Global Clinical Engieering 15-31-PB VOL 4 N3-2022

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J Global Clinical Engineering Vol.4 Issue 3: 2022


Editor’s Corner
Who owns the right to repair? 5. Lack of awareness of the advantages of preventive
maintenance
I recently participated in an effort led by members of
the health technology management community in North Since manufacturers weren’t supporting the repair of
America about what is becoming to be known as “the their products, Frank decided to do it himself. He runs a
right to repair” movement. This is not just a healthcare website2, dedicated to training technicians. Unfortunately,
equipment issue but rather it origin is from outside the Weyer, General Electric, and other manufacturers regularly
healthcare industry and spread throughout many in- send him legal threats and take-down notices demanding
dustries including information technology (computers), that he stop teaching people to repair life-critical medi-
consumer electronics (phones), agricultural products, cal equipment.” The US FDA issued a report on the topic
appliances, automotive and more. The debate is about in May 20183 summarizing, in part, that “the objective
the principal question: Why do consumers not have the evidence indicates that many OEMs and third party enti-
right to access parts, tools, or guides (service manuals) ties provide high quality, safe, and effective servicing of
for the equipment that they own? Holding back infor- medical devices” and that “The continued availability of
mation or placing replacement parts as inaccessible to third party entities to service and repair medical devices
consumers/owners or an independent equipment service is critical to the functioning of the U.S. healthcare system.”
providers takes away the owner’s property rights. The However, this did not address the questionable access to
right to repair coalition maintains programs aimed to manuals and spare parts. Others, including an Apple Inc.
change that by raising awareness including within the co-founder, Steve Wozniak, stated during an interview with
healthcare technology management field. The coalition’s one of the supporters of this movement in part4 “if you
website post a quotation, under their medical technology know what you’re doing and you’re doing certain steps
tab1, that “In some developing countries, up to 50% of that other solved…why stop the self-repair community?”
the medical equipment is unusable at any given time. In Even politicians engage with this debate, like US Senator
some hospitals, up to 80% of their medical equipment Mr. Ron Wyden and US Representative Y. D. Clarke who
is inoperative …” World Health Organization. To access together introduced a bill in the Senate of the US tilted
service information, you and many others are probably ‘‘Critical Medical Infrastructure Right-to-Repair Act of
familiar with, and perhaps even used, the Frank’s Hospital 2020”5 attempting to alleviate medical equipment repairs
workshop site2 to find needed information not otherwise during COVID-19 crisis.
provided for repairing your medical equipment.
However, as medical equipment is used at times in
This coalition’s website posts Frank’s story as follows: life critical conditions, we must ask the question: who
“Frank Weithoener is a well-regarded biomedical repair is competent to service such important technology. This
technician in Tanzania. He identifies five major barriers led me to search for an answer to the question what is a
to medical device repair in developing countries: competent clinical engineer? I visited variety of sources
1. No spare parts for repairs and maintenance and came across an article A day in the life of a clinical
engineer system supervisor6 where “this sophisticated
2. No technical manuals
technology requires constant assessment, management
3. Poorly trained biomedical technicians and maintenance to deliver on that promise” points to
4. No technical support from the manufacturers the public expectations that the equipment will improve

J Global Clinical Engineering Vol.4 Issue 3: 2022 2


providers’ ability to manage their patient’s conditions REFERENCES
and raise their care outcomes. 1. https://www.repair.org/medical
During my search I used terms such as how to become 2. http://www.frankshospitalworkshop.com/
an engineer where the Quora website that states its mission
3. FDARA 710 - 3rd Party Servicing Report, https://www.
is “to share and grow the world’s knowledge”, showed as a
fda.gov/media/113431/download?mod=article_inline
response one of the titles that asked: Can anyone become
an engineer, or do you have to be born into it with natural 4. Steve Wozniak speaks on Right to Repair, https://
skills?7. An interesting angle that I wonder if it suggests www.youtube.com/watch?v=CN1djPMooVY
that it is possible that engineers’ DNA set us apart? Hope- 5. Wyden and Clarke Introduce Bill to Eliminate Bar-
fully, they are not serious about that. Another source adds riers to Fixing Critical Medical Equipment During
the suggestion that soft and interprofessional skills must the Pandemic | U.S. Senator Ron Wyden of Oregon
be part of clinical engineering education program8,9. So, (senate.gov)
while I believe in the principal of right to repair, I also 6. https://www.chop.edu/news/
strongly recommend that clinical engineers should seek day-life-clinical-engineer-system-supervisor
demonstration of their competency through credentialing
7. https://www.quora.com/Can-anyone-become-an-
program. In a recent article Is Clinical Engineering an oc-
engineer-or-do-you-have-to-be-born-into-it-with-
cupation or profession?10, where I am included as one on natural-skills
the list of international authors, it states in part: “Clinical
engineers also need to recognize, like other professions 8. https://www.careercloud.com/news/2017/4/24/
that when establishing defined requirements to enter the the-most-important-soft-skills-engineers-need
professional practice, there needs to be consensus about 9. https://www.researchgate.net/publication/228592803_
and adopting clinical engineering practice criteria. This Developing_Interprofessional_Skills_in_a_Clini-
includes domain boundaries, establishing a minimum cal_Engineering_Program
qualifications criterion for entering clinical engineering 10. https://www.globalce.org/index.php/GlobalCE/
practice in healthcare, a commitment for compliance article/view/131/74
with life-long continuing education, adherence to ethi-
cal behavior, service stewardship to their communities,
and rules for self-governing. Adoption of these cannons
will gain wider recognition and elevate the professional
Together we are making it better!
standing they desire.”
Did you experience any of the obstacles when looking
for service manuals or access to replacement parts or
software keys to equipment apps? Would you agree with
me that, since we are concerned with patients’ lives, the
Right to Repair movement should modify their poster to Dr. Yadin David
reflect that it’s argument should be about the Right to
Repair by Competent Workers. Let me know your opinion.

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.

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


CONTENTS

Editor’s Corner 2
By Yadin David

The Status of Medical Devices and their Utilization in 9 Tertiary


Hospitals and 5 Research Institutions in Uganda 5
By Robert Tamale Ssekitoleko, Beryl Ngabirano Arinda, Solomon Oshabahebwa, Lucy Kevin Namuli,
Julius Mugaga, Catherine Namayega, Emmanuel Einyat Opolot, Jackline Baluka, Charles Ibingira,
Ian Guyton Munabi, Moses Lutakome Joloba

Overview of Trending Medical Technologies 16


By Jean Marie Vianney Nkurunziza, Jean Claude Udahemuka, Jean Baptiste Dusenge, Francine Umutesi

Clinical Engineering Role in the Development of Emergency Use


Medical Devices 47
By Roberto Ayala

Analysis and Solution of Dental Unit Failure 50


By J. J. Jin, H. Liu, K. Li, Y. H. Chu

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


Received April 10, 2021, accepted June 4, 2021, date of publication July 30, 2021

The Status of Medical Devices and their Utilization in 9


Tertiary Hospitals and 5 Research Institutions in Uganda
By Robert Tamale Ssekitoleko1, Beryl Ngabirano Arinda1, Solomon Oshabahebwa1, Lucy Kevin Namuli1, Julius Mugaga1, Catherine
Namayega1, Emmanuel Einyat Opolot, Jackline Baluka, Charles Ibingira2, Ian Guyton Munabi2, Moses Lutakome Joloba3
1
Biomedical Engineering Unit, Department of Physiology, School of Biomedical Sciences, College of Health Sciences, Makerere
University, Uganda
2
Department of Anatomy, School of Biomedical Sciences, College of Health Sciences, Makerere University, Uganda
3
School of Biomedical Sciences, College of Health Sciences, Makerere University

ABSTRACT
Backgrounds and Objective: Advancements in technology have led to great strides in research and innovation that have
improved healthcare provision around the world. However, the majority of the technology available is underutilized in Sub-
Saharan Africa. In addition, the ever-increasing sophistication and cost of medical equipment means that access and proper use
is limited in low- and middle-income countries (LMICs). There is, however, a general paucity of well-documented evidence for
the utilization of medical equipment in LMICs. Therefore, this study evaluates the current availability and utilization of medi-
cal equipment in tertiary hospitals and research facilities in Uganda and provides baseline information to clinical/biomedical
engineers, innovators, managers, and policymakers.
Material and Methods: The study evaluated the equipment currently used in 9 purposively selected public tertiary hospitals
and 5 research laboratories representing different regions of Uganda. Data were collected by personnel specialized in biomedi-
cal engineering utilizing a mixed-method approach that involved inventory taking and surveys directed to the health workers
in the designated health facilities.
Results: The hospitals contributed 1995 (85%) pieces of medical equipment while the research laboratories contributed 343
(15%) pieces amounting to 2338 pieces of equipment involved in the study. On average, 34% of the medical equipment in the
health facilities was faulty, and 85.6% lacked manuals.
Discussion and conclusion: Although innovative solutions and donated equipment address the immediate and long-term
goals of resource-constrained settings, our study demonstrated several issues around existing medical devices, and these need
immediate attention.
Keywords – Medical Devices, Biomedical Engineering, Healthcare Technology, Clinical Engineering, Appropriate Healthcare
Technologies, Health Technology Management.

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.

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


INTRODUCTION attributed to the rising costs of medical devices, lack of
Advancements in technology have led to great strides in reliable power and water, lack of public infrastructure such
innovations and research, resulting in a general improve- as air-conditioned rooms, and inadequate planning.16,22
ment in healthcare provision, greatly impacting diagnos- Perry and Malkin23 report that 38.3% of medical equipment
tics, monitoring, and therapy. Medical device technology in developing countries is non-functional because of the
has played a key role in preventing, diagnosing, treating, lack of trained professionals able to execute the needed
and rehabilitating many diseases and contributes to repairs or maintenance, mainly biomedical engineering
complex research and innovations such as understanding technicians (BMET) or biomedical engineers.23
the entire human genome.1–3 Many innovative devices Several approaches were been taken to spur innova-
have been applied to the early diagnosis of complicated tions in contextually appropriate healthcare technologies
diseases, including non-communicable diseases such to respond to the challenges outlined above. Funding
as cancer, and management of chronic illnesses such as mainly came from international donors and philanthro-
diabetes and HIV/AIDS. They have also been utilized to pists.24 However, with the recent cessation or reduction
invent and track many drug regimens for most deadly of this funding due to shifting priorities such as the recent
diseases such as tuberculosis and HIV.4–7 Access and ef- COVID-19 pandemic, most of these innovations have been
fective use of healthcare technologies leads to improved abandoned due to the absence of sustainability plans.
quality of healthcare provision to most of the population This has led to a setback in this field with actual progress
worldwide.8,9 It is therefore essential to have functional showing little clinical efficiency.25,26 Apart from limited
equipment. This is particularly urgent in Sub-Saharan funding, WHO highlights other barriers that hinder the
Africa,10–13 a region with 24% of the world disease burden, effective adoption of innovative solutions in low- and
1% of the global financial resources and 3% of the human middle-income countries: inadequately trained support
resource capacity.14 Lack of functional equipment has a staff to manage the novel equipment, shortage of technical
devastating effect on the quality of healthcare provision expertise, and designs not being suitable for the African
and research in resource-poor settings and affects the setting.27
overall healthcare system.10,15 Steps have been taken to avert the challenges in medi-
Many medical technologies have been made available cal equipment management, including designing novel
to improve healthcare services in hospitals and research medical equipment suitable for sub-Saharan Africa set-
laboratories in Sub-Saharan Africa.16 Application of these ting,28,29 developing policies on donations and equipment
technologies in service delivery ensures improved work procurement,30 and training biomedical engineers locally
efficiency and enhanced quality, leading to cost-effective to enhance technical support.31 There is little evidence
medical care for patients.9 However, the availability of medi- published on how these efforts have improved medical
cal equipment does not necessarily translate to improve equipment access to the people in most need.
health service delivery in health facilities in low resource Therefore, this paper aimed to evaluate the current
countries.17 Indeed, health institutions worldwide are still availability, status, and utilization of medical equipment
struggling with managing quality healthcare delivery in in tertiary hospitals and research facilitates in Uganda.
resource-constrained conditions.18 Most Sub-Saharan
countries hugely depend on medical equipment donations
METHODOLOGY
to facilitate healthcare and research technology needs.19 In
fact, nearly 80% of medical devices available in healthcare Study design and setting
facilities in developing countries are donated or funded This was a cross-sectional study that utilized a mixed-
by international donors or foreign governments.20 Most method approach that involved inventory taking and
of these devices are poorly maintained, under-utilized, surveys. The study evaluated the equipment in current
and or out of service due to various reasons such as inac- use in 9 purposively selected public tertiary healthcare
cessibility to spare parts, accessories, and consumables.21 facilities and five research laboratories to represent dif-
In addition, the high rate of dysfunctional equipment is ferent regions of Uganda in January 2017. The research

