Consideration of the Human Factor in the Design and Development
of a New Medical Device: Example of a Device to Assist Manual
Ventilation
L. Pazart
1
, F. S. Sall
1,2
, A. De Luca
1,2
, A. Vivot-Pugin
1
, S. Pili-Floury
3
,
G. Capellier
1,4
and A. Khoury
1,2
1
Clinical Investigation Centre Inserm CIC-1431, University of Franche-Comté - Medical Centre, 25000 Besançon, France
2
Department of Emergency Medicine and Critical Care, University of Franche-Comté - Medical Centre,
25000 Besançon, France
3
Department of Anesthesia and Critical Care, University of Franche-Comté - Medical Centre, 25000 Besançon, France
4
Monash University, Melbourne, VIC 3800, Australia
Keywords: Human Factor Evaluation, Human Factor Engineering, Usability, Medical Device.
Abstract: The human factor is often critical in the performance and safety of a large number of medical devices. To
minimize risks to users and patients, health authorities have reinforced their requirements including human
factors and usability testing during the development of new technologies. Human factors engineering (HFE)
is an interdisciplinary approach to evaluating and improving use safety, efficiency, and robustness of work
systems. The new device should be tested to show its safety and effectiveness for the intended users, uses
and use environments. In order to fulfill these regulatory requirements, international standards suggest
implementing the User Centered Design process during the technology design and development lifecycle.
We would like to present here a case study of a HFE plan about an ongoing medical device development in
order to illustrate how to practically process; then we will present some more general considerations on
HFE development for medical devices.
Manual ventilation is an essential step in the resuscitation of respiratory distressed patients. It must be
carried out adequately so as not to worsen patient’s condition. This technique has its advantages but also
risks such as excessive insufflated pressures resulting in pulmonary barotrauma and gastric insufflation. In
fact, many studies have shown that manual ventilation practices are far above recommended guidelines.
Several solutions have been proposed by some manufacturers to achieve better control over manual
ventilation parameters, but none has really convinced the medical community to date. Thus we propose to
develop a new technology guided by a well adapted HFE.
We first carried out a study with the existing material to observe the practices of 140 professionals in
several clinical situations on an artificial lung, allowing to reproduce situations of respiratory deficiency and
to record the parameters. The preliminary results showed a fairly low rate of manual ventilation
performance with high ventilation rates, confirming the fragmented data of the literature on the subject.
Thus, with the help of a local company, Polycaptil, we developed a new medical device, with an algorithm
for real-time analysis on the basis of the 54,000 ventilatory cycles recorded during our study. After the
prototype reached the technical objectives and demonstrated good reliability, we organized a usability
validation test with 40 end-users. After the ventilation tests, participants were asked to complete a survey on
the ease of use of the prototype, including the ergonomics of the entire system, the human-machine interface
and its main functions.
Both usability surveys provided important guidance for the development of the final device. Finally, the
human factors validation testing should be realized during a prospective clinical trial of the first use in
humans of a device for monitoring manual ventilation.
The human factor is one of the most differentiating characteristics of the development of a medical device
compared to the development plan of a drug. Specific methodologies are being developed and adapted tools
have been set up. Based on our example, methods and purposes of HFE evaluation will be described at
every stage of the device development lifecycle in order to sensitizing designers of new technologies.
Pazart L., Sall F., De Luca A., Vivot-Pugin A., Pili-Floury S., Capellier G. and Khoury A.
Consideration of the Human Factor in the Design and Development of a New Medical Device: Example of a Device to Assist Manual Ventilation.
DOI: 10.5220/0006250102150223
In Proceedings of the 10th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2017), pages 215-223
ISBN: 978-989-758-216-5
Copyright
c
2017 by SCITEPRESS Science and Technology Publications, Lda. All rights reserved
215
1 INTRODUCTION
The human factor is often critical in the performance
and safety of a large number of medical devices.
Multiple cases were reported on side effects such as
patient harm or death due to misconception or
misuse of medical devices (Jans 2016), for example
overdoses with drug pen injectors (Schertz 2011),
radiation damages during radiotherapy (Ash 2007),
or deaths associated with implantable cardioverter
defibrillator (Hauser 2004). These observations have
led to a growing interest in the effect of the human
factor on medical device use outcome (BSI 2016,
Xuanyu 2015).
