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CLINICAL ENGINEERING SKILLS & CURRICULUM FOR THE 21 st

CENTURY WORKFORCE Clinical Engineering Skill & Curriculum for
GLOBAL 21st Century Workforce

Conference Paper · October 2019

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Elliot Sloane
Villanova University
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 CLINICAL ENGINEERING SKILLS &
CURRICULUM FOR THE 21st CENTURY
WORKFORCE
Elliot B. Sloane, PhD, CCE (Foundation for Living, Wellness, & Health)
Co-Authors: Nilmini Wickramasinghe, PhD (Swinburne University), and
Ricardo Silva PhD, CCE & Vijay Gehlot, PhD (Villanova University)

Clinical Engineering Skill & Curriculum

for GLOBAL 21st Century Workforce
Ablity to assure:
• SAFETY
• EQUITY
• ACCESS
• AFFORDABILITY
• QUALITY
• SECURITY
• RELIABLITY
• SCALABILITY
• MAINTAINABILITY
• SUSTAINABILITY

Credit: https://healthmediapolicy.com/2011/08/09/2518/

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Major additional contributors to this
global discussion have included:
Yadin David
Antonio Hernandez
Fred Hosea
Robert Hoyt, MD
Ernesto Iadanza
Tom Judd
Calil Saide
Angelo Thalasinnidis
Adriana Velazquez

... and MANY others!

CE – Respected global Health

Technology leadership!
Around the globe, Clinical Engineers
exist in – and contribute to – the
expanding 21st Century’s healthcare
technology environment.
HOWEVER, there are growing elements
of volatility, uncertainty, complexity,
and ambiguity (VUCA)!

2
 In this complicated System of
Systems (SoS) world, Ministries of
Health (MoH) and Health Delivery
Organizations (HDOs) are in dire
need of competent, contemporary,
and innovative solutions!

CEs share a novel, powerful mission!

Clinical Engineers share a common goal of harnessing

any and all technologies to safely produce desired
health outcomes, and improve the quality, equity,
safety, and cost-effectiveness of care for all
populations.
The question is: Where will needed skills in
Medical Devices and Health Information
Technologies, and Digital Health Technologies
come from to meet these challenges?

3
Our CE Portfolio is growing quickly!

WHO, PAHO, and US Institute of Medicine

publications indicate that the standard practice for
Biomedical and Clinical Engineering roles in
healthcare includes managing and dealing with
comprehensive interoperability of pervasive
networked Personal Care Devices (PCD),
including medical and personal applications
connected via cloud, app, and widespread
Electronic Health/Medical Records.

One workforce forecast from the US

Department of Labor predicts that the
US will have a workforce of 25,000
biomedical engineers by 2022, and
another 60,000 technicians, and
100,000 related IT staff!!!

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e.g., WHO’s Human Resources for
Medical Devices (2017)

Free download at:

https://www.who.int/medical_devices/publications/hr_med_dev_bio-engineers/en/

e.g., Notice Fred Hosea’s Clinical

Engineering job field expansions
in his chart from the 2017 WHO
Human Resources book!

Fred

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Realize, too: Our Medical Technology Life
Cycle Management must now embrace
IT Life Cycle management, too!!
i.e., “Devices” are becoming part of
larger systems and networks of cell
phones, sensors, LANS, MANS, medical
records, medicine distribution, IoT, and
other “Health IT” or “Health Informatics”
tools and systems!

“Digital Health” i.e., personal care, via

telehealth to the person and patient at
home, is moving rapidly from concept to
reality!

Needed new CE skills include:

1. Software, Systems (and Systems of Systems) Engineering Analysis & Design

2. Network management (& Cybersecurity)
3. Medical/Personal Device and IT Record Interoperability (& Security)
4. Data and database management (& Analytics)
5. Systems Project, Portfolio, & Life Cycle Management

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Sample curriculum (and courses) exist.
They can help us all work together!
• General Health Informatics and Systems
• Health IT Ethics, Safety, Security, & Law
• Database Systems and Health Informatics

• Artificial Intelligence and DSS

• Software and System Engineering
• Software/System Project Management

+ Disaster Planning and Recovery

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 Careful curation and selection of text
materials by Ricardo Silva and Elliot Sloane
has reduced course costs!
e.g., All but the PDF eTextbook by Dr.
Robert Hoyt and Dr. William Hersch can be
taught using open source, free materials.
Dr. Hoyt’s eTextbook, in open PDF format,
can be purchased online for $40.

These ARE the types of

curriculum topics that 21st
Century Clinical Engineering
leaders need!

They’ve been developed AND

taught by CCE’s too!

