Design, Safety and Ergonomics of Biomedical Devices

A special issue of Applied Sciences (ISSN 2076-3417). This special issue belongs to the section "Applied Biosciences and Bioengineering".

Deadline for manuscript submissions: closed (10 October 2021) | Viewed by 10733

Special Issue Editors


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Guest Editor
School of Nursing, Midwifery, and Health Practice, Victoria University of Wellington, Level 7, Clinical Services Block, Riddiford Street, Wellington, New Zealand
Interests: safe patient care; human factors in healthcare; health devices for patient self-management; usability and safety of medical devices

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Guest Editor
School of Design Innovation, Victoria University of Wellington, WG405, Te Aro Campus, 139 Vivian Street, Wellington, New Zealand
Interests: human factors in healthcare; health devices for patient self-management; user experience design; accessibility

Special Issue Information

Dear Colleagues,

Technology-driven developments of biomedical devices and software continue to generate new, alternative ways of providing healthcare diagnoses, treatments, and therapies. This growth of biomedical technology supports the development of processes to provide more complex care that can be outside the usual health settings, and provides patients options to provide new and complex self-management. While this should theoretically improve health outcomes, these benefits are not always realized, as the realities of the factors affecting the efficacy, usability, and unintended harm are unanticipated. The application of design and ergonomics methodologies can be used to create safe biomedical devices.

This Special Issue focusses on how design and ergonomics are combined with the disciplines of the safety sciences to develop new, effective, and safe health technologies. These can include, but are not limited to, the following:

  • Usability of biomedical devices
  • Human-factor approach to biomedical device and design
  • Methodologies to create safe biomedical devices and technologies
  • Creating technologies for patient-centered care
  • Ergonomics, technologies, and safe patient care
  • The impact of design and ergonomics on effective and safe health outcomes

Dr. Brian Robinson
Dr. Gillian McCarthy
Guest Editors

Manuscript Submission Information

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Keywords

  • ergonomics
  • design
  • human factors
  • interface
  • medical device design
  • product development
  • risk management
  • usability engineering
  • user

Published Papers (3 papers)