The introduction of any new method requires a
learning curve of varying length. The dexterity of
the users explains in part the variability of operator
performances observed with a new medical device.
The clinical benefit may not only depend on the
medical device itself or on the operator, but also on
the performance of the medical team, on the new
organization of the actors and on the technical
platform available. These organizational changes
and their repercussions must be considered when
introducing a new medical device into an existing
technical and human environment. The diversity of
intended users and the possible changes between
them (physician, healthcare professional, patient,
natural caregiver, etc.) requires the development of a
particularly "intuitive" use of some medical devices,
such as, for example, automated external
defibrillators which are supposed to be usable by
anyone anywhere, or almost. Studies of the human-
machine interface, human-machine interactions, and
usability have thus become essential in the
development of a number of medical devices.
Thus, to minimize risks to users and patients,
health authorities have reinforced their requirements
including human factors and usability testing. In the
US, such testing is required for manufacturers to
provide the FDA with validation of control and
prevention of use-related risks for new or modified
devices for their intended use (FDA 2016). In
Europe, "ergonomics" essential requirement for CE
marking was enhanced in the latest EU revised
Medical Device Directive (2007/47) (European
Parliament Council 2007) and emphasized in the
future 2017 European Rules on Medical Devices.
Human factors engineering (HFE) is an
interdisciplinary approach to evaluating and
improving use safety, efficiency, and robustness of
work systems. Thus, the Human Factors and
Ergonomics Society propose several definitions of
human factors and ergonomics so that the reader can
see how different groups vary in their use of the
terms (HFES 2016). Nevertheless, a valuable
definition from an industrial point of view is driven
by regulatory agencies. Human factors engineering
is defined by the FDA (FDA 2016) as: “The
application of knowledge about human behavior,
abilities, limitations, and other characteristics of
medical device users to the design of medical
devices including mechanical and software driven
user interfaces, systems, tasks, user documentation,
and user training to enhance and demonstrate safe
and effective use.” For the FDA, the Human factors
engineering and usability engineering can be
considered to be synonymous (FDA 2016). The new
device should be tested to show its safety and
effectiveness for the intended users, uses and use
environments. In order to fulfill these regulatory
requirements, international standards suggest
implementing the User Centered Design process
during the technology design and the development
lifecycle (IEC 2007). The User Centered Design
process is an iterative design and evaluation strategy
which involves end-users as well as recipient by
taking into account their needs and by including
them in design and evaluation activities (ISO 2010).
We would like to present here a case study of a
HFE plan about an ongoing medical device
development in order to illustrate how to practically
proceed; then we will present some more general
considerations on HFE development for medical
devices.
2 EXAMPLE FOR A DEVICE
2.1 Context and Issues
Respiratory distress is frequently encountered in
emergency situations. Providing enough oxygen and
removing carbon dioxide from the patient with
respiratory failure and / or in cardiac arrest is an
important emergency procedure, and in this respect,
manual ventilation is always used as a first aid by
rescuers. Manual ventilation is an essential step in
the resuscitation of anesthetized or respiratory
distressed patients. It must be carried out adequately
so as not to worsen patient’s condition. However,
the implementation of adequate manual ventilation
is difficult even when performed by experimented
health professionals (Busko 2006, Elling 1983,
Martin 1993, Wynne 1987). Although this technique
has its advantages its drawbacks are excessive
insufflated pressures resulting in pulmonary
barotrauma and gastric insufflation. In fact, many
BIODEVICES 2017 - 10th International Conference on Biomedical Electronics and Devices
216
studies (Bergrath 2012, von Goedecke 2005, Cooper
2006) have shown that manual ventilation practices
are far above recommended guidelines from the
European Resuscitation Council, or American Heart
Association, or the French Society of Anesthesia &
Critical Care. “Ventilation during Cardio Pulmonary
Resuscitation is usually overzealous. Both
emergency medical personnel and in-hospital
resuscitation teams have been shown to deliver
artificial breaths at rates far exceeding the
published recommendations” (Cooper 2006).