J Global Clinical Engineering Vol.4 Issue 3: 2022 6


laboratories included three research-based institutions, various devices currently available in the study facilities.
that is, the microbiology laboratory at Makerere University The inventory assessment included all medical equipment
College of Health Sciences (central region), the microbiol- available at the study site when conducting the study
ogy and molecular biology laboratories at Gulu University and excluded furniture, instruments, drugs, computers,
(Northern Region), and Mbarara University of Science computer accessories, and disposable tools and instru-
and Technology (MUST) clinical and research laboratory ments. The equipment details collected in the inventory
(Western Region) and two independent research labora- included the medical equipment name, type, model, equip-
tories; Uganda Virus Research Institute (UVRI) and Infec- ment number, serial number, functionality, manufacturer,
tious Disease Institute (IDI). Each of these laboratories year of manufacturer, and location. The condition of the
serves as a reference laboratory receiving samples from medical equipment was recorded using an A to F scale
neighboring hospitals for clinical diagnosis support and recommended by the Uganda Ministry of Health32 and the
analyzing samples for research and academic purposes. non-functional equipment in categories B, C, D, E, and F
Figure 1 below shows the spread of the facilities sur- were further categorized as shown in Table 1.
veyed. The healthcare facilities selected serve about 21% The data were analyzed using STATA version 14.0.
of Uganda’s Population, translating to about 7.9 million Discrete variables were summarized by their means and
people as of 2017 Uganda population census estimates.
TABLE 1. Key to the A-F Scale of Medical Equipment Conditions
Data collection and analysis Used To Assess Medical Equipment in this Study
Category Interpretation
A Equipment in good working condition and in use
B Equipment in good working condition but not in use
C Equipment in use but need repair
D Equipment in use but needs replacement
E Equipment out of use but repairable
F Equipment out of use, to be disposed of

standard deviations, whereas categorical variables were


presented as frequencies and percentages. Logistic regres-
sion was used to compare the functionality of equipment
between groups, and results were reported with odds
ratios. All differences with a p-value less than 0.05 were
considered statistically significant.
Ethical consideration
Ethical approval was obtained from Makerere Univer-
FIGURE 1. A map of Uganda showing the different locations sity School of Biomedical Sciences Institutional Review
of the study sites and nearby regional Biomedical Engineering
Board and the Uganda National Council of Science and
workshops.
Technology (UNCST; # SS 4166). Informed consent was
obtained from all participants before enrolment into the
All data collectors had a bachelor’s degree in biomedi- study. Confidentiality was assured through de-identification
cal engineering and were given uniform data collection of the data.
tools and were trained to conduct interviews and collect
inventory. Data on the collection inventory was aimed at
generating information on the working condition of the

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


RESULTS manuals, and the number of manufacturers supplying the
This study included 2338 pieces of medical equipment hospital with medical equipment. A total of 12 biomedical
categorized in 255 medical equipment types, of which engineers and technicians (BMETs) were identified to be
the hospitals contributed 85% (1995). Table 2 shows the working in the hospitals studied, out of which only 3 had
characteristics of the facilities included in the study. The a bachelor’s degree while the 9 were diploma holders.
out-patient department attendance per day character- In the hospitals where the availability of manuals was
ized the study, number of admissions per day, population recorded, more than 50% of the medical equipment had
served, number of biomedical engineers and technicians no manuals. On the other hand, the IDI research labora-
(BMETs), number of pieces of medical equipment found, tory had manuals for all their equipment. The number of
the percentage of medical equipment classified as non- manufacturers was also relatively high, with the highest
functional, the number of pieces of equipment without recorded being 120 manufacturers supplying a single
hospital served by 2 BMETs.

TABLE 2. Characteristics of the Hospitals and Research Laboratories Included in the Study
No. of pieces
% of
Location OPD No. of of equipment No. of
Admissions Population equipment
Health Facility (Region in attendance BMETs included (% of manufacturers
per day served without
Uganda) per day employed equipment non- recorded
manuals
functional *)
Regional Referral
Hospitals (RRH)
3.5
Arua RRH North Western 443 65 1 200 (50%) 91% 78
million
Fortportal RHH Western 254 70 2 240 (4%)
Hoima RHH Western 413 65 3 million 2 53 (26%) 77% 31
Kabale RHH South Western 178 33 2 million 2 510 (30%)
Mbale RHH Eastern 210 135 1 347 (36%)
Mbarara RHH South Western 468 85 4 million 2 392 (52%) 53% 120
1.5
Moroto RHH North Eastern 160 20 1 138 52%) 74
million
General hospitals
Kotido Hospital North Eastern 77 15 0 59 (54%) 75% 29
Health centre IV
1.2
Kawolo hospital Central Region 217 30 1 56 (50%) 68% 25
million
Research
laboratories
MUST Western 24 (29%) 14
UVRI Central 153 (29%)
Makerere Univ. Central 23 (22%) 11
Gulu Univ. Northern 114 (10%) 41% 57
IDI Central 29 (7%) 0% 20
*All medical EQUIPMENT IN CONDITIONS B, C, D, E, F WERE CLASSIFIED AS NON-FUNCTIONAL.

J Global Clinical Engineering Vol.4 Issue 3: 2022 8


Table 2 shows the percentage of non-functional equip- manuals for the equipment and revealed that 345 (14.4%)
ment was 4 to 54% with an average of 37%, while the pieces of equipment had manuals, whereas 2055 (85%)
research laboratories had a better performance with the pieces of equipment had no manuals available (Table 2).
non-functional equipment ranging from 7 to 29% with a Thus, 80% of the donated equipment had no manuals,
mean of 20%. According to the A-F scale, further break- whereas 86% of the equipment purchased had manuals.
down of the equipment categories (see Table 1) revealed Table 3 also shows the distribution of some of the equip-
that the non-functional medical equipment was spread out ment types identified in the six equipment categories. This
in categories B, C, and E, as shown in Table 3. Out of 2338 table shows that a high number of oxygen concentrators
pieces of equipment, 157 were identified in category B, and pipettes were found in category C. This was because
296 in category C, and 193 identified in category E. The the facilities did not have working oxygen sensors to de-
top reasons identified for equipment in category B were termine the concentration of oxygen concentrators and
lack of user training and lack of consumables. On the other lacked a clear basis for their use. Similarly, the pipettes
hand, the equipment in categories C and E was usually were never or rarely calibrated. Many glucometers were
there because of a lack of spare parts, testing equipment not used despite being in good working conditions (cat-
to identify faulty equipment, and technical knowledge on egory B) because of a lack of strips, while a large number
performing repairs. of infant incubators and nebulizers in the same category
The medical equipment manufacturers were recorded were mainly due to lack of user training.
at 6 of the health facilities and 4 of the research facilities. The non-functional equipment (categories B, C, D,
The number of manufacturers supplying the facilities E, and F) was further categorized according to the host
ranged from 11 to 120, with an average of 46. This number departments, and analysis revealed that dental and
varied with the number of pieces of medical equipment sterilization departments had the highest percentage of
at each facility (Figure 2). non-functional equipment. In contrast, the laboratory
equipment in both laboratories within the hospitals and
research laboratories had a significantly lower percent-
age of non-functional equipment than the mean. Indeed,
when all pieces of laboratory equipment were excluded
from analysis, the average percentage of non-functional

FIGURE 2. Bar graph showing variation in the number of equipment


manufacturers supplying 6 of the 9 healthcare facilities and 4 of the 5
research facilities included in this study. The number corresponding
to the highest point of each bar is the number of pieces of equipment
in each facility and the number represented by the dot above each bar
is the number of equipment pieces in that facility.

According to the study, 358 (15%) pieces of equipment


were donated and the facilities bought 195 (8%) pieces
of equipment. The remaining 77% of the equipment was
classified as unknown because the interviewees could FIGURE 3. Percentage of non-functional equipment categorized
not ascertain whether they were donated or bought. The according to the department, the mean percentage of non-functional
study also assessed the availability of user and technical equipment and then mean percentage of the non-functional equipment
excluding medical and research laboratory equipment.

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


TABLE 3. The Condition of Medical Equipment in the Hospitals, Health Facilities, and Top Medical Equipment Types Are Broken
Down Into Each of the Six Categories in the A-F scale
Equipment condition categories Total # of pieces
A B C D E F of equipment

Total 66% 7% 13% 1% 8% 6% 2,338

Hospitals 63% 7% 13% 1% 9% 6% 1995


Research laboratories 80% 3% 11% 0% 4% 2% 339
Medical Equipment Types
Refrigerator 77% 1% 5% 2% 4% 10% 135
Weighing Scale 58% 5% 9% 2% 18% 9% 126
Patient Monitor 66% 9% 12% 0% 11% 2% 117
Suction Machine 48% 5% 9% 0% 15% 24% 105
Autoclave 53% 8% 19% 1% 8% 10% 98
Microscope 76% 7% 8% 1% 6% 3% 90
Centrifuge 76% 1% 4% 1% 1% 17% 78
BP Machine 69% 9% 10% 0% 6% 5% 77
Oxygen Concentrator 67% 4% 21% 0% 3% 5% 76
Operating Light 57% 3% 10% 13% 11% 6% 63
Examination lamp 59% 17% 7% 0% 9% 9% 46
Infant Incubator 65% 30% 4% 0% 0% 0% 46
Pipette 7% 0% 70% 0% 0% 23% 43
Freezer 74% 5% 5% 0% 13% 3% 39
Anesthesia Machine 62% 11% 14% 0% 8% 5% 37
Glucometer 43% 37% 10% 0% 10% 0% 30
Operating Table 83% 3% 7% 7% 0% 0% 30
Nebulizer 39% 25% 14% 0% 18% 4% 28
Vortex Mixer 88% 0% 8% 0% 0% 4% 24
Ultrasound Machine 43% 0% 13% 0% 30% 13% 23
Hematology analyzer 86% 0% 0% 0% 9% 5% 22
Ventilator 17% 11% 6% 0% 67% 0% 18

equipment in the other departments increased from 37


to 47%, as seen in Figure 3.
results agree with a similar study done in Southwest
Ethiopia in 2016 that reported that 32.1% of healthcare
DISCUSSION equipment was broken.10,23 In addition, Malkin in 2011
This study found that, on average, 37% of the medical reported that, on average, 40% of medical equipment in
equipment found both in the hospitals were not in use, resource-constrained countries is out of service.23 Our
needed repair, and was completely non-functional. These studies showed that the percentage of non-functional

J Global Clinical Engineering Vol.4 Issue 3: 2022 10


equipment in research laboratories was reduced to 20%. use of faulty equipment on patients affected the overall
Strategies identified that led to this improvement included outcomes in diagnosis and therapy.34
(1) the provision of technical and user manuals. The IDI
research laboratories had manuals for all their medical Factors affecting medical equipment utilization
equipment, whereas all the hospitals surveyed did not have
manuals for more than 50% of their equipment, implying Medical equipment management
a lack of technical support in proper use, maintenance, This study found that hospitals did not have manuals
and repair; and (2) the laboratory equipment in both for 68% of their medical equipment. Logistic regression
hospitals and research laboratories were supplied with analysis showed that the lack of equipment manuals was
service contracts usually from a local distributor. The statistically related to medical equipment being non-func-
distributor is tasked with user training, regular preventive tional (p-value <0.001). Without these guides, equipment
maintenance (usually on a 6-month basis), and corrective maintenance becomes very difficult, especially in Uganda,
maintenance upon breakdown. In general, medical equip- where nearly all medical equipment is imported with limited
ment in the other department was procured with hardly contact with the manufacturers. A survey conducted by
any plans for their service and maintenance during their the ministry of health in 2015 supported these findings,
life span; (3) Research laboratories usually have funds which found that only 13.4% of the health facilities in
to support medical equipment maintenance and repair. Uganda had scheduled medical equipment maintenance
It was observed that 7% of medical equipment was in and that only 37% of the health facilities in Uganda have
good condition but out of service. These results fall within a budget for routine maintenance and repair of medical
the same range as another study conducted in Ethiopia, equipment.35 This failure to follow routine maintenance
which found the frequency of equipment in good condi- procedures results in the escalation of equipment faults.
tion but not in use ranging from 3 to 21%, with a mean of Therefore, collective efforts from medical equipment
12%.10 An example we saw in our study was glucometers, manufacturers, local distributors, health facilities, and the
which have a huge potential in the fight against diabetes ministry of health are essential to provide the technical
by providing fast and affordable point-of-care blood glu- and user guides for medical equipment, put measures
cose measurement in low-resource settings. While the in place to provide technical support, source and avail
devices are cheap, the glucometer strips are unaffordable funding for medical equipment management, and carry
for many patients in low-resource settings thus are never out routine user training and preventive maintenance.
used. Other reasons for not putting functional equipment Technical human resource
to use included not knowing how to use the equipment Our results show that in each of the hospitals included
correctly, lack of installation space, and lack of required in the study, one or two BMETs, was responsible for
infrastructure and utilities.21 maintaining and repairing the medical equipment at the
The results also show that 13% of the medical equip- health facility. When this workload is compared with the
ment identified in the health facilities was faulty but number of pieces of equipment identified and the num-
used on patients. For example, we found some oxygen ber of manufactures supplying each hospital, on average,
concentrators in use but delivered oxygen concentrations each BMET was charged with maintaining 167 pieces
as low as 45% compared to the recommended concentra- of equipment and from 51 variant manufacturers, each
tions greater than 82%.33 This was often due to a lack of supplying a unique model of medical equipment. In addi-
the right tools or testing equipment for the equipment tion, the BMETs in the regional referrals were expected to
functionality. There were also cases where the users were maintain the medical equipment in the lower-level health
aware that the equipment was faulty but used it due to facilities. With little funding, lack of spare parts, manuals,
a lack of alternative options. This was usually coupled and limited technical support from the manufacturers,
with a lack of spare parts and technical personnel and these BMETs are indeed overwhelmed.
insufficient funds to support corrective maintenance. The There have been considerable efforts to train BMETs
locally; as of March 2021, seven teaching institutions train

