clinical specialists in negotiating
development projects and recommending solutions to instrumentation and
electrical- safety problems
11. Represent the hospital at conferences on biomedical instrumentation and electrical
safety and in dealing with engineers from manufacturers and other organizations
12. Design of independent living centers which allow physically or neurologically
disabled individuals to live independently through the use of assistive services
13. Creation and implementation of augmentative communication systems which give
the ability to communicate to disabled individuals
14. Design materials which help improve the quality of life and health of a client
15. Modification of a motor vehicle such that a disabled client can independently
operate it
16. Represent the hospital in dealings with outside organizations involving professional
engineering responsibilities
17. Develop and conduct instructional courses in the application of instruments and
devices
18. Implementation of a hospital's electrical safety program for medical instrumentation
19. Implementation of a maintenance program for medical instrumentation
Associate Engineer

4. Do you suggest any modifications to the above list of CE roles and their weight?

Many of the above mentioned items are not applicable in German hospitals because of
different health care system, different hospital finanziation and different professional groups
acting: rehabilitation engineering tasks like prosthetics are fullfilled by “Orthopädiemechanik-
Meister”, optics by optricians, hearing aids by respective technologists etc. In-house
design/manufacture of medical devices is nearly completely forbidden unless it is just for a
specical single patient (and outside orthopedics the insurance companies do not pay for
individual designs).

Different grades of CEs are:

 1. Trainee clinical engineer: Bachelor in Biomedical, Computer, Electrical, Electronic or
Mechanical Engineering or equivalent
2. Basic grade CE: Bachelor in Biomedical, Computer, Electrical, Electronic or Mechanical
Engineering or equivalent, plus + 2 years training with associated education,
or
Master degree in Biomedical, Computer, Electrical, Electronic or Mechanical
Engineering or equivalent
3. Senior grade CE: Bachelor degree + 4 years training + Core Clinical Engineering
Certificate
or
MSc in Biomedical, Computer, Electrical, Electronic or Mechanical Engineering or
equivalent + Core Clinical Engineering Certificate + 2 years training

4. Principal CE: MSc in Biomedical, Computer, Electrical, Electronic or Mechanical

Engineering or equivalent + Core Clinical Engineering Certificate + 4 years training

5. Chief CE: MSc in Biomedical, Computer, Electrical, Electronic or Mechanical

Engineering or equivalent + Core Clinical Engineering Certificate + 6 years training

5. Do you agree to these grades?

Yes: …. No: X, because “training” is not specified, and other countries do not have any
history of “professional charter” ….
6. If no, which modifications do you suggest?
First define objectives in the sense of knowledge and experience, and the modalities to
check/examine them. And then care for uniform CE occupational rules all over Europe
(without a law dictating dedicated professional levels no German hospital will be interested in
a paper of “charter”. Until today the professional experience proven by explicit references
(“Arbeitszeugnis”) of former employers has had a higher relevance than a certificate from a
professional association. Just for youngsters (= beginners) the university degree in conjunction
with the diploma supplement defines the qualification.)
7. Should there be an accreditation requirement for institutions offering CE training?
Yes: …X. No: ….
 The training will consist of the core clinical engineering and the specialization in two
specialty areas.

8. Do you agree to this statement?

Yes: ….. No: X…..
If no, please specify: …”Specialization in 2 speciality areas” does not take into account any
BME/CE specialization in the degree course preceeding. And for somebody without previous
qualification in BME/CE just 2 are not enough. What if the person will change to a job in
another hospital and need another speciality there?

According to the ACCE, the core areas of Clinical Engineering training are:
1. Management 32 %
2. Technology Assessment 15 %
3. Regulatory/QA Issues 11 %
4. Repair/Systems Thinking 6%
5. Risk Management/Safety Issues 9%
6. Education 8%
7. Product Development 8%
8. Miscellaneous Topics 11 %

9. Do you suggest any modifications to this list of core CE areas?

Add the amount in units of study time…………

The contents of the core areas are:

I. Management
A. Overall Clinical Engineering Program Management
B. Technical Supervision
C. Financial Management
D. Service Contract Management
E. Computer Management Systems
F. Help Desk/Call Tracking

II. Technology Assessment

A. Technology Assessment
B. Product/Vendor Selection
C. Capital Planning
D. Clinical Trials Management
E. Building Plan Review
F. Building Design

III. Regulatory/QA Issues

A. Regulatory Compliance
B. Quality Assurance
C. Healthcare Performance
D. Product/Systems Quality Management

IV. Repair/Systems Thinking

A. Equipment Repair
B. Equipment Installation
C. Other Facility Tasks

V. Risk Management/Safety Issues

A. Incident Investigation
B. Hospital Safety
C. Risk Management/Legal Issues
D. Radiation Safety
E. Medical Gas Testing
 F. Emergency Preparedness

VI. Education
A. Technician Education
B. Engineering Education
C. Other Education
D. User/Nurse Training

VII. Product Development

A. Product Research and Development
B. Documentation Development
C. Medical Device Design
D. Other Product Development
E. Product Sales and Support