Professional rescuers were observed to excessively
ventilate patients during out-of-hospital Cardio
Pulmonary Resuscitation. Subsequent animal studies
demonstrated that similar excessive ventilation rates
resulted in significantly increased intrathoracic
pressures and markedly decreased coronary
perfusion pressures and survival rates. Some
investigations in animals have shown that a
significant reduction in respiratory rates from 30 to
12 cycles / min could lead to an increase in the
survival rate from 14% to 86%. Several solutions
have been proposed by some manufacturers to
achieve better control over manual ventilation
parameters, such as insufflation or leakage volumes,
but none has really convinced the medical
community to date.
2.2 Study of Practices for the
Conception of Device Design
We first carried out a study with the existing
material (Laerdal and Ambu balloons) to observe the
practices of professionals on an artificial lung,
enabling to reproduce clinical situations of
respiratory deficiency and to record the parameters
(frequency , insufflated volume, leaks) during
ventilation (Khoury 2016).
140 professionals (anesthesiologists, emergency
workers, firefighters, paramedics, nurses,
physicians,) were asked about the difficulties
encountered in manual ventilation and then
ventilated a lung simulator (ASL5000 - Ingmar
Medical
®
) by sequences of 5 minutes under different
conditions.
The preliminary results showed a fairly low rate
of manual ventilation performance with high
ventilation rates, confirming the fragmented data of
the literature on the subject. The main reason
advanced by health professionals was the lack of
feedback: "we do not know what we are doing". The
importance and the necessity of this feedback was
confirmed by a study by Bowman et al. which
showed the interest of the visualization of the
insufflated volumes by a significant improvement of
47% in ventilation performances (Bowman 2012).
The control of this manual ventilation is an
important challenge for health professionals and
clearly shows the need to develop a device to help
with the use and to control this ventilation.
The results of our study and the clinical practice
guidelines enabled us to define the expected
specifications for a new product. This product
should be a medical device inserted between the
balloon and the mask (or the endotracheal tube) in
order to provide rescuers with some feedbacks,
whether on the delivered and expired volumes, or on
the ventilation rate.
Thus, with the help of a local company,
Polycaptil, we developed a new medical device, the
VEDIAS system, with an algorithm for real-time
analysis of the manual ventilation. The 54,000
ventilatory cycles recorded during our study were
used as the basis for the development of this
algorithm.
2.3 Simulated-use Testing on Prototype
Several prototypes of assistance to manual
ventilation have been developed and evaluated on
bench-test. After the prototype reached the technical
objectives and demonstrated good reliability, we
organized a usability validation test with end-users.
40 health professionals (egalitarian stratification
on hospital origin or not) were randomly selected
from the initial 140 volunteers. The goal of this
simulated-use testing is to evaluate the performance
of the new prototype in the bench conditions
similarly to the first study. Thus, there is a study of
usability and technical validation of the pre-final
prototype.
The ventilation tests were performed with both a
ventilation mask and a tracheal tube for 5 minutes
each time. After the ventilation test, participants
were asked to fill in a survey on the ease of use of
the prototype, including the ergonomics of the
system, the human-machine interface and its
functions.
Both usability surveys provided important
guidance for the development of the final device.
Firstly, the device has been effective in regularizing
manual ventilation in accordance with the
recommendations of the learned societies (see figure
1).
The results obtained showed a very clear
improvement in the ventilation rate increasing from
15 to 90% with the use of the prototype, (in press).
The device was considered relevant in the
Consideration of the Human Factor in the Design and Development of a New Medical Device: Example of a Device to Assist Manual
Ventilation
217
management of patients with dyspnea or
cardiorespiratory arrest: 97.5% of participants found
it to be useful for the management of artificial
ventilation. The display of following items: bar
graph, ventilatory parameters and alarms appeared to
be relevant to at least 95% of the participants,
although some doctors have suggested additional
parameters that will be considered for future
development of the device.
The human-machine interface was easy to use
and intuitive, and the screen ensured sufficient
visibility for 97.5% of the participants. However,
25% of users felt that the weight and size of the
device could be detrimental to the practice and a
great effort has been made to design the final
product.
