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Global atlas of
medical devices
DEVELOPMENT
OF MEDICAL HUMAN RESOURCES
FOR MEDICAL DEVICES
DEVICE POLICIES, The role of biomedical
ACTION PLANS
Research
WHO MEDICAL DEVICE TECHNICAL SERIES
and development
*in development
2011 2017
Medical device
innovation
WHO Medical device tecHnical series
Management
Research and development
Medical devices
Regulation
Regulation
Assessment
2017
PROCUREMENT
Ch
MEDICAL DEVICE
ild
ho
od
PROCESS DONATIONS:
Co
lon
RESOURCE GUIDE
Le u
CONSIDERATIONS FOR
kem
ia L
PROVISION
Prostate
2016 2017
2011 2011
*in development
ISBN 978-92-4-156547-9
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Preface.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Medical device technical series – methodology. . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Acknowledgements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Executive summary.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3 Professional associations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
3.1 Purpose of professional associations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
3.2 Global biomedical engineering associations . . . . . . . . . . . . . . . . . . . . . . . 55
3.2.1 International Union for Physical and Engineering Sciences
in Medicine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
3.2.2 International Federation for Medical and Biological Engineering. . . . . 56
4 Certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
4.1 Defining certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
4.2 International certification of biomedical engineers . . . . . . . . . . . . . . . . . . 63
4.3 Certification by region . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
4.3.1 Certification in Africa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
4.3.2 Certification in the Americas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
4.3.3 Certification in Asia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
4.3.4 Certification in Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Annex 7 Current and proposed profiles for ILO for biomedical engineers and
biomedical engineering technicians. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218
References.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222
Health technologies are essential for a fully functioning health system. Medical devices,
in particular, are crucial in the prevention, diagnosis, treatment and palliative care of
illness and disease, as well as patient rehabilitation. Recognizing this important role of
health technologies, the World Health Assembly adopted resolution WHA60.29 in May
2007. The resolution covers issues arising from the inappropriate deployment and use of
health technologies, and the need to establish priorities in the selection and management
of health technologies, specifically medical devices.
This publication has been produced in accordance with the request to the World Health
Organization (WHO) by Member States in the WHA60.29.(1) The resolution:
(2) to formulate as appropriate national strategies and plans for the establishment
of systems for the assessment, planning, procurement and management of health
technologies, in particular medical devices, in collaboration with personnel involved in
health-technology assessment and biomedical engineering…”
One of WHO’s strategic objectives is to “ensure improved access, quality and use
of medical products and technologies.” To meet this objective, WHO and partners
have been working towards devising an agenda, an action plan, tools and guidelines
to increase access to good quality, appropriate medical devices. The Medical device
technical series developed by WHO already includes the following publications:
• Development of medical devices policies(3)
• Health technology assessment for medical devices(4)
• Health technology management
›› Needs assessment process of medical devices(5)
›› Procurement process, resource guide(6)
›› Medical devices donations, considerations for solicitation and provision(7)
›› Introduction to medical equipment inventory management(8)
›› Medical equipment maintenance overview(9)
›› Computerized maintenance management systems(10)
And will include, in 2017, the following publications, which are under development:
• Human resources for medical devices (the present document)
• Model regulatory framework for medical devices
• Priority medical devices for cancer management
The first documents in the Medical device technical series were written by international
experts in their respective fields, and reviewed by members of the Technical Advisory
Group on Health Technology (TAGHT). The TAGHT was established in 2009 to provide
a forum for both experienced professionals and country representatives to develop
and implement the appropriate tools and documents to meet the objectives of the
Global Initiative on Health Technologies (GIHT). The group met on three occasions.
The first meeting was held in Geneva in April 2009 to prioritize which tools and topics
most required updating or developing. A second meeting was held in Rio de Janeiro in
November 2009 to share progress on the health technology management tools under
development since April 2009, to review the current challenges and strategies facing the
pilot countries, and to hold an interactive session for the group to present proposals for
new tools, based on information gathered from the earlier presentations and discussions.
The last meeting was held in Cairo in June 2010 to finalize the documents and to help
countries develop action plans for their implementation. In addition to these meetings,
experts and advisers have collaborated through an online community to provide
feedback on the development of the documents. The concepts addressed in the Medical
device technical series were discussed further during the First Global Forum on Medical
Devices in September 2010. Stakeholders from 106 countries made recommendations
on how to implement the information covered in this series of documents at the country
level.(13) These extensive discussions formed the background for the current book in
the series: Human resources for medical devices.
For the development of the current book the following activities took place:
1. Global BME surveys, the outcomes of which are highlighted in this book and results
presented in the WHO medical devices website and in the WHO Global Health
Observatory.(14)
Global atlas of
medical devices
DEVELOPMENT
OF MEDICAL HUMAN RESOURCES
FOR MEDICAL DEVICES
DEVICE POLICIES, The role of biomedical
ACTION PLANS
Research
WHO MEDICAL DEVICE TECHNICAL SERIES
and development
*in development
2011 2017
Medical device
innovation
WHO Medical device tecHnical series
Management
Research and development
Medical devices
Regulation
Regulation
Assessment
2017
PROCUREMENT
Ch
MEDICAL DEVICE
ild
ho
od
PROCESS DONATIONS:
Co
lon
RESOURCE GUIDE
Le u
CONSIDERATIONS FOR
kem
ia L
PROVISION
Prostate
2016 2017
2011 2011
*in development
To collect the information, an electronic survey was tailored for each of the four stages of
the project. Surveys were distributed through a network of over 3200 BME professionals
using the WHO medical devices Listserv tool.(16) Survey participants were encouraged
to resend the survey to other key informants with the intention of collecting a greater
amount of current global information.
The surveys were consistently structured into three sections: (1) country profile;
(2) educational institutions; and (3) professional societies. An additional section (4)
was added to the 2015 version targeting international organizations and including
questions regarding female presence within the profession. The survey was designed
so respondents only completed the section for which they held information, ensuring
that information was supplied by national health authorities or similar for section 1,
BME academics for section 2, professional societies secretariats for section 3 and
international organization focal points for section 4. For the data analysis, 140 fully
completed survey forms were retrieved from the data collection tool (WHO DataForm).
(17) Additional information was collected from IFMBE reports, other BME professional
organizations and web-based inquiries.
The collected data are available at the WHO medical devices site: http://www.who.int/
medical_devices/support/en/ and the density of biomedical engineers is available on
WHO Global Health Observatory (GHO) as a new indicator of global health: http://apps.
WHO intends to collect data annually and expects to retrieve data from unreported
countries, validate reported data, maintain accurate estimates and record global trends
in BME.
3. The Second Global Forum on Medical Devices, held in November 2013, included
a session focused specifically on human resources for medical devices and the
required survey methodology addressing the role of the biomedical engineer.(18)
The forum had diverse country representation, with a total of 572 participants
representing 103 countries.
4. Formal discussions about the role of BME in Hangzhou, China, at a global BME
summit on 23 October 2015, following the First International Clinical Engineering
and Health Technology Management Congress, which was sponsored by the
Chinese Society of Biomedical Engineering. The congress was organized by a
leadership panel of 25 representatives of national and international organizations
related to BME. The group produced a document that lays out the scope of
professional activities of biomedical engineers and provides a rationale and evidence
for the recognition and proper classification of BME.(19)
5. Review of whole text by international experts on biomedical engineering.
Scope
It should be noted that there are many professionals who use medical devices, for
example radiographers, sonographers, laboratory technicians, surgeons, anaesthetists,
ophthalmologists, orthopaedists, neurologists, radiologists, radiotherapists, pathologists,
nurses, and almost all health-care workers. And, there are others who manage their
supply, such as procurement and logistics officers, others that evaluate them as health
economists, others that support the design and manufacture, including engineers,
industrial designers, chemists, physicists, etc.
This publication addresses only the role of the biomedical engineer in the development,
regulation, management, training and use of medical devices in general, and it should
Definitions
Recognizing that there are multiple interpretations for the terms listed below, they
are defined as follows for the purposes of this publication of the WHO Medical device
technical series.
Health technology: The application of organized knowledge and skills in the form of
devices, medicines, vaccines, procedures and systems developed to solve a health
problem and improve quality of life.(20) It is used interchangeably with health-care
technology.
Medical equipment: Used for the specific purposes of diagnosis and treatment of
disease or rehabilitation following disease or injury; it can be used either alone or in
combination with any accessory, consumable or other medical equipment. Medical
equipment excludes implantable, disposable or single-use medical devices. Medical
equipment is a capital asset and usually requires professional installation, calibration,
maintenance, user training and decommissioning, which are activities usually managed
by clinical engineers.(22)
Health technology assessment (HTA): The term refers to the systematic evaluation of
properties, effects and/or impacts of health technology. It is a multidisciplinary process to
evaluate the social, economic, organizational and ethical issues of a health intervention
or health technology. The main purpose of conducting an assessment is to inform a
policy decision-making process.(23)
Clinical engineer: In some countries, this defines the biomedical engineer that works in
clinical settings. The American College of Clinical Engineering defines a clinical engineer
as, “a professional who supports and advances patient care by applying engineering and
managerial skills to health care technology”.(25) The Association for the Advancement
of Medical Instrumentation describes a clinical engineer as, “a professional who brings
to health-care facilities a level of education, experience, and accomplishment which will
enable him to responsibly, effectively, and safely manage and interface with medical
devices, instruments, and systems and the user thereof during patient care…”.(26)
Rehabilitation engineers: Those who design, develop and apply assistive devices and
technologies are those whose primary purpose is to maintain or improve an individual’s
functioning and independence to facilitate participation and to enhance overall well-
being.(27)
The publication Human resources for medical devices: The role of biomedical engineers
was developed under the coordination of Adriana Velazquez Berumen, WHO Senior Advisor
and Focal Point on Medical Devices, with the supervision of Gilles Forte and Suzanne Hill in
the WHO Essential Medicines and Health Products Department, and from James Campbell
and Giorgio Cometto, in the Health Workforce Department under the Health Systems and
Innovation Cluster of the World Health Organization.
Each chapter of the book was authored by an expert in the field, along with contributions
from collaborators from different regions of the world and diverse sectors of the BME field
during 2014 and 2015.
The BME 2015 survey was developed in January 2015 by Daniela Rodriguez-Rodriguez
and Megan Smith. The first results were presented in the World Congress on Biomedical
Engineering and Medical Physics in Toronto, June 2015, and are included in this publication.
The first draft of this book was edited in 2015, for discussion at the First International Clinical
Engineering and Health Technology Management Congress in China.(29)
WHO is grateful to the following chapter coordinators for their contributions of content,
editorial advice, and for managing the input from contributors from around the world; and
to the chapter contributors for their expert research and information submitted.
4 Certification
Chapter coordinator: Mario Medvedec, Croatia.
Chapter contributor: James O Wear, United States of America; Anthony Chan, Canada.
In this book, part of the Medical device technical series, WHO presents the different
roles the biomedical engineer can have in the life cycle of a medical device, from
conception to use.
It is important to mention that for this publication, the concept “biomedical engineer”
includes medical engineers, clinical engineers and related fields as categorized in
different countries across the world and encompasses both university level training as
well as that of technicians.
Working together with other health-care workers, biomedical engineers are part of the
health workforce supporting the attainment of the Sustainable Development Goals,
especially universal health coverage.
This book has two parts. The first looks at the biomedical engineering profession
globally as part of the health workforce: global numbers and statistics, and professional
classification, general education and training, professional associations and the
certification process.
The second part addresses all the different roles that the biomedical engineer can have
in the life cycle of the technology, from research and development, and innovation,
mainly undertaken in academia; the regulation of devices entering the market; the
assessment or evaluation in selecting and prioritizing medical devices (usually at
national level); to the role they play in the management of devices from selection and
procurement, to safe use in health-care facilities.
This publication can be used to encourage the availability, recognition and increased
participation of biomedical engineers as part of the health workforce, particularly
following the recent adoption of the recommendations of the UN High-Level Commission
on Health Employment and Economic Growth, the WHO Global Strategy on Human
Resources for Health, and the establishment of national health workforce accounts. The
document also supports the aim of reclassification of the role of the biomedical engineer
as a specific engineer that supports the development, access and use of medical
devices, within the national, regional and global occupation classification system.
A key objective of biomedical engineers is to have devices that are of good quality,
effective for the intended purpose, available, accessible and affordable. When these
objectives are met and devices are used safely, patients’ lives may be saved, quality of
life increased and there will be positive economic outcomes; the final goal is attainment
of better levels of care. The prerequisites for this to happen are health technology policies
in national health plans, available human and financial resources, and scientific and
technological advances that lead to usable knowledge and information. The interrelations
of these concepts are presented in Figure 2.
Figure 3 Da Vinci’s Vitruvian Man drawing (from around 1490) featured on a key reference book on medical
instrumentation
Biomedical engineering professionals are key players in developing and advancing the
usage of medical devices and clinical services. Depending on their training and sector
of employment, the responsibilities of biomedical engineering professionals can include
overseeing the research and development, design, safety and effectiveness of medical
devices/systems; selection and procurement, installation, integration with electronic
medical records systems, daily operations monitoring, managing maintenance and
repairs, training for safe use and upgrading of medical devices available to health-care
stakeholders. Biomedical engineering professionals are employed widely throughout
the health technology and health-care industries, in the research and development
(R&D) of new technologies, devices and treatment modalities, in delivery of health-care
in hospitals and other institutions, in academia, government institutions and in national
regulatory agencies.
Health-care providers
When biomedical engineering professionals are employed in health-care institutions,
their roles can include asset management, equipment selection, installation and
maintenance, planning of clinical areas for health-care delivery, support other health-
care professionals to define appropriate technologies for patient diagnostic, treatment
and rehabilitation as well as development of specialized instruments or devices for
research or treatment and customized, patient-specific devices.
Government
Many biomedical engineering professionals are also engaged by government such
as ministries of health, working on central or regional level health-care technology
management, or governmental organizations such as health technology assessment or
regulatory agencies, where their skills are applied to the evaluation for selection of public
procurement, reimbursement schemes or examination or testing of medical devices to
ensure those to be placed on the market are safe and in compliance with international
standards and regulatory requirements.
Industry
A part of the biomedical engineering professionals in industry work in R&D. Another
branch of activities is in sales and service, where biomedical engineering professionals
can play a role in assuring customers are supported in making choices and providing
after-sales service, like training, maintenance and repair.
INNOVATIONS
• R&D
• Basic Sciences • Clinical trials
• Applied Sciences • Lobbying
• Standards • Manufacturing
• Legislation Biomaterials • Marketing, Sales
• Regulation Industry Clinical services • Third-party services
• Safety Prototyping
Devices
• Grants Startups
• Service programs Artificial organs
• Credentialling Patents R&D partnerships Support systems
• Accreditation
• Licensing Device design
• Safety-nets
Registration Academic education, • Tech assessment
• Public Health
R&D, Continuing Ed • Acquisition,
Licensing contracting
R&D Degrees
Certification Fellowships • Supply-chain mgt
Credentials • IT integration
Conferences
INSTITUTIONAL • Service strategy
FOUNDATIONS • Planning
Health-care • Project mgt
Government Biomedical and • Training
Providers
Clinical Systems • Tech management
Engineering • Risk management
• Quality and Safety
Biomedical engineering
Trained and qualified BME professionals are required within health-care systems
in order to design, evaluate, regulate, acquire, maintain, manage and train on safe
medical technologies. The BME profession, however, is often not included in the official
definitions of the health workforce or policy frameworks, and this absence significantly
impairs the advancement and sustainability of these health-care systems, even in
settings with available resources.
In the past, biomedical engineering professionals have worked “in the shadow” of more
recognized professions, such as doctors and nurses. This has been in part due to lack
of official research and dissemination of information about the presence and essential
value of biomedical engineering professionals worldwide. This gap in acknowledgement
and inclusion of BME within the health-care workforce, and the lack of current data
on the profession, both urgently need to be addressed, to ensure that the health-care
sector has the necessary mix of professionals to guide the dynamic changes in science,
technology and services in the 21st century.
Should ISCO re-classify biomedical engineering professionals along with other health-
care professions in 2018 or future years, more statistics and data will be available at the
country level, and formal recognition processes could be initiated by member countries
to recognize BME as a profession within their national or regional labour organizations
and ministries.
In May 2014, the Sixty-seventh World Health Assembly adopted resolution WHA67.24 on
Follow-up of the Recife Political Declaration on Human Resources for Health: renewed
commitments towards universal health coverage. In paragraph 4(2) of that resolution,
Member States requested the Director-General of WHO to develop and submit a new
global strategy for human resources for health (HRH) for consideration by the Sixty-
ninth World Health Assembly. A summary of the Global Strategy on Human Resources
for Health: Workforce 2030 can be found in Annex 5.(35)
The goal of the global strategy is: to improve health, social and economic development
outcomes by ensuring universal availability, accessibility, acceptability, coverage and
quality of the health workforce through adequate investments to strengthen health
systems, and the implementation of effective policies at national, a regional and global
levels.
The global strategy, includes all cadres involved in delivery of health services, as
described section 16 of the strategy:
16. "This is a cross-cutting agenda that represents the critical pathway to attain coverage
targets across all service delivery priorities. It affects not only the better known cadres of
midwives, nurses and physicians, but all health workers, from community to specialist
levels, including but not limited to: community-based and mid-level practitioners, dentists
and oral health professionals, hearing care and eye care workers, laboratory technicians,
biomedical engineers, pharmacists, physical therapists and chiropractors, public
health professionals and health managers, supply chain managers, and other allied
health professions and support workers. The Strategy recognizes that diversity in the
health workforce is an opportunity to be harnessed through strengthened collaborative
approaches to social accountability, inter-professional education and practice, and closer
integration of the health and social services workforces to improve long-term care for
ageing populations."
The global strategy requests the support of professional organizations to regulate the
workforce competency as described below:
"The innovation and diversification pathway illustrates how some countries have invested
in their health sector specifically to promote economic growth. The health sector has
been driving technological innovations in many areas, including genetics, biochemistry,
engineering and information technology. Exports of pharmaceuticals, equipment and
medical services have also been an important driver of growth in many countries."
http://www.who.int/hrh/com-heeg/reports/en/
The commission’s recommendations are aligned with the SDGs. The specific target and
goals related to this publication on human resources for medical devices are:
Target 4.b: By 2020, substantially expand globally the number of scholarships available
to developing countries, in particular least developed countries, small island developing
States and African countries, for enrolment in higher education, including vocational
training and information and communications technology, technical, engineering and
scientific programmes, in developed countries.
Figure 1.1 Density of biomedical engineers per 10 000 population globally (as at January 2016)
Source: Data was collected from three different sources: government offices and ministries of health (through surveys launched by WHO between 2010–2015); IFMBE; and
universities offering BME programmes.
