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Received September 6, 2021, accepted February 21, 2022, date of publication March 1, 2022

Clinical Engineering Role in the Development of Emergency 
Use Medical Devices

By Roberto Ayala 

CE/HTM Consultant, Mexico

ABSTRACT

Clinical Engineering (CE) professionals have a crucial role in healthcare institutions during the pandemic caused by the CO-
VID-19 disease, mainly by supporting the front line by allowing the proper and timely access to the medical equipment required 
to diagnose and treat patients affected. But another one of their roles, probably not so expected, has been their contributions 
to the development of emergency use medical devices, especially those for respiratory and oxygen therapy. Using the case of 
critical care use ventilators, and as presented during an IFMBE-CED webinar on the topic, this paper mentions the role of CE 
for the rapid response manufacturing of such vital care devices in three main aspects: development, regulation, and education. 
The results from such efforts have paid off by having safe and efficient support equipment while the shortage from commercial 
products has been receding, by establishing international guidelines for future innovators to take into consideration, and by 
leaving valuable knowledge in the form of educational and training videos for future generations to consult from. 

Keywords – Clinical engineering, medical devices, ventilators, pandemic.

Copyright © 2021. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY): Creative Commons - Attribu-
tion 4.0 International - CC BY 4.0. The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) 
are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is 
permitted which does not comply with these terms.

INTRODUCTION

COVID-19 pandemic put healthcare and industry sys-
tems to the test, and it has been evident that healthcare 
professionals and workers were in the middle of it all. CEs 
were no exception, and their responsibilities doubled as 
they were required to look after the medical technology 
needs of front-line workers and the rest of the clinical 
services personnel. CEs did not hesitate when new chal-
lenges required their skilled efforts. For example, early 
in the pandemic expansion, there was a shortage of sev-
eral types of medical devices needed for respiratory and 

oxygen therapy, and one, in particular, was the most in-
demand – ventilators for critical care units. As it became 
clear that the industry was struggling to cope with the 
shortage, several technical groups, including academia, 
professional organizations, and non-medical devices 
companies, started their own efforts to build locally pro-
duced ventilators. However, they soon realized that it was 
necessary to consult CE professionals with expertise in 
this vital equipment’s use, technical specifications, safety 
considerations, and normative and regulatory concerns. 

http://www.globalce.org
http://globalce.org
http://globalce.org


J Global Clinical Engineering Vol.4 Issue 3: 2022  48

Ayala : Clinical Engineering Role in the Development of Emergency Use Medical Devices

This collaboration focused on three main areas: contribu-
tions to the design and development of ventilators, health 
regulation considerations, and education and training.

Clinical Engineering Role in the Development of 
Medical Devices

Medical device design and development is no easy task, 
especially with equipment that operates using mechanical, 
electrical, electronic, and pneumatic components, such as 
vital support devices like ventilators. Many of the initial 
initiatives were non-invasive ventilation mechanisms that 
certainly couldn’t comply with safety and performance 
standards, and that’s where CEs entered the scene to help 
with the efforts. CEs contributed to the manufacturing of 
locally produced, emergency use ventilators with actions 
such including:

• Putting engineering knowledge and skills together 
with the development of the devices.

• Helping companies, academia, researchers, and inves-
tors to identify clinical needs and the right normative 
and tech specs for this type of device.

• Testing the prototypes and finished products through 
the proper metrology practices.

Clinical Engineering Role in Health Regulation

No matter how urgent the need for a medical device 
may be, the authorization process must be approved by 
a competent health regulatory authority because such 
a device needs to prove its safety and efficacy. In the 
pandemic, authorities understood that they had to offer 
fast-tracking processes without losing their objectives 
related to the emergency use authorizations. Once again, 
CEs stepped up as the connection between the regulatory 
process and unexperienced ventilators developers with 
some of the following interventions:

• Identifying international standards and normative 
and best practices to establish a local, applicable 
normative.

• Developing technical specifications for local produc-
tion based on established specifications but adjusting 
as necessary for a proper response.

• Support WHO/PAHO efforts for worldwide use guide-
lines and other relevant technical documentation.

Clinical Engineering Role in Education

Because of their multidisciplinary approach, clinical 
engineers are well known as skilled trainers and educators, 
and this aptitude has helped share knowledge and experi-
ences regarding the manufacturing, principles, operation, 
care, and safety topics for critical care use ventilators. In 
a world that was forced to social distancing, the use of 
web-based meeting platforms was rightly exploited for 
these purposes of education and training, something that 
clinical engineers used in the form of: (1) webinars on 
diverse topics related to patient ventilators, (2) training 
courses on manufacturing and standards applications, 
and (3) calls with other health professionals around the 
globe to exchange knowledge and experiences. 

One prime example of the noble and vital role of knowl-
edge sharing has been the efforts from IFMBE-CED, which 
right away began with organizing and offering relevant 
webinars, with helping hands from experts from all cor-
ners of the World and with a variety of topics regarding 
clinical engineering approach for the pandemic.

CONCLUSIONS

CE has been evolving almost at the same pace as 
medical devices increase in complexity, from participat-
ing in service and safety checks, going through integral 
management, and even collaborating with policymaking 
at a national health system level. These evolving skills 
now can cover research, innovation, and development of 
medical devices, and the pressing circumstances of the 
COVID pandemic just set the stage for clinical engineers 
worldwide to showcase such abilities. The challenge now 
is to write down the experiences in scientific papers and 
pass the knowledge to younger generations because the 
inertia to strengthen these skills shouldn’t be subjected 
only to health emergencies. There is a lot of health tech-
nology yet to be discovered.

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49 J Global Clinical Engineering Vol.4 Issue 3: 2022

Ayala : Clinical Engineering Role in the Development of Emergency Use Medical Devices

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