Considering the users' feedbacks, reinforced by
the very high improvement of their performances,
the prototype has evolved towards a demonstrator
that can be used for the first-in-man clinical trials.
Nevertheless, other usability studies will be
necessary, firstly during the clinical feasibility study
focusing on the handling and taking into account of
the information transmitted by the device (video
recording to be done), and secondly during the
pivotal study to integrate certain environmental
conditions of the emergency (stress, fatigue,
behavior of others, parasitic noises, meteorological
situations, luminosity etc.).
2.4 From the Concept to the Product
The next figures (figure 2, 3 and 4) show the
progress of conception from the computer-aided
design to the redesigned version after the feedback
from users in tests.
2.5 Human Factors Validation Testing
The human factors validation testing should be
realized during a prospective clinical trial of the first
use in humans of a device (the demonstrator) for
monitoring manual ventilation. This study will have
three objectives:
Evaluate and compare intra-individual
variability of vital parameters between
ventilator and manual ventilation (with or
without the device)
Evaluate the reliability and accuracy of the
ventilatory parameters measured by the device
Obtain a "reasonable assurance" of the
security of the device
This study will take place in the operating room
under stable conditions. During this phase, the
device will be connected between the respirator and
the endotracheal tube to study the reliability and
accuracy of the ventilatory parameters measured
relative to those displayed on the respirator. Then
the intubated patient will be ventilated manually
Figure 1: Comparison of ventilation cycle (orange: tidal volume, yellow: airway pressure) without (A) and with (B) our
prototype.
B- VENTILATION with PROTOTYPE
A- CLASSICAL VENTILATION
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Figure 2: First stage of conception by Computer-aided design.
Figure 3: Second stage of conception with scalable prototyping (3A: first prototype, 3B: operational prototype for end-user
tests).
Figure 4: Final stage of conception with demonstrator (4A: device alone, 4B: device in place between the mask and the
balloon).
3A
3B
4A
4B
Consideration of the Human Factor in the Design and Development of a New Medical Device: Example of a Device to Assist Manual
Ventilation
219
manually with an Ambu® Spur® II self-filling
balloon by the anesthesiologist either with the device
or without the device for minutes. During this phase,
the anesthesiologist will be blinded in relation to the
hemodynamic parameters of the patient displayed on
the multiparametric scope. Another physician will
continuously monitor the hemodynamic parameters
of the patient and will judge the need to discontinue
the study at any time. The tank of the balloon will be
connected to an air / oxygen mixer to obtain a FiO2
equivalent to that of the respirator. The
hemodynamic parameters will be recorded
continuously. The anesthesiologist will use bag-
valve either according to his habits (occurrence
without the device) or according to the indications
given by the device.
The main criterion for the efficiency of manual
ventilation will be the value of the End Tidal Carbon
Dioxide (EtCO2), which is a parameter for
monitoring the ventilation of intubated patients and
under general anesthesia, very sensitive to the
change in minute volume (current volume x
ventilatory frequency). If this value is outside the
recommended range (between 35 and 45), the
manual ventilation will be considered a failure and
the patient will be put back under the respirator
(before the end of the 10 minutes ventilation). The
secondary parameters will be oxygen saturation
(SpO2), heart rate (HR) and systolic blood pressure
(SBP).
At the "demonstrator" stage, clinical studies are
genuine "clinical trials" with specificities to be taken
into account such as reproducibility, learning curve,
human-machine interface, etc. The major risks
would be poor patient ventilation if the instructions
provided by the medical device to guide the act of
ventilation are not used correctly by the healthcare
professional. The video equipment of the used
operating rooms will allow continuous video
recording centered on the handling of the new
device.
The expected benefit is a regular and efficient
ventilation of the patient during the period of manual
ventilation thanks to the intuitive use of a new
device to guide ventilation.
This study will allow the finalization of the
technical and regulatory documentation to get the
CE marking of the product in order to be launched
on the market. Subsequently, a demonstrative
clinical trial (multicenter prospective randomized
controlled trial) will be in actual condition of use
with a view to social security coverage and
reimbursement.