Table 1.1 Biomedical engineering professionals per 10 000 population in the WHO African Region
BWA 0.23
GMB 0.09
ZAF 0.06
ZMB 0.03
CIV 0.02
NGA 0.02
SEN 0.02
ETH 0.02
BEN 0.01
UGA 0.01
TCD 0.01
CMR 0.01
SWZ <0.01
KEN <0.01
RWA <0.01
NAM <0.01
BFA <0.01
n=25
COD <0.01
SLE <0.01
GHA <0.01
TZA <0.01
DZA <0.01
MOZ 0.00
LBR 0.00
GIN 0.00
IND 0.31
BTN 0.08
MDV 0.03
TLS 0.01
LKA 0.00
THA <0.01
NPL <0.01
n=10
BGD <0.01
MMR <0.01
IDN <0.01
Table 1.3 Biomedical engineering professionals per 10 000 population in the WHO Region of the Americas
PAN 0.83
USA 0.49
CHL 0.36
ARG 0.35
SLV 0.31
TTO 0.29
MEX 0.24
CAN 0.18
PER 0.11
DOM 0.09
GRD 0.09
SUR 0.09
COL 0.06
PRY 0.05
CUB 0.05
BOL 0.04
BRB 0.04
URY 0.03
BLZ 0.03
VEN 0.02
BRA 0.02
ECU 0.02
GUY <0.01
JAM <0.01
n=27
HTI <0.01
HND <0.01
GTM <0.01
0.00 0.10 0.20 0.30 0.40 0.50 0.60 0.70 0.80 0.90 1.00
Source: Data from surveys launched by WHO 2010–2015.
32 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Table 1.4 Biomedical engineering professionals per 10 000 population in the WHO Western Pacific Region
SGP 5.71
JPN 1.58
MYS 0.82
MNG 0.81
KIR 0.27
AUS 0.13
VNM 0.11
NZL 0.06
FSM 0.04
VUT 0.04
CHN 0.03
FJI 0.03
LAO 0.01 n=15
PHL <0.01
KOR <0.01
Table 1.5 Biomedical engineering professionals per 10 000 population in the WHO Eastern Pacific Region
LBN 1.28
JOR 0.66
EGY 0.11
SAU 0.10
SDN 0.09
PAK 0.02
TUN 0.02
BHR 0.01
DJI 0.01
ARE <0.01
n=12
YEM <0.01
AFG <0.01
The European Region (EUR), Eastern reported the highest density (1.58). In
Mediterranean Region (EMR) and the European Region, Finland (2.73 or
Western Pacific Region (WPR) reported one per 3663 people) and Israel (2.48
the greatest density of BME professionals; or one per 4032 people) reported the
nonetheless all regions reported some highest densities. All three are classified
country densities below 0.01 (one per as high-income countries.
million people). Japan, in the WPR,
FIN 2.73
ISR 2.48
LVA 1.78
ISL 1.70
AUT 0.94
SWE 0.87
LTU 0.87
BEL 0.87
SVN 0.84
DNK 0.79
IRL 0.70
ROU 0.64
GEO 0.63
HRV 0.47
EST 0.46
HUN 0.41
SRB 0.34
NLD 0.30
GRC 0.27
DEU 0.25
MNE 0.24
ITA 0.23
ESP 0.22
ALB 0.18
CHE 0.14
CYP 0.13
TUR 0.12
SVK 0.12
FRA 0.09
PRT 0.09
UKR 0.08
GBR 0.07
BGR 0.05
POL 0.04
MKD 0.02
BIH 0.01
NOR <0.01
RUS <0.01
Note: Finland and Israel reported the highest densities in this region, with more than five BME professionals per 10 000 of the population.
Source: Data from surveys launched by WHO 2010–2015.
SWZ 0.80
TZA 0.54 African Region
ZAF 0.34 Region of the Americas
CIV 0.30 South-East Asia Region
BFA 0.18 European Region
ZMB 0.14 Eastern Mediterranean Region
Western Pacific Region
BEN 0.10
KEN 0.09
NGA 0.09
ETH 0.09
SLE 0.39
RWA 0.03
COD 0.02
MOZ 0.00
BRA 1.25
PAN 0.74
TTO 0.80
SUR 0.54
MEX 0.16
URU 0.15
CHL 1.25
ARG 0.05
ECU 0.03
JOR 0.16
TUN 0.37
LBN 0.21
SDN 0.18
EGY 0.16
BEL 1.35
IRL 1.21
MKD 0.71
SWE 0.52
EST 0.47
SRB 0.32
ROU 0.30
ISR 0.09
UKR 0.01
MNE 0.00
CYP 0.00
BIH 0.00
BHU 0.40
IND 0.12
FSM 4.83
JPN 3.50
KIR 2.93
BRU 1.25
MYS 0.84
VUT 0.79
MNG 0.74
AUS 0.43
LAO 0.30
n=54
PHL 0.05
PAK 0.01
VNM 0.01
MYS 0.8
UKR 0.62
MKD 0.6
0.58 Female
SDN
Male
ARG 0.52
SWE 0.5
CHL 0.5
BTN 0.5
BEL 0.48
MEX 0.46
JOR 0.45
EGY 0.45
BOL 0.45
VNM 0.4
ROU 0.4
BRA 0.4 n=55
MNG 0.39
PAK 0.3
KIR 0.3
ISR 0.3
BRU 0.267
URY 0.25
SRB 0.25
TTO 0.2
SUR 0.2
JPN 0.2
GRC 0.2
EST 0.2
HRV 0.2
PAN 0.18
TUN 0.15
KEN 0.15
IND 0.12
ZMB 0.1
MNE 0.1
LBN 0.1
ECU 0.1
CIV 0.1
BFA 0.1
AUS 0.1
CYP 0.07
ETH 0.06
BEN 0.06
SWZ 0.05
PHL 0.05
IRL 0.05
NGA 0.01
COD 0.01
BIH 0.01
VUT 0
TZA 0
SLE 0
RUS 0
FSM 0
LAO 0
0.00 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1
Source: January 2015 Global Survey - Professional and Academic Profiles on Biomedical Engineers and Technicians.
2.1 Defining training and and artificial organs to aid in the treatment
education of the injured or diseased patient to
allow them to enjoy a better quality of
In general, learning can be split into life. Biomechanical engineers have
education and training; education is been responsible for the development
about acquiring knowledge whereas of devices such as prosthetic implants
training is about acquiring skills. When to replace diseased or damaged
both forms of learning are related to skeletal joints such as hips, knees and
the biomedical profession and teaching shoulders. Their understanding of the
institutions, education relates to biomechanics and fluid dynamics of the
universities creating biomedical engineers central circulatory system has helped
and vocational training institutes creating the development of artificial heart valves
biomedical engineering technicians and and implantable stents used to improve
technologists. Training includes pre- blood flow in diseased blood vessels.
service training, meaning a training one Development of other, less complex,
finishes before joining the workforce, implants such as bone plates and
normally being full time and in-service screws also benefits from the skills and
training, which can be via short-term knowledge of the biomechanical engineer
courses or part-time training. Where in understanding the mechanical loading
vocational training institutes normally requirements imposed on bone structures
teach pre-service training, commercial to ensure these devices can safely replace
companies, professional associations or or supplement the bone.
other stakeholders can provide in-service
training. Engineering: Biomedical engineers
working in areas associated with
diagnosis and treatment of disease or
2.2 Core curriculum and elective injury, biological signal measurement
specialization and processing, diagnostic imaging and
ensuring a safe environment for patient
The biomedical profession includes many treatment, need exposure to knowledge
different professions, normally coming often associated with electronic
from a similar base (the core curriculum), engineering. As examples, biomedical
with different specializations (elective engineers working on bioinstrumentation
specializations). specialize in the detection, collection,
processing and measurement of many
2.2.1 Core curriculum physiological parameters of the human
Human anatomy and physiology: body, ranging from the simple, such
Biomechanical engineering professionals as temperature measurement, ECG
apply engineering principles to further detection and heart rate measurement, to
the understanding of the structure of the more complex, such as quantification
the human body, the skeleton and of cardiac output from the heart, detection
surrounding muscles and the functioning of the depth of anaesthesia in the
of the body’s organs. They use the unconscious patient and neural activity
knowledge gained to develop and apply within the brain and central nervous
devices such as implantable prostheses system. They have been responsible
“The African Biomedical Engineering Initial entrants into the BME profession
Consortium (ABEC) is a regional held degrees and/or certificates in
platform for promoting innovation traditional engineering areas such
and entrepreneurship in health-care as electrical, mechanical or chemical
infrastructure and technologies for engineering. These individuals needed to
improved health-care outcomes in acquire BME skills to be able to manage
Africa.” biomedical equipment. While “formal
education” emphasizes the development
Figure 3.1 Number of biomedical engineering professional associations at global, national and subnational
level stratified by WHO region
64 50
IEEE
AFR 8%
AMR
EMR 5%
17%
EUR
SEAR
WPR
13%
50% 7%
Figure 3.3 Countries with at least one BME professional society by income grouping
Low income
Lower middle income 12%
Upper middle income
High income
44% 15%
29%
In Latin America and the Caribbean, 5.2.3 United Nations Children’s Fund
UNOPS manages health projects from The health technology area in UNICEF’s
the planning, design, construction and Supply Division in Copenhagen deals with
reconstruction of health facilities, to the procurement, supply chain of essential
procurement of medical equipment and products, including medical devices
medicines, including the analysis and and assistive devices for children in low-
reorganization of the supply chain at resource settings. Biomedical engineers
national or institutional levels. play an essential role within UNICEF,
This chapter offers insights on how That medical devices (including in vitro
biomedical engineers can lead the diagnostics) play an important role in health
innovation process in the design of care at all levels of health system delivery,
medical devices to respond to health and in both well resourced and poorly
needs, paying particular attention to the resourced settings, is widely accepted. Yet
roles and responsibilities they may have there remain many challenges, globally in
in different sectors and resource settings. optimizing the technology mix to ensure
optimal efficiencies (both allocative and
technical). WHO has been instrumental
6.1 Introduction in helping address these challenges with,
inter alia, the publication of a series of
The world has changed greatly since the technical guides covering many aspects
1950s and the dawn of the electronic of the health technology/medical device
age when innovators such as Wilson life cycle (Medical device technical series).
Greatbach, an assistant professor of WHO has also played a leading role in
electrical engineering at the University of examining and supporting the role of
Buffalo in the United States of America, medical device innovation, with a particular
built the first cardiac pacemaker in his focus on developing countries.(90)
garage. The regulatory requirements
alone could render such a scenario It is worth noting at this point that
impossible today. And yet there are some there are different types of generic
similarities with those times 60 years ago. innovation, ranging from basic research
With software now also classified as a to incremental (by far the most common
medical device, why couldn’t a student at type of innovation in the context of medical
any university, say, develop a new mobile devices), breakthrough, disruptive and
phone or tablet app that would have the sustaining (see Table 6.1).
same impact in terms of health outcomes
that Greatbach’s invention has achieved The following disclaimer should be noted
globally? with regard to this chapter. There are
many texts dealing with medical device
Therein lies the excitement of medical innovation as well as with the various
device innovation, attracting some of the fields of BME research. This chapter
brightest talent on the one hand while therefore, aims to provide an overview
on the other maintaining a multi-billion of medical device innovation from
dollar global industry, and given the the perspective of applied biomedical
wide range of medical devices, from a engineering to underline the importance
syringe to a MRI scanner (there are some of the knowledge, skills and competencies
10 000 generic items in the medical of the thousands of individuals and
device universe) and changing disease teams that engage themselves in both
patterns globally, there remains a strong the art and the science of medical device
demand for investment in medical device innovation. Space constraints do not allow
innovation, with biomedical engineers in for in-depth examination of all the many
particular playing a central role. relevant issues.
Figure 6.1 Biodesign model (innovation phases) (functional groups and activities)
Journal of Medical Devices
Source: Pietzsch JB et al (2009). Stage-gate process for the development of medical devices. Journal of Medical Devices.
The limited availability of highly trained WHO has been instrumental in supporting
health providers presents another the innovation of medical devices for low-
extraordinary challenge in providing resource settings, particularly through
universal quality care. For instance, while initiatives such as its Compendium of
Africa bears more than 24% of the global innovative health technologies for low-
burden of disease, it only has access to resource settings: Assistive devices,
2% of the global supply of physicians;(111) eHealth solutions, medical devices
47% of the WHO Member States reported published in 2014. The objective of the
having less than one physician per 1000 compendium series is to provide a neutral
population.(112) The mismatch reported platform for technologies which are likely
between the number of commercially to be suitable for use in low-resource
available medical devices and the settings. It presents a snapshot of several
projected global burden of disease, as well health technologies which might have the
as the limited number of available devices potential to improve health outcomes and
designed for use in primary health-care the quality of life, or to offer a solution
facilities by lay health workers (30 out of to an unmet medical/health technology
358 medical devices) will challenge policy- need. It celebrates notable success stories
makers and the global health community while raising awareness of the pressing
to provide intellectual, financial and need for appropriate and affordable
regulatory support in order to develop the design solutions and to encourage more
necessary technology in a timely manner. innovative efforts in the field. This effort
(113) Although it is not possible to separate also aims to encourage greater interaction
the effects of medical devices from the among ministries of health, procurement
effects of social, political, economic and officers, donors, technology developers,
health-care measures on mortality in manufacturers, clinicians, academics
LICs,(106) availability and accessibility and the general public, to ensure greater
of medical devices are important and, investment in health technology and to
if part of a comprehensive solution, can move towards universal access to essential
positively impact global mortality and health technologies.
morbidity trends.
Resources such as the WHO compendium
This poses a design challenge on how to serve as effective stimulants of further
develop medical devices that are simple R&D and innovation of medical devices
enough to use that lay health providers for low-resource settings, as well as
can deliver or perform some of the more supporting the development of local and
common and urgent health services regional capabilities. The constraints
and tasks previously undertaken only typical of low-resource settings also
by highly trained health providers. This present opportunities for innovation
can have a tremendous implication for by encouraging the design of devices
both developing and developed countries. that are adaptable to the realities of
Such, presumably task shifting, medical health care in these settings, such as
AFR EUR
Certificate of need/carte sanitaire AMR SEAR
EMR WPR
100%
80%
60%
Reimbursement/package of benefits 40%
Clinical practice guidelines and
protocols
20%
Health technology
Health technology
Health technology management
assessment
regulation
Procurement
Clinical effectiveness
Safety Selection
Ethics
Performance Training
Social issues
Quality Use
Organizational
100 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
called HTA. HTA “refers specifically to or technical or economic dimensions are
the systematic evaluation of properties, not considered full HTA if they are not
effects, and/or impacts of health run systematically and in multidisciplinary
technology. It is a multidisciplinary perspective.(135)
process to evaluate the social, economic,
organizational and ethical issues of a Technical and economic evaluations
health intervention or health technology. are important primary studies and the
The main purpose of conducting an HTA knowledge synthesis that is key to full
assessment is to inform policy decision- HTA. Without such primary studies
making.”(133) by biomedical engineers, clinicians,
epidemiologists, economists, social
8.1.1 From performance to use in scientists, ethicists and other researchers
health care and evaluators, it is impossible to do
Figure 8.3 represents the stages and comprehensive HTA. Effective HTA
values of HTA and their relationship mobilizes the scientific knowledge
to regulatory processes.(134) There is of stakeholders, including clinicians,
a lack of emphasis on organizational administrators and patients to inform
impact, equity, ethical issues, feasibility decision-making processes.(136)
considerations and acceptability to
patients and health-care providers. The important contribution of biomedical
Value for money is similarly neglected engineers in HTA goes beyond producing
unless the device forms part of a vertical primary evidence to be included in HTA,
programme that needs to be assessed – especially regarding medical devices.
even then the individual device may not They have an essential part to play in the
always be considered; shared use devices comprehensive HTA process for medical
are rarely evaluated. devices as they have specific knowledge
and background to analyse and review
It is important to note that, partial technical characteristics, clinical use and
assessments focusing “only” on clinical
Figure 8.3 Stages and values of HTA and their relationship to regulatory process
Health technology assessment
Implementation
How should the technology be
implemented in this setting?
Appropriateness
Should the technology be
implemented in this setting?
Effectiveness
Acceptability to patients
80% Clinical
70%
effectiveness
60%
50%
40%
Acceptability to health 30% Economical considerations
care providers 20% (e.g. cost-effectiveness analysis)
10%
Feasibility considerations
(e.g. availability
of: budget‚ human Budget impact analysis
resources‚ infrastructure)
quality and safety issues, pricing and of HTA reports. Nevertheless, HTAs
comparison with similar technologies. systematically examine various
The purpose of this chapter is to combinations of the following dimensions:
describe the current and potential role of the technical performance, safety, clinical
biomedical engineers in HTA in national efficacy and effectiveness, cost, cost-
agencies. It should be noted that HTA can effectiveness, organizational implications,
be developed at various levels: social consequences, and legal and
ethical implications of the application
• Global or national to enhance policy of a health technology. A HTA report is
decision-making. based on sound evidence and not only
• Meso- and micro-level, e.g. in contains investigations on all aspects that
hospital-based HTA which directly influence the technology but also those
support decision-making in hospitals, aspects that the technology influences.
where biomedical engineers The choice of the different dimensions
play a fundamental role in the for an assessment report depends on the
interdisciplinary analysis on medical specific context of the policy question –
devices to be used in the institution. one can concentrate on safety, clinical
efficacy and effectiveness and cost as in
Biomedical engineers typically work in the pre-marketing phase(137,138,139) or
hospitals but an increasing number is more on organizational issues as in the
moving into national policy positions hospital-based HTA.(140)
related to the HTA process.