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


biomedical engineers and technicians at various levels. administrators in the appraisal of new equipment before
Makerere University, which pioneered bachelor’s training purchasing in low-resource settings.42 This primarily con-
for Biomedical Engineers in Uganda, has graduated 150 tributed to the observed 7% of medical equipment being
biomedical engineers at bachelor’s level. However, the level purchased or donated but never put to use due to lack of
of uptake by the Ministry of Health into the public health installation space, lack of consumables, or incompatibility
care system has been low. This is reported to be due to with existing infrastructure and resources in this study.
limited financial recourses. In addition, inadequate person- Additionally, it seemed that hospitals were eager to acquire
nel available in health facilities to guide the procurement medical equipment at low initial costs without consider-
process, train users, and conduct routine maintenance and ing the lifetime / hidden costs of the medical equipment,
repair of medical equipment significantly contributes to such as cost of consumables, maintenance costs, and
medical equipment failure.31,36 cost of required utilities, among others. It was observed
Administrative support that medical equipment suppliers commonly offer health
facilities medical equipment at low or no cost but charge
Administrative structures play a crucial role in medical
them highly to procure reagents and consumables over
equipment management. This can explain the variations
long periods. However, the equipment procured under this
observed in the percentage of non-functional equipment
contract ends up unused as the hospitals and patients can-
among the health facilities in this study. For example, most
not afford the cost of reagents. Another example observed
research laboratories have autonomous or semi-autonomous
was sterilization equipment procured by the hospital, but
administrative structures and considerable donor funding
it later realized that the equipment’s electricity consump-
that enable fast procurement of the required spare parts,
tion was way above the hospital’s budget, thus putting it
consumables, and contracting skilled human resources to
out of use. These point to deficiencies in the procurement
increase medical equipment utilization.37 Public hospitals,
appraisal process and a lack of technical guidance during
on the other hand, are characterized by long bureaucracies
procurement.
in the procurement process and minimal funding to sup-
port medical equipment maintenance.38 Some hospitals Supporting infrastructure and resources
have, however, streamlined their procurement process System-wide deficiencies in infrastructure and resources
to support infrastructural and resource utilization. The to support medical technologies in low-resource countries
Biomedical Engineering workshop in one of the hospitals, have been shown to affect the utilization of medical devices.
for example, operates with a framework contract in which The lack of clean water, stable electricity supply, space, and
a comprehensive list of spare parts and consumables administrative structures also affects medical equipment
is submitted to procurement at the beginning of each utilization, especially in the lower level health facilities
financial year, and the items are purchased in a batch.39 and facilities in hard-to-reach areas. For example, some
This, therefore, eases repairs of medical equipment that of the equipment identified in the study was designed
require spare parts previously identified and listed. Thus, for use with a 110V power supply, and yet Uganda has a
practical approaches to abridge convoluted administra- 240V power supply. Without a step-down transformer,
tive procedures to enhance infrastructural and resource this equipment will remain unused in category B for years.
utilization are paramount to improving medical equipment Another example is autoclaves designed to operate with
utilization in health facilities in low-resource settings. distilled water, yet the hospitals struggle to get access to
Procurement guidelines distilled water. These are thus used with ordinary tap
water, which significantly reduces their lifespan. This is,
Despite recommendations by WHO30 and Ministry of
therefore, vital to consider in the design of novel medical
Health40 to regulate donated equipment, many hospitals in
equipment or during the procurement process.
Uganda still accept medical equipment donations without
following the guidelines to ensure that the equipment is Innovations and implications
fit for purpose and the setting.41 Additionally, there is still Novel approaches custom-made to suit low resource
a lack of adequate procurement tools to assist hospital settings provide an alternative to the hugely dependent

J Global Clinical Engineering Vol.4 Issue 3: 2022 12


on donated equipment. Development of these innova- analysis, and interpretation of the data or writing of the
tive inventions have been supported and financed by manuscript.
international donors and philanthropist.25 However, the
majority of the funding comes to an end, and the inven- REFERENCES
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one significant barrier to the effective adoption of these izing medical devices in health care facilities. PT
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38. Sekyonda Z, et al. Supply chain of routine orthopae- 40. Ministry of Health. National Medical Equipment
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Glob Heal Innov 2018;1. Utilization of Medical Equipment Under Uganda
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and Distribution of Essential Medicines and 42. Houngbo PT, et al. The root causes of ineffective
Health Supplies by National Medical Stores. 2016. and inefficient healthcare technology management
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(Accessed: 18th February 2021)

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


Received January 31, 2022, accepted February 9, 2022, date of publication March 1, 2022

Overview of Trending Medical Technologies


By Jean Marie Vianney Nkurunziza, Jean Claude Udahemuka, Jean Baptiste Dusenge, Francine Umutesi
Medical Technology Division, Rwanda Biomedical Center, Kigali, Rwanda

ABSTRACT
Healthy population is regarded as the most valuable asset of any country. Unfortunately, the health challenges that hinder man-
kind's wellbeing are enormously increasing. Examples include but are not limited to: the diversity of emerging diseases afflict-
ing the global population, the projected demographic growth of elderly people who need consistent monitoring, the deficiency
in medical staff, the lower density of physicians, and the challenging geographical location of the population from healthcare
providers. The mitigation of such health challenges calls for novel technologies to improve patient outcomes. In this article,
seven emerging technologies, namely: Wearable Devices and Internet of Things, Artificial Intelligence, Blockchain Technology
or Distributed Ledger Technology, Robotics Technology, Telehealth and Telemedicine, Big Data Technology and Nanomedicine
have been highlighted. For each discussed technology, its historical background, development drivers, market status and trends,
significance to healthcare, key player companies, and associated challenges have been presented. The information contained in
this paper was collected from different journal articles, websites, reports, conference proceedings, and books. It was observed
that though the technologies discussed in this article show growth at different rates, healthcare technology development and
implementation are very promising in revolutionizing the health sector and improving the health of the population. Therefore,
healthcare providers and countries are recommended to put in place Healthcare Technology Assessment Programs to help them
collect data regarding the technology efficacy, relevance, safety, outcomes, and alternative technologies towards better planning
for healthcare services improvement.
Keywords – Wearable devices, Internet of Things, Blockchain, Telehealth and Telemedicine, Artificial Intelligence, Big Data,
Nanomedicine, Market, Drivers, Challenges and Companies.

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
The triumph of modern medicine is axed to the emerging
of diseases have become largely dependent on innova-
technological innovations, and there is no doubt that the
tion and discoveries in newer drugs, surgical techniques,
medical expenditures and life expectancy are variables
diagnostic and therapeutic equipment.3 Medical doctors
driven by technological progress.1-2 Medical technology
themselves are becoming more reliant on technology to
uses scientific knowledge to improve healthcare by new
diagnose and carry out treatments.4 The scope of medi-
and improved equipment to make work easier, pleasant,
cal technology is vast; it covers consumables (bandage,
quick, and productive.3 The management and treatment
syringes, hearing aids, wheelchairs, etc.), implants (hips

J Global Clinical Engineering Vol.4 Issue 3: 2022 16


and knees, stents, pacemakers, etc.), medical equipment Today the actual figures for medical technologies are
(imaging machinery, dialysis equipment, etc.), and in-vitro not available, but it is estimated that 500,000 different
diagnosis.5 Technological innovations are appreciated by types of medical devices are in service.12 From 1960 to
the general population because they enable a 4P-model 2007, health care expenditure in OECD countries increased,
for medicine (predictive, preventive, personalized, and on average, from 3.8–9.0% of GDP.1
participatory).6 In 2020 it was forecast that the global market for
The factors that reinforce the market for medical medical technology would achieve a volume of 490 billion
technology include advances in science and engineer- euros.11 In 2025, global turnover for medical devices is
ing, patent protection, increasing prevalence of chronic estimated at approx. 615 billion dollars.11
diseases, aging population, emerging pathogens, financial The main categories of healthcare technology include
incentives of technology companies, mass media reports, but are not limited to: drugs, biologics, devices/equip-
public demand driven by direct-to-consumer advertis- ment and supplies, medical and surgical procedures,
ing, consumer awareness and advocacy, rising prices of public health program, support systems, organization,
physician and hospital services, off-label use of drugs and managerial systems. However, not all technologies fall
and devices, malpractice avoidance, strong and growing neatly into the category, and certain hybrid technologies
economies.7-8 The maintainability of high quality of life combine drugs and devices.7
in the aging population is probably the most significant In the past decade, the medical technology revenues
underlying global which requires requiring technological have increased by 44.7% (USD 352.9 billion to USD
mindset.9 For example, Japan has the longest life expec- 510.9 billion for 2011 and 2021, respectively), and the
tancy, and its aging population ratio is still increasing. forecast is to reach USD 594.5 billion in 2024.13 In 2022,
This has called for rising expenditures, giving con- the strongest medical technologies segments will be in
cerns about the future inflation of health costs.10 In 2050, cardiology, imaging diagnostics, orthopedics, and surgery.
16% (1.5 billion) of the world’s population will be above These technologies will account for 50% of the market.11
65 years old.11 In China, 2.4 young people will have to Although there are giant companies in medical technol-
support 7.9 old people in 2050.11 The physical nature, ogy, 95% of all medical technologies businesses are small
purpose, and stage of diffusion constitute the three ways and medium-sized companies (SME), with the majority
to describe a healthcare technology.7 According to the having fewer than 50 employees.11 As of 2020, Medtronic
stage of diffusion, medical technologies classification is Inc. was the leading medical technology company with a
presented in Table 1. revenue of 30.12 billion USD.
TABLE 1. Classification of Medical Technologies According to It was seconded by Johnson&Johnson with total revenue
the Stage of Diffusion7 of 23 billion USD. In a survey conducted about medical
Medical
technology in Belgium,5 106 companies participated,
Explanation and the results are that 67.9% were active in medical
Technology Class
devices-consumables, 15.1 % in In-vitro diagnosis, 12.7%
in a conceptual stage, anticipated, or in the
Future in pharmaceutical products, 6.6% in para-pharmaceutical
earliest stages of development
products, 43.4% in medical software, 40.6 % in implants
undergoing bench or laboratory testing using
Experimental and 45.3% in medical equipment and systems. Medical
animals or other models
technologies are classified into preventive, screening,
undergoing initial clinical (i.e., in humans)
Investigational
evaluation for a particular condition or indication
diagnosis, rehabilitation, palliation, and treatment types.7
considered by clinicians to be a standard
The technological acceptance and use expansion vary
Established approach to a particular condition or indication from society cultures. The Technology Acceptance Model
and diffused into general use developed by Davis, Theory of Planned Behavior, and
Obsolete/ Unified Theory of Acceptance and Use of Technology 2
Superseded by other technologies or (UTAUT2) developed by Venkatesh showed that perceived
outmoded/
demonstrated to be ineffective or harmful
abandoned usefulness, perceived ease of use, price value, and habit

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


are the key factors that determine the application and
market expansion of a particular technology in a certain
region.14,15 In addition to those factors, commercial-grade,
durability, reliability, sustainability, technical support,
disinfection, alarm management, network, and device
security also advocate adopting a particular technology.16,17

LITERATURE REVIEW
It is not easy to cover all details of the medical tech-
nologies available in a single paper due to their diversity.
In this paper, the following trending technologies are
looked at: Health Wearables and Internet of Things, Ar-
tificial Intelligence (AI), Blockchain Technology (BCT) or
Distributed Ledger Technology (DLT), Robotics Technology,
Nanomedical Technology, Telemedicine and Telehealth,
Big Data
Health Wearables and Internet of Things
Environmental, psychological, behavioral, and physi-
ological domains that adversely impact the quality of
life are recognized by the World Health Organization.19
Wearables as medical technologies are becoming part of
personal analytics, measuring physical status, recording
physiological parameters, or informing schedules for
medication.20 FIGURE 1. Evolutional milestones in wearable devices.21

The journey of wearables started with the invention


of spectacles around the 13th century by English friar
Roger Bacon.21 Growth in wearables was slow until the
20th century, when in 1907, the first portable camera was
put on the market. Since then, the pace of developing new
devices never ceased to increase until 2014, when android
wearables were commercialized. The whole evolution of
wearable technology is picturesquely presented in the
chronological sequence in Figure 1.
From a monetary perspective, the market of wearable
devices is anticipated to grow exponentially at a rate of
20% and is expected to reach 150 billion EUR by 2028,
as presented in Figure 2.