VIII. Miscellaneous Topics

A. Consulting in Healthcare
B. Information Technology applied to Healthcare
C. EMI/EMC Consulting
D. Expert Witness
E. Forensic Medical Technology Related Investigation
F. Legal Consulting
G. International Healthcare
H. Chief Technology Officer
I. Healthcare Administration
J. Telecommunications in Healthcare

10. Do you suggest any modifications to this list of contents for the core CE areas?
The list, esp. no. VIII seems to give just examples/keywords but not all “subjects of study”…
So it must be discussed………
The core areas of Clinical Engineering according to the Biomedical Engineering Division of The
Institution of Engineers of Ireland are:
1. Qualified appraisal of equipment support and safety requirements. This ensures that each asset
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;
2. Project Management at electromedical equipment level;
3. The management of service contracts and the supervision and control of external equipment
service suppliers, where it is not feasible for this same support to be directly provided by the
Clinical Engineering Department;
4. Financial management and accountability for all medical equipment assets supported by Clinical
Engineering Department regarding costs and service;
5. Provision of technical advice and equipment training for clinical users;
6. Technical investigation of injury / death incidents where medical equipment is implicated;
7. Documenting and filing of all records pertaining to the support of this equipment, with
integration to the hospital asset register. This facilitates the extraction of statistical data and
preserves full service records relating to each item of equipment;
8. Provide and implement an extensive preventative maintenance program for clinical, pathology,
radiology and radiotherapy assets;
9. Implementation of Risk Management and Health and Safety policies for medical equipment
assets which address the health service obligations and reduces the potential for patient injury;
10. Provision of financial projections and reports concerning the support of the various categories of
medical equipment;
11. Provision of advice to hospital administration regarding the purchase, application,
commissioning, support and eventual decommissioning of all Clinical Engineering equipment;
12. Preparation of equipment technical specifications for tender purposes and the subsequent
evaluation of prospective equipment as part of the standard purchasing tender procedure;
13. Continuous development of service / support initiatives within the department that pertain to
medical equipment management and will enhance the facilities provided by the hospital in the
context of user / patient satisfaction and financial efficiency;
14. Liasing with medical staff, service suppliers and device manufacturers to develop or enhance
medical devices or establish new protocols for the optimum use of technology from a clinical
perspective;
15. To contribute to Research & Education programmes in the hospital environment;
16. To be a source of advice on Standards and Legislation impacting on medical technology;
17. Contribution to Industry and Commerce through co-ordination of for example, Beta test sites.

11. Do you suggest any modifications to this list of core CE areas?

That seem to be nearly all tasks, CEs could take over in their jobs, not study subjects which
every CE must learn before. …………
The specialty areas are:
1. Medical Electronics and Equipment Management
2. Information Management and Technology
3. Rehabilitation Engineering
4. Radiotherapy Technology
5. Diagnostic Imaging Technology
6. Expert Systems/Decision Support Systems
7. Biomaterials
8. Biomechanics

12. Do you suggest any modifications to this list of specialty areas?

List depends on individual hospital and will change with advancement of medical science.
What has medical electronics in common with equipment management? (2) and (6) can
belong together. Same as (3) and (8). Total list must be discussed.
…………

Management/Administration of Training

For the management of the CE training there should be a European Clinical Engineering Professional
Development Panel (ECEPDP).
Representatives to the Panel should come from:
- the CE Training Committees of the IFMBE and EAMBES
- the Board of Examiners of the IFMBE and EAMBES
- the European Educational Institutions
- the Employers
- the Biomedical Industry and Medical Equipment Suppliers
- the Clinical Engineering Professionals
Between the ECEPDP and the trainee there is the Training Co-ordinator (1 per Training Centre) and
the Training Supervisor (1 for each Trainee).

13. Do you agree to this Management/Administration Structure for the CE Training?

Yes: ….. No: …X..
If not, which modifications do you suggest? Too many questions are left open!
What are the tasks, the competences of ECEPDP? Election of its representatives? (e.g. who –
in this sense – is “Industry” and “Supplieres”? “Employers”? Until now the German Hospital
Association is not willing to define CE standards or even discuss about technical
qualifications. What’s meant by “Europ. Educational Institutions”? Every single university /
institute for continuous education?). Without support of the ministries of education, of
occupation and of health of all European countries I see no chance to establish a professional a
certification system for CEs. And even if the hospitals are forced to employ just certified staff
– they will outsource CE services as soon as they have to pay for additional qualification.
…………….

14. Are there any other important issues with regard to European CE training requirements
that have not been mentioned in the questionnaire?
Please specify:
CE is more than the CE department or engineer in hospital.
CE training requirements must be integrated in the respective Bachelor courses, accredited
together with the total degree.
What about continuous education (by printed and electronic journals , workshops,
conferences, congresses etc.)? Role of the professional associations?
What about the qualification of existing CEs? No – German – hospital will be willing to pay
an additional training. In contrary, if the CE announces that he will do a training the hospital
administration is afraid of being asked for a higher salary. As long as no severe incidents due
to faults/incompetence of CEs are reported the German government will not see any reason
for a qualification initiative. ………….