3 DISCUSSION
The presented usability studies relate to the same
product at a different stage of development. Since
medical device must be used quickly, under highly
stressful conditions, and possibly by inexperienced
healthcare professionals, it was crucial to design and
develop a product that incorporated HFE, risk
analyses, and actual testing of user-device
interaction without training. They were made
necessary in relation to the very operator-dependent
characteristic of the performance of the gesture with
the existing materials, attested by literature and our
results with a sample of 140 health professionals.
Here we have the glaring example of the importance
of the human factor in the performance of the act. As
a result, several usability studies are required, as
well as a reproducibility study and a fine analysis
(by video recording) of the handling of the apparatus
and of the reactions of the professional to the
information communicated by the latter. Several
prototypes are then made using the «feedback»
systematically analyzed in each of the studies.
The human factor is one of the most
differentiating characteristics of the development of
a medical device compared to the development plan
of a drug. Specific methodologies are being
developed and adapted tools have been set up in
several centers (living lab, simulation center, rapid
prototyping platform, fab-lab etc.) whose
certification is obtained or in progress.
The Human factors validation testing is included
into a first in man clinical study with a demonstrator
to verify the functionalities of the device in stable
clinical situations. The experimental design is a
comparative intervention study on the one hand with
the "gold standard" constituted by a respirator and
on the other hand the reference device in practice for
the same final purpose (manual ventilation). At this
stage of development, the judgment parameters
analyze the technical performance of the apparatus:
technical sensitivity, accuracy, reliability,
reproducibility of the measurement, functions
claimed (in this case stability of ventilation and
provision of ventilation according to standards).
HFE validation studies, such as those performed
here, have some limitations: the tests were
simulation tests rather than real clinical practice use,
and the study design of the validation studies was
more observational rather than interventional. In
addition, safety data other than outrange frequency
rate and excessive volume were not captured.
However, the HFE validation studies were designed
to demonstrate optimal user–device interactions, and
BIODEVICES 2017 - 10th International Conference on Biomedical Electronics and Devices
220
the simulation testing conducted here is defined as
an acceptable method for assessing safe and
effective use of a new medical device according to
regulatory requirements.
It is important that HFE studies are adequately
representative of the real-world setting. This was
achieved by simulation of the anticipated use
environment, and testing the performance of users to
ventilate patients with the device.
Human behavior in the medical device context
involves interaction with it in the environment of
use: not only related to device control, but also
because of the wrong medical device being
prescribed at the wrong time for the wrong type of
patients. Tools supporting human–device interaction
can greatly improve the care that patients receive,
and increase their engagement in their care.
However, these tools also need to support the user
(e.g., patient, health-care provider, caregiver). This
is particularly important for lifesaving devices, such
as manual ventilation, that require situational
awareness, management, and interaction.
Human factors methods have been developed in
many different fields such as aeronautics for decades
and have appeared in the medical field for medical
devices mainly at the beginning of the sixties last
century, and really after year 2000.
HFE addresses multiple aspects on how the
medical device is used, for whom, by who, under
what conditions, and in what environments. The goal
of HFE is “to optimize the relationship between
humans and systems by studying human behavior,
abilities, and limitations and using this knowledge to
design systems for safe and effective human use
(Gawron 2006).
HFE includes multiple steps and follows an
iterative process during the device lifecycle (Gosbee
2002). Along with risk assessment, an essential part
of the HFE process involves assessing the
interactions between the users and the device in an
environment that mimics the real-world experience
of the user. HFE evaluation focuses on four main
purposes depending on the stage of the device
development lifecycle:
1/ Conception of the Device Design. The FDA
recommends that HFE be applied early as possible
in the design process to allow for the most efficient,
purposeful, and optimal product design possible,
ensuring safe and effective use. An important first
step includes qualitative studies on end-users needs
with interviews and observation of the real-world
tasks actually performed in the intended-use of the
new device. Sometimes called “Cognitive walk-
through” or “think aloud”, this evaluation encourage
participants to explain any difficulties or concerns
they have (FDA 2016). In parallel, risk management
plan and performing use-related risk analysis (failure
modes and effects analysis) should be started
(FMEA 2011).