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 These materials can be translated
by language, culture, & national
norms, as needed…
We are open to ALL suggestions,
and are prepared to rapidly proceed
on a Global Basis with collaborating
universities and faculty!

More work remains to be done!

• There are great opportunities for new research, writing,
and training
• e.g., Systems of Systems Engineering for CE
• New, enhanced forensics methods for CE
• New management, budgeting, and strategic planning for CE
• New HTA and HTM methods
• New professional certification

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e.g.,
Systems of Systems Engineering (SoSE)
New courses, labs, and research are needed because
SoS have complex, interdependent behaviors
• Discrete devices must be Verified and Validated (V&V)
• Verify = works as specified
• Validated = works correctly for the intended use
• For SYSTEMS, though, V&V must proceed in layers
• Each discrete device (e.g., an ECG monitor)
• Each subsystem of devices (Central ECG monitoring system, w/ all
monitors, including all Operating Systems, LANS, etc)
• Plus the orchestrated system of all devices and subsystems
• e.g., Intensive Care patient management system, including ALL monitors,
all monitoring subsystems, the patient medical record system, AND any
Decision Support or Data Analysis modules.

“Emergent Behavior” is a risk in SoS!

• “Emergent Behavior” is a common human characteristic of Systems of
Systems
• e.g., Nurses may turn off many basic alarms at a central station to make the
environment less stressful
• BUT, critical patient alarms may be missed
• or, in home care, Patients (or parents or other caregivers) may turn off alarms or “app
notifications” for peace and quiet, without realizing that may cause death!
• Emergent behaviors must be expected in complex systems, sometimes called
“unintended consequences” because the human operator is overwhelmed.
• New research is needed, and CE’s HTA tools must be expanded, for SoS

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Systems of Systems Engineering (SoSE)
• SoS have complex behaviors
• Discrete devices must be Verified and Validated (V&V)
• Verify = works as specified
• Validated = works correctly for the intended use
• V&V must proceed in layers
• Each discrete device (e.g., an ECG monitor)
• Each subsystem of devices (Central ECG monitoring system, w/ all
monitors)
• Plus the orchestrated system of all devices and subsystems
• e.g., Intensive Care patient management system, including ALL monitors,
all monitoring subsystems, the patient medical record system, AND any
Decision Support or Data Analysis modules.

“Emergent Behavior” is a risk in SoS!

• “Emergent Behavior” is a common human characteristic
of Systems of Systems
• e.g., Nurses may turn off many basic alarms at a central station
to make the environment less stressful
• BUT, critical patient alarms may be missed
• or, in home care, Patients (or parents or other caregivers) may
turn off alarms for peace and quiet, but may cause death!
• Emergent behaviors must be expected in complex
systems, sometimes called “unintended consequences”
because the human operator is overwhelmed.

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New, enhanced CE Certification
may be needed
e.g., In addition to the Certified Clinical
Engineer (CCE), could/should there be
more complex/extended Certifications like
CCE-ICT, and/or a CCE-HTM, and or a CCE-
PM (Project Management)?
Or, perhaps, a CCE-1, CCE-2, CCE-3
designation to designate higher levels of
accomplishment.

IFMBE CED Curriculum and

Professional Certification Challenge
• Create a 1-year CED curriculum project using Agile methodology
• 1-month SCRUMS
1. Identify disciplines & agree on the 1-month scrums, perhaps using this framework
2. Prioritize disciplines on a risk/benefit basis, top 1, 2, 3
3. Gather curriculum options for 1, 2, 3
4. Evaluate and rank curriculum alternatives for 1, 2, 3
5. Develop proposed model curriculum for 1, 2, 3
6. Publish, review, refine model curriculum for 1, 2, 3
7. Define Body of Knowledge and Competencies for 1, 2, 3
8. Define 4 experiential learning labs for Model Curriculum 1, 2, 3
9. Public review and approval of items 6, 7, and 8 above
10. Define Professional Certification criterion for 9
11. Build prototype question library for 10
12. Turn over results of step 11 to Certification bodies for local/regional/national
deployment.

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 We encourage and invite discussion and
collaboration!

We created this field nearly 50 years

ago; we need to own and lead its
future!

Thank you!
Questions and collaboration are
welcome! Send me an email!!!!
Elliot B. Sloane, PhD, CCE, FACCE, FAIMBE, FHIMSS
ebsloane@gmail.com ebsloane@villanova.edu ebsloane@flwh.org
(or English/Spanish: rjsilvab@gmail.com, rjsilvab@flwh.org)
Founder/President, Foundation for Living, Wellness, and Health,
& Visiting Professor, Villanova University and South University

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