Authors:
L. Pazart
1
;
F. S. Sall
1
;
A. De Luca
1
;
A. Vivot-Pugin
1
;
S. Pili-Floury
1
;
G. Capellier
2
;
1
and
A. Khoury
1
Affiliations:
1
University of Franche-Comté - Medical Centre, France
;
2
Monash University, Australia
Keyword(s):
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 ven
tilation 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.
(More)