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

, F. S. Sall

1,2

, A. De Luca

1,2

, A. Vivot-Pugin

, S. Pili-Floury

G. Capellier

1,4

and A. Khoury

1,2

Clinical Investigation Centre Inserm CIC-1431, University of Franche-Comté - Medical Centre, 25000 Besançon, France

Department of Emergency Medicine and Critical Care, University of Franche-Comté - Medical Centre,

25000 Besançon, France

Department of Anesthesia and Critical Care, University of Franche-Comté - Medical Centre, 25000 Besançon, France

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

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

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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).

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

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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.

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