2/ Optimization of the Prototypes. A formative
evaluation consists of iterative and fast simulated-
use testing of safety and performances of early
mock-ups and prototypes up to the pre-final version
of the device. Risks mitigation should be one of the
primary focus for device optimization, to eliminate
or reduce potential harm to the user (AAMI 2013).
This kind of testing involves systematic collection of
data from test participants using a device, device
component or system in realistic use scenarios but
under simulated conditions of use (FDA 2016).
Thus, HFE may affect product design (e.g.,
handling, buttons, covers, threshold and type of
alarms) to allow for optimal and safe use and
appropriate device functions.
3/ Validation of Premarket Device. A
summative HF evaluation generates the validation of
the usability of the final version of the product
before its release for clinical use. Human factors
validation testing is generally conducted under
conditions of simulated use, but when necessary,
human factors data can also be collected under
conditions of actual use or as part of a “first in man”
clinical investigation.
4/ Post Market Surveillance. This is a part of
the “clinical evaluation plan” claimed for the CE
mark, and included in the risk management plan in
US. Data could be collected within direct
observation, users' questionnaire or interview, or
review of incidents reports. The safety follow up is
performed through database like MAUDE
(Manufacturer and User Facility Device Experience)
including declaration by manufacturers, device user
facilities, health care professionals, patients or
consumers. Usability feedbacks could improve new
version of the product.
4 CONCLUSIONS AND
PERSPECTIVES
Our examples show the feasibility of HFE for
medical device development,.
The development stages of medical devices from the
idea to the market can include, from the outset,
clinical studies according to the "predictability of the
action" of the device. If this is not obvious, or does
not correspond to a known function, then a clinical
Consideration of the Human Factor in the Design and Development of a New Medical Device: Example of a Device to Assist Manual
Ventilation
221
proof-of-concept study of the benefit of this function
may be necessary.
The study of the actual need by observing
existing practices and pathophysiology studies can
contribute to the proper design of the new device by
providing the relevant technical specifications for
the product specifications. These data would
reinforce the interest of the new device in its
"preclinical" file.
Risk analysis of the product should systematically
include usability data.
A "performance analysis" should include study
of the learning curve, inter- and intra-operator
performance variability, potential misuse, and in
general the implications of the human factor, in
addition to "pure" technical performance.
ACKNOWLEDGEMENTS
The program “VEDIAS” received grants from
European funds (FEDER), BPiFrance, Regional
Council of Franche-Comté, Doubs country council,
Besançon Area.
REFERENCES
Jans A, Plogmann S, Radermacher K. 2016 Human-
centered risk management for medical devices – new
methods and tools. Biomedical Engineering /
Biomedizinische Technik. Volume 61, Issue 2, Pages
165–181, ISSN (Online) 1862-278X, ISSN (Print)
0013-5585, DOI: 10.1515/bmt-2014-0124.
Schertz JC, Saunders H, Hecker C, Lang B, Arriagada P.
2011 The redesigned follitropin alfa pen injector:
results of the patient and nurse human factors usability
testing. Expert Opin Drug Deliv. Sep;8(9):1111-20.
doi: 10.1517/17425247.2011.
608350. Epub 2011 Aug 16.
Ash D, 2007 Lessons from Epinal, Clin Oncol 19(8), 614-
5.
Hauser RG, Kallinen L. 2004 Deaths associated with
implantable cardioverter defibrillator failure and
deactivation reported in the United States Food and
Drug Administration Manufacturer and User Facility
Device Experience Database. Heart Rhythm.
Oct;1(4):399-405.
British Standards Institution (BSI), 2016 The growing role
of human factors and usability engineering for medical
devices, white paper, http://www.bsigroup.com/en-
GB/medical-devices/resources/whitepapers, last access
11 February 2016.
Xuanyue M, Pengli J, Longhao Z, Pujing Z, Ying C,
Mingming Z. 2015 An Evaluation of the Effects of
Human Factors and Ergonomics on Health Care and
Patient Safety Practices: A Systematic Review. PLoS
One.; 10(6): e0129948. doi: 10.1371/
journal.pone.0129948.