A HTA report starts with the policy
question. A policy question is raised
8.2 Methods of health technology either by the decision-makers or by the
assessment institution itself. If the policy question
Worldwide there are various methods, is not properly defined, then the first
degrees of detail and scope of practice step is to formulate it. One framework
102 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
proposed by the European Collaboration medical devices.(145) Conversely, the
on HTA(141) contains the following increasing application of HTA to inform
steps: submission of an assessment decisions around medical devices and
request, followed by prioritization and the shift in health-care costs towards
commissioning, conducting the particular medical devices will require biomedical
assessment, and then dissemination. The engineers to play a greater role in HTA
assessment process itself comprises of than they have in the past.
defining the policy question, a preliminary
protocol, collection of background For example, a recent study on medical
information, definition of the research device prioritization in Gambia and
questions, data search pertaining to Romania revealed a lack of biomedical
the different dimensions, draft report engineers across both countries; where
which is reviewed externally and, finally, present biomedical engineers were not
publication. invited to take part in HTA or resource
allocation decisions, instead they were
An alternative programme of HTA(142) only consulted on maintenance and
may go through identification and servicing issues. Should biomedical
specification of assessment topics, engineers be consulted and empowered
evidence retrieval and collection to play a role in HTA, it is reasonable
of appropriate data, appraisal and to assume both settings would see
integration of evidence followed by report considerable improvements in medical
generation and dissemination. However, devices management and use.(146)
not all agencies or Institutions follow
all the steps or as a matter of fact in a
chronological order. 8.4 Core competencies required
for health technology
There are numerous materials on the assessment
methodology of conducting HTA, e.g.
the handbook on HTA published by the A pre-workshop on capacity building for
Danish Centre for Health Technology an efficient and effective HTA agency
Assessment, which gives a sound was conducted at the Health Technology
overview on the methodologies.(143) Assessment international conference in
Washington (DC), USA in June 2014. The
objective of this workshop was to provide
8.3 Different disciplines in health a preliminary exploratory discussion on
technology assessment the skills needed for HTA. The results
of the workshop showed certain skills
By definition, HTA is a multidisciplinary (both “hard” and “soft”) or competencies
field of policy analysis. The three most needed to practise or use HTA (see
common disciplines involved in HTA are Table 8.1).(147)
evidence-based medicine, economic
evaluation in health care, and population 8.4.1 Interdisciplinary teams
and public health ethics.(144) Currently, In 2008, a survey of international HTA
the discipline of BME is less represented organizations revealed that the majority
in HTA agencies, than in other areas like of the participating organizations had
R&D, regulation or health technology “clinical specialists” (71.1%) in their
management. One of the reasons could organizations followed by “economists”
be that national agencies do not have (68.4%) and “information specialists”
specific teams of procedures for HTA of (65.8%) (Table 8.2). In addition to the
Notes: *None: Number of HTA agencies with no specialist professional working in the organization; 1–5: number of HTA agencies with 1 to 5 specialist professionals; >5: number
of HTA agencies that had more than 5 specialist professionals.
** Number of respondents replying to each category.
104 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
other professionals listed in Table 8.2, analysis, priority setting, legal, social and
biomedical engineers were mentioned in ethical aspects.(151) The specific roles
an additional category of content specific of these professions vary across HTA
experts such as dentists, pharmacists, organizations, but they are all likely to be
physiotherapists, lawyers, chemists and involved in the collection and synthesis of
nutritionists.(148) clinical and/or economic data, which form
the basis for evidence-based decision-
The WHO 2015 Global Survey on Health making. HTA specialists should be able
Technology Assessment by National to perform literature searches, assessing
Authorities documented that legal, and avoiding the several types of bias (e.g.
4.4 Professionals involved
engineering and information professionals in HTA ing epidemiologists, biostatisticians, health economist
publication bias,
preparation and decision making and others) and language
experts in bias,
clinicalretrieval
sciences (medical
are involved in the assessment of medical bias,
doctors, nurses, pharmacists, and healththe
reporting bias), synthesizing professional
Respondents
devices, as reported
can be seen that the in preparation
Figure 8.5.of HTA re-evidence (may be
organizations) qualitative,
(Chart 4.4a). Thequantitative
involvement of different
ports and the decision-making process had high level
[meta-analysis]
professionals in HTA ordidformal
not varydecision-
markedly across tech-
of involvement from public health professionals (includ-
As shown in Figure 8.5,(150) the analysis) and publishing the results (both
nologies or interventions (Chart 4.4b).
number of engineers increased when paper and electronic versions).(152)
CHART 4.4: Number and proportion of professionals involved in (a) preparation of HTA reports
the objective of HTA was medical devices.
and (b) making decision
Individuals from these professions have 8.5 Survey of biomedical
knowledge
A and skills in the areas of engineers involved in health
Clinical interventions 120 118
clinical epidemiology, evidence-based technology15assessment
44 15
(cost-effectiveness) analysis,
Population level health consensus
interventions 132 Holmes, 91 Banken 24 and
41 Muller,
28 to gather
conferences, technology
Service deliverymanagement,
models 94 information
78 for this
18 section
34 21and it showed
decision-making, Surgicalpolicy-making/
interventions 102 that 94the involvement 10 42 of12 biomedical
Vaccines 115 99 7 32 16
0 20 40 60 80 100
%
Public Clinical Bioethics and Legal, Engineering Consumer
health science sociology and information science needs
Figure 8.5 Professionals involved in assessment of medical devices
%
Public Clinical Bioethics and Legal, engineering and Consumer
health science sociology information science needs
Public health: Epidemiologists, Biostatisticians / Statistician, Economists/ health economists, Public Health professional
Clinical science: Medical doctor, Nurse, Pharmacist, Health professional organization
Bioethics and sociology: Sociologist, Ethicist
Legal, Engineering and information science: Biomedical and /or clinical engineer, Lawyer, Librarian/information specialist
Consumer needs: Civil society representative, Patients representative
19
HTA is a core topic in the majority of Some HTA agencies do not usually have
European BME courses. In 2010, it was job descriptions specific to biomedical
included among the core topics of BME. engineers – rather the same skills are
(155) required as for any other member of
the HTA team. However, one of the
In Latin America(156) there are more agencies stated that they specifically hire
biomedical engineers working in HTA biomedical engineers in their unit in order
agencies, as can be found in the National for them to contribute and share their
Center for Health Technology Excellence expertise “on the technical aspects of
in the Ministry of Health in Mexico medical devices and procedures”.
(CENETEC).(157)
The few agencies(160) that have job
descriptions specifically for biomedical
engineers, request a postgraduate
106 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Figure 8.6 European patent applications
Evolution 2006–2015
Medical technology
11 124
Top 10 technical fields
Electrical machinery,
appartus, energy
10 944
Digital
communication
Pharmaceuticals
10 018
5 270
Engines,
pumps, turbines Computer
5 318 technology
9 869
Biotechnology
5 905
Transport
7 533
Organic
fine chemistry
Measurement
6 132
7 228
This implies that over the next years, Is global collaboration in HTA necessary?
thousands of new medical devices will Global collaboration can facilitate the
be available for adoption, causing a exchange of know-how (between limited
significant shift in health-care costs from resource countries and developing
drugs to devices, and a growing request countries, between individuals,
for HTA studies focusing on devices. To agencies, and industry and policy-
cope with this huge change, the European makers), lessons learned and global/
legislation on medical devices is currently regional/national work. This section will
under revision and, according to first consider the different activities and goals
drafts, will require device assessment as of international organizations dealing
a prerequisite for market admission. This with HTA and also some of the regional
is a huge challenge for HTA as, different networks that have emerged in the
from drugs, there is a well-recognized Americas, Europe and Asia.(174)
lack of methods and tools to support HTA
for medical devices,(162) especially in Depending upon the background and
pre-market phases,(163,164) which many interest of the individuals – whether they
authors tend not to consider relevant for are users, producers and those interested
HTA field. in HTA – they could become members in
one or more of the organizations, societies
This shift will require a reinforcement of or networks mentioned below.
BME contribution in HTA studies, which
has already been recognized by the BME One of the strengths in using HTA
international community; though this as a tool in decision-making is that it
will take a few years to work through to involves a multidisciplinary team in which
national HTA entities. For the first time biomedical engineers have an important
HTA was introduced as a core topic for role to play to play.
biomedical engineers in 2009;(165) since
2012 all the IFMBE conferences(166) 8.7.1 Health Technology Assessment
have had sessions on HTA(167) and since international
2015 a whole dedicated track, which in H e a l t h Te c h n o l o g y A s s e s s m e n t
IFMBE conferences is a pool of invited international (HTAi) is an interdisciplinary
and proposed sessions chaired by one or global scientific and professional society
two experts and often resulting in special with a focus in HTA.(175) Its members
issues on relevant BME journals; and for come from academic institutions, health
the first time there was an invited keynote service producers, industry, business,
talk at the 2015 World Congress of BME government, patients and consumers
108 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
from all continents and it acts as a The INAHTA website plays an important
neutral forum for collaboration, sharing part in facilitating communication
of expertise and information. between the members and includes
information on HTA reports and ongoing
The objectives of the society are: activities. The Brief series of INAHTA
encourages member agencies to present
• To collaborate actively with WHO, their overviews on recently published
various networks and regionally reports, with some indication of impacts
based HTA societies to increase the on decisions made by governments at
application of HTA in health policy- regional, national or international level.
making Furthermore, the website encourages
• Support the HTAi policy forum by member agencies and/or individuals
fostering open debates on issues to take a consistent and transparent
involving HTA related to health policy approach to HTA.(176)
matters both in the public and private
sectors 8.7.3 EuroScan International Network
• Conduct annual international The International Information Network on
meetings, which serve as meeting New and Emerging Health Technologies
points for all stakeholders and (EuroScan International Network)
address the interests and needs of is a collaborative network of member
the members agencies for the exchange of information
• To develop its work with interest on emerging new drugs, devices,
subgroups and facilitate information procedures, programmes and settings in
exchange in specific focus areas health care.(177)
• To support the publication and
diffusion of the International Journal The members of the network strive to:
of Technology Assessment in Health
Care. • Establish a system of sharing skills
and experiences in early awareness
8.7.2 International Network of and alert activities.
Agencies in HTA • Develop applied methods for early
The International Network of Agencies in identification and assessment.
HTA (INAHTA), which was established in • E x c h a n g e a n d d i s s e m i n a t e
1993, has 57 member agencies from six information on new and emerging
continents. All members are non-profit technologies.
making organizations linked to regional
and national government, which produce 8.7.4 HTAsiaLink
HTA reports. The members meet face-to- HTAsiaLink was established in 2010.
face once a year in conjunction with the The aim of the network is to strengthen
HTAi conference. Additionally, INAHTA individual and institutional capacity in the
provides networking opportunities field of HTA and enhance the integration
throughout the year as a member of the of evidence into policy decisions. The
various community of practices. It serves network facilitates information exchange
as a platform to share information and (not only between members but also
provides opportunities for cooperation other networks and organizations),
internationally and regionally. It also joint research projects, annual regional
facilitates information exchange between conference and other activities.(178)
members through Listserv.
110 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
The specific activities covered by HTAD 8.8 Conclusion
include:
In quite a few HTA agencies biomedical
• To increase the knowledge of HTA engineers are part of multidisciplinary
among biomedical engineers, teams. However, they are still not
supporting the introduction of HTA automatically involved when health
related content at BSc, MSc, PhD technologies, particularly for medical
and continuous education levels, and devices, are assessed. HTA of medical
developing learning resources. Here, devices seems to be the area in which
the division has produced more than the contribution of biomedical engineers
100 hours of eLearning content on to the HTA process will grow significantly,
basic concepts, methods, tools together with early stage HTA.
and case studies, which are freely
accessible to the IFMBE associates The Sustainable Development Goals
through their member societies’ published in 2015, include universal
websites. Moreover, a summer school health coverage, under Goal 3. This
on HTA, specifically conceived for implies that decisions on coverage
biomedical engineers and medical will have to be made on the selection,
physicists was launched in 2015 and prioritization, and reimbursement
will run every two years.(183) of medical technologies. Decisions
• Encouraging basic and applied are required to select priority clinical
research in HTA; an open access interventions for prevention, screening,
journal is being launched,(184) and diagnostic, treatment, rehabilitation
increasing space has been devoted and palliative care. When medical
to HTA in IFMBE conferences since technologies are being assessed it is
2012. important to consider the competencies
• Stimulating cooperation and of the biomedical engineer. Therefore,
promotion of worldwide collaboration HTA agencies should consider including
between different societies involved this profession in their multidisciplinary
in HTA. HTA teams developing assessments and
• To support guidelines and case providing information for better policy
studies of particular relevance (e.g. decision-making, especially involving
HTA of medical devices, guidelines medical technologies.
for multi-criteria decision analysis for
HTA of medical devices, early stage In settings with few resources in HTA,
HTA). where it may not be possible to hire
• Reinforcing the dialogue between biomedical engineers, strong links could
medical device researchers and be developed with BME departments
policy-makers, through HTA. HTAD in hospitals and universities, to share
coordinated the organization of the knowledge and resources. By improving
first European Parliament Interest the contribution of biomedical engineers
Group on BME, launched the 31 May to the HTA process, the necessary links
2016 at the European Parliament. This between innovation, regulation, HTA
group of six Members of the European and HTM of medical technologies will
Parliament from five countries, will be strengthened and the contribution of
meet twice a year, supporting action HTA to sustainable health systems will be
regarding HTA of medical devices enhanced.(186)
in European regulations (e.g. the
regulation on medical devices,
currently under revision).(185)
114 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Figure 9.2 Health-care technology life cycle
Technology assessment
Evaluation
De-commissioning
Planning
Maintenance
Procurement
Training
Installation
Operation
ACQUISITION Commissioning UTILISATION
Source: Medical device regulations: Global overview and guiding principles (http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf).
HTA
HTM
Decommissioning
116 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
include cardiology information system day it arrives. The safety of the medical
(CIS), laboratory information system device must be guaranteed and verified in
(LIS), PACS and RIS. These systems are order to protect patients and health-care
totally independent even if they could workers. Generally, an acceptance form
interact and exchange information. More is filled out for this process (see sample
information can be found in Chapter 10. acceptance test log sheet for equipment).
(193) The acceptance test includes:
9.2.5 Health technology management
Traditionally, the core activities of a • Correspondence check of medical
biomedical engineer concern HTM, and device purchased with that delivered
include all management activities relating • Visual inspection
to medical devices within the hospital. • Functional check
In HTM activities a biomedical engineer • Electrical safety check
is often supported by a biomedical • Calibration and measurement (for
equipment technician who is in charge specific medical devices).
of detailed technical activities. The most
important tool for HTM is the medical Each acceptance test should be recorded
devices inventory, which provides a as “pass/fail” or not applicable (n/a). Once
technical assessment of the technology all the regulatory criteria for acceptance
on hand, giving details of the type and have been satisfied, the device can be
quantity of equipment, and the current labelled with an asset number, and then
operating status. Furthermore, when formally handed over to the user.(194)
linked to standard equipment lists and
an appropriate nomenclature, it provides Maintenance
the basis for effective asset management, These activities represent an essential
including facilitating scheduling and segment of HTM activities. There are two
tracking of preventive maintenance, types of maintenance activities: corrective
repairs, alerts and recalls.(192) and preventive. Corrective maintenance
involves activities aimed at fixing a
Key elements of the HTM life cycle are: medical device following a breakdown.
The biomedical engineer’s role is to
• Acceptance testing: The act of identify a breakdown and its causes
accepting a new medical device in and to manage all activities, technical,
a hospital, checking it is safe and organizational and logistic, which
functional. allow re-establishing medical device
• Maintenance: Keeping a medical functionality. Preventive maintenance or
device in safe and functional planned preventive maintenance (ppm)
condition by regular checks and is identified as the set of maintenance
repair as necessary. activities carried out at pre-set intervals
• Decommissioning: Permanent or according to predetermined criteria.
removal of a medical device from This kind of maintenance is necessary to
use in a hospital, for obsolescence reduce breakdown likelihood, to maintain
or other reasons. medical equipment functionality, and to
prevent possible damage for patients
Acceptance testing and health-care workers. The biomedical
This process checks that a medical engineer should plan a real maintenance
device meets safety standards, clinical policy, established and discussed within
requirements and the procurement the hospital, in order to ensure the
requirements of the hospital from the
118 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Figure 9.4 In-house personnel model – main activities
External corrective
interventions
Spare part
Third-party
(ISO) service
In-house personnel
Manufacturer
(OEM) service
supplying spare parts and contracts with service organization (ISO) or a mix of
manufacturers.(10) the two.(11,198) The management of the
contracts with manufacturers and the
9.3.2 Mixed model provisioning of spare parts and other
In this model the hospital stipulates high-level activities are carried out by in-
contracts regarding servicing the house personnel.
maintenance of biomedical equipment.
BME department managers should decide 9.3.3 Third-party multi-vendor
if this service should be performed by the service model
original equipment manufacturer (OEM), In this model the hospital stipulates
by a third party such as an independent a contract to service the full-risk
President/Director General
Medical or Administrative
Director
Biomedical
engineering
Pharmacy department head
Medical
Departments Tech Specs Spare parts
Institutional
Procurement
Department
Surgical
Departments Research Lab CE Service Center
Inventory Installation
Acceptance Training
Calibration Maintenance
Warehouse
120 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
9.3.5 Key roles in a biomedical engineer will have a BSc in BME
engineering department and (depending on the position) four
These functions would differ depending to five years’ hospital experience
on the type of health facility, the in: conducting research; leading
organization, the needs and the resources procurement processes; organizing
available. and supervising service centre
activities; and supervising technicians,
• Biomedical engineering director/ students.
manager: The biomedical engineering
director acts as a manager and • Biomedical engineering technician:
technical director of the BME A biomedical equipment technician
department or service. Their typical is an engineering technician or
background will be a MSc in BME other technical equipment specialist
or equivalent programme and three “trained to maintain instruments
years’ minimum experience as a biomedical equipment used in
biomedical engineer. Furthermore, hospitals, laboratories and other
they must have some business clinical areas”.(199) They perform
knowledge and management skills troubleshooting, corrective and
that enable them to participate in preventive maintenance, electrical
budgeting, cost accounting and safety tests and calibration of a wide
personnel management.(1) variety of medical devices, medical
equipment and in vitro diagnostics
devices.
9.4 Biomedical
• Biomedical engineering
engineer/junior biomedical
around the
engineer: world a biomedical
Typically,
Gambia does not possess a programme for general training on medical devices maintenance that would
provide the fundamental qualifications to work safely as a biomedical technician in hospitals and other
health-care facilities. Generally, maintenance staff working on medical devices in all health-care facilities
only had prior professional training in electrical/electronic technologies. However, the Medical Research
Council Unit, in Gambia has, by contrast, a quite successful BME department. In 2015, the department
consisted of a biomedical engineer, one senior BMET, three BMETs, two assistant BMETs and two local
trade students. The department now supports almost 99% of biomedical technologies “in-house” and
performs regularly with measurable indicators.
The acceptance of BME in the health system is improving because the failure of a single item of equipment
has the potential to bring service delivery to a standstill and serious suffering to patients. The main
difficulties faced are the absence of strong financial support and a safety standards system within the
health-care system. There is a need for the government to introduce schools to train engineers in this
discipline and to develop specific policies to help improve the situation.