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Research

16 pages, 1744 KiB  
Article
Deleterious Effect of Participant Positioning on the Acceptability and Acceptance of a Wellness Management System under Development
by Fabien Lemoine, Kévin Nadarajah, Guy Carrault, Anaïs Guguen-Allain and Alain Somat
Appl. Sci. 2021, 11(23), 11250; https://0-doi-org.brum.beds.ac.uk/10.3390/app112311250 - 26 Nov 2021
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Abstract
Managing everyday wellness using sensors requires user buy-in and acceptance. The Unified Theory of Acceptance and Use of Technology (UTAUT) was used to measure at D-0 the acceptability (a priori), and at D-21 the acceptance of an ambulatory monitoring system under development, the [...] Read more.
Managing everyday wellness using sensors requires user buy-in and acceptance. The Unified Theory of Acceptance and Use of Technology (UTAUT) was used to measure at D-0 the acceptability (a priori), and at D-21 the acceptance of an ambulatory monitoring system under development, the SHERPAM system. Interviews with the participants revealed that they no longer viewed the system in the same way at the different stages of the study. The results of the qualitative analysis suggest that the time of the research led the participants to stop seeing themselves as potential future users and to take on the role of critical testers of the technology (which corresponds more to a user test). This role change led participants to question the usefulness of the technology, which affected their intention to use the technology in the future (5.30 vs. 4.24; t = 2.58 *). This research identified the reasons why it was crucial to have a fully functional device in the second phase (acceptance study). The results of this study suggest that it is inappropriate to undertake an acceptability study when the technology is under development. While the SHERPAM platform has been the subject of several user tests, none have been carried out in a situation of use. Thus, this study seems to suggest that the dysfunctions observed are more related to the absence of a development phase in the daily activity of the users. Thus, to ensure a good appropriation of the technology and to predict its use, the technology must not only be in perfect working order, but must also have been developed according to the daily activities of the individuals. Full article
(This article belongs to the Special Issue Design, Safety and Ergonomics of Biomedical Devices)
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16 pages, 7606 KiB  
Article
Biomechanical Evaluation of Cortical Bone Trajectory Fixation with Traditional Pedicle Screw in the Lumbar Spine: A Finite Element Study
by Kuo-Chih Su, Kun-Hui Chen, Chien-Chou Pan and Cheng-Hung Lee
Appl. Sci. 2021, 11(22), 10583; https://0-doi-org.brum.beds.ac.uk/10.3390/app112210583 - 10 Nov 2021
Cited by 7 | Viewed by 3969
Abstract
Cortical bone trajectory (CBT) is increasingly used in spinal surgery. Although there are many biomechanical studies, the biomechanical effect of CBT in combination with traditional pedicle screws is not detailed. Therefore, the purpose of this study was to investigate the effects of the [...] Read more.
Cortical bone trajectory (CBT) is increasingly used in spinal surgery. Although there are many biomechanical studies, the biomechanical effect of CBT in combination with traditional pedicle screws is not detailed. Therefore, the purpose of this study was to investigate the effects of the traditional pedicle screw and CBT screw implantation on the lumbar spine using finite element methods. Based on the combination of the traditional pedicle screw and the CBT system implanted into the lumbar spine, four finite element spinal lumbar models were established. The models were given four different load conditions (flexion, extension, lateral bending, and axial rotation), and the deformation and stress distribution on the finite element model were observed. The results show that there was no significant difference in the structural stability of the lumbar spine model between the traditional pedicle screw system and the CBT system. In addition, CBT may reduce stress on the endplate. Different movements performed by the model may have significant biomechanical effects on the spine and screw system. Clinical spinal surgeons may also consider using the CBT system in revision spinal surgery, which may contribute to smaller wounds. Full article
(This article belongs to the Special Issue Design, Safety and Ergonomics of Biomedical Devices)
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11 pages, 3037 KiB  
Article
Investigating the Vacuum Extractors of Biomedical Devices of Different Materials and Pressures on the Fetal Head during Delivery
by Yu-Hsuan Chen, Kuo-Min Su, Ming-Tzu Tsai, Chi-Kang Lin, Cheng-Chang Chang and Kuo-Chih Su
Appl. Sci. 2021, 11(17), 8237; https://0-doi-org.brum.beds.ac.uk/10.3390/app11178237 - 05 Sep 2021
Cited by 1 | Viewed by 4868
Abstract
Operative delivery requires the use of a vacuum extractor; obstetricians can choose the appropriate vacuum extractor to make the delivery process smoother and safer. However, there is no biomechanical literature focused on the imposed effects of a vacuum extractor prepared with different materials [...] Read more.
Operative delivery requires the use of a vacuum extractor; obstetricians can choose the appropriate vacuum extractor to make the delivery process smoother and safer. However, there is no biomechanical literature focused on the imposed effects of a vacuum extractor prepared with different materials and vacuum pressure on the fetal head during the process of delivery. Therefore, we first established and performed the finite element analytical model to explore the influences of vacuum extractors manufactured from different materials on the fetal head under various extractive pressures. The model of the vacuum extractor was designed as a hemispherical shape, and the material of the vacuum extractor was composed of silicone rubber and stainless steel for comparison. Four different vacuum pressures (500 cm H2O, 600 cm H2O, 700 cm H2O, and 800 cm H2O) were applied as the factors for investigation. The reaction force on the fetal head, von Mises stress of vacuum extractor, and von Mises stress on the skull of fetal head were measured and analyzed to evaluate the effects. The results revealed that subtle divergent influences of different vacuum pressures were observed, and the stainless-steel vacuum extractor induced a larger reaction force (358.04–361.37 N), accompanied with stress (13.547–13.675 MPa), on the fetal head than non-metallic or relatively softer materials. The results provide a reliable basis for selecting proper vacuum extractor during operative delivery to avoid obstetrical complications, such as scalp scratch, cephalohematoma and even intracerebral hemorrhage. Full article
(This article belongs to the Special Issue Design, Safety and Ergonomics of Biomedical Devices)
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