In the third quarter of 2021, the Chinese market


shipped 35.28 million units across the globe,22 and the FIGURE 2. Wearable market growth forecast.21

J Global Clinical Engineering Vol.4 Issue 3: 2022 18


market was dominated by Huawei.23 From a technological detecting general patterns and trends within a popula-
point of view, wearables are self-contained devices with tion, contributing to improved public health responses.26
embedded sensors worn by the user to detect, diagnose, Wearables are positioned to different body parts depending
monitor, and communicate the health and performance on the parameter to be measured, as shown in Figure 4.
data of the user.24 Wearable technologies include smart- Wearable devices come into 4 main classes25:
watches, wristbands, hearing aids, electronic/optical
• Lifestyle and fitness devices. This includes fitness
tattoos, head-mounted displays, subcutaneous sensors,
Smart belts, electronic footwear (Smart shoes and socks),
and Smart textiles (Smart pants, Smart shirts).20,25 Gener-
ally, wearables devices are composed of five components:
sensors, connectivity, battery, interface, materials/
algorithm.25 From the design and manufacturing con-
sideration, wearable devices contains microprocessors,
interface including data communication, different types
of sensors: inertial measurement units (gyroscopes, ac-
celerometers, barometers, and magnetometers), optical
sensors (complementary metal-oxide-semiconductor
[CMOS]) sensors, spectrophotometers, cameras, tempera-
ture sensors, chemical probes, electrodes, microphones,
shock detectors, strain gauges.20
These days, when the world is dealing with COVID-19,
vital-sign wearable solutions were implemented in differ-
ent countries. Wearables can provide a key early-warning FIGURE 4. Wearables based on on-body location.26
system about the likelihood of COVID-19 infection and
its surveillance.26 For example, in Singapore, ViSi mobile trackers, sport and activity trackers (e.g., Moov Now,
developed by Sotera was used as a wearable device on Misfit Shine, Fitbit charge2).
patients in mild illness to monitor heart bit rate, respira-
tory rate, body temperature, and oxygen saturation.16 • Diagnostics and monitoring devices. These non-
invasive devices provide valuable health information
Wearable devices find different application in biomedi-
(e.g., DexcomG4, Quardio Core).
cal and clinical services, as shown in Figure 3.
Apart from measuring vital signs, aggregate data taken • Therapeutic devices. These devices monitor disease
from wearables can also contribute to the research by states, track activity, store data, and deliver feedback
therapy (e.g., Quell, Minimed530GInsulin Pump).
Injury prevention and rehabilitation devices. This
includes body motion monitoring devices, wearable sens-
ing garments, fall detection devices (e.g., Philips lifeline,
sprouting baby monitor).
The International Electro-technical Committee Stan-
dardization Management Board Strategic Group10 distin-
guishes wearable technologies into near-body electronics,
on-body electronics, in-body electronics, and electronic
textiles.17,21 Wrist-worn and handheld wearables are the
most widely adopted and market-filled niche covering
Smart rings, wrist bands, smartwatches, and gesture
FIGURE 3. Some biomedical applications of medical wearables.27 control devices.21

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


Unlike conventional testing in a clinical setting, which
may occur a few (or less) times a year, wearables offer
continuous access to real-time physiological data.28 In
their use, wearable devices are applications of the Inter-
net of things, a concept used by devices for sending and
receiving data via the Internet.18 Embedded intelligence
connectivity offers a unique opportunity for condition
monitoring, localization, identification, personal contextual
notifications, information display, and virtual assistance.21
The wearables data processing cycle follows 6 stages,
as presented in Figure 5.
The wearable market is growing faster in patients
with specific conditions like epilepsy, chronic obstructive FIGURE 5. Wearables data processing cycle.21
pulmonary disease, asthma, heart arrhythmia, chronic
pain, and breast cancer.17 Asia Pacific region, while in the rest of the world, the mar-
Today, many wearable devices are commercially available, ket growth is lower. Reports about the future of wearable
such as rings, headsets, sleep masks, wearable patches, technologies predict that the market volume will be 27.8
arm straps, finger clips, chest straps, fitness bracelets, fit- billion dollars in 2022 and 93.19 billion dollars in 2027.18
ness bands, and flex garments. Specific products include Some of the challenges of wearable devices include the
Google Glasses, GOW Pack, LUMOback, Metria Wearable feeling of constant surveillance, inefficient data analytics,
Sensor Technology, nECG Platform, Peeko Monitor, PER- lack of appropriate data labeling, insufficient comput-
Smobile, NuMetrex Heart Sensing Racer Tank, Re-Timer, ing capabilities, inefficient switching among resources
SleepShirt, T. Jacket, 360 Kids Guardian, and Vega.15,24,29 in hybrid networks, lack of modern energy harvesting
Significant growth in purchased wearable devices has opportunities, low data resolution.21 The major market
been recorded in North America, Western Europe, and the players in wearable medical technologies are: Apple, Fitbit,

TABLE 2. Wearable Wireless Technologies, Operating Frequency, and Range.21


Communication Technology Frequency Range Range
Short-range RFID 125–134 kHz, 13.56 MHz, 860–960 MHz Up to 100 m
NFC 13.56 MHz <0.2 m
BLE (IEEE 802.15.1) 2.4–2.48 GHz Up to 100 m
Zigbee Zigbee (IEEE 802.15.4) 868–868.6 MHz, 902–928 MHz, 2.4–2.49 GHz Up to 100 m
2.4–2.48 GHz,
Wi-Fi (IEEE 802.11a/b/g/n) 20-250 m
4.9–5.8 GHz
Wi-Fi 5 (IEEE 802.11ac) 4.9–5.8 GHz Up to 70 m
Wi-Fi 6 (IEEE 802.11ax) 1–6 GHz Up to 120 m
WiGig (IEEE 802.11ad/ay) 57–70 GHz 10–100 m
VLC (IEEE 802.15.7) 400–800 THz Up to 100 m
VLC (IEEE 802.15.7) LTE frequency bands Up to 15 km
Long-range LTE-M LTE frequency bands Up to 10 km
LoRa 867–869 MHz Up to 50 km
Sigfox 868–878.6 MHz Up to 50 km

J Global Clinical Engineering Vol.4 Issue 3: 2022 20


Jawbone, Misfit, Mykronoz, Samsung, Garmin Ltd, Xiaomi 190.61 billion dollars in 2025. AI can add about $15.7
Technology Co. Ltd, Qualcomm Technologies, Inc; Adidas trillion to the world economy by 2030,38 with China lead-
Group, Sony Corporation, Lifesense Group.18 The details ing the global market in 2030 with a share of 26.1%.39
on many body-worn devices are presented in Figure 6. These assertions are justified by the research article
Artificial Intelligence (AI) published by Chinese universities from 2015 to 2019, as
AI is rapidly evolving in clinical practice in dealing seen in Figure 7.
With AI, patients will receive more rapid, accurate diag-
noses and reduced adverse events. The top applications of
AI include robot-assisted surgery, virtual nursing assistant,

FIGURE 6. Wearable devices worn on various body parts and the


parameters they can monitor.27

with a significant amount of data provided by Smart


wearables, Smartphones, and other monitoring systems
in medical services.6 The concept of AI was first conceived
in 1950 by Alan Turing in his book entitled Computers
and Intelligence in what was called Turing test when he
was trying to determine whether computers were capable
of human intelligence. In 1956, John McCarthy described
“Artificial Intelligence” as the science and engineering FIGURE 7. Top 10 institutions with the most AI-related publications
of making intelligent machines.30 The systematic evolu- (2015-2019).40
tion of AI is presented in Figure 8. Today, AI is defined as
using computers and technology to simulate intelligent
behavior and critical thinking comparable to a human be- administrative workflow assistance, fraud detection, dos-
ing or the science and engineering of making intelligent age error reduction, clinical trial participant identifica-
machines.31-34 tion, preliminary diagnosis, automated image diagnosis,
cybersecurity, health research, and drug discovery and
The evolution of AI is presented in Figure 3. AI is not
one type of machine or robot but a series of approaches, development.41 AI also finds application in diagnosis and
case identification and prognosis and prediction.
methods, and technologies that display intelligent behavior
by analyzing their environments and taking actions—with The AI umbrella encompasses the following subfields30:
some degree of autonomy—to achieve specific targets that • Machine learning (ML): Machine learning involves
can improve health services.35,36 Studies about AI have training an algorithm to perform tasks by learning from
exponentially increased from 826 in 2012 to 12563 in patterns in data rather than performing an explicitly
2019.37 By 2019, there were 279,145 AI patent applica- programmed job.42 Machine learning algorithms can
tions in the US, with the global market expected to reach automatically learn and improve from experience

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


without explicitly programming. The most common • Computer Vision (CV): CV allows the building of
algorithms of ML are: supervised learning (used artificial systems capable of retrieving any informa-
when we can precisely define the task we want the tion from an image previously obtained. CV involves
algorithm to learn based on data that we already different stages, namely: image acquisition (image
have), unsupervised learning (It is like learning capture with a sensor and transformation of visual
without a teacher. We have a group of patients with information into digital information), pre-processing
different sets of data, but we do not know their (preparing the image for the next level handling),
individual diagnoses. We build a model, then try to feature extraction (detection of some objects to be
cluster patients based on similar attributes such as analyzed), segmentation (separation of images into
the symptoms they presented with, their lab markers cohesive regions), noise reduction and high-level
or age and gender), Reinforcement Learning (this processing.48 Today, there are many practical ap-
allows the algorithm to learn how to complete the plications where AI was successfully useful.
tasks with a sequence of decisions by itself without The key challenges of AI are their computing power,
being told how to do it).35,37 trust deficit, data privacy and security, data scarcity,38
• Deep learning (DL): It is a subset of ML with simi- ethical regulations, high resource and research cost, short-
lar functions but with different capabilities.37 This
method of AI allows a machine to be fed with large TABLE 3. Examples of Success of Artificial Intelligence.37
quantities of raw data and to discover the representa- Company Application
tions necessary for detection or classification.43 DL
Software application for online consultation
uses chips called graphics processing units to rapidly
Babylon Health where the system gives medication based on the
perform required calculations, a single card of which symptoms entered in the system
can potentially process hundreds of millions of im-
Sensely A virtual nurse that was designed to have a
ages a day.42 DL mammography is used for breast
(developed Molly smiling face coupled with a pleasant voice to
cancer detection, in computed tomography (CT) for app) assist patients with monitoring their health
column cancer diagnosis, in chest radiographs, for
Deep Genomics
the detection of pulmonary nodules.41 To match genetic mutations found in patients’
(developed
tumor samples with ongoing clinical trials
• Natural language processing: This branch of AI is Oncecompass
worldwide
concerned with the use of computational methods in Medecine app)
understanding and interpreting human language.35,42 Software that provides evidence-based treatment
IBM Watson
Artificial Neural Networks (ANN) or Simulated options for oncologists
Neural Networks (SNN): ANN are considered the Uses supercomputers to root out treatments from
Atomwise
heart of DL. ANN is technology based on a human a database of molecular structures
neural network.44 Examples of ANN include hand-
writing recognition, speech-to-text transcription,
age of transparency, poor governance and accountability,
weather prediction, and facial recognition.45 An SNN
notability of data annotation.49
contains a node layer, one or more hidden layers,
and an output layer. Each node, or artificial neuron, Globally, the AI companies are NVIDIA Corporation,
connects to another and has an associated weight Amazon.com, Inc., Meta Platforms, Inc., DeepMind, OpenAI,
and threshold. If the output of any individual node is Affectiva, DataRobot, Ubiquity6 CloudMinds.50,51 To ensure
above the specified threshold value, that node is acti- appropriate utilization of AI, companies need to embrace
vated, sending data to the next layer of the network.46 techniques that help them achieve fairness, security, and
ANN are used in economics, ecology, environment, explainability.49
biology. In medicine, the most widely used family
is the multilayer perceptron (PMC) in therapeutic
decisions to process data for anthropology.47

J Global Clinical Engineering Vol.4 Issue 3: 2022 22


TABLE 4. Applications of Artificial Intelligence in Diagnosis and Prediction.43
Diagnosis and case identification
Prognosis and prediction
Function Clinical area Applications
Obstetrics Intrapartum monitoring
Waveform analysis
Neurology Remote monitoring of gait
Cardiovascular risk prediction,
Detection of lymph node metastases in breast
Pathology Prediction of breast cancer
cancer
survival. Prediction of outcomes
Identification of benign and malignant tumors, in colorectal cancer, Predicting
Dermatology identification of fungal infection, classification of of survival in non-small cell
skin cancer lung cancer. Prediction of
Identification of diabetic retinopathy, grading of hospitalization due to heart
Image processing Ophthalmology disease. Prediction of sepsis in the
macular degeneration
intensive care unit, emergency
Diagnosis of acute coronary syndrome,
department, and hospital floor
Cardiology identification of heart failure status through
Prediction of treatment outcome
remote patient monitoring
in social anxiety. Prediction of
Mammography, diagnosis of pneumonia from psychiatric readmission from
Radiology
chest x-ray discharge summaries
Identification of sepsis in the emergency department, Identification of breast
Electronic health cancer symptoms, Heart failure case identification, Identification of patient
records analysis phenotype from analysis of intensive care unit data, identification of medical
subdomains in clinical notes

FIGURE 8. Historical evolution of artificial Intelligence.30

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


BCT or DLT the ideal blockchain model would be scalable with high
Patients and healthcare practitioners are faced with security and data privacy. In finance, bitcoin and Ethereum
the challenge of accessing, managing, integrating, and are examples of cryptocurrencies that use blockchain
sharing health records securely.52 In many countries data technology.61
are recorded on legacy papers and numerous discon- In medical and clinical services, by using BCT, patients
nected electronic systems. In the US, 90% of physicians become the platform, owning and controlling access to
use unconnected computerized systems. Patients must their healthcare data. The data are stored in the private
recount their history multiple times, which may be done blockchain cloud, where they cannot be changed by
incompletely. Medical errors are estimated to be the third anybody, including physicians and patients themselves
leading cause of death for Americans. In 2015, 140 mil- internally and natively.
lion patient records were breached according to Protenus Because data is stored on a decentralized network,
Breach Barometer Report.53 The WHO estimates that many there is no single institution that can be robbed or
countries in Africa and parts of Asia and Latin America hacked to obtain a large number of patient records. Data
have areas where more than 30% of the medicines on is encrypted in the blockchain and can only be decrypted
sale can be counterfeit.54 with the patient’s private key. Even if a malicious party
In 2018, the healthcare industry continued to be plagued infiltrates the network, there is no practical way to read
by data breaches involving sensitive patient information. patient data.62,63
According to the Breach Barometer 2019 Report, more In terms of patients’ full control of their health record
than 15 million patient records were breached in 2018. history, there are three major aspects of privacy that need to
Such incidents allow blockchain vendors to launch new be considered: (a) data ownership; (b) fine-grained access
solutions.54 control; (c) data transparency, integrity, and auditability.53
To alleviate the associated adverse effects, an intercon- In healthcare services, the key enablers of blockchain
nected system is needed. In the UK, the NHS planned to are the need for patient data security, desire to reduce
interconnect all computerizing health network records by medical errors and mistakes, breakthroughs in genomics,
2018; however, this target was delayed first to 2020 and drug traceability and safety, government partnerships,
again to 2023.55 Nevertheless, during COVID-19, which removal of unscrupulous attacks, reduction of cost in
is ravaging the globe, blockchain technology was used by medical transactions, and improved confidentiality in
two UK hospitals to keep tabs on the storage and supply healthcare business operations.63
of temperature-sensitive COVID-19 vaccines.56 A blockchain is a ledger of transactions where an iden-
In March 2021, Moderna, a biotechnology and phar- tical copy of the ledger is visible to all the members of a
maceutical company based in the United States, signed a computer network. It is a digital healthcare system man-
new agreement with IBM to use blockchain technology to agement from which authorized users, such as providers
manage its COVID-19 vaccines. Additionally, 3M Pharma- and patients, have access.62 BCT is a permanent record of
ceuticals, another American pharmaceutical giant, uses online transactions distributed, shared, and maintained
blockchain technology to curb counterfeit pharmaceuti- by multiple parties.
cals. Recently, it has started using blockchain technology The first blockchain was developed by Satoshi Naka-
to identify and stop counterfeit face masks.57 moto in 2009. The technology brought breakthroughs
BCT, though initially designed for the financial market, until 2021 when Dubai hosts all government operations
its inherent characteristics make it suitable for the health and record-keeping operations on blockchain as part of
sector, insurance, pharmacy, IoT, food science, industries, the Smart Dubai 2021 initiative.64
e-voting, tourism, energy, and legal contract.58-60 BCT helps The data-sharing practice is essential to enable clinical
streamline business processes by establishing trust, ac- practitioners to transfer their patients' clinical data to the
countability, and transparency.58 In medical applications, concerned authority for a quick follow-up.60 BCT differs