Distribution of biomedical engineers: Medium (90 for 30 ministry of health hospitals and 1200 health-care
medical centres)
BME societies: Absent
Main BME activities: HTM, procurement
Jordanian BME experience is the only one in the EMR. It belongs to the Directorate of Biomedical
Engineering (DBE), officially established in 2001 to be the technical arm for the Jordanian Ministry of
Health and to overcome all the challenges and difficulties related to medical equipment. Nowadays DBE
has become a unique establishment covering all issues and activities related to medical devices and
equipment life cycle, with fully automated, web-based, paperless software as an integrated comprehensive
solution. All HTM system components and procedures are automated, locally developing and implementing
a unique technical management software system, within DBE according to DBE needs.
The complete web-based system includes a powerful software package designed on an Oracle base and
implemented on a network covering different locations of the DBE. The core of the system is a fully paperless
computerized maintenance management system where all maintenance operations are performed fully
paperless, including spare orders management. The system also includes a powerful reporting module
capable of producing all types of standard and customized reports about all activities and information related
to any medical equipment such as inventory information, life cycle cost and including any other information
such as staff productivity, travel hours, performance, training etc. The main lesson learned was that every
country or health organization needs a HTM system developed to meet local requirements. Copying systems
from more developed countries may not necessarily work. This system presents a unique model in terms of
setup, cost and performance. It contributes to better quality patient care.
The main challenge currently is to transform the health-care system into an interoperable health-care
system. Medical device interoperability refers to the ability of medical devices to exchange information
with each other and with patient data repositories such as electronic health records (EHRs). In the context
of device and EHR interoperability, it refers to information sharing from one device to another or between
devices and EHRs.
122 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
European Region: Croatia
Distribution of biomedical engineers: Low (1500 estimated for 16 000 health-care facilities)
BME societies: Biomedical Engineering Society of India, Clinical Engineering Society of India has been in
existence for a couple of decades
Main BME activities: HTM (focusing on corrective maintenance), procurement
Leaders of health-care systems in India are well aware that use of modern medical technology is essential
for providing advanced diagnostic and therapeutic services to patients. In recent years, there has been
a great influx of modern, sophisticated and expensive equipment into all types of hospitals. However, an
understanding that well qualified, highly trained and certified biomedical engineers are equally essential
within the system for effectively and safely managing this advanced technology, has been lacking. This
has been one major factor for causing suboptimal development of the BME profession in India. Absence of
a formal state recognized nationwide programme for certification of biomedical engineers is another hurdle
in correctly projecting the importance of this profession to other health-care professionals and to the
society at large. Though recent efforts have managed to make some progress in attracting the attention of
health-care system leaders and policy-makers towards these lacunae, much more effort is needed to bring
about the required strengthening of the BME profession in India.
124 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
9.5 Conclusion physicians and nurses. For this reason,
it is important that they become more
This chapter presents a general overview involved in health-care delivery systems,
of BME in hospitals. It could be useful for with countries recognizing the biomedical
those health-care facilities considering engineer as an essential professional for
introducing a BME service, as well as 21st-century health-care.
for those who wish to improve their
department. WHO encourages all biomedical engineers
to dedicate substantial time during their
Activities performed inside a BME service academic preparations in hospital settings
are diverse, but all are related to medical (via internships, fellowships, practicals) to
devices and health technologies. The understanding health technologies for the
most important is undoubtedly HTM, widest contexts and uses.
which is the core of BME. Nevertheless,
HTA, research, procurement, planning This recognition of biomedical engineers
of health facilities and other activities as essential health-care figures is very
are performed with the same aims of important for WHO, IFMBE and other
HTM: patient safety, proper use of health national BME associations globally.
technologies and cost minimization of Today, these organizations are making
health-care services. great efforts to increase the availability
of biomedical engineers worldwide in
It is important to underline that the figure order to support health service delivery.
of the biomedical engineer is the only one It is therefore important to advocate for
assigned to the management of medical the inclusion of the biomedical engineer
devices, encompassing both hardware (and clinical engineer) in the national and
and software functions. Biomedical regional classifications of occupations as
engineers could be considered as well as in the International Classification
health-care professionals in parallel with of Occupations published by ILO.(200)
Devices are being made dramatically smaller, enabling portable monitoring and
Miniaturization
decentralized management of care.
Devices that used to require external power, controls and maintenance can be
Implantation
implanted for long periods of time, with mobile power sources and controls.
Multicore processors and increased memory capacity enable medical devices to
execute a much wider range of functions, including self-monitoring and reporting,
Smart device
remote management, process controls, embedded security and stand-alone
functions when disconnected from the network.
Devices can synthesize multiple functions previously requiring several devices,
Hybridization servers and databases, expanding to include monitoring, diagnostic and
treatment capabilities.
Devices can connect to other devices and wired/wireless networks, disseminating
Networking data to aggregators, monitoring stations, mobile devices, specialized servers,
EMRs and exercising new safety controls.
Devices now must produce data in formats that are compatible with national
Informatics standard
standards that cross organizational and sectoral boundaries.
Clinical process re- Devices will play an increasing role in controlling compliance with built-in safety
engineering “guardrails” and best clinical processes.
The granularity and scale of what constitutes a medical device is becoming
Molecular and nano- increasingly refined to molecular and nano-scale structures and processes,
technical engineering creating radically new levels of specificity for detection, diagnosis, monitoring and
treatment.
Models of care are expanding beyond the hospital to include retail sites, business
Virtualization of care
locations, other community-based locations such as gyms, shops, schools,
away from hospital
monitoring and advice centres, and to include new providers and services.
Point-of-care labs on a Micro-diagnostic technologies will enable rapid and decentralized laboratory
chip services, extending care into new locations and populations.
New materials will enable devices to be used in novel ways, swallowed as pills,
implanted as dissolvable devices, materials with bonding specificity that pairs
Materials science
with imaging and ultrasound technologies to target diagnosis and therapies more
precisely.
Multiple devices and information systems may need to interact with each other in
Interoperability order to monitor and adjust care in real-time. Timing synchronization, data models
and control language will require standardization.
Devices will play a stronger role in providing clinicians with decision support at
Clinical decision support the point of care and remotely. Device reliability will be crucial to reliable decision
support.
Telehealth and wellness New devices will come into use as consumers and providers move to adopt more
models of care preventive, mobile models of “care anywhere.”
New research methods New methods and disciplines will be needed to take advantage of cloud- and
based on new sources of crowd-sourced health data derived from multiple new sources and device types.
data
Biomedical and clinical engineers will need to take a more active role in shaping
Design and performance
the design of medical devices, and evaluating competing alternatives in terms of
analytic
the overall system life cycle of costs, benefits and operational requirements.
Increasingly, devices will be defined by changeable software capabilities that
will enable more rapid upgrading and evolution of medical devices, requiring
Software evolution
significant skills in configuration, change management and ongoing IT
partnerships.
New devices, analytics and procedures will enable health care to be delivered in
Personalized medicine
ways that are specific to individual genetic and personal circumstances.
128 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Device performance and safety characteristics are becoming interdependent with
other devices and/or information systems. e.g. self-adjusting medication infusion
Interdependencies
may be controlled by one or more physiological monitoring systems and/or central
clinical decision support software.
Devices are expected to function without wires that limit deployment flexibility or
Wireless and mobility
that can themselves introduce hazards into the clinical environment.
Devices can be worn by the patient, which has some of the benefits of
Wearable technologies implantation but exposes the device to additional environmental risks and risks of
interruptions in wireless communication.
Smart, networked medical devices are now being hacked and attacked, creating
Cybersecurity
novel safety and performance threats which may be hidden from easy detection.
Heterogeneous Devices are being combined in novel ways that challenge traditional detection or
integration of multi- assignment of “fault”.
vendor, multi-modality
devices
10.3 Other contextual factors Taken together, these forces lay out
driving change in health-care a challenging landscape that both
systems experienced and novice biomedical
engineers need to consider, understand
In addition to the technological and and respond to with critical thinking,
clinical changes identified in Table 10.1, study, formal education, interdisciplinary
there are numerous socioeconomic discussions with health-care colleagues,
factors that both inspire and constrain life-long learning and a spirit of innovation
change, including: that attempts to envision more effective
health-care, not just in terms of devices,
• Supply-chain problems that obstruct but also in terms of processes, multiple
the economic and timely flow of parts interacting systems and systems-of-
and services needed to keep medical systems.
devices in proper running condition,
affordably.
• Aggressive plans for modernization 10.4 Biomedical engineers work
of obsolete national health-care in many sectors
infrastructures.
• Embedded traditions of business and Because of how critical medical devices
political corruption, institutional and are in all health-care programmes,
professional rigidity, and outmoded biomedical engineers have evolved
bureaucratic practices that impede diverse career paths to ensure that
adoption of more effective, affordable appropriate engineering and clinical
health-care practices. expertise is applied along the entire
• New ethical questions about eligibility strategic and operational life cycle of
for care, end-of-life care, and medical devices and the systems they
prioritization of care under conditions interact with.
of limited resources.
• Increasing numbers of well-educated These practitioners may have similar
health-care professionals are capable academic preparation, but eventually
and motivated to create 21st-century develop specialized skills as they move
health-care systems, but they often between sectors. These careers may
must work against historical, political evolve in different directions over time
and economic obstacles. depending on personal motives, abilities,
training, certification and organizational
There are three major domains and Being trained as a biomedical engineer
institutional complexes where BME can lead to employment in a wide range
expertise is needed to create and manage of sectors, with a variety of job titles
safe and effective medical devices and (Figure 10.1).
services – institutional foundations,
130 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
10.4.1 Evolution in biomedical being designed with software/firmware
engineering career paths features and control capabilities that
Traditional BME responsibilities typically are critical to their interactive role with
have included: informatics systems, electronic medical
records, clinical decision support systems,
• Evaluation of the existing device and both patients and caregivers.
infrastructure Stand-alone devices, single-purpose
• Identification and evaluation of devices, and/or hardware-defined
emerging technologies in terms of devices are quickly becoming obsolete
cost, effectiveness, efficiency, safety or marginalized to narrow roles. Most
and fit with clinical interventions devices use embedded microprocessors,
• Procurement and contracting of new data storage and communication chips
devices, support services, rentals that allow them to be networked to
and parts deliver sophisticated new functions. New
• Installation of new technologies safety and clinical features are emerging
• Planning of health facilities through local and distributed-intelligence
• Integration of medical technologies capabilities, remote software and data
with electronic medical records and access, configurability, and sharing and
other IT systems functional interoperability with other
• Training of health-care workers devices and systems. Today’s software-
• Ongoing maintenance and repairs based devices are configurable to provide
• Documentation required for hospital customized or optimized functions and
accreditation features throughout their life cycle. Such
• Analysis of failure trends and devices need to be understood both as
costs, in order to identify need for evolving, adaptive technologies and as
replacements components or subsystems within larger
• Management of hazard alerts and clinical systems of systems (SoS), not
recalls merely as static, fixed machines. This
• Forensic investigation of product- evolutionary SoS framework adds a
related failures, injuries and deaths significant, highly dynamic dimension
• Retirement or cascading re-use of to the BME career that calls for constant
ageing devices. learning, research, collaborative design
intelligence and troubleshooting, and
Many of these traditional responsibilities leadership skills for working in wider
will undergo significant transformation institutional contexts. This new expertise
and growth in coming years as a can help inform and guide the health-
consequence of the numerous changes care strategy of provider organizations,
in technology, government policy and regulators, insurers and manufacturers.
models of care.
10.5.1 Telehealth and telemedicine
Technological innovations in telehealth
10.5 Evolution of modern medical and telemedicine are expanding the
devices physical and social dimensions of health
care, and the range of services, beyond the
Modern medical devices are evolving to traditional hospital setting, with increasing
be smarter and more complex – more emphasis on prevention, wellness,
interconnected, integrated, interoperable real-time monitoring and use of social
and interdependent. They are increasingly media. This expanded scope involves
132 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
The International Council on Systems replacement parts, ergonomic design,
Engineering (INCOSE) provides supply-chain weaknesses, facility
networking and training resources to infrastructure needs, weaknesses in the
support formal education in the emerging managerial and leadership levels, end-
SoSE field. Because the language user training, vulnerabilities to variations
and focus of INCOSE’s community is in IT system performance, etc.
generalized for many different industrial
fields, the biomedical engineer will need Because of this wider, “end-to-end”
to adapt it to the health-care paradigm. systems perspective, biomedical
Given the enormous importance and cost engineers often understand the
of health-care systems, it may become a bigger picture better than many of the
societal imperative to develop health-care administrative, financial and IT specialists
systems engineering as a profession of who may be making important decisions
importance equivalent to that of engineers with incomplete understanding or
who design outer-space systems, large historical experience. Biomedical
metropolitan settlements, and national engineers may be better prepared to
security infrastructures. work in the planning and budgeting
discussions, to ensure that their systemic
Biomedical engineers could explore experience informs the decision-making
the V-model of system verification and process.
validation (V&V) that has been described
by INCOSE and others instructive for Working upward from the most basic
managing SoSE projects. Also, writings level of services (from family homes and
by Barry Boehm(201) on the “spiral schools to village outposts and clinics
model” of project management may to hospitals, regional systems, national
assist in mapping traditional “waterfall” systems and international systems),
and newer “agile” and “extreme” project health-care planners and biomedical
management methods into longer term, engineers can use tools such as WHO’s
multi-year projects such as hospital or OneHealth(202) software, “to link strategic
health system modernization. objectives and targets of disease control
and prevention programmes to the
required investments in health systems.
10.7 Elements of an ideal, The tool provides planners with a single
integrated health and framework for scenario analysis, costing,
information technology health impact analysis, budgeting and
system financing of strategies for all major
diseases and health system components.
Health-care systems of all kinds are It is thus primarily intended to inform
evolving through several stages of sector wide national strategic health plans
maturity to achieve higher levels of and policies”.
clinical quality and wider extension
of their services. Because biomedical Within this strategic framework,
engineers may work for years in hospitals representatives from the various
or regional service networks, they often jurisdictions can begin to coordinate
have extensive experience with the their plans and staffing models to provide
numerous performance issues affecting the desired capabilities. All medical
clinical services, not just related to devices must be understood in terms of
devices but to the wider “performance the medical services they support, and
ecosystem” of manufacturers, third party the contextual factors impacting those
service providers, physical materials and services. As medical devices evolve,
134 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Figure 10.2 Clinical system life cycle
1 7 13 18 24
Manage receipt,
Manage multi- Define integration Implement preventive
Conduct lifecycle staging, inspection, and remote support
equipment inventory disciplinary technology and interoperability testing, assembly
assessment teams requirements, and services and monitor
and cost analysis of new devices and systems performance
deployment plans systems
2 8 14 19 25
3 9 15 20 26
Maintain asset and
Maintain utilization Coordinate data service management
and performance Upgrade and migration (when
Engage in design needed), testing, databases, accounts
partnerships with databases, for replacement planning payable, metrics,
capacity planning and toward national configuration, quality
industry and user acceptance safety, service level
management standards agreements and
testing compliance documents
4 10 21 27
Define clinical and PROCUREMENT Perform ongoing
technical requirements, Coordinate
Support multi-region infrastructure upgrades
repairs, corrective
plans and working process & functional and preventive
specifications, service and integration across
relationships divisions
maintenance on
level agreements schedule
5 11 16 22 28
Conduct state-of-art Schedule and
technology evaluations, Tag new system for
Maintain service area Submit and monitor asset management
implement upgrades,
representation on including evidence- purchase requests, application patches,
based and life cycle and develop system
assessment teams orders documentation
manage hazard alerts
cost analysis and equipment recalls
6 12 17 23 29
SAFETY, RISK, COMPLIANCE, GOVERNANCE, CAPITAL PLANNING, HOSPITAL STATEGY, UTILIZATION, CAPACITY,
METRICS, ANALYTICS
Source: Fred Hosea, 2016.
136 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
IT systems alignment and integration: safety risks and challenges, clinical
Biomedical engineers, clinical engineers technology management staff will likely
and biomedical equipment technicians will need EMR/EHR support skills in order
need more than a casual understanding to perform point-to-point or device-to-
of core IT infrastructure components device or device-to-system safety and
and skills, including topics like performance validation and verification.
software, networks, databases, security
management, change management, The ITIL framework: The Information
user interface design and configuration, Technology Infrastructure Library (ITIL)
decision support systems and wireless provides an indispensable model for
communication systems. Many, perhaps aligning mission-critical services, business
most, devices will have one or more of processes, data models and activities
these IT components embedded, and the between IT and biomedical systems.
selection, safe deployment, and ongoing The criticality of aligning these dynamic
maintenance and repair will require service functions cannot be overstated,
competent IT troubleshooting with IT as IT and biomedical systems become
peers, and coordinated repair processes. more interoperable and interdependent.
Further, because most devices will likely Biomedical engineers are urged to
be interconnected with one or more receive formal training in the ITIL model
electronic medical record systems (EMR and participate in ongoing efforts to
or EHR) and since those systems may architect the organizational capabilities
themselves introduce significant patient needed to enable IT and biomedical
Service Transition
ITIL® SERVICE LIFECYCLE • Transition Planning and
Support
• Change Management
• Service Asset and
Service Strategy Configuration Management
• Service Portfolio • Release and Deployment
Management Management
• Financial • Service Validation
Management Management
• Demand • Service Validation and
•
Management
ROI
Service Service Testing
• Evaluation
Design Transition • Knowledge Management
Service
Strategy
Service Design
• Service Catalogue
Management
• Service Level Service Operation
Management • Event Management
• Capacity Service • Incident Management
• Request Management
•
Management
Availability
Operation • Problem Management
• Access Management
Management Functions
• IT Service ⁻ Service Desk
Continuity Continual Service Improvements ⁻ Technical Management
• Information • Seven Step Improvement ⁻ Application
Security Management
Management ⁻ Operations
Management
138 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Figure 10.4 Internal and external career paths
clinical changes. Biomedical engineers not addressed, or paid for, in the daily job
will need to pursue activities outside of descriptions that govern formal work life.
their primary employing organization
to build knowledge, connections and In view of the increasing speed of change,
experience that will nurture their career complexity of devices and processes,
possibilities. These “external” professional and the interdependencies of systems,
development activities not only improve biomedical engineers will need to
career potential as an employee; they have very dynamic, life-long learning
also lay the foundation for meaningful approaches to their professional life, and
professional service after retirement. organizations are urged to provide routine
support for this learning process.
In addition to the “internal” career stages
typical of professional employment, 10.10.3 Key emerging biomedical
Figure 10.4 identifies other external engineering competency
disciplines, institutions and initiatives opportunities
where biomedical and clinical engineers The following trends are re-defining the
can become fruitfully involved. These realities that biomedical engineers will
“outside” activities can be indispensable need to understand, to provide new
not only for the aspiring professional value-added competencies:
personally, but for the wider society as
well, because they create considerable • Convergence of technologies: This
value-added in social capital – in will accelerate novel decision support
knowledge, creativity and alignment of tools (IBM’s emerging Watson
professional resources that are typically programme is an example) using
140 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
• Legal and regulatory definitions are created to support its evolution in
of medical devices and medical coming years.
information systems
• Hospital accreditation procedures.
