Design and development of the BD Odon DeviceTM: a human factors evaluation process

Stephen O'brien, Amy Mouser, Jorge Odon, Cathy Winter, Timothy Draycott, Tirza Sumitro, Darius Alisantoso, Wan Leng Lim, Mario Merialdi, Ana Stankovic, Joanna Crofts

Research output: Contribution to journalArticle (Academic Journal)

3 Citations (Scopus)
268 Downloads (Pure)

Abstract

Objective
To (i) determine how intended users interact with and use the BD Odon Device in simulation, (ii) use these findings