J Global Clinical Engineering Vol.4 Issue 3: 2022 24


scientific publications about blockchain technology shifted
from 5 in 2016 to 64 in 2018. This was another indicator
that this market was rapidly attracting researchers.65 In
its structure, the components of blockchain technology
are listed below.
• Blocks are the base of a blockchain and contain
records linked lists, chains, genesis blocks, and con-
sensus protocol.66 Blocks contain records of the past
transactions and have segments reserved to save the
data for future transactions. A block on a blockchain
network consists of hash codes, root hash of merkle
tree, and nonce.61
• Chains are blocks inside a blockchain network that
are connected to each other. Multiple blocks that are
joined together form a chain of blocks.
• Nodes contain the entire history of a blockchain
network. Nodes are the devices that store these
vast amounts of data. Computers, laptops, and big
servers function as nodes. All the nodes in a block-
chain network are linked together. Nodes verify the
signatures, double-check the answer of the hash
code after authenticating the details, and add a new
block to the blockchain network. Nodes can stay both
online and offline.61
FIGURE 9. Theoretical schematic of blockchain technology in
healthcare.59
• Master nodes. Selective blockchain networks have
master nodes which are are more capable than
from a personal ledger in the number of security checks, normal nodes.61
whereby a blockchain makes many security checks.61 • Peer-to-peer networks (P2P) are networks designed
This technology is interpreted as blocks linked together for linking two nodes.
to form a chain to offer patients and caregivers the abil- There are four types of blockchains:
ity to securely share the patient identity and healthcare
• Public blockchains are permissionless blockchains
information across platforms.
that allow anyone to join. All nodes of the blockchain
Today, the market for blockchain technology is very have equal rights to access the blockchain, create
promising because it is forecast to save $100 billion per new blocks of data, and validate blocks of data.58,67
year since 2025. The saving will be realized in a reduction
• Private or managed blockchains are permissioned
in data-breaching related costs, operations costs, informa-
blockchains controlled by a single organization. In a
tion technology (IT) costs, counterfeit-related fraud, and
private blockchain, the central authority determines
insurance fraud.52 In healthcare, the blockchain market
who can be a node. The central authority also does
in healthcare was valued at USD 2.12 billion in 2020 and not necessarily grant each node with equal rights to
is expected to reach USD 3.49 billion by 2026 and USD 4.7 perform functions.67
billion in 2027 with a CAGR of 8.7% during the forecast
period, 2021–2026, with North America as the fastest- • Consortium blockchains are permissioned block-
chains governed by a group of organizations, rather
growing market.54 Regarding research, the number of

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


than one entity. However, setting up consortiums the mechanical functions of a human being but lacks
can be a fraught process as it requires cooperation sensitivity. The first robot was developed by Leonardo
between several organizations presenting logistical Da Vinci in 1495, purposed at amusing royalty. It was
challenges and potential antitrust risks.67 followed the creation of the first operational robot by
• Hybrid blockchains are controlled by a single orga- Joseph Marie Jacquard in 1801, in which an automated
nization, but with a level of oversight performed by loom, controlled by punch cards, created a reproducible
the public blockchain, which is required to perform pattern woven into cloth.73
specific transaction validations.67 In medicine, robotic systems were first introduced in
Some key players in the blockchain market are IBM the mid-80s, and today they make an impact in various
Corporation, Microsoft Corporation, Gem, Patientory Inc., medical disciplines, including general surgery, research,
Guardtime Federal, Isolve, and Factom57 therapy, rehabilitation, neurosurgery, orthopedic surgery,74
and medical transport (for example, TUG Robot able to
Robotics Technology
carry around more than 400 kilograms of medication).75
Technological advancement has revolutionized how
As per 2017, 20% of the world population experience
medical procedures take place, including surgical opera-
TABLE 5. Challenges of Blockchain Technology59,62,60 difficulties with physical, cognitive, or sensory function-
Blockchain software is still in its infancy, ing mental and behavioral health, which can be solved
Technology with robotics technology application.76 The very first
continually being developed and refined
Must initially be co-existent with current mechanical robot to be used in surgery was the Puma
Integration 560 in 1985 for the precise positioning of the cannula
technologies, must be integrated overtime
Adoption of new technologies will incur for brain biopsies.77
Cost
initial greater costs to institutions Statistics show that 1in every 25 patients will contract
Government institutions have yet to settle hospital-acquired infection (HAIs) in the USA, and 1 in 9
Regulation regulatory concerns over blockchain will die.75 That is why next-generation smart hospitals
technology have robotics that can help reduce infections, viruses,
Adoption of the technology will require and bacteria.78 For example, Xenex Robot allows for fast
Culture significant buy-in from the global and effective systematic disinfection of any space within a
community healthcare facility by destroying deadly microorganisms
Maintaining the blockchain requires a causing HAIs using special ultraviolet (UV) disinfection
Energy network of nodes, and resulting substantial methodology.75 Data from the USA show that surgery
computing power
costs annually are estimated to be $170 billion, with an
Emerging cyber security concerns must be estimated $41 billion US spent on readmission due to
Privacy addressed before individuals will entrust
complications. In Europe. over half (52%) of all surger-
data to a public blockchain
ies were due to unexpected complications. Consequently,
tions. Credits go not only to the development of actuators, robotics can lower the readmission rate by up to 50%,
sensors, control systems, and materials but also to the resulting in a saving of $10 billion annually.79 The global
growth of imaging systems for medical applications such landscape of robotics application in healthcare and well-
as higher resolutions and magnetic imaging.71 Apart from being are presented in Table 7.
the industrial robot (a word originating from the Czech In their general design and construction, medical robots
word “robota” meaning compulsory labor) first developed consist of a Central Processing Unit (the robot's brain for
50 years ago, today’s medical and healthcare robots are coordinating all its activities) and Sensors (acting as the
used in tremendous clinical work.72, 73 powerhouse of the robot feedback mechanism). These
According to the Robotic Institute of America, a robot include light sensors, sound sensors, temperature sen-
is a machine in the form of a human being that performs sors, contact sensors, proximity sensors, distance sensors,

J Global Clinical Engineering Vol.4 Issue 3: 2022 26


FIGURE 10. Blockchain structure in hospital applications.68

FIGURE 11. Properties of blockchain technology.69

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


TABLE 6. Blockchain Potentials for Healthcare and Life Science52,59,70
Category Potential use Key Benefits
Increases patient trust. Improves patient access to trusted
Patient empowerment. Patients can keep track data. Facilitates better collaboration, Increases transparency.
of their medical background. Patients can check Improves and personalizes the patient experience. Increases
Patients
their latest medical prescriptions, Patients can efficiency and reduces operations costs, Enables patient access
share their data securely across their providers to their health records anywhere in the world. Enables patient
access to their latest prescriptions
Establishes a trusted audit trail verifiable in real-time.
Regulation and Compliance tracking, Smart contract-based Establishes a platform to enforce privacy regulations
compliance check automatically. Enables monitoring of who has shared data and
with whom, without revealing the data itself
Facilitates automated payments through smart contracts.
Increases speed for payments. Provides full transparency of
Inter-company Transfer of funds. Medical devices supply chain.
assets across the supply chain to the patient. Enables certified
processes Temperature-controlled supply chains, Services
& private messaging between medical devices and service
providers. Brings all transactions into a single platform
Improves efficiencies in tracking and tracing areas where
Administration and
Revenue management leakage occurs. Reduces admin costs, Increases reliability and
back offices
auditability. Speeds up financial transactions process
Tracks and traces pharmaceuticals, Proof of authenticity for
anti-counterfeiting techniques. Helps prevent the transport
Verifies drug provenance. Creates an industry-
Pharmaceuticals and sale of counterfeit products. Makes it is possible to detect
wide, single source of aggregate information
the full spectrum of complications related to pharmaceutical
treatment
Prevents theft of intellectual property. Enables users to
Research and authenticate any document and ensuring proof of the existence.
Securing clinical trials
development Enables access to a huge anonymous and authenticated
database of patients

pressure sensors, positioning sensors, etc.). Also included players, well-defined market entry routes, and a good
are Actuators (the robot's hydraulic, pneumatic, or electric product innovation pipeline.80
muscles), End-Effectors (the tools that perform the actual In 2020, the leading global company in medical ro-
work and interact with the environment or a workpiece), botics was Intuitive Surgical, with a market cap of $121
the Power Supply (energy required for robot operation), billion, 6335 robots in service,78 with more than 1.2 mil-
and the Program (for providing the logic that drives the lion procedures performed globally, and with a growth
robot behaviors and activities).81 of 18% per year.80
Robotics applications in medicine involve different Other companies in service include Boston Dynam-
stakeholders, including primary stakeholders (direct ics, Stryker, Accuracy, Vicarious Surgical, Medtronic, GE
robot user, clinicians, and caregivers), secondary stake- Healthcare, Myomo, Stereotaxis, Ottava77,78 Neocis.Inc,
holders (robot makers, environmental service workers, Medtronics, Brainlab, Smith & Nephew plc, Corindus
health administrators), and tertiary stakeholders (policy Vascular Robotics, Inc., Riverfield Co., Ltd, Auris Health,
makers, insurers, advocacy groups).76 Among robotics Inc., etc.80
applications, surgical robots have a high revenue growth
market segment, are highly competitive with established

J Global Clinical Engineering Vol.4 Issue 3: 2022 28


TABLE 7. Medical Robotics Market Potential Assessment Summary80
Technology Breadth of
Healthcare robotics Current adoption Growth potential
Readiness level application

Surgical
Robots
Medical robots
Diagnostics
Robots

Medication delivery and


dispensing

Cleaning and disinfecting


Healthcare Service
robots
Telepresence and remote
monitoring

Autonomous vehicles

Personal assistant/
Companion robots
Care robots
Assistive robots

Between 2015-2020, China emerged as a leader for


next-generation surgical robotic systems’ innovations
with 237 (36.5%) patents published in this area from
2015 to 2020 (Figure 12).80
The global medical robot market is expected to reach
USD 12.7 billion by 2025 from an estimated USD 5.9
billion in 2020 at a CAGR of 16.5% during the forecast
period. On the other hand,82 medical robotics market
is forecast to account for $43.22 billion in 2028 with a

FIGURE 12. Medical robotics patent filings from 2015 to 2020.80

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


compound annual growth rate of 22.3% from 2021 to instruct them to wear masks properly. One robot called
2022 (Figure 13).82 Urumuli deployed at Kigali International Airport had the
The key drivers of medical robotics market evolution capacity of screening 50 to 150 people per minute and
include demand for minimally invasive procedures for reporting abnormalities to officers on duty.84
diagnosis, improved precision in diagnosis and treatment, Later, on 9 February 2021, in partnership with the
technological advancement in AI, management of surge United Nations Development Programme, the govern-
capacity during peak demand, and improvement of the ment deployed another set of three THOR UVC robots to
Nyarugenge District Hospital to strengthen the national
response to COVID-19 pandemic.85 Robots were also used
to store patients’ data during diagnosis and treatment,
reduce the workload of healthcare providers, ease the di-
agnosis procedures, and assist the physicians and students
in learning more about the new disease in a short time.86
In South Korea, a self-driving robot with cameras
and an LED screen was used to greet clients at the coun-
try’s biggest mobile operator, check their temperatures,
dispense hand sanitizers, and disinfect the floor. Other
robots were used to disinfect 33 square meters in 10min
using ultraviolet radiation. In addition, they could detect
people's gatherings, advise them to disperse, and wear face
masks.87 In China, Wuhan City, where the pandemic was
first detected, constructed a fully robot-staffed hospital
where patients entering were screened by connected
5G thermometers to alert staff for feverish. In addition,
FIGURE 13. Market growth for medical robotics.82 Patients wore smart bracelets and rings that synced with
Cloud Minds’ AI platform so their vital signs, including
overall efficiency of logistics. Also, there is a desire to temperature, heart rate, and blood oxygen levels, could be
increase the automation of pharmacy operations, large monitored. Doctors and nurses also wore the devices to
population living with chronical illnesses, hospitals’ will catch any early signs of infection.88 Regarding the future
to maintain hygiene protocols and standards, especially as of medical robotics, up to 2013, Nanorobotics was still
it directly impacts hospital accreditation, reduces manual the largely hypothetical technology of creating machines
labor, improves efficiency and cost savings for cleaning or robots at or close to the scale of a nanometer.73
and disinfection. Increasing prevalence of stroke, multiple Though the growth of the medical robotics industry
sclerosis, Parkinson's disease, cerebral palsy, Rise of the is promising, it is humped by the following challenges:
elderly population, and shortage of caregivers.80 high establishment cost, fewer trained professionals to
Nowadays, since 2019 when the whole world experi- administer the tests, technical complexities leading to
enced the COVID-19 outbreak, robotics has been finding operational issues, the high running cost for disadvan-
applications in undertaking human-like activities.83 In taged people.80
Rwanda, robots were deployed to minimize contact time
Nanomedical Technology
with confirmed cases and reduce the risk of contamination
of health professionals in COVID-19 treatment centers. It is a technology for diagnosing, treating, and preventing
The 5 human-size robots are programmed to perform disease and traumatic injury, relieving pain, preserving
temperature screening, take vitals readings, deliver video and improving human health using molecular tools and
messages, detect people not wearing masks, and then molecular knowledge of the human body.89 Nanotechnology