FDA 2016 - Applying Human Factors and Usability
Engineering to Medical Devices Guidance for Industry
and Food and Drug Administration Staff Document
issued on: February 3, 2016
http://www.fda.gov/downloads/MedicalDevices/Devic
eRegulationandGuidance/GuidanceDocuments/UCM2
59760.pdf.
European Parliament Council, 2007 Council Directive
2007/47/EC,
http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri
=OJ:L:2007:247:0021:0055:en:PDF, last access 11
February 2016.
Human Factors and Ergonomics Society, 2016 Definitions
of Human Factors and Ergonomics,
http://www.hfes.org/Web/EducationalResources/HFE
definitionsmain.html, last access 11 November 2016.
International Electrotechnical Commission, 2007 Medical
devices - Application of usability engineering to
medical devices (Rep N° 62366), Geneva,
International Electrotechnical Commission.
Busko JM, Blackwell TH. 2006 Impact of a pressure-
responsive flow-limiting valve on bag-valve-mask
ventilation in an airway model. Can J Emerg Med 8 :
158–163.
Elling R, Politis J. 1983 An evaluation of emergency
medical technician’s ability to use manual ventilation
devices. Ann Emerg Med; 12 : 765–768.
Martin PD, Cyna AM, Hunter WAH, Henry J, Rammaya
GP. 1993 Training nursing staff in airway
management for resuscitation. A clinical comparison
of a facemask and laryngeal mask. Anaesthesia; 48 :
133-137.
Wynne G, Marteau TM, Johnson M, Whiteley CA, Evance
TR. 1987 Inability of trained nurses to perform basic
life support. Br Med J (Clin Res Ed); 294 : 1198–
1199.
Bergrath S, Rossaint R, Biermann H, Skorning M,
BIODEVICES 2017 - 10th International Conference on Biomedical Electronics and Devices
222
Beckers SK, Rörtgen D, Brokmann JC, Flege C,
Fitzner C, Czaplik M. 2012 Comparison of manually
triggered ventilation and bag-valve-mask ventilation
during cardiopulmonary resuscitation in a manikin
model. Resuscitation; 83 : 488–493.
Von Goedecke A, Bowden K, Wenzel V, Keller C,
Gabrielli A. 2005 Effects of decreasing inspiratory
times during simulated bag-valve-mask ventilation.
Resuscitation; 64 : 321–325.
Cooper JA, Cooper JD, Cooper JM. 2006
Cardiopulmonary Resuscitation: History, Current
Practice, and Future Direction. Circulation; 114 :
2839–2849.
Khoury A, Sall FS, De Luca A, Pugin A, Pili-Floury S,
Pazart L, Capellier G. 2016 Evaluation of Bag-Valve-
Mask Ventilation in Manikin Studies: What Are the
Current Limitations? Biomed Res Int. 4521767. doi:
10.1155/2016/4521767.
Bowman TA, Paget-Brown A, Carroll J, Gurka MJ,
Kattwinkel J. 2012 Sensing and responding to
compliance changes during manual ventilation using a
lung model : can we teach healthcare providers to
improve? J Pediatr; 160 : 372-376.
Gawron VJ, Drury CG, Fairbanks RJ, Berger RC. 2006
Medical error and human factors engineering: where
are we now? Am J Med Qual. Jan-Feb;21(1):57-67.
Gosbee J. 2002 Human factors engineering and patient
safety. Quality and safety in health care., 11: 352-354.
10.1136/qhc.11.4.352.
Institute for Healthcare Improvement Failure Modes and
Effects Analysis (FMEA) tool. 2011 Available from:
http://www.ihi.org/knowledge/Pages/Tools/FailureMo
desandEffectsAnalysisTool.aspx. (Last accessed 28
May 2014)
Association for the Advancement of Medical
Instrumentation. AAMI TIR49:2013. Design of
training and instructional materials for medical devices
used in non-clinical environments. Association for the
Advancement of Medical Instrumentation; Arlington,
VA.
Consideration of the Human Factor in the Design and Development of a New Medical Device: Example of a Device to Assist Manual
Ventilation
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