10.13 Further reading
Websites
ANSI Health Information Technology
Standards Panel Useful Clinical
Engineering standards in c lu d e :
Interoperability Standard (IS-77): Remote
Patient Monitoring and the Technical
Note (TN-905): General Medical Device
Interoperability: http://www.HITSP.org
142 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Credit: Adriana Velazquez; policy-makers at the Ethiopian Ministry of Health, November 2016.
11 Conclusions and recommendations
144 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
technology innovations, biomedical manage the transition into 21st-century
engineers can help integrate the vertical care. The relentless flood of scientific
intelligences of the various sectors in an and technological innovation is radically
integrated, holistic manner according redefining the nature of health care in
to population needs. As is shown in virtually every dimension, from nano-
the present publication, the role of engineered theranostics at the molecular
biomedical engineers spans national level to telehealth and telemedicine
policy, regulation, technical standards, at the national and global level. The
professional education, academic challenge of achieving universal health
and industry R&D, device and service coverage implies having appropriate
design, prototyping, clinical research health technologies, in particular, medical
and trials, technology assessment, devices, to support health interventions
contracting, supply chain and service from prevention to early diagnostics,
strategy, deployment, integration with screening when possible, effective
IT and business systems, operational treatment, and palliative care. There
monitoring, process re-engineering, are many challenges in this respect: the
device maintenance and repairs, hazard availability of the technology (medical
alerts and recalls, inventory analysis and devices), the availability and training of
replacement planning. This “life cycle” health-care workers and the affordability
intelligence is an essential professional of interventions. Most health-care systems
resource for any 21st-century health-care are not adequately staffed to comprehend
innovator, manufacturer, planner, care or manage these forces of change. Most
provider or relevant government agency; systems are structured around vertically
and should, therefore, be considered as expert professions (doctors, nurses,
such along with other members of the administrators) and annual plans, and
health workforce. most lack the expertise that biomedical
engineers can provide, to understand
and manage the complex life cycles of
11.1 Future role of biomedical medical devices and processes.
engineers in low- and
middle-income countries Low- and middle-income countries,
especially, face a double challenge of
In order to support the Sustainable selectively “catching up” with developed
Development Goals and the universal countries (in terms of infrastructure and
health coverage included in Goal 3 human resources), at the same time
(Health), it is necessary that medical that developed countries themselves
devices are safe, of good quality and are re-defining their models of care,
accessible to health-care providers. beyond hospital-centric “ill care” to
The biomedical engineer can play an include wellness promotion, remote
important role in this, especially in LMICs, monitoring and decentralized, point-
as described in this publication. of-care technologies that enable “care
anywhere”. Biomedical engineers can
Beyond the ongoing health-care play vital roles in all sectors of this
burdens of population growth, political transformation, as guarantors that new
and economic instability, disease medical devices and related processes
management, disasters, millions of are intelligently designed and managed
refugees, accidents, terror attacks from the outset with careful understanding
and routine medical services, our of all performance requirements at each
world’s health-care systems are facing stage of the life cycle of medical services.
enormous organizational challenges to This expertise will be of critical value in
146 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
11.3 Final statement sector in more than 100 countries. These
numbers express only a head count and
Recalling the WHO resolutions on some data on certification, accreditation of
medical devices, the SDGs, the WHO programmes and roles in the health-care
Global Strategy on Human Resources sector. A priority for the near future is that
for Health, and ComHEEG, this book on data should be compiled and classified
human resources for medical devices to include biomedical engineers within
raises awareness of the role of biomedical National Health Workforce Accounts, so
engineers in health sector provision to as to be able to adequately monitor their
ensure appropriate medical technologies workforce situation to achieve universal
are used depending on local settings and health coverage, define gaps and suggest
needs to comply with universal health ways to address them locally.
coverage.
This publication demonstrates the
The book Human resources for medical availability and the different areas of
devices, the role of biomedical engineers is work of biomedical engineers. However,
part of the WHO Medical device technical specifically in LMICs, it will be important
series and it comprehensively presents to increase: academic programmes,
the different roles biomedical engineers demand within the health-care sector,
perform in the development, innovation, availability, and funded positions in
regulation, assessment, supply and use health-care services, at national level
of medical devices in the health-care for policy-making and at local level
sector. The biomedical engineer needs (particularly in secondary and tertiary
to interact with many other professionals level hospitals) and ensure cadres are
in engineering, economic, political and developed locally to meet local needs,
clinical spheres. Most users of medical in line with the WHO Global Strategy on
technologies are health-care workers with Human Resources for Health.
medical and clinical background.
This book is a contribution to the evolution
It is important to note that the studies, of the profession itself, and serves as a call
surveys and review of published material to institutional leaders to look to BME to
clearly show there are biomedical expand the professional capabilities that
engineers and biomedical technicians health-care systems worldwide need as
in more than 100 Member States of they grapple with the often overwhelming
WHO, including LMICs, across the six complexities and questions that no one
WHO regions. The data presented in this seems adequately prepared to answer.
publication were compiled from 2009 Biomedical engineering is and most
to 2015, and demonstrate the growing certainly will be part of the solution to
initiatives in education at professional and providing better health care to those in
technical level and theincreasing uptake need in order to achieve the Sustainable
of biomedical engineers in the health-care Development Goals.
Number of
Reported biomedical
number of engineers per
Population Income biomedical 10 000
Country Code (2015) grouping engineers (2015)
African Region
Algeria DZA 39 666 519 Upper middle- 1 0.000252102
income
Benin BEN 10 879 829 Low income 16 0.014706113
Botswana BWA 2 262 485 Upper middle- 52 0.229835778
income
Burkina Faso BFA 18 105 570 Low income 7 0.003866214
Cameroon CMR 23 344 179 Lower middle- 19 0.008139074
income
Chad TCD 14 037 472 Low income 12 0.008548548
Côte d'Ivoire CIV 22 701 556 Lower middle- 50 0.022024922
income
Democratic COD 7 726 6814 Low income 20 0.002588433
Republic of the
Congo
Ethiopia ETH 99 390 750 Low income 150 0.015091948
Gambia GMB 1 990 924 Low income 17 0.085387488
Ghana GHA 27 409 893 Lower middle- 4 0.001459327
income
Guinea GIN 12 608 590 Low income 0 0
Kenya KEN 46 050 302 Lower middle 20 0.004343077
income
Liberia LBR 4 503 438 Low income 0 0
Mozambique MOZ 27 977 863 Low income 0 0
Namibia NAM 2 458 830 Upper middle- 1 0.004066975
income
Nigeria NGA 182 201 962 Lower middle- 280 0.015367562
income
Rwanda RWA 11 609 666 Low income 5 0.004306756
Senegal SEN 15 129 273 Lower middle- 23 0.015202317
income
Sierra Leone SLE 6 453 184 Low income 1 0.001549623
South Africa ZAF 54 490 406 Upper middle- 300 0.055055563
income
Swaziland SWZ 1 286 970 Lower middle- 1 0.007770189
income
Uganda UGA 39 032 383 Low income 49 0.012553679
United Republic TZA 53 470 420 Low income 4 0.000748077
of Tanzania
Zambia ZMB 16 211 767 Lower middle- 46 0.028374452
income
150 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Number of
Reported biomedical
number of engineers per
Population Income biomedical 10 000
Country Code (2015) grouping engineers (2015)
United States of USA 321 773 631 High income 15700 0.487920653
America
Uruguay URY 3 431 555 High income 10 0.029141308
Venezuela VEN 31 108 083 Upper middle- 60 0.019287592
(Bolivarian income
Republic of)
Eastern Mediterranean Region
Afghanistan AFG 32 526 562 Low income 1 0.000307441
Bahrain BHR 1 377 237 High income 2 0.014521829
Djibouti DJI 887 861 Lower middle- 1 0.011263024
income
Egypt EGY 91 508 084 Lower middle- 1000 0.109279963
income
Jordan JOR 7 594 547 Upper middle- 500 0.658367115
income
Lebanon LBN 5 850 743 Upper middle- 750 1.281888471
income
Pakistan PAK 188 924 874 Lower middle- 360 0.019055193
income
Saudi Arabia SAU 31 540 372 High income 300 0.095116189
Sudan SDN 40 234 882 Lower middle- 365 0.090717303
income
Tunisia TUN 11 253 554 Upper middle- 20 0.017772163
income
United Arab ARE 9 156 963 High income 3 0.003276195
Emirates
Yemen YEM 26 832 215 Lower middle- 1 0.000372686
income
European Region
Albania ALB 2 896 679 Upper middle- 53 0.182968151
income
Austria AUT 8 544 586 High income 800 0.936265373
Belgium BEL 11 299 192 High income 980 0.867318654
Bosnia and BIH 3 810 416 Upper middle- 5 0.013121927
Herzegovina income
Bulgaria BGR 7 149 787 Upper middle- 35 0.048952507
income
Croatia HRV 4 240 317 High income 200 0.47166285
Cyprus CYP 1 165 300 High income 15 0.128722217
Denmark DNK 5 669 081 High income 450 0.79377945
Estonia EST 1 312 558 High income 60 0.457122657
Finland FIN 5 503 457 High income 1500 2.725559589
France FRA 64 395 345 High income 600 0.093174437
152 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Number of
Reported biomedical
number of engineers per
Population Income biomedical 10 000
Country Code (2015) grouping engineers (2015)
South East Asia Region
Bangladesh BGD 160 995 642 Low income 2 0.000124227
Bhutan BTN 774 830 Lower middle- 6 0.077436341
income
India IND 1 311 050 527 Lower middle- 40000 0.305098844
income
Indonesia IDN 257 563 815 Lower middle- 1 3.88253E-05
income
Maldives MDV 363 657 Upper middle- 1 0.027498439
income
Myanmar MMR 53 897 154 Low income 1 0.000185539
Nepal NPL 28 513 700 Low income 1 0.000350709
Sri Lanka LKA 20 715 010 Lower middle- 3 0.001448225
income
Thailand THA 67 959 359 Upper middle- 5 0.000735734
income
Timor-Leste TLS 1 184 765 Lower middle- 1 0.008440492
income
Western Pacific Region
Japan JPN 126 573 481 High income 20001 1.580188823
Malaysia MYS 30 331 007 Upper middle- 2500 0.824239037
income
Mongolia MNG 2 959 134 Lower middle- 240 0.811048097
income
Kiribati KIR 112 423 Lower middle- 3 0.26684931
income
Australia AUS 23 968 973 High income 320 0.133505929
Viet Nam VNM 93 447 601 Lower middle- 1000 0.107011843
income
New Zealand NZL 4 528 526 High income 26 0.057413825
Micronesia FSM 526 344 Lower middle- 2 0.037997963
(Federated income
States of)
Vanuatu VUT 264 652 Lower middle- 1 0.037785469
income
China CHN 1 376 048 943 Upper middle- 4497 0.032680524
income
Fiji FJI 892 145 Upper middle- 1 0.01120894
income
Lao People's LAO 6 802 023 Lower middle- 7 0.010291056
Democratic income
Republic
Philippines PHL 100 699 395 Lower middle- 50 0.004965273
income
Republic of KOR 50 293 439 High income 5 0.000994165
Korea
Singapore SGP 5 603 740 High income 320 0.57104
African Region
Algeria Upper middle University of Tlemcen Tlemcen
Benin Low Ecole Polytechnique Cotonou Département X
Abomey Calavi part de Maintenance
of Université Abomey Biomédicale et
Calavi Hospitalière
Burkina Faso Low Ecole Superieur des Ouagadougou Génie Biomédical X
Techniques Avancees
Burkina
Faso Low Institut Superieur de Ouaga-dougou Génie Biomédical X
Technologies IST
Cameroon Lower middle Lycée Technique de
Garoua
Cameroon Lower middle Universite de Yaoundé Biomedical X
Yaoundé Equipment
Maintenance
Cameroon Lower middle Université des Bangangte Ingénierie X
Montagnes Biomédicale
Cameroon Lower middle Université des Bangangte Génie Biomédical X
Montagnes
Cameroon Lower middle Université des Bangangté Ingénierie X X
Montagnes Filère Biomédicale
Instrumentation
et Maintenance
Biomédicale
Democratic Low Institut Supérieur Kinshasa Maintenance de
Republic of des Techniques Matériel Médical
Congo Appliquées
Ethiopia Low Addis Abba Addis Ababa Biomedical X X
University Engineering
Ethiopia Low Comcbocha College Comc-bocha BMT X
Ethiopia Low Debere Markos Debre Markos BMT X
College
Ethiopia Low Jimma Institue of Jimma Biomedical X
Technology and Engineering
Engineering
Ethiopia Low Tegbare-ID College BMT X
Ghana Lower middle All Nations University Koforidua Biomedical X
Engineering
Ghana Lower middle Kwame Nkrumah Kumasi
University of Science
and Technology,
Ghana Lower middle University of Ghana Accra Biomedical X
Engineering
154 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Ghana Lower middle Valley View Adentan Bio-Medical X
University Equipment
Technology
Kenya Lower middle Kenya Medical Nyeri Medical X
Training College Engineering
Kenya Lower middle Kenya Medical Eldoret, Medical X
Training College Loitokitok, Engineering
(KMTC) Nairobi
Kenya Lower middle Technical University Mombasa Medical X
Mombasa (fomerly Engineering
Mombasa Services
Polytechnic)
Madagascar Low Institut Superieur de Antananarivo Génie Biomédical X X
Technologies (IST)
Malawi Low Malawi University Blantyre BME X
of Science and
Technology
Malawi Low The Malawi Blantyre BME X
Polytechnic
Mozambique Low Centro Regional de Maputo Health X
Desenvolvimento Maintenance
Sanitário (CRDS) Technology
Namibia Low Polytechnic of Windhoek
Namibia
Nigeria Lower middle Ahmadu Bellon Zaria Biomedical X
University Teaching Engineering
Hospital Technologist
(BMET)
Nigeria Lower middle Bells University of Ota Biomedical X
Technology Engineering
Nigeria Lower middle Federal University of Akure Biomedical X
Technology, Akura Engineering
Nigeria Lower middle Federal University of Owerri Biomedical X
Technology, Owerri Engineering
Nigeria Lower middle School of BME, Zaria BMET X
Ahmadu Bellon
University Teaching
Hospital
Nigeria Lower middle School of BME, Biomedical X
University of Benin Engineering
Teaching Hospital Technology
Nigeria Lower middle School of BME, BME X
University of
Maiduguri Teaching
Hospital
Nigeria Lower middle University of Benin Benin City Biomedical X
Teaching Hospital Engineering
Technology
Nigeria Lower middle University of Ilorin Ilorin Biomedical X
Engineering
Nigeria Lower middle University of Lagos Lagos Biomedical X
Engineering
156 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Iran (Islamic Upper middle Iran University Tehran Biomechanics X X X
Republic of) of Science and
Technology
Bioelectrics
Iran (Islamic Upper middle Isfahan University of Isfahan
Republic of) Technology
Iran (Islamic Upper middle K.N. Toosi University Tehran Bioelectrics X
Republic of) of Technology
Iran (Islamic Upper middle Shahid Beheshti Tehran Bioelectrics X
Republic of) University
Iran (Islamic Upper middle Sharif University Tehran Bioelectrics X X
Republic of)
Iran (Islamic Upper middle Tabriz Modares Tehran Bioelectrics X X
Republic of) University
Biomaterials
Iran (Islamic Upper middle University of Isfahan Tehran Biomechanics X X
Republic of) Biomaterials
Iran (Islamic Upper middle University of Tehran Tehran Biomechanics
Republic of) Bioelectrics
Jordan Upper middle Al-Ahliyya Amman Amman X
University
Biomaterials
Jordan Upper middle German Jordan Amman
University
Jordan Upper middle Hashemite University Zarqa
Jordan Upper middle Institute of Amman
Biomedical
Technology/Royal
Medical Services
Jordan Upper middle Jordan University Irbid
of Science and
Technology
Jordan Upper middle Yarmouk University Irbid
Lebanon Upper middle American University Beirut
of Beirut
Oman High College of Muscat
Engineering at
Sultan Qaboos
University (SQU)
Pakistan Lower middle Aga Khan University Karachi
Hospital, Nairobi
Pakistan Lower middle Hamdard University Karachi
Pakistan Lower middle Mehran University Jamshoro
Pakistan Lower middle NED University of Karachi
Engineering and
Technology
Pakistan Lower middle Sir Syed University Karachi
of Engineering and
Technology
European Region
Armenia Lower middle State Engineering Biomedical X X
University of Armenia Engineering
Armenia Lower middle UNESCO Chair in Biomedical X X
Life Sciences - Life Engineering
Science International
Postgraduate
Educational Center
Austria High Fachhochschule Vienna Biomedical X X
Technikum Wien Engineering
Austria High Fachhochschule Vienna Healthcare and X
Technikum Wien Rehabilitation
Technology
Austria High Medical University of Vienna
Vienna
Austria High Technische Graz Biomedical X X
Universität Graz Engineering
Austria High Technische Graz Electrical and X
Universität Graz Biomedical
Engineering
Austria High Technische Graz Molecular X
Universität Graz Bioengineering
Austria High UMIT Österreich
Austria High Upper Austria Linz Medical X X
University of Applied Engineering
Sciences
Azerbaijan Upper middle Khazar University Biomedicine X X
Belarus Upper middle Belarussian National Biotechnical and X X
Technical University medical apparatus
and systems
Belarus Upper middle Belarussian National Instruments and X
Technical University articles for medical
purposes
158 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Belarus Upper middle Belarussian State Medical Electronics X X X
University of
Informatics and
Radioelectronics
Belgium High IBiTECH Universiteit Gent
Gent
Belgium High Katholieke Diepenbeek
Hogeschool
Limburg - Radiation
Protection
Belgium High Katholieke Heverlee Biomedical X
Universiteit Leuven and Clinical
Engineering/
Biomedical
Technology
Belgium High Université Louvain Biomedical X X
Catholique de Engineering
Louvain
Belgium High Vrije Universiteit Brussels Biomedical X
Brussel and Ghent Engineering
University
Belgium High Université Libre de Brussels Civil Biomedical X X
Bruxelles Engineering
Bulgaria Upper middle Technical University Plovdiv Electronics X
of Sofia - Branch
Plovdiv
Bulgaria Upper middle Technical University Medical Electronics X X
of Varna
Croatia High University of Zagreb Zagreb Medical X
Construction
Design
Croatia High University of Applied Biomedical X
Sciences Varaždin Electronics
Czech High Brno University of Brno Biomedical X
Republic Technology Technology and
Bioinformatics
Czech High Brno University of Brno Biomedical and X
Republic Technology Environmental
Engineering
Czech High Czech Technical Prague Biomedical and X X X
Republic University Clinical Technology
Czech High Czech Technical Prague Radiological X X X
Republic University Technology
Czech High Czech Technical Prague Devices and X
Republic University Methods in
Biomedicine/
Biomedical and
Rehabilitation
Engineering
Czech High Czech Technical Prague Artificial X
Republic University Intelligence and
Biocybernetics/
Biomechanics
160 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