J Global Clinical Engineering Vol.4 Issue 3: 2022 30


classically refers to the matter in a size range of 1–100 molecules and cells, MRI contrast enhancement and phago-
nm but can be extended to include materials below 1 μm kinetic studies, company directory and to deliver drugs,
in size.90 Nanomedicine is also defined as the application heat, light or other substances to specific types of cells
of nanobiotechnologies to medicine.91,92 (such as cancer cells).91,97 Its use in diagnostics is at the
Though the concept of nanotechnology dates to 1959, development stage. The use of nanoparticles will reduce
the optimistic expectation of nanoparticles and nanoscale damage to healthy cells in the body and contribute to the
tools to improve the diagnosis and pharmacological early detection of diseases.91 The global Nanomedicine
treatment of several diseases was first established in market size is projected to reach USD 232 million by
1990.93 The basis of this new science derives from the 2026, from USD 150 million in 2019, at a CAGR of 6.4%
development of an array of ultramicroscopic devices during 2021-2026.98
and the studies of cellular, molecular, and finally atom- The nanomedicine market segmentation by type includes:
sized structures in biology, chemistry, and physics in the • Quantum dots (QD): QD are semiconductor nano-
20th century. Nanotechnology is not in itself a single crystals that have a reactive core (made of cadmium
emerging scientific discipline, but rather a meeting of selenide CdSe, cadmium telluride [CdTe], indium
different traditional sciences linking physics, chemistry, phosphide [InP], or zinc selenide [ZnSe]), for control-
biology, medicine, electronics, and IT.94 Nanotechnology ling their optical properties. QD are used in medical
in medicine was recently focused on because there is a real-time tissue imaging,99 biological probes, for
diversity of diseases originating from the alteration in live cells labelling,100 drug delivery vehicles, in vivo
biologic processes at the molecular level like mutated imaging, therapeutic delivery,101 blood cancer assay,
genes, misfolded proteins, and infections caused by viruses and cancer detection and treatment, in vivo animal
or bacteria (Figure 14).95 The three main subsections of targeting, tracking different particles, forecasting of
nanomedicine are: nanobiotechnology, nanotechnology, disease stage.102
and nanobiomimetics.96 • Nanoparticles: A considerable fraction of the solid
Currently, in medicine, nanotechnology is used in matter on earth can be found in the size range of
antibacterial treatment, wound treatment, cardiovascu- colloids and nanoparticles, and in the last 2 decades,
lar diseases, ophthalmology, cancer-fighting, cell repair, scientists have shown that colloids and nanoparticles
imaging, probing of DNA structure, tissue engineering, are present everywhere in the environment.103 NPs
tumor detection, separation and purification of biological are categorized into three types: natural nanopar-
ticles, incidental nanoparticles, and engineered
nanoparticles (Figure 15).104
From a chemical point of view, nanoparticles are classi-
fied into inorganic and organic types. Inorganic nanopar-
ticles are used as antimicrobial agent against bacteria,
fungi, parasites, and viruses.104 Organic nanoparticles
prepared from various materials, including polymers
and lipids, have found exciting therapeutic delivery and
imaging applications.105
The choice of material impacts various properties,
including drug encapsulation, immunogenicity, and target-
ing. At the same time, the design of nanoparticles, such as
size, shape, flexibility, and compartmentalization, will also
impact nanoparticle performance. These two attributes
FIGURE 14. Relationship of nanobiotechnology to nanomedicine
and other biotechnologies.91

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


• Nanoshells: The discovery of nanoshells was made
by Professor Naomi J. Halas and her team at Rice
University in 2003.107 These are a special class of
nanomaterials that consist of concentric particles.108
A nanoshell is a type of nanoparticle with a dielectric
(e.g., silica) core and a thin metal coating (usually
gold).109
Nanoparticles find a place in medicine because of their
safety, biocompatibility, stability, bioavailability, optically
tunable, and photo-luminescent ability as well as high ability
to attach to many therapeutic materials. Nanoshells (and
especially gold nanoshells) show promise application in
biomedical imaging, target therapy, gene delivery, tissue
welding, drug delivery systems, therapeutic applications in
general, and cancer imaging and treatment (Figure 17).110
FIGURE 15. Types of nanoparticles.104 Gold nanoshells exhibit unique optical properties
because their interaction with the electromagnetic field
is greatly intensified by a phenomenon known as local-
(choice of material and nanoparticle design) collectively
ized surface plasmon resonance. They are designed to
determine the therapeutic outcome (Figure 16).105
Other applications of nanoparticles within medicine
include tissue engineering, bio-micromechanical systems
(bioMEMS), biosensors, anticancer drugs, microfluidics,
and diagnostics.106

FIGURE 17. Use of nanoshells for cancer treatment (Source: National


Cancer Institute).

absorb radiation at various frequencies absorb certain


types of radiation. Once the nanoshells are attached to
the cancerous cells, only laser light is needed to treat
cancer. Near-infrared (NIR) light passes through the body
and reaches the gold nanoshell. The tuned gold nanoshell
receives the NIR light and converts the light energy into
heat, killing the cancer cells.107
FIGURE 16. Design parameters for nanoparticles.105

J Global Clinical Engineering Vol.4 Issue 3: 2022 32


• Nanotubes: Nanotubes, usually made in carbon atomic absorption spectrometer, profilometers, raman
(CNTs), consist of carbon atoms arranged in a series microscopes, calorimeters, cryogenic probe stations,
of condensed benzene rings rolled up into a tubular scratch testers, flow chemistry reactors, graphene, surface
structure.111 Carbon nanotubes (CNTs) are cylin- analyzers, Spectroscopic ellipsometer, wafer bonders,
drical molecules that consist of rolled-up sheets of x-ray detectors, x-ray diffractometer, etc.106
single-layer carbon atoms (graphene). They can be The challenges faced by nanotechnology include high
single-walled (SWCNT) with a diameter of less than 1 manufacturing costs, technical challenges, raised skepti-
nanometer (nm) or multi-walled (MWCNT), consist-
cal opinions within the scientific community about the
ing of several concentrically interlinked nanotubes,
clinical relevance of nanomedicine.93 The competitive
with diameters reaching more than 100 nm. Their
landscape of the industry has also been examined along
length can reach several micrometers or even mil-
with the profiles of the key players who include Abbott
limeters (Figure 18).112
Laboratories, Arrowhead Pharmaceuticals Inc., General
Their impressive structural, mechanical, and electronic Electric Company, Luminex Corporation, Merck & Co. Inc.,
properties are due to their small size and mass, incred- Nanobiotix, Novartis AG, Pfizer Inc., Sanofi SA, Starpharma
ible mechanical strength, and high electrical and thermal Holdings Limited.115
Telemedicine and Telehealth
The provision of primary healthcare has been challeng-
ing during the recent and current periods of COVID-19 due
to overcrowding of medical services seekers to different
health facilities.116 It is evident to many that COVID-19
accelerated the adoption of Telemedicine globally.117
Telemedicine uses electronic communications and in-
formation technologies to provide clinical services when
participants are at different locations.118,119 Some writers
prefer to use the term “telehealth” interchangeably with
“telemedicine,” but Telehealth is broader because it also
FIGURE 18. Conceptual diagrams of single-walled carbon nanotubes
considers even non-clinical services. Telehealth refers to
(a) and multiple-walled carbon nanotubes (b).111
‘the use of telecommunications and IT to provide access to
health assessment, diagnosis, intervention, consultation,
conductivity. In medicine, nanotubes are used in pharma- supervision and information across distance.120
ceuticals, drug delivery systems, gene delivery and therapy, Telemedicine is traced back many centuries, starting
tissue engineering, bio-imaging, biosensor applications, from ancient hieroglyphs and scrolls to share informa-
lab-on-chip devices, photo-thermal therapy, diagnostics, tion about health-related events such as outbreaks or
and high-performance composites for implants.113,114 epidemics. This was followed by using smoke signals to
Although there are advantages of nanotubes (like warn nearby cities of sickness.120 In contemporary times,
biocompatibility, rigidity, mimicking of natural tissue Telemedicine through telephone and video technology
nanofibers, stimulating the adhesion and proliferation has been used since the 1960s in the military and space
of cells and ability to form strong 3-D architectures, sectors.121 Apart from military services, Telehealth was
high surface area, high photo-stability and absence of first used in 1972 when Murphy and Bird conducted 500
quenching, special optical, mechanical, and electronic patient consultations via interactive television.122 Today,
properties),114 concerns related to their toxicity, biosafety, Telemedicine is applied in radiology, dermatology, surgical
and biodegradation still remain.113 Examples of nano- peer monitoring, medication management, mental health,
technology equipment in medicine include atom probes, diagnosis, patient monitoring, etc.123

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


The drivers of Telemedicine include: enhancement of to work remotely.128 In Telemedicine, cloud-based
care coordination, patients and doctors are fascinated services help user-friendly access to medical records
by the services offered by Telemedicine, society, and for both clinicians and patients from anywhere they
healthcare tendency to digital life (in OECD countries, can access the Internet.129
nearly 65% of people aged 65 to 84 years are estimated When the world experienced COVID-19 pandemic,
to have more than one chronic condition, a prevalence social distancing measures were put in place to fight its
that reaches 89% for those aged 85 and over), bridging sustainability. Moreover, the rapid global spread of CO-
of the rural gap, continuous innovation in the consumer VID-19 has increased the volume of data generated from
technology market, projected shortages in the health pro- various sources.130 The cloud technology had a major
fessional workforce, growth of consumerism in health care role in fighting the epidemic; it became a salvation for
cost-effectiveness, quick access to medical services,123,124 governments and organizations in numerous fields of
improved quality, medication management, changes in life, education, health, industry, communication, remote
care models.125,126 surveillance, and more information (Figure 19).131
The services offered by Telemedicine include special- Generally, the lines of action of the telehealth program
ist referral services (assisting a general practitioner in are based on three components, as presented in Figure 20.
rendering a Diagnosis), direct patient care (sharing audio, From 2010 to 2017 the world experience growth in
video, and medical data between a patient and a health the use of Telemedicine, with three diseases dominating
professional for use in generating a diagnosis, treatment the growth rate. Those are diabetes, congestive heart
plan, prescription or advice), remote patient monitoring
(devices to remotely collect and send data to a monitor-
ing station for interpretation), medical education and
mentoring, consumer medical and health information,
patient support service (reminders to take medication,
supervision, scheduling of appointments and similar ap-
plications which are not implicitly medical).118
There are four key elements needed for a successful
telemedicine program.
1. Collaboration tools are devices that help patients
to connect with healthcare service providers. They
include smartphones, laptops, tablets, etc.127
2. Medical peripherals are the diagnostic tools used
in Telemedicine, such as otoscopes, ultrasound
machines, or digital stethoscopes.127
3. Workflow represents adequate software to man-
age the complete process of connecting patients to
medical professionals and to integrate Telemedicine
with their existing IT resources.127
4. Cloud-based services: Cloud computing delivers dif-
ferent services through the Internet. These resources
include tools and applications like data storage,
servers, databases, networking, and software. When
using cloud computing, the user is not required to
be in a specific place to access it, allowing the user FIGURE 19. Use of Telemedicine by doctors and patient benefits.123

J Global Clinical Engineering Vol.4 Issue 3: 2022 34


failure (CHF), and chronic obstructive pulmonary disease
(Figure 21).

FIGURE 22. Quarterly global telehealth funding (2018-2021) in $M.134

• Store and forward telemedicine or asynchronous


Telemedicine. In this type of Telemedicine, patient
information such as medical images or bio-signals
can be sent to the specialist as needed when it has
been acquired from the patient.136 It is regarded as
the acquisition and storing of clinical information
such as lab reports, data, images, sound, and videos
FIGURE 20. General lines of action of telehealth.132 that are then forwarded to (or retrieved by) another
site for clinical evaluation.122
Since 2018, the quarterly investment in Telehealth has
experienced peaks and bottoms, but when WHO officially • Real-time video or synchronous Telemedicine.
declared COVID-19 as a pandemic on 13 March 2020, In this type of Telemedicine, consultations use video
the investment in Telehealth has drastically increased conferencing to connect the patient with the physi-
compared to previous years, as presented in Figure 22. cian. Patients from their homes can use smartphones,
tablets, or computers to interact with physicians. This
method enables the physician to conduct a medical
consultation as they would in person.122
• Remote monitoring telemedicine. This uses a
range of technological devices to remotely monitor
a patient's health and clinical signs. This is exten-
sively used in the management of chronic diseases
such as cardiovascular disease, diabetes mellitus,
and asthma.136
The key challenges hindering the growth of Tele-
medicine are system development costs, digital literacy,
Digital Technology Acceptance, less accurate diagnosis for
specific images transmitted with Telemedicine concern-
ing the original images, aspects linked to security and
FIGURE 21. World Telehealth Patients (thousand) per disease.133
confidentiality in the doctor-patient relationship through
Generally, the global telemedicine market was valued appropriate interfaces, and system implementation by
at $50 billion in 2019, with forecast potential growth to the involvement of different parties.132,137
increase to $460 billion by 2030.135 Although Telemedicine has many challenges to overcome,
There are three types of Telemedicine: there are also opportunities to sustain its development.
They include gap service coverage (for example, in the
USA, teleradiology predominates other services), urgent

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


service coverage (a case of a mobile telemedicine system Big Data help to identify individual and community
for consulting acute stroke even remotely by employing trends and develop better treatment plans or predict
a wireless LAN or a mobile phone network), and video- at-risk patients, forecast patient admissions trends and
enabled multisite group chart rounds (model of medical schedule the correct number of staff, drive innovation,
education liked to clinical care).138,139 compare chronic disease and population growth in
Big Data neighborhoods, streamline insurance claims processes,
easy detection of fraud and inventory tracking.147 The
The healthcare landscape is saturated with a large,
global health data in 2013 only was estimated to be 153
diversified amount of data. Big Data in healthcare is over-
Exabytes, with forecast potential growth to 2,314 Exabytes
whelming because of its volume and the diversity of data
in 2020 alone.135
types, and the speed at which it must be managed.140 Those
data could be an enabling resource for deriving insights Big Data analytics are divided into four categories:
for improving care delivery and reducing waste.141 Over • Descriptive analytics. This consists in decrying the
more than a decade, as in other industries, the medical current situation and reporting on it.
industry has experienced rapid digitization due to an • Diagnostic analytics aim to explain why certain
increase in electronic medical records (EMR).142 events occurred and what factors triggered them.
Driven by mandatory requirements and the potential • Predictive analytics. This reflects the ability to
to improve the quality of healthcare delivery and obtain predict future events; it also helps identify trends
the best healthcare services meanwhile reducing the costs, and determine probabilities of uncertain outcomes.
requires a significant diversified quantity of electronic
• Prescriptive analytics. This proposes suitable ac-
health records to help in clinical decision support, disease
tions leading to optimal decision-making.148
surveillance, and population health management.140,143
The global Big Data analytics in healthcare market size
Big Data should be collected and used to ensure agree-
was valued at $16.87 billion in 2017 and is projected to
ments between patients, healthcare service providers, and
reach $67.82 billion by 2025, growing at a CAGR of 19.1%
policy and research. Today, there is no common definition
from 2018 to 2025.149
to explain what Big Data is. However, some researchers
tried to formulate the meaning of Big Data. According to The nine stages that make analyzed data useful are
McKinsey the term “Big Data” refers to “datasets whose shown in Figure 23. Big Data come from clinical practices
size is beyond the ability of typical database software and research, patient-generated data, medical claims,
tools to capture, store, manage, and analyze.”144 Big data electronic healthcare records, social media, patient sum-
is unmanageable using traditional software. We need maries, genomic and pharmaceutical data, clinical trials,
technically advanced applications and software to employ Telemedicine, mobile apps, sensors, and information on
fast and cost-efficient high-end computational power to wellbeing, behavior, and socio-economic indicators.142,144
utilize it properly. The term Big Data is described by the Big Data are used in medical services to gain advantages
following characteristics: value, volume, velocity, variety, as shown in Figure 24, and Big Data architecture for
veracity, and variability, denoted as the 6 “Vs”.143 healthcare is presented in Figure 25.
According to some studies have shown that 93% of The Big Data analysis ensures that the health facility
healthcare organizations have experienced a data breach manager sees a big picture of the hospital, the attendance,
because personal data is extremely valuable and profitable its nature, the costs incurred, etc., which will help run it
on the black markets, and this pushed organizations to smoothly. An example of a dynamic dashboard for patient
start using data analytics to help them prevent security care is shown in Figure 26.146 The challenges facing Big
threats by identifying changes in network traffic, or any Data technology are: segmentation of data in healthcare
other behavior that reflects a cyber-attack.146 providers (clinical data, financial data, administrative
data, patient data are not linked and shared), protection

J Global Clinical Engineering Vol.4 Issue 3: 2022 36


FIGURE 24. Application areas of Big Data technology in medicine.146

emphasis by healthcare agencies towards early diagnosis


and treatment, many countries and healthcare providers
are struggling to scale-up technology level to provide
adequate services to patients. In addition, physicians
themselves believe in introducing new technologies to
help them prevent, diagnose, treat, monitor, and care for
patients.
Technology advancement has proven effective in
providing access to information, facilitating remote care,
improving efficiency by connecting the patients with
physicians, cost-effective and time-saving solutions.
Medical technologies encompass data centers, medical
devices, software, drugs, IT services, public clouds, cyber-
security, communication services, surgical procedures,
FIGURE 23. The nine stages of the Big Data analytics lifecycle.150 and Internet of things.
The medical technology market is growing fast in Asia,
of patient’s privacy,151 data capturing, cleaning and stor- with different and bulky products available on almost all
age, stewarding and querying.152,153 global markets. As a result, the global market for medical
There are several challenges in adopting Big Data devices only is projected to grow from USD 455.34 billion
technology: data in many health care providers are often in 2021 to USD 657.98 billion in 2028.
segmented or siloed, complicated use Big Data is compli- The key challenges humping the development of medical
cated, long system response time.151,154 The key players technology are biomedical complexity, standardization,
in healthcare data analytics include IBM, Cerner, Health cybersecurity and data privacy, higher starting costs, and
catalyst, McKesson, Oracle.155 regulatory and environmental consideration.
The revolution of healthcare technology applications
CONCLUSION in medical services requires knowledge and skills in as-
In conclusion, driven by needed increases in medical sessment, planning, procurement, inventory management,
productivity, the growing prevalence of chronicling dis- installation, and maintenance. Therefore, healthcare pro-
eases, the increasing aging population, and the increasing viders need to be watchful about Healthcare Technology

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


FIGURE 25. Big Data architecture for health system.148

FIGURE 25. Big Data architecture for health system.148

J Global Clinical Engineering Vol.4 Issue 3: 2022 38


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J Global Clinical Engineering Vol.4 Issue 3: 2022 46


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- most in-demand – ventilators for critical care units. As
tems to the test, and it has been evident that healthcare it became clear that the industry was struggling to cope
professionals and workers were in the middle of it all. CEs with the shortage, several technical groups, including
were no exception, and their responsibilities doubled as academia, professional organizations, and non-medical
they were required to look after the medical technology devices companies, started their own efforts to build
needs of front-line workers and the rest of the clini- locally produced ventilators. However, they soon real-
cal services personnel. CEs did not hesitate when new ized that it was necessary to consult CE professionals
challenges required their skilled efforts. For example, with expertise in this vital equipment’s use, technical
early in the pandemic expansion, there was a shortage specifications, safety considerations, and normative and
of several types of medical devices needed for respira- regulatory concerns. This collaboration focused on three
tory and oxygen therapy, and one, in particular, was the

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


main areas: contributions to the design and development Clinical Engineering Role in Education
of ventilators, health regulation considerations, and edu- Because of their multidisciplinary approach, clinical
cation and training. engineers are well known as skilled trainers and educators,
Clinical Engineering Role in the Development of and this aptitude has helped share knowledge and experi-
Medical Devices ences regarding the manufacturing, principles, operation,
Medical device design and development is no easy task, care, and safety topics for critical care use ventilators. In
especially with equipment that operates using mechanical, a world that was forced to social distancing, the use of
electrical, electronic, and pneumatic components, such as web-based meeting platforms was rightly exploited for
vital support devices like ventilators. Many of the initial these purposes of education and training, something that
initiatives were non-invasive ventilation mechanisms that clinical engineers used in the form of: (1) webinars on
certainly couldn’t comply with safety and performance diverse topics related to patient ventilators, (2) training
standards, and that’s where CEs entered the scene to help courses on manufacturing and standards applications,
with the efforts. CEs contributed to the manufacturing of and (3) calls with other health professionals around the
locally produced, emergency use ventilators with actions globe to exchange knowledge and experiences.
such including: One prime example of the noble and vital role of knowl-
edge sharing has been the efforts from IFMBE-CED, which
• Putting engineering knowledge and skills together
right away began with organizing and offering relevant
with the development of the devices.
webinars, with helping hands from experts from all cor-
• Helping companies, academia, researchers, and inves- ners of the World and with a variety of topics regarding
tors to identify clinical needs and the right normative clinical engineering approach for the pandemic.
and tech specs for this type of device.
• Testing the prototypes and finished products through CONCLUSIONS
the proper metrology practices. CE has been evolving almost at the same pace as
Clinical Engineering Role in Health Regulation medical devices increase in complexity, from participat-
No matter how urgent the need for a medical device ing in service and safety checks, going through integral
may be, the authorization process must be approved by management, and even collaborating with policymaking
a competent health regulatory authority because such at a national health system level. These evolving skills
a device needs to prove its safety and efficacy. In the now can cover research, innovation, and development of
pandemic, authorities understood that they had to offer medical devices, and the pressing circumstances of the
fast-tracking processes without losing their objectives COVID pandemic just set the stage for clinical engineers
related to the emergency use authorizations. Once again, worldwide to showcase such abilities. The challenge now
CEs stepped up as the connection between the regulatory is to write down the experiences in scientific papers and
process and unexperienced ventilators developers with pass the knowledge to younger generations because the
some of the following interventions: inertia to strengthen these skills shouldn’t be subjected
only to health emergencies. There is a lot of health tech-
• Identifying international standards and normative nology yet to be discovered.
and best practices to establish a local, applicable
normative.
REFERENCES
• Developing technical specifications for local produc-
tion based on established specifications but adjusting 1. Forbes Staff. Gobierno de AMLO presenta ventiladores
as necessary for a proper response. hechos en México para atender COVID-19. Forbes.
México CDMX. Forbes Staff; 2020. Available at
• Support WHO/PAHO efforts for worldwide use guide- https://www.forbes.com.mx/politica-gobierno-
lines and other relevant technical documentation. de-amlo-presenta-ventiladores-hechos-en-mexico-
para-atender-covid-19/.

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


2. World Health Organization. Priority medical devices 2020. Available at https://www.gob.mx/cofepris/
list for the COVID-19 response and associated techni- articulos/informacion-sobre-los-lineamientos-de-
cal specifications. WHO. 2020. Available at https:// ventiladores-actualizacion-9-de-mayo?idiom=es
apps.who.int/iris/handle/10665/336745 5. Biomédicos de México. Canal de videos del Colegio
3. IFMBE-CED. IFMBE-CED courses/webinars. Author; de Ingenieros Author. CIB YouTube. México; 2020.
2020. Available at https://ced.ifmbe.org/resources/ Available at https://www.youtube.com/channel/
courses/gurupcategs.html UCyUCzX_6BeEMz26HxAZy3vg
4. Gobierno de Mexico. Información sobre los lin-
eamientos de ventiladores. COFEPRIS. México CDMX;

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


Received June 27, 2021, accepted Februry 23, 2022, date of publication March 1, 2022

Analysis and Solution of Dental Unit Failure


By J. J. Jin1, H. Liu1, K. Li2, Y. H. Chu1
1
Department of Clinical Medical Engineering, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou
310009, China
2
Equipment Department, Ningbo Chinese Medicine Hospital, Ningbo 315010, China

ABSTRACT
Objective: To discuss and analyze the common causes of dental unit failures and summarize maintenance experiences.
Methods: The failures were studied through retrospective analysis in our dental clinic from January 2019 to December 2019.
Causes for four common failures were analyzed deeply, and the corresponding improvement solution was implemented.
Results: These solutions reduced the failure rate for dental units and improved understanding of the importance of using and
maintaining the equipment correctly.
Conclusion: Analysing and improving proper maintenance can save costs for the hospital and effectively enhance the manage-
ment level of medical equipment maintenance.
Keywords – dental unit, failure, solution, maintenance.