France High Ecole Centrale Paris Engineering of X
Medical Research
Biotechnological
Data
France High Groupe des Ecoles Biomedical X
des Mines, Graduate engineering
School of Nancy/
Saint-Etienne
France High University Joseph Health and Medical X
Fourier, Grenoble and Engineering
Grenoble Institute of
Technology
Germany High Aachen University of Jülich Biomedical X X
Applied Sciences Engineering
Germany High Anhalt University of Köthen Biomedical X X
Applied Sciences Engineering
Germany High Ansbach University Ansbach Biomedical X
of Applied Sciences Engineering
Germany High Bautzen University Bautzen Medical
of Cooperative Engineering
Education
Germany High Chemnitz University Chemnitz Medical X X
of Technology Engineering
Germany High Dresden University of Dresden
Technology
Germany High Hamburg University Hamburg Biomedical X X
of Applied Sciences Engineering
Germany High Hamm-Lippstadt Hamm Biomedical X X
University of Applied Engineering
Sciences
Germany High Heidelberg University Heidelberg Biomedical X
Engineering
Germany High Hochschule Furtwangen Biomedical X
Furtwangen Engineering
University
Germany High Hochschule Furtwangen Medical X
Furtwangen Engineering
University
Germany High Ilmenau University of Ilmenau Biomedical X X
Technology Engineering
Germany High Jade University of Wilhelmshaven Biomedical X
Applied Sciences Engineering
Germany High Koblenz University of Remagen Medical X
Applied Sciences Engineering
Germany High Landshut University Landshut Biomedical X
of Applied Sciences Engineering
Germany High Leibniz University of Hannover Biomedical X
Hanover Engineering
Germany High Mannheim University Mannheim Biomedical X
of Applied Sciences Engineering
162 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Germany High University of Applied Offenburg Medical X X
Sciences Offenburg Engineering
Germany High University of Applied Stralsund Medizinisches X
Sciences Stralsund Informations
management/
eHealth
Germany High University of Applied Stralsund Medizintechnische X
Sciences Stralsund Systeme
Germany High University of Applied Schweinfurt
Sciences Würzburg-
Schweinfurt
Germany High University of Duisburg, Medical X X
Duisburg-Essen Essen Engineering
Germany High University of Erlangen Medical X X
Erlangen-Nuremberg Engineering
Germany High University of Lübeck Lübeck Medical X X
Engineering
Science
Germany High University of Rostock Rostock Biomedical X X
Engineering
Germany High University of Stuttgart Medical X X X
Stuttgart Engineering
Germany High University of Tübingen Biomedical X X
Tübingen Technologies
Germany High West Saxon Zwickau
University of Applied
Sciences of Zwickau
Germany High Westphalian Gelsenkirchen Mikrotechnology X
University of Applied and Medical
Sciences Engineering
Greece High National Technical Athens
University of Athens
Greece High University of Patras Patras Biomedical X X
Engineering
Greece High Aristotle University of Thessaloniki Medical Informatics X X
Thessaloniki
Hungary Upper middle Budapest University Budapest Biomedical X
of Technology and Engineering
Economics
Iceland High Reykjavik University Biomedical X
Engineering
Ireland High Dublin Institute of Dublin Signal Processing X
Technology Engineering with
Biomedical and
Advanced Image
Processing
Ireland High Trinity College Dublin Bioengineering/ X
Clinical
Engineering
Ireland High University of Biomedical X
Limerick Engineering
164 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Italy High Università degli Napoli Biomedical and ICT X
Studi di Napoli Engineering
"Parthenope"
Italy High Università degli Padova Biomedical X X
Studi di Padova Engineering
Italy High Università di Pisa Pisa Biomedical X X
Engineering
Italy High Università di Pisa Pisa Automation, X
Robotics and
Bioengineering
Italy High Politecnico di Torino Torino Biomedical X X X
Engineering
Italy High Università degli Roma Clinical X
Studi di Roma "La Engineering
Sapienza"
Italy High Università degli Roma Biomedical X
Studi di Roma "La Engineering
Sapienza"
Italy High Università degli Roma Automation and X
Studi di Roma "La Bioengineering
Sapienza"
Italy High Università degli Roma Medical X
Studi di Roma "Tor Engineering
Vergata"
Italy High Università degli Roma Electronic/ X X
Studi “Roma Tre” Biomedical
Engineering
Italy High Università “Campus Roma Biomedical X
Bio-Medico” Engineering
Italy High Università degli Pavia Bioengineering X X
Studi di Pavia
Italy High Università degli Pavia Bioengineering and X
Studi di Pavia Bioinformatics
Italy High Università degli Trieste Clinical X
Studi di Trieste Engineering
Italy High Università degli Trieste Information X
Studi di Trieste Engineering
Italy High Università degli Trento Tissue-materials X
Studi di Trento Interactions
Italy High Università degli Trieste Post-Bachelor X
Studi di Trieste (I lev) Master
Course in Clinical
Engineering
Italy High Università degli Trieste Post-MSc (II lev) X
Studi di Trieste Master Course
in Clinical
Engineering
Italy High Università degli Pavia Post-MSc (II lev) X
Studi di Pavia Master Course
in Clinical
Engineering
166 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Romania Upper middle University Bucharest Bioinformatics/ X
“Politehnica” of Medical
Bucharest and Clinical
Engineering/
Biomaterials
Russian High Kursk State Kursk
Federation Technical University
Russian High Ryazan State Ryazan
Federation Radio Engineering
University
Russian High Tomsk Polytechnic Tomsk Biomedical X
Federation University Engineering
Russian High Nizhny Novgorod Nizhny Biomedical X
Federation State Technical Novgorod Engineering
University
Russian High Vladimir State Bio-Technical X
Federation University and Medical
Apparatuses
and Systems/
Engineering in
Medical-Biological
Practice
Serbia Upper middle University of Novi Novi Sad
Sad
Serbia Upper middle University of Belgrade Biomedical X
Belgrade Engineering and
Technologies
Slovakia High The Technical Kosice Prosthetics and X
University of Košice Orthotics
Slovakia High The Technical Kosice Bionics and X
University of Košice Biomechanics
Slovakia High University of Zilina Biomedical X X
Engineering
Slovakia High Slovak University Bratislava Radioelectronics, X
of Technology in specialization
Bratislava Biomedical
Technology
Slovenia High University of Maribor Biomedical X
Technology
Spain High Universidad de Pamplona Biomedical X X
Navarra Engineering
Spain High Universidad de Valencia Biomedical X X
Valencia/Universidad Engineering
Politécnica de
Valencia
Spain High Universidad Madrid Bioengineering and X X
Politecnica de Telemedicine
Madrid, E.T.S.I. de
Telecomunicacion
168 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Turkey Upper middle Gediz University
Turkey Upper middle Işik University
Turkey Upper middle İstanbul Arel
University
Turkey Upper middle İstanbul Medeniyet
University
Turkey Upper middle İstanbul Medipol
University
Turkey Upper middle İstanbul Technical
University
Turkey Upper middle İstanbul University
Turkey Upper middle İzmir Katip Çelebi Biotechnology, X
University Bioengineering
Turkey Upper middle Karabük University
Turkey Upper middle Kocaeli University
Turkey Upper middle Middle East Bioelectric X
Technical University Engineering/
Biomaterials/
Biomechanics/
Biomolecular
Engineering
Turkey Upper middle Namik Kemal
University
Turkey Upper middle Near East University
Turkey Upper middle Pamukkale
University
Turkey Upper middle Sabanci University Istanbul Biological Sciences X X X
and Bioengineering
Turkey Upper middle Süleyman Demirel
University
Turkey Upper middle Tobb University
of Economics and
Technology
Turkey Upper middle Yeditepe University Biomedical X
Engineering
Turkey Upper middle Yeditepe University Genetics and X
Bioengineering
Turkey Upper middle Yeni Yüzyil University
Ukraine Lower middle Kharkov National Kharkov Biomedical X
University of Radio engineering
and Electronics
Ukraine Lower middle Kharkov National Kharkov Biotechnical and X
University of Radio Medical Apparatus
and Electronics and Systems/
Biomedical
Electronics
Ukraine Lower middle National Technical Kiev Medical Equipment X
University of Ukraine and Systems
170 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
United High University of Glasgow Biomedical X
Kingdom Strathclyde Engineering/
Medical Technology
United High University of Surrey Surrey Biomedical X
Kingdom Engineering
Region of the Americas
Argentina Upper middle Instituto Tecnológico Buenos Aires Bioengineering X
de Buenos Aires
Argentina Upper middle Universidad de Buenos Aires Biotechnology X
Buenos Aires
Argentina Upper middle Universidad de Buenos Aires Bioengineering X
Maimonides and Biomedical
Engineering
Argentina Upper middle Universidad de Mendoza Bioengineering X
Mendoza and Biomedical
Engineering
Argentina Upper middle Universidad del Mar Mar del Plata
del Plata
Argentina Upper middle Universidad Favaloro Buenos Aires Biomedical X
Engineering
Argentina Upper middle Universidad Nacional Buenos Aires Bioengineering X
Arturo Jauretche
Argentina Upper middle Universidad Nacional Córdoba Biomedical X
de Córdoba Engineering
Argentina Upper middle Universidad Nacional Entre Ríos Bioengineering X X
de Entre Ríos and Biomedical
Engineering
Argentina Upper middle Universidad Nacional San Juan Bioengineering X
de San Juan
Argentina Upper middle Universidad Nacional San Miguel de Bioengineering X
de Tucumán Tucumán and Biomedical
Engineering
Argentina Upper middle Universidad Nacional San Luis Bioengineering X
de Villa Mercedes
Argentina Upper middle Universidad Mar del Plata
Tecnológica Nacional
Bahamas High The College of the Nassau
Bahamas
Barbados High University of the Cave Hill
West Indies
Belize Upper middle Universidad de
Concepción
Belize Upper middle University of Belize Belmopan
Bolivia Lower middle Universidad Católica Biomedical X
(Plurinational Boliviana San Pablo Engineering
State of)
Bolivia Lower middle Universidad del Valle Biomedical X
(Plurinational Engineering
State of)
172 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Brazil Upper middle Universidade Federal São Paulo
de São Paulo
Brazil Upper middle Universidade Federal São Paulo Biomedical X X
de Uberlândia Engineering
Brazil Upper middle Universidade Federal Rio de Janeiro Bioprocesses X X X
do Rio de Janeiro Engineering
Brazil Upper middle Universidade Guarapuava Biotechnology X
Tecnológica Federal Engineering
do Paraná
Canada High British Columbia Vancouver Biomedical X
Institute of Engineering
Technology
Canada High Carleton University Ottawa Biomedical, Elec, X X X X
Mech. Engineering
and MEng Clinical
Engineering
Canada High College of The North Station Seal Electronics X
Atlantic Cove Engineering
Technology
(Biomedical)
Canada High Concordia University Montreal
Canada High Dalhousie University Halifax Biomedical X X
Engineering
Canada High Durham College Oshawa Biomedical X
Engineering
Technology
Canada High École Polytechnique Montreal Biomedical X
Montréal Technology
- Electronic
Instrumentation
Canada High McGill University Montreal Biological and X X
Biomedical
Engineering
Canada High McMaster University Hamilton Biomedical X X X
Engineering
Canada High Memorial University St. Johns Biomedical X X X
of Newfoundland Engineering
Program
Canada High Northern Alberta Edmonton Biomedical X
Institute of Engineering
Technology Technology
Canada High Queen's University Kingston Biomedical X X
Engineering
Canada High Ryerson University Toronto Biomedical X X X
Engineering
Canada High Simon Fraser Burnaby Biomedical X X X
University Engineering
Canada High St. Clair College Biomedical X
Engineering
Technology
174 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Colombia Upper middle Escuela de Medellín Biomedical X
Ingeniería de Engineering
Antioquia
Colombia Upper middle Instituto Tecnológico Medellín
Metropolitano
Colombia Upper middle Pontificia Bogotá Bioengineering X
Universidad
Javeriana
Colombia Upper middle Universidad Antonio Bogotá Biomedical X
Nariño Engineering
Colombia Upper middle Universidad Manizales Biomedical X
Autónoma de Engineering
Manizales
Colombia Upper middle Universidad
Autónoma del Caribe
Cebi
Colombia Upper middle Universidad Cali Biomedical X
Autónoma Occidente Engineering
de Cali
Colombia Upper middle Universidad CES Medellín
(convenio)
Colombia Upper middle Universidad de Bioengineering X
Antioquia
Colombia Upper middle Universidad de la Bogotá Bioscience X
Sabana Doctorate
Colombia Upper middle Universidad de los Biomedical X X
Andes Engineering
Colombia Upper middle Universidad Manuela Bogotá Biomedical X
Beltrán Engineering
Colombia Upper middle Universidad Medellín
Pontificia
Bolivariana
Colombia Upper middle Universidad Cali Bioengineering X
Santiago de Cali
Cuba Upper middle Instituto Superior Havana Biomedical X X X
Politécnico José Engineering
Antonio Echeverría
Cuba Upper middle Universidad “Martha Las Villas Signal processing X X
Abreu” and Systems
Cuba Upper middle Universidad de Santiago de Biomedical X X X
Oriente Cuba Engineering
Dominica Upper middle Dominica State
College, Escuela de
Salud Pública
Dominican Upper middle Universidad Santo Domingo
Republic Autónoma de Santo
Domingo
Ecuador Upper middle Universidad Central
del Ecuador
El Salvador Lower middle Don Bosco University San Salvador Biomedical X
Engineering
176 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Mexico Upper middle Universidad Aguas Biomedical X
Autónoma de calientes Engineering
Aguascalientes
Mexico Upper middle Universidad Tijuana Bioengineering X
Autónoma de Baja
California
Mexico Upper middle Universidad Mexico City Biomedical X X X
Autónoma Engineering
Metropolitana
Mexico Upper middle Universidad Querétaro Biomedical X
Autónoma de Engineering
Querétaro
Mexico Upper middle Universidad Querétaro Biosystems X
Autónoma de Engineering
Querétaro
Mexico Upper middle Universidad San Luis Potosí Biomedical X
Autónoma de San Engineering
Luis Potosí
Mexico Upper middle Universidad de Celaya Biomedical X
Celaya Engineering
Mexico Upper middle Universidad de Guadalajara Biomedical X
Guadalajara Engineering
Mexico Upper middle Universidad de León Biomedical X
Guanajuato Engineering
Mexico Upper middle Universidad de la Mexico City Biomedical X
Salle Engineering
Mexico Upper middle Universidad de las Puebla Biomedical X
Américas Engineering
Mexico Upper middle Universidad de Monterrey Biomedical X
Monterrey Engineering
Mexico Upper middle Universidad Mexico City Biomedical X
Iberoamericana Engineering
Mexico Upper middle Universidad Nacional Mexico City Biomedical X
Autónoma de México Systems
Engineering
Mexico Upper middle Universidad Guanajuato Biomedical X
Politécnica Engineering
Bicentenario
Mexico Upper middle Universidad Chiapas Biomedical X
Politécnica de Engineering
Chiapas
Mexico Upper middle Universidad Pachuca Biomedical X
Politécnica de Engineering
Pachuca
Mexico Upper middle Universidad Sinaloa Biomedical X
Politécnica de Engineering
Sinaloa
Panama Upper middle Universidad Especial Panamá City Biomedical X
de las Américas Engineering with
specialization in
Electromedicine
178 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
United States High City College of New New York, New Biomedical X X X
of America York York Engineering
United States High City University of New York, New Biomedical X X X
of America New York York Engineering
United States High Clemson University Clemson, Bioengineering X X X
of America South Carolina
United States High Colorado State Fort Collins, Bioengineering X X
of America University Colorado
United States High Colorado State Fort Collins, Biomedical X
of America University Colorado Engineering
United States High Colorado State Pueblo, Biomedical X
of America University Colorado Engineering/
Chemical and
Biological
Engineering
United States High Colorado State Pueblo Bioengineering X X
of America University
United States High Columbia University New York, New Biomedical X X X
of America York Engineering
United States High Cornell University New York, New Biomedical X X
of America York Engineering
United States High Cornell University New York, New Biological X X X
of America York Engineering
United States High Cuyahoga Cleveland, Electrical/ X
of America Community College Ohio Electronic
Engineering
Technology-Bio-
Medical (BMET)
United States High Devry Institute of Rego Park, New
of America Technology and York
Keller Graduate
School of
Management, New
York
United States High Devry University, Phoenix, Biomedical X
of America Arizona Arizona Engineering
Technology
United States High Devry University, Pomona, Biomedical X
of America California California Engineering
Technology
United States High Devry University, Colorado
of America Colorado Springs,
Colorado
United States High Devry University, Hollywood, Biomedical X
of America Florida Florida Engineering
Technology
United States High Devry University, Decatur, Biomedical X
of America Georgia Georgia Engineering
Technology
United States High Devry University, Downers Grove, Biomedical X
of America Illinois Illinois Engineering
Technology
180 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
United States High Illinois Institute of Chicago, Biomedical X X X
of America Technology Illinois Engineering
United States High Indiana Institute of Fort Wayne, Biomedical X
of America Technology Indiana Engineering
United States High Indiana University Bloomington, Biomedical X X X
of America Indiana Engineering
United States High Indiana University Indianapolis, Biomedical X X X
of America - Purdue University Indiana Engineering
Indianapolis
United States High Indiana University Indianapolis, Biomedical X
of America - Purdue University Indiana Engineering
Indianapolis Technology
United States High Iowa State University Ames, Iowa Biological Systems X X X X
of America Engineering
United States High Johns Hopkins Baltimore, Biomedical X X X
of America University Maryland Engineering
United States High Johns Hopkins Baltimore, Bioengineering X
of America University Maryland Innovation and
Design
United States High Johnson College Scranton,
of America Pennsylvania
United States High Kansas State Manhattan, Biological Systems X X X
of America University Kansas Engineering
United States High Lawrence Southfield, Biomedical X
of America Technological Michigan Engineering
University
United States High Lehigh University Bethlehem, Bioengineering X X X
of America Pennsylvania
United States High Louisiana Tech Ruston, Biomedical X X X
of America University Louisiana Engineering
United States High Louisiana State Ruston, Biological X X X
of America University and A&M Louisiana Engineering
College
United States High Manhattan College New York, New
of America York
United States High Marquette University Milwaukee, Bioengineering X X X
of America Wisconsin
United States High Massachusetts Cambridge, Biological X X X
of America Institute of Massachusetts Engineering
Technology
United States High Massachusetts Cambridge, Biomedical X
of America Institute of Massachusetts Engineering
Technology
United States High Mayo Graduate Rochester,
of America School Minnesota
United States High Mercer University Atlanta, Biomedical X X
of America Georgia Engineering
United States High Miami University Oxford, Ohio Bioengineering X
of America
182 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
United States High Pennsylvania State University Bioengineering X X
of America University Park,
Pennsylvania
United States High Pennsylvania State University Biomedical X
of America University Park, Engineering
Pennsylvania
United States High Pennsylvania State University Biological X X X
of America University Park, Engineering
Pennsylvania
United States High Pennsylvania State New Biomedical X
of America University Kensington, Engineering
Pennsylvania Technology (BET)
United States High Portland Community Portland,
of America College Oregon
United States High Purdue University Lafayette, Biomedical X X X
of America Indiana Engineering;
Biological
Engineering
United States High Rensselaer Troy, New York Biomedical X X X
of America Polytechnic Institute Engineering;
Chemical and
Biological
Engineering
United States High Rice University Houston, Texas Bioengineering X X X
of America
United States High Rose-Hulman Terre Haute, Biomedical X X X
of America Institute of Indiana Engineering
Technology
United States High Rutgers University - New Biomedical X X X
of America Cook College Brunswick, Engineering
New Jersey
United States High Saint Augustine Raleigh, North
of America College Carolina
United States High Saint Louis St. Louis, Biomedical X
of America Community College- Missouri Engineering
Florissant Valley Technology
United States High Saint Louis St. Louis, Biomedical X X X
of America University Missouri Engineering
United States High Snead State Boaz, Alabama
of America Community College
United States High Southwest Georgia Thomasville,
of America Technical College Georgia
United States High Stanford University Stanford, Bioengineering X X X
of America California
United States High Stevens Institute of Hoboken, New Biomedical X X X
of America Technology Jersey Engineering
United States High Stony Brook Stony Brook, Biomedical X X X
of America University New York Engineering
United States High Syracuse University Syracuse, New Bioengineering X X X
of America York
184 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
United States High University of Arizona Tucson, Arizona Biosystems X X X
of America Engineering;
Biomedical
Engineering
United States High University of Fayetteville, Biological and X X X
of America Arkansas Arkansas Biomedical
Engineering
United States High University of Berkeley, Bioengineering; X X X
of America California - Berkeley California Translational
Medicine
United States High University of Davis, Biomedical X X X
of America California - Davis California Engineering;
Biological Systems
Engineering
United States High University of Irvine, Biomedical X X X
of America California - Irvine California Engineering
United States High University of Los Angeles, Bioengineering X X X
of America California - Los California
Angeles
United States High University of Riverside, Bioengineering X X X
of America California - Riverside California
United States High University of La Jolla, Bioengineering X X X
of America California - San California
Diego
United States High University of La Jolla, Biotechnology; X
of America California - San California Bioinformatics;
Diego BioSystems
United States High University of Central Orlando, Bioengineering X
of America Florida Florida (minor)
United States High University of Central Edmond, Biomedical X
of America Oklahoma Oklahoma Engineering
United States High University of Cincinnati, Biomedical X X X
of America Cincinnati Ohio Engineering
United States High University of Boulder, Chemical and X X
of America Colorado Colorado Biological
Engineering
United States High University of Hartford, Biomedical X
of America Connecticut Connecticut Engineering
(Clinical
Engineering)
United States High University of Storrs, Biomedical X X X
of America Connecticut Connecticut Engineering
United States High University of Newark, Biomedical X X X
of America Delaware Delaware Engineering
United States High University of Florida Gainesville Agricultural X X X
of America Florida and Biological
Engineering
United States High University of Florida Gainesville Biomedical X X X
of America Florida Engineering
United States High University of Georgia Athens, Biological X X X
of America Georgia Engineering
186 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
United States High University of North Chapel Hill, Biomedical and X X X
of America Carolina at Chapel North Carolina Health Sciences
Hill Engineering;
United States High University of Norman, Biomedical X X X
of America Oklahoma Oklahoma Engineering
United States High University of the Stockton, Bioengineering X
of America Pacific California
United States High University of Philadelphia, Bioengineering X X X
of America Pennsylvania Pennsylvania
United States High University of Pittsburgh, Bioengineering X X X
of America Pittsburgh Pennsylvania
United States High University of Rhode Kingston, Biomedical X
of America Island Rhode Island Engineering
United States High University of Rochester, New Biomedical X X X
of America Rochester York Engineering
United States High University of South Columbia, Biomedical X X X
of America Carolina South Carolina Engineering
United States High University of South Tampa, Florida Biomedical X X X
of America Florida Engineering
United States High University of Los Angeles, Biomedical X X X
of America Southern California California Engineering
United States High University of Los Angeles, Neuroengineering; X
of America Southern California California Medical Imaging;
Medical device
Engineering
United States High University of Knoxville, Biomedical X X X
of America Tennessee Tennessee Engineering
United States High University of Texas at Arlington,Texas Biomedical X X X
of America Arlington Engineering
United States High University of Texas at Austin, Texas Biomedical X X X
of America Austin Engineering
United States High University of Texas at El Paso, Texas Biomedical X X X
of America El Paso Engineering
United States High University of Texas at San Antonio, Biomedical X X X
of America San Antonio Texas Engineering
United States High University of Toledo Toledo, Ohio Bioengineering X X
of America
United States High University of Toledo Toledo, Ohio Biomedical X
of America Engineering
United States High University of Utah Salt Lake City, Biomedical X X X
of America Utah Engineering
United States High University of Virginia Charlottesville, Biomedical X X X
of America Virginia Engineering
United States High University of Seattle, Bioengineering X X X
of America Washington Washington
United States High University of Madison, Bioengineering; X
of America Wisconsin Wisconsin Biological Systems
Engineering
United States High University of Laramie,
of America Wyoming Wyoming
188 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
190 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
India Lower middle Gokaraju Rangaraju Telengana
Institute of
Engineering and
Technology
India Lower middle Government Gandhinagar
Engineering College,
Gandhinagar
India Lower middle Gujarat University
India Lower middle Guru Jambheshwar
University
India Lower middle Indian Institute of Mumbai
Technology, Bombay
India Lower middle Indian Institute of Delhi
Technology, Delhi
India Lower middle Indian Institute Kharagpur
of Technology,
Kharagpur
India Lower middle Indian Institute of Madras
Technology, Madras
India Lower middle Institute of
Engineering
and Technology
Bundelkhand
University
India Lower middle Institute of
Technology, Banaras
Hindu University
India Lower middle J.B. Institute of
Engineering and
Technology
India Lower middle Jadavpur University
India Lower middle Jawaharlal Nehru Telengana
Technological
University
India Lower middle Jerusalem College of
Engineering
India Lower middle K.L.E. Society College
of Engineering and
Technology
India Lower middle Karunya Deemed
University
India Lower middle Khaja Banda
Nawaz College of
Engineering
India Lower middle L.D. Engineering
College, Ahmedabad
India Lower middle Mahatma Gandhi
Mission College of
Engineering and
Technology
192 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
India Lower middle Rajiv Gandhi College
of Engineering and
Technology
India Lower middle Rayat and Bahra
Institute of
Engineering and Bio-
Technology
India Lower middle Region of the
Americasita School
of Biotechnology
India Lower middle Region of the
Americasita
University
India Lower middle Sahrdaya College
of Engineering and
Technology
India Lower middle Saroj Institute of
Technology
India Lower middle School of Chemical
and Biotechnology
India Lower middle Sengunthar College
of Engineering for
Women
India Lower middle Shobhit University
India Lower middle Shree Motilal
Kanhaiyalal
Fomra Institute of
Technology
India Lower middle Shri Govindram
Seksaria Institute
of Technology and
Science
India Lower middle Sree Chitra Tirunal
Institute for Medical
Sciences and
Technology
India Lower middle Sri Belimatha
Mahasamasthana
Institute of
Technology
India Lower middle Sri Krishna Institute
of Technology
India Lower middle Sri Ramakrishna
Engineering College
India Lower middle Sri Siddartha
Institute of
Technology
India Lower middle Sri Sivasubramaniya
Nadar College of
Engineering
194 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Indonesia Upper middle Swiss-German Jakarta Biomedical X
University Engineering
Thailand Upper middle Chiang Mai Chiang Mai
University
Thailand Upper middle Chulalongkorn
University
Thailand Upper middle King Mongkut’s Thonburi
University of
Technology
Thailand Upper middle Mahidol University Salaya
Thailand Upper middle Prince of Songkla Songkla
University
Timor-Leste Lower middle National University
of East Timor
196 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
China Upper middle China Medical Shenyang X X X
University
China Upper middle China Nanjing X X
Pharmaceutical
University
China Upper middle Chinese University of Hong Kong Biomedical X X X
Hong Kong Engineering
China Upper middle Chongqing Medical Chongqing Biomedical X X X
University Engineering
China Upper middle Chongqing University Chongqing Biomedical X X X
Engineering
China Upper middle Chongqing University Chongqing X X X
of Posts and
Telecommunications
China Upper middle Chongqing University Chongqing Biomedical X X
of Technology Engineering
China Upper middle Chung Yuan Chung Li, Biomedical X X X
Christian University Taiwan Engineering
China Upper middle Dali University Dali Biomedical X
Engineering
China Upper middle Dalian Medical Dalian X
University
China Upper middle Dalian Ocean Dalian Biomedical X X
University Engineering
China Upper middle Dalian University of Dalian X X X
Technology
China Upper middle Donghua University Shanghai Biomedical X X X
Engineering
China Upper middle East China Normal Shanghai X X
University
China Upper middle East China Shanghai X X X
University of Science
and Technology
China Upper middle Fourth Military Xian Biomedical X X X
Medical University Engineering
China Upper middle Fudan University Shanghai Biomedical X X X
Engineering
China Upper middle Fujian Journal of Fuzhou X
Traditional Chinese
Medicine
China Upper middle Fujian Normal Fuzhou X X
University
China Upper middle Fuzhou University Fuzhou X X
China Upper middle Gannan Medical Ganzhou Biomedical X
University Engineering
China Upper middle Guangdong Medical Guangzhou X
University
China Upper middle Guangdong Guangzhou X
Pharmaceutical
University
198 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
China Upper middle Jilin Medical College Jilin X
China Upper middle Jilin University Changchun Biomedical X X X
Engineering
China Upper middle Jinan University Guangzhou Biomedical X X X X
Engineering
China Upper middle Jinggangshan Ji’an Biomedical X
University Engineering
China Upper middle Jining Medical Jining X
University
China Upper middle Kunming University Kunming Biomedical X
of Science and Engineering
Technology
China Upper middle Kunming University Kunming X
of Science and
Technology
China Upper middle Lanzhou University Lanzhou Biomedical X X X
Engineering
China Upper middle Macao Polytechnic Macau Science in X
Institute Biomedical
Technology
China Upper middle Medical School of Beijing Biomedical X X
Chinese PLA Engineering
China Upper middle Mudanjiang Medical Mudan-jiang X
University
China Upper middle Nanchang Hangkong Nanchang Biomedical X X X
University Engineering
China Upper middle Nanchang University Nanchang X X X
China Upper middle Nanjing Medical Nanjing X X X
University
China Upper middle Nanjing University Nanjing Biomedical X X X
Engineering
China Upper middle Nanjing University Nanjing Biomedical X X X
of Aeronautics and Engineering
Astronautics
China Upper middle Nanjing University Nanjing Biomedical X
of Posts and Engineering
Telecommunications
China Upper middle Nanjing University Nanjing X X
of Science and
Technology
China Upper middle Nankai University Tianjin Biomedical X X
Engineering
China Upper middle Nantong University Nantong X X X
China Upper middle National Cheng Kung Tainan, Taiwan Biomechanics, X X X
University Biomedical
Electronics,
Biomaterials,
Medical
information and
Rehabilitation
technologies
200 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
China Upper middle Shanghai University Shanghai X
of medical and
Health Science
China Upper middle Shanghai University Shanghai X
of Traditional
Chinese Medicine
China Upper middle Shenyang Shenyang Biomedical X
Pharmaceutical Engineering
University
China Upper middle Shenyang University Shenyang Biomedical X X X
of Technology Engineering
China Upper middle Shenzhen University Shenzhen X X X
China Upper middle Sichuan Agriculture Chengdu X
University
China Upper middle Sichuan Medical Chengdu X
University
China Upper middle Sichuan University Chengdu Biomedical X X X
Engineering
China Upper middle Sichuan University Zigong X
of Science and
Engineering
China Upper middle Soochow University Soochow X X
China Upper middle South China Guangzhou Biomedical X X X
University of Engineering
Technology
China Upper middle South University Shenzhen X
of Science and
Technology of China
China Upper middle South-central Wuhan Biomedical X X
University for Engineering
Nationalities
China Upper middle South-central Wuhan X X X
University of
Technology
China Upper middle Southeast University Nanjing Biomedical X X X
Engineering
China Upper middle Southern Medical Guangzhou Biomedical X X X
University Engineering
China Upper middle Southwest Jiaotong Chengdu Biomedical X X X
University Engineering
China Upper middle Southwest University Mianyang Biomedical X
of Science and Engineering
Technology
China Upper middle Sun Yat-sen Guangzhou Biomedical X X X
University, SYSU Engineering
China Upper middle Taishan Medical Taishan X
University
China Upper middle Taiyuan University of Taiyuan Biomedical X X X
Technology Engineering
202 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
China Upper middle Xi`an International Xi’an X
University
China Upper middle Xi`an Technological Xi’an X
University
China Upper middle Xi’an Jiaotong Xi’an Biomedical X X X
University Engineering
China Upper middle Xiamen University Xiamen Biomedical X X
Engineering
China Upper middle Xi'an Jiaotong Xi’an X X X
University
China Upper middle Xidian University Xi’an Biomedical X X
Engineering
China Upper middle Xinxiang Medical Xinxiang Biomedical X X X
University Engineering
China Upper middle Xuzhou Medical Xuzhou X
University
China Upper middle Yancheng Teachers Yancheng X
University
China Upper middle Yangtze Normal Chongqing X
University
China Upper middle Yanshan University Qinhuangdao Biomedical X X X
Engineering
China Upper middle Yunnan University Yunnan X X
China Upper middle Zhejiang Chinese Hangzhou X
Medical University
China Upper middle Zhejiang Gongshang Hangzhou X
University
China Upper middle Zhejiang University Hangzhou Biomedical X X X
Engineering
China Upper middle Zhejiang University Hangzhou X
of Technology
China Upper middle Zhengzhou University Zhengzhou Biomedical X
Engineering
Japan High Chiba Institute of Chiba
Science
Japan High Chubu University Nagoya
College of Medical
Technology
Japan High Fujita Health Toyoake
University
Japan High Hokkaido Institute of Hokkaido
Technology
Japan High Kanazawa University Kanazawa
Japan High Kawasaki University Kurashiki
of Medical Welfare
Japan High Kitasato University Sagamihara
204 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Income Educational Level
Country group institution City Programme BSc MSc PhD Other
Malaysia Upper middle Universiti Teknologi Johor
Malaysia (UTM)
Malaysia Upper middle Universiti Teknologi Perak
PETRONAS (UTP)
Malaysia Upper middle Universiti Tunku Selangor
Abdul Rahman
(UTAR)
Malaysia Upper middle University Kuala
Lumpur - British
Malaysian Institute
Malaysia Upper middle University of Malaya Kuala Lumpur Biomedical X X
Engineering
Malaysia Upper middle University of Malaya Kuala Lumpur Biomedical X
Engineering
(Prosthetics and
Orthotics)
Malaysia Upper middle University of Iskandar
Southampton Puteri, Johor
(Malaysia Campus)
Marshall Upper middle Kolej Kemahiran Ledang, Johor
Islands Tinggi Mara Ledang
(KKTM)
New Zealand High University of Auckland Biomedical X
Auckland Engineering
New Zealand High University of Otago Dunedin Bioengineering X
Philippines Lower middle De La Salle Manila
University
Republic of High Hanyang University Seoul
Korea
Republic of High Kyung Hee University Wonju
Korea
Republic of High Sangji University Seoul
Korea
Republic of High Seoul National Suwon
Korea University
Republic of High Sungkyunkwan Seoul
Korea University
Singapore High Nanyang Polytechnic Singapore Biomedical X
Engineering
Singapore High National University Singapore Biomedical X
of Singapore Engineering
Singapore High Ngee Ann Polytechnic Singapore Biomedical X
Engineering
Singapore High Republic Polytechnic Singapore Biomedical X
Electronics
Singapore High SIM University Singapore Biomedical X X
Engineering
Singapore High Singapore Singapore Bioengineering X
Polytechnic
206 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Annex 3 National and international
professional biomedical engineering
associations
Reported
number of
Country Name of society Acronym members Income grouping
African Region
Burkina Faso L'ASSOCIATION BURKINABE DES TECHNICIENS ATBIB … Low income
ET INGENIEURS BIOMEDICAUX
Burundi ASSOCIATION BURUNDAISE DE L'INGENIERE ABIB … Low income
BIOMEDICALE ET HOSPITALIERE
Cameroon CAMEROONIAN ASSOCIATION OF CAP-BME … Lower middle
PROFESSIONAL BIOMEDICAL ENGINEERING income
Côte d’Ivoire SYNDICAT NATIONAL DES BIOMEDICAUX DE SYNABIOCI … Lower middle
COTE D'IVOIRE income
Democratic ASSOCIATION DES INGENIEURS ET … Low income
Republic of the TECHNICIENS BIOMEDICAUX
Congo
Ethiopia ETHIOPIAN BIOMEDICAL ENGINEERING EBEA 80 Low income
ASSOCIATION
Gambia (The) GAMBIA BIOMEDICAL ENGINEERING GAMbeta … Low income
TECHNOLOGISTS ASSOCIATION
Ghana GHANA SOCIETY OF BIOMEDICAL ENGINEERS … Lower middle
income
Kenya ASSOCIATION OF MEDICAL ENGINEERING OF AMEK … Lower middle
KENYA income
Nigeria NIGERIAN INSTITUTE FOR BIOMEDICAL NIBE … Lower middle
ENGINEERING income
Rwanda RWANDA MEDICAL ENGINEERING ASSOCIATION RMEA Low income
South Africa BIOMEDICAL ENGINEERING SOCIETY OF SOUTH … … Upper middle
AFRICA income
South Africa CLINICAL ENGINEERING ASSOCIATION SOUTH CEASA … Upper middle
AFRICA income
Uganda UGANDA NATIONAL ASSOCIATION FOR MEDICAL UNAMHE 49 Low income
AND HOSPITAL ENGINEERING
United Republic ASSOCIATION OF MEDICAL ENGINEERS AND AMETT Low income
of Tanzania TECHNICIANS TANZANIA
Zambia BIOMEDICAL ENGINEERING ASSOCIATION Lower middle
ZAMBIA income
Eastern Mediterranean Region
Iran (Islamic IRANIAN SOCIETY FOR BIOMEDICAL ISBME … Upper middle
Republic of) ENGINEERING income
Jordan JORDAN BIOMEDICAL ENGINEERING SOCIETY JBMES … Upper middle
income
Source: January 2015 Global Survey - Professional and Academic Profiles on Biomedical Engineers and Technicians, WHO.
208 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Reported
number of
Country Name of society Acronym members Income grouping
Lithuania LITHUANIAN SOCIETY FOR BIOMEDICAL LBID … High income
ENGINERING
Montenegro THE SOCIETY OF BIOMEDICAL ENGINEERING … … Upper middle
AND MEDICAL PHYSICS, SERBIA AND income
MONTENEGRO
Netherlands THE NETHERLANDS SOCIETY FOR BIOPHYSICS BIOPM … High income
AND BIOMEDICAL TECHNOLOGY
Norway NORWEGIAN SOCIETY FOR BIOMEDICAL … … High income
ENGINEERING
Poland POLISH SOCIETY FOR BIOMEDICAL PTIB … High income
ENGINEERING
Poland POLISH SCIENTIFIC AND TECHNICAL … … High income
COMMITTEE FOR BIOMEDICAL ENGINEERING
OF SEP
Portugal SOCIEDADE PORTUGUESA DE EGENHARIA SPEB 65 High income
BIOMEDICA
Romania SOCIETATEA NATIONALA DE INGINERIE SNIMTB … Upper middle
MEDICALA SI TECHNOLOGIE BIOLOGICA income
Slovakia SLOVAK SOCIETY OF BIOMEDICAL SBIMI … High income
ENGINEERING AND MEDICAL INFORMATICS
Slovenia SLOVENE SOCIETY FOR MEDICAL & DMBTS … High income
BIOLOGICAL ENGINEERING
Spain SPANISH SOCIETY OF BIOMEDICAL SEIB … High income
ENGINEERING
Sweden SWEDISH SOCIETY FOR MEDICAL ENGINEERING MTF … High income
& PHYSICS
Switzerland SWISS SOCIETY FOR BIOMEDICAL SSBE … High income
ENGINEERING
Turkey BIOMEDICAL ENGINEERS ASSOCIATION BIYOMED 95 Upper middle
income
Ukraine INSTITUTE OF MEDICAL ENGINEERING AND … … Lower middle
CLINICS income
United Kingdom INSTITUTION OF PHYSICS AND ENGINEERING IN IPEM … High income
MEDICINE
Region of the Americas
Argentina SOCIEDAD ARGENTINA DE BIOINGENIERA SABI … Upper middle
income
Brazil SOCIEDADE BRASILEIRA DE ENGENHARIA SBEB 250 Upper middle
BIOMÉDICA income
Canada CANADIAN MEDICAL & BIOLOGICAL CMBES … High income
ENGINEERING SOCIETY
Chile SOCIEDAD CHILENA DE INGENIERIA BIOMEDICA SOCHIB 65 Upper middle
income
Colombia COLOMBIAN ASSOCIATION OF BIOENGINEERING … … Upper middle
AND MEDICAL ELECTRONICS income
Costa Rica ASOCIACION COSTARRICENSE DE ACOBEM … Upper middle
BIOINGENIERIA Y ELECTROMEDICINA income
Cuba SOCIEDAD CUBANA DE BIOINGENIERIA SOCBIO … Upper middle
income
210 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Reported
number of
Country Name of society Acronym members Income grouping
Singapore BIOMEDICAL ENGINEERING SOCIETY BES … High income
(SINGAPORE)
International societies (includes national societies with international membership)
International AMERICAN COLLEGE OF CLINICAL ACCE 300 N/A
ENGINEERING
International COMMISSION FOR THE ADVANCEMENT OF CAHTMA 28 N/A
HEALTHCARE TECHNOLOGY MANAGEMENT IN
ASIA
International EUROPEAN ALLIANCE FOR MEDICAL AND EAMBES 8000 N/A
BIOLOGICAL ENGINEERING & SCIENCE
International EUROPEAN SOCIETY FOR ENGINEERING AND ESEM … N/A
MEDICINE
International IEEE ENGINEERING IN MEDICINE AND BIOLOGY EMBS 10000 N/A
SOCIETY
International INTERNATIONAL COUNCIL ON MEDICAL AND ICMCC … N/A
CARE COMPUNETICS
International INTERNATIONAL FEDERATION FOR MEDICAL IFMBE 27538 N/A
AND BIOLOGICAL ENGINEERING
International INTERNATIONAL UNION FOR PHYSICAL AND IUPESM 40000 N/A
ENGINEERING SCIENCES IN MEDICINE
International ASSOCIATION FOR THE ADVANCEMENT OF AAMI 7000 N/A
MEDICAL INSTRUMENTATION
International AUSTRALASIAN COLLEGE OF PHYSICAL ACPSEM 649 N/A
SCIENTISTS AND ENGINEERS IN MEDICINE
International ASSOCIATION FRANCOPHONE DES AFPTS-RD 20 N/A
PROFESSIONNELS DE TECHNOLOGIES DE CONGO
SANTE©
Organization Contact
Auckland Clinical Practice Committee (Auckland CPC) Stephen Munn
Adelaide HTA Tracy Merlin
Singapore Ministry of Health Pwee Keng Ho
NECA, Republic of Korea Jeonghoon Ahn
CENETEC, Centro Nacional de Excelencia Tecnológica Rosa Maria Ceballos
en Salud, Mexico
Toronto, Canada (Centre for Global eHealth Innovation, Tony Easty
Toronto General Hospital)
Osteba, Osasun Teknologien Ebaluazioaren Zerbitzua/ Iñaki Gutiérrez-Ibarluzea
Basque Office for HTA
GÖG – Gesunheit Österreich GmbH, Austria Ingrid Rosian-Schikuta
CEDIT, Comité d´Evaluation et de Diffusion des Alexandre Barna
Innovations Technologiques, France
IETS – Instituto de Evaluación Tecnológica en Salud, Aurelio Mejía
Colombia
University Hospital Centre Zagreb, Department of Mario Medvedec
Nuclear Medicine and Radiation Protection, Croatia
CGATS Departamento de Ciência e Tecnologia, Brazil Eduardo Coura Assis (translated from Portuguese)
ASERNIP-S – Australian Safety and Efficacy Register of Alun Cameron, Senior Research Officer
New Interventional Procedures – Surgical
CENGETS, Pontifical Catholic University of Peru Luis Vilcahuaman
CENGETS, Healthcare Technopole, Peru Rossana Rivas
Neuquén, Argentina Santiago Hasdeu
Biomedical Technology Unit, BITU, Greece Nicolas Pallikarakis
PathCare Laboratories, Nigeria Gbemileke Ogunlana
VASPT, State Health Care Accreditation Agency under Irena Zujiene
the Ministry of Health of the Republic of Lithuania
AdHopHTA, Spain Laura Sampietro-Colon
Agency for Healthcare Research and Quality AHRQ, Elisabeth U Kato
United States of America
University of Warwick Leandro Pecchia
AETSA, Andalusia, Spain Eduardo Briones
CADTH, Canada Michelle Mujoomdar
212 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Annex 5 Global Strategy on Human
Resources for Health: Workforce 2030 –
summary
Vision
Accelerate progress towards universal health coverage and the UN Sustainable
Development Goals by ensuring equitable access to health workers within strengthened
health systems.
Overall goal
To improve health, social and economic development outcomes by ensuring universal
availability, accessibility, acceptability, coverage and quality of the health workforce
through adequate investments to strengthen health systems, and the implementation
of effective policies at national, a regional and global levels.
Principles
• Promote the right to the enjoyment of the highest attainable standard of health.
• Provide integrated, people-centred health services devoid of stigma and
discrimination.
• Foster empowered and engaged communities.
• Uphold the personal, employment and professional rights of all health workers,
including safe and decent working environments and freedom from all kinds of
discrimination, coercion and violence.
• Eliminate gender-based violence, discrimination and harassment.
• Promote international collaboration and solidarity in alignment with national
priorities.
• Ensure ethical recruitment practices in conformity with the provisions of the WHO
Global Code of Practice on the International Recruitment of Health Personnel.
• Mobilize and sustain political and financial commitment and foster inclusiveness
and collaboration across sectors and constituencies.
• Promote innovation and the use of evidence.
Objectives
1. To optimize performance, quality and impact of the health workforce through
evidence informed policies on human resources for health, contributing to healthy
lives and well-being, effective universal health coverage, resilience and strengthened
health systems at all levels.
2. To align investment in human resources for health with the current and future
needs of the population and of health systems, taking account of labour market
dynamics and education policies; to address shortages and improve distribution
of health workers, so as to enable maximum improvements in health outcomes,
social welfare, employment creation and economic growth.
3. To build the capacity of institutions at sub-national, national, regional and global
levels for effective public policy stewardship, leadership and governance of actions
on human resources for health.
214 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Provide normative guidance and technical cooperation, and facilitate the sharing of best
practices on health workforce planning and projections, health system needs, education
policies, health labour market analyses, and costing of national strategies on human
resources for health. Strengthen evidence on, and the adoption of, macroeconomic
and funding policies conducive to greater and more strategically targeted investments
in human resources for health.
Review the utility of, and support the development, strengthening and update of tools,
guidelines and databases relating to data and evidence on human resources for health
for routine and emergency settings. Facilitate yearly reporting by countries to the WHO
Secretariat on a minimum set of core indicators of human resources for health, for
monitoring and accountability for the Global Strategy. Support countries to establish and
strengthen a standard for the quality and completeness of national health workforce
data. Streamline and integrate all requirements for reporting on human resources for
health by WHO Member States. Adapt, integrate and link the monitoring of targets in
the Global Strategy to the emerging accountability framework of the UN Sustainable
Development Goals. Develop mechanisms to enable collection of data to prepare and
submit a report on the protection of health workers, which compiles and analyses the
experiences of Member States and presents recommendations for action to be taken
by relevant stakeholders, including appropriate preventive measures.
1. JOB CREATION
Stimulate investments in creating decent health sector jobs, particularly for women and
youth, with the right skills, in the right numbers and in the right places.
5. TECHNOLOGY
Harness the power of cost-effective information and communication technologies to
enhance health education, people-centred health services and health information
system
216 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
8. PARTNERSHIP AND COOPERATION
Promote intersectoral collaboration at national, regional and international levels; engage
civil society, unions and other health workers’ organizations and the private sector; and
align international cooperation to support investments in the health workforce, as part
of national health and education strategies and plans.
9. INTERNATIONAL MIGRATION
Advance international recognition of health workers’ qualifications to optimize skills use,
increase the benefits from and reduce the negative effects of health worker migration,
and safeguard migrants’ rights.
This unit group covers engineering professionals not This unit group covers engineering professionals that
classified elsewhere in Minor group 214, Engineering apply knowledge of engineering and medical field to
Professionals (excluding electrotechnology) and 215: health-care systems to optimize and promote safer,
Electrotechnology engineers. higher quality, effective, affordable, accessible,
appropriate, available, and socially acceptable health
For instance, the group includes those who conduct technology to populations.
research, advise on or develop engineering procedures
and solutions concerning workplace safety, biomedical In such cases tasks would include:
engineering; optics; materials; nuclear power a) Conducting research, advise or development
generation and explosives. of medical devices for prevention, diagnosis,
treatment, rehabilitation and palliative care across
In such cases tasks would include: all levels of the health-care delivery;
a) applying knowledge of engineering to the design, b) Innovating, designing, developing, regulating,
development, and evaluation of biological and managing, assessing, installing, and maintaining
health systems and products, such as artificial such medical devices or health technologies.
organs, prostheses, and instrumentation;
c) Applying engineering principles and design
b) designing devices used in various medical concepts to medicine and biology for the pursuit of
procedures, imaging systems such as magnetic new knowledge and understanding at all biological
resonance imaging (MRI), and devices for scales;
automating insulin injections or controlling body
d) Designing medical devices, software, processes
functions;
and techniques to be used in health care, including
c designing components of optical instruments such consumables, artificial organs, diagnostic and
as lenses, microscopes, telescopes, lasers, optical therapeutic instrumentation and related systems
disc systems and other equipment that utilize the such as magnetic resonance imaging, and devices
properties of light; for automating insulin injections or controlling
d) designing, testing, and coordinating the body functions;
development of explosive ordnance material to e) Designing, developing, evaluating and managing
meet military procurement specifications; technologies used to promote and support life
e) designing and overseeing construction and quality and longevity, including assistive products
operation of nuclear reactors and power plants and technologies for monitoring or rehabilitating
and nuclear fuels reprocessing and reclamation activities of daily living; such as wheelchairs,
systems; prosthesis leg, hearing aid and personal
f) designing and developing nuclear equipment emergency response systems;
such as reactor cores, radiation shielding, f) Designing, developing and managing medical
and associated instrumentation and control technologies for focus disease areas such as
mechanisms; reproductive, maternal, neonatal and child health;
g) assessing damage and providing calculations for infectious and noncommunicable diseases;
marine salvage operations; g) Designing, developing and managing systems
h) studying and advising on engineering aspects for optimal sustained healthcare operations in
of particular manufacturing processes, such as both resource-scarce and well-resourced settings
those related to glass, ceramics, textiles, leather as well as during challenging events such as
products, wood, and printing; disasters and emergencies;
i) identifying potential hazards and introducing h) Designing, developing and applying safety
safety procedures and devices. programme methodologies to mitigate risks when
dealing with medical devices throughout their life
cycle. Including biosafety, patient and health-care
Included occupations worker safety and personal protection;
Examples of the occupations classified here:
- Biomedical engineer
- Explosive ordnance engineer
218 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
- Marine salvage engineer i) Supporting and training health-care workers on the
- Materials engineer appropriate and safe use of medical technologies;
- Optical engineer j) supporting the design of health-care facilities.
- Safety engineer
Examples of the occupations classified here:
Excluded occupations - Biomedical engineer
- Electro medical engineer
Some related occupations classified elsewhere: - Clinical engineer
- Industrial and production engineer - 2141
- Medical engineer
- Environmental engineer - 2143
- Surveyor - 2165 Excluded occupations
Note: it should be noted that, while they are Some related occupations classified elsewhere:
appropriately classified in this unit group with other - Industrial and production engineer - 2141
engineering professionals, biomedical engineers - Environmental engineer - 2143
are considered to be an integral part of the health
- Surveyor - 2165
workforce alongside those occupations classified in
Sub-major Group 22: Health Professionals, and others
classified in a number of other unit groups in Major Note: it should be noted that, while they are
Group 2: professionals. appropriately classified in this unit group with other
engineering professionals, biomedical engineers
are considered to be an integral part of the health
workforce alongside those occupations classified in
Sub-major Group 22: Health Professionals, and others
classified in a number of other unit groups in Major
Group 2: professionals.
Current profile for ILO for biomedical engineering Proposed profile for ILO for biomedical
technician engineering technician
Unit Group 3119. Unit Group 311X
Biomedical engineering technicians
Physical and engineering science technicians not
elsewhere classified (considering information from Biomedical engineering science technicians
Unit Group 3111 to 3119). perform technical tasks to aid in research, design,
manufacture, assembly, operation, maintenance and
repair of medical equipment, and in the development
of medical applications of research results;
220 HUMAN RESOURCES FOR MEDICAL DEVICES • The role of biomedical engineers
Name Institution Email Conflict of interests
Paolo Lago Fondazione IRCC Policlinico p.lago@smatteo.pv.it None
San Matteo, Italy
Kang Ping Lin Chung Yuan Christian kplin@cycu.edu.tw None
University
Ratko Magjarevic FMBE and University of ratko.magjarevic@fer.hr As officer of IFMBE
Zagreb and IUPESM partially
supporting travel to
conferences.
Mario Medvedec University Hospital Centre mmedvede@kbc-zagreb.hr None
Zagreb
Debjani Mueller Charlotte Maxeke Medical dbmueller7@yahoo.de None
Research Cluster
Shauna Mullally UNICEF/Government of the shaunamullally@gmail.com Consultant to THET,
Northwestern Territories, NGO in Zambia during
Canada 2011–2013
Valentino Mvanga Ministry of Health, United vmvanga@yahoo.com None
Republic of Tanzania
Kenneth I Nkuma- Association of Biomedical drkinkumaudah@gmail.com None
Udah Engineers and Technologists
of Nigeria
Ebrima Nyassi Medical Research Council enyassi@mrc.gm None
Unit, the Gambia
Nicolas Pallikarakis University of Patras, Greece nipa@upatras.gr None
Leandro Pecchia University of Warwick, United l.pecchia@warwick.ac.uk None
Kingdom
Ledina Picari Ministry of Health of Albania ledinapicari@yahoo.com None
Mladen Poluta Western Cape Government mladen.poluta@uct.ac.za Consultant to University
Department of Health, South of Cape Town, to WHO
Africa and to Northwestern
University
Daniela Rodriguez- Swiss Tropical and Public daniela.rodriguez@unibas.ch None
Rodriguez Health Institute
Amir Sabet University of Michigan, asabet@umich.edu None
Sarvestani United States of America
Mario Secca IFMBE marioforjazsecca@mac.com None
Elliot Sloane Center for Healthcare ebsloane@gmail.com None
Information Research and
Policy
Megan Smith University of Guelph, Canada msmith32@mail.uoguelph.ca None
Consuelo Varela Centro para el Control consuelo.varela@infomed.sld.cu None
Corona Estatal de Medicamentos,
Cuba
Herb Voigt Boston University, United hfv@bu.edu Served as President of
States of America IUPESM with invited
participation conferences
in various countries
James O Wear None, United States of james.wear@gmail.com None
America
Anna Worm THET, Benin anna@worm.nl None
Martha Zequera Pontificia Universidad mzequera@javeriana.edu.co None
Javeriana, Colombia
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Department of Essential Medicines and Health Products
Innovation, Access and Use unit
World Health Organization
20 Avenue Appia ISBN 978 924 156 547 9
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Tel: +41 22 791 1239
E-mail: medicaldevices@who.int
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