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
With the improvement of people’s living standards units, have been introduced and installed. With preventive
and the enhancement of oral health awareness, oral maintenance and emergency repair by hospital engineers’,
health has been paid more and more attention. The dental they run stably. As we all know, dental units are generally
clinic of most domestic hospitals is often overcrowded, composed of a dental chair, delivery system, cuspidor, and
and the number of patients treated every day is much support center, dental light, etc. The schematic diagram
higher than in some foreign hospitals. The dental unit is is shown in Figure 1.
a piece of essential medical equipment in the clinic. Since
The structure of dental unit is complex and includes a
the establishment of BinJiang Hospital, 30 A-DEC dental
waterway, electrical circuits, and gas circuits. During the
units, including 4 A-DEC 500 units and 26 A-DEC 300

J Global Clinical Engineering Vol.4 Issue 3: 2022 50


the A-dec brand as an example in recent years. From the
engineers’ point of view, the corresponding improvement
measures were put forward to prevent and solve the com-
mon malfunctions for peer reference.
Fault statistics
According to the statistics, from January 2019 to Decem-
ber 2019, our hospital’s dental unit received maintenance
780 times. Specific failure conditions are shown in Table
1 below. As can be seen from the table, the failure rate of
dental units is relatively high in the waterways, electrical
circuits, air circuits, and human factors. Particular failures
include water pipe rupture, water valve failure, saliva
ejector failure, and dental syringe accessories absence.2
FIGURE 1. The schematic diagram of dental units.
METHODS
installation of the dental units, dealers generally recom-
Cause Analysis and Solution of Four Common
mend that the hospital use an independent water storage
Failures
tank with pure water or a treated centralized water supply
as oral treatment water. The hospital should use oil-free Replace worn parts and plug potential water
and dry air, in which the pressure is not less than 80 psi leaks
to drive high-speed air-powered handpieces. Considering The waterway is an essential part of the dental unit
the actual diagnosis and treatment needs in China, most and provides the water supply during oral diagnosis and
hospitals will choose a centralized water supply, and the treatment. A water leakage problem is one of the most
water quality should meet the requirements of GB 5749- common malfunctions of the dental unit.
2006. After the dental units are installed, the hospital At the initial installation stage, the manufacturer
engineer will carefully check whether the functions of the equipped each unit with a water heater to heat the internal
equipment are normal and whether the accessories are waterways. The structure of the heater was simple, the
consistent with the contract. However, many accessories appearance of the heater was made of stainless steel, it
may not be original but might be domestic accessories, was supplied by 24V power, and the material of the inlet
so the service life cannot be accurately judged. During and outlet water pipes was brittle. Therefore, it was com-
the use of the equipment, the manufacturer recommends mon to see cracks that can lead to water leakage after 2-3
preventive maintenance and regular replacement of some years of use. This phenomenon had a high failure rate.
wearing parts. The hospital will also handle it according Engineers assessed the situation and determined that
to the actual situation. To ensure the water quality of the water leakage problem was caused by unapproved
dental units, many domestic hospitals will regularly use material supplied by the manufacturer. So the engineer
sodium hypochlorite or other disinfectants to sanitize comprehensively checked all the pipes inside all the den-
waterways. However, this solution will cause certain tal chairs, recorded the pipe diameter and length details,
damage to the internal valve and pipeline of dental units purchased approved water pipes, and replaced the water
and increase the failure rate, bringing some challenges pipes at potential leakage risk one by one to prevent the
to hospital engineers.1 occurrence. After monitoring over time, all dental units
As a maintenance engineer, the author has been re- did not have a recurrence of the problem.
sponsible for oral-related equipment maintenance work
for many years and has accumulated rich experience in
maintenance. In the following, the author summarized
and analyzed the care of our hospital dental units by using

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


TABLE 1. Failure Statistical Table of Dental Units in 2019
Fault
Fault Point Fault Phenomenon Fault Cause Number of Cases Proportion %
Classification
Handpiece drips water or no Handpiece failure 18 2.31
Delivery system
water Water valve failure 38 4.87
Heater leakage water Water pipe rupture 19 2.43
Waterway Solenoid valve failure 19 2.43
Cuspidor and Spittoon or gargle cup
Circuit board failure 2 0.26
support center leakage water or no water
Communication failure 21 2.69
Cuspidor water contains air Diaphragm rupture 22 2.82
Circuit board failure 2 0.25
Chair base can’t move
Dental chair Communication failure 13 1.67
Chair back can’t move Sensor failure 1 0.13
Panel error Panel failure 22 2.82
Pipeline rupture 32 4.10
Delivery system Shelf valve loose 46 5.90
Handpieces failure
Circuit Handpiece failure 15 1.92
Circuit board failure 5 0.64
Solenoid valve failure 6 0.77
Cuspidor and
No water Circuit board failure 4 0.51
support center
Communication failure 15 1.92
Bulb failure 12 1.54
Dental light Cannot work
Switch failure 3 0.38
Handpiece lack of
5 0.64
driving gas
Delivery system Handpiece failure Improper regulation 21 2.69
Handpiece failure 12 1.54
Gas Circuit Water pipe rupture 31 3.97
Small negative pressure Saliva ejector failure 68 8.72
Cuspidor and Relay failure 5 0.64
support center No negative pressure Positioning valve
11 1.41
malfunction
Plate tilt Overuse 18 2.31
Handpiece failure Incorrect setup 5 0.64
Handpiece leakage water Incorrect installation 7 0.90
Human Causes Delivery system
Handpiece no Panel incorrect setup 5 0.64
Water Water master switch off 12 1.54
Dental syringe leakage water Accessories absence 74 9.49

J Global Clinical Engineering Vol.4 Issue 3: 2022 52


Fault
Fault Point Fault Phenomenon Fault Cause Number of Cases Proportion %
Classification
Dental chair Armrest failure External force 3 0.38
Cuspidor and
Unreasonable Flush time Incorrect setup 81 10.38
support center
Human Causes Handpieces work
Footswitch Footswitch failure 12 1.54
automatically when lift
Doctor’s chair or The assistant chair sprang up Hydraulic failure 59 7.56
assistant chair Back failure Lack of parts 36 4.61

Improve the existing structure to ensure strategy. After each disinfection, the nurse extended the
adequate disinfection and instrument integrity discharge water time to 20 minutes on the day. Before
The study showed that the water supply of the dental starting the machine, the nurse discharged water for 10
unit was seriously polluted due to multiple factors such as minutes every morning for the next 5 days to remove the
the suction effect of the treatment instruments and water residual disinfectant in the pipeline and reduce the corro-
stagnation, and regular disinfection of the water, which is sion of the disinfectant on the dental unit parts. Because
vital in controlling nosocomial infections.3 Our hospital the discharge water at all the outlet points of the existing
disinfects the water pipes of dental units every quarter. dental unit cannot be controlled with one key, and the
The Hospital Infection Management Department uses a discharge and disinfection time cannot be controlled, the
500 mg/L sodium hypochlorite solution to disinfect the medical staff need to discharge water manually, which
lines. The medical staff in the department of stomatology undoubtedly increases the workload of medical staff.
discharge water on all the effluent parts of dental units For this reason, based on existing dental units, our
one by one, and the continuous discharge time shall not engineers have added an automatic discharge water
be less than 10 minutes so that the disinfectant can flow control device.5 This design has been authorized national
out of each terminal effluent point, ensuring effective utility model patent. The specific structure is shown in
disinfection. However, the high concentration of this Figure 2 below.
chlorine-containing disinfectant can corrode the internal The specific working process is as follows: firstly, select
structure of the dental unit, mainly the valve, rubber band, the knob above of the time relay to 10min, and then press
and diaphragm. Specifically, high-speed handpieces, low-
speed handpieces, motors, and tooth cleaning machines
hung on the valve after use will automatically leak water
in varying degrees from spittoons and cup water spills.4
Looking back to 2019, this kind of failure frequently oc-
curred about 3-5 days after each pipe disinfection, and
several dental units leaked varying degrees.
Given this phenomenon, engineers searched for rel-
evant information, consulted manufacturers, analyzed,
and discussed the main reason for such failure. Specifi-
cally, the disinfectant had a particularly corrosive effect
on the copper and rubber parts inside the dental unit.
Specific damaged parts included water valve, solenoid
valve assembly, diaphragm, etc. Considering the balance
between disinfection effectiveness and the damage rate FIGURE 2. Structure drawing of automatic draw water control
of the dental unit component, we proposed a preventive device.

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


the switch, the time relay starts the timing, the exhaust (2) the lack of effective maintenance of the dental unit.
solenoid valve opens, the backup air of dental unit will Notably, medical staff only knew the use but did not
open four water valves in the water and air control module, know the regular maintenance for the suction tube.6 For
four handpieces will drain away water at the same time, this reason, the engineer actively communicated with
the solenoid valve of cup water and spittoon water will the users of the equipment and formulated a routine
open, and cup water and spittoon water will also drain maintenance items list for the dental chair according to
away water at the same time. After the timing is over, Pin the infection control guidelines recommended by the
1 and Pin 4 of the time relay will disconnect, Pin 1 and Centers for Disease Control and Prevention of the United
Pin 3 will pull, Pin 5 and Pin 8 will disconnect, and Pin 6 States and the Australian Dental Association,7 as well as
and Pin 8 will pull. The exhaust solenoid valve, cup water the manufacturer’s maintenance manual. The guidelines
solenoid valve, and spittoon water solenoid valve will stop were implemented in April 2020, and relevant records
working, The water valves in the water and air control were made. The specific contents are shown in Table 2.
module are closed, and the handpieces will not drain
Strengthen medical education to prevent the
away water. Cup water solenoid valve and spittoon water
loss of dental syringe accessories
solenoid valve are closed, cup water and spittoon water
will stop drain away water. The clinical use of the device Each dental unit in our hospital is equipped with a
can not only realize the one-button control discharge of TABLE 2. Routine Maintenance Items List of Dental Units in
water and effective disinfection at all outlet points of the Dental Clinics
dental unit, but control the time of water discharge and Maintenance
Project Content
disinfection accurately. However, this will also reduce the Frequency
workload of medical staff and improve the compliance of After use, draw clean water
Once per person
medical staff in daily waterway disinfection, which is of and rinse for 1 min
great significance to clinical diagnosis and treatment in After treatment, detergent
the department of stomatology. Suction tube Once per day
was attracted for 3 min
Do a good job of regular maintenance to reduce Clean suction tube solid
Two times per week
the occurrence of suction malfunction Attract strainer
tube Flush the pipeline for 2-3
Daily before use
Oral suction has a high utilization rate in daily oral min
Handpieces
diagnosis and treatment, and the subsequent failure Between each
Flush waterway for 20-30 sec
rate is relatively high. The suction tube absorbs a large patient
amount of dental debris and blood in the patient’s oral Spittoon and
Between each
cavity every day, and the oral pollutants are discharged mouthwash Rinse and wipe
patient
underground through a long and thin tube, which is prone cup stand
to pipe obstruction or suction failure. The negative pres-
sure pump in the center of the hospital generates suction, three-use spray gun for the doctor and a three-use spray
and the positioning valve on the dental unit controls the gun for the assistant. Engineers often receive repair calls
start and stop of the negative pressure. Then the doctor during daily use, such as leaking or unusable dental sy-
can attract the patient’s mouth through the suction tube to ringes. After careful observation of the use and malfunc-
remove the dirt in the mouth. The main fault phenomena tion of the three-use gun in the oral clinic, it was found
in the use process are suction pipe obstruction result- that most malfunctions were caused by the absence of
ing in reduced suction, pipe aging rupture resulting in accessories. Engineers analyzed such problems mainly
insufficient suction, positioning valve failure resulting in due to improper operation of medical staff and insufficient
no negative pressure. If the suction malfunctions, it will understanding of the spray gun structural components.
negatively impact the doctor. For this kind of problem, Prevention measures could be taken from two aspects:
engineers analyzed: (1) the high frequency of use, and First, strengthen the education and training of medical

J Global Clinical Engineering Vol.4 Issue 3: 2022 54


staff. The engineer communicated with the director of prevent water leakage from the heater. Figure 3 (a) shows
the department using the equipment and organized the heater failure trend, and the number of failures is re-
training on daily use and other matters of attention with duced to zero. After the dental unit pipes are disinfected,
the dental unit. This ensures that the medical staff can the failure rate of water valves are significantly reduced,
understand the structure of the dental unit, be familiar and water valves replacement costs are saved through the
with the structure of the three-use gun, master the daily installation of automatic discharge water control device
disassembly and assembly, and put the three-use gun and the implementation of relevant measures. Figure 3
into the daily inventory list. The nurse at each position (b) is the failure trend diagram of the water valve. Since
was responsible for checking the related accessories of the routine maintenance items list of the dental unit was
each tooth chair and reported if anything was missing.8 implemented in April 2020, the saliva ejector’s failure
Second, engineers should strengthen regular inspection rate has decreased significantly. Figure 3 (c) shows the
and prepare relevant accessories as needed. trend chart of the failure rate of the saliva ejector. In ad-
dition, since the management of the dental syringe was
RESULTS strengthened in May 2020, the failure rate of the dental
syringe decreased significantly. Figure 3 (d) shows the
Since the beginning of 2020, engineers have purchased
failure trend of the dental syringe.
and replaced all the internal pipes of our dental units to

3(a). Heater fault trend chart 3(b). Water valve failure trend chart

3(c). Saliva ejector fault trend chart 3(d). Dental syringe fault trend chart

FIGURE 3. Chart showing the different kinds of fault trends before and after improvement measures.

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


Although the daily maintenance will increase a certain CONCLUSIONS
amount of work and maintenance time, it can effectively Maintenance engineers not only need to deal with
reduce the downtime of dental unit failure, reduce the daily failures but also need to deeply analyze the causes
number of repairs, reduce the repair expenditure, pro- of failures and how to prevent similar failures. Medical
long the service life of the equipment, and improve the engineers and technicians should use their professional
quality of clinical diagnosis and treatment. Comparison knowledge to make appropriate innovations and feasible
of items before and after maintenance are shown in Table improvements to the existing equipment to solve the cur-
3. Among them, the average downtime was based on the rent problems.10 In the context of the current advanced
time of failure to treat patients caused by each repair, management of medical equipment, engineers should
and the average maintenance time was based on the time improve their maintenance concepts, transform their
spent to complete the maintenance project. The average experience into practical maintenance practices, and use
number of repairs was based on the number of repairs information technology and quality management methods
per dental unit in a year. The repair cost mainly includes to improve medical equipment maintenance.11
replacing the water valve, saliva ejector, and position valve.
The average repair expenditure was based on the repair
ACKNOWLEDGMENT
expenditure per dental unit in one year.
We want to extend our sincere gratitude to Dr. Yadin
TABLE 3. Comparison of Items Before and After Maintenance David for his revising this paper. We are also deeply
indebted to our other clinical engineering staff that sup-
Before After
Items ported our work.
Maintenance Maintenance
Average downtime/ min 20±5 5±2
CONFLICT OF INTEREST
Average maintenance time/ min 3±1 30±3
The authors declare that they have no conflict of interest.
Average number of repairs/time 26±1 5±1
Average repair expenditure/ ¥ 353±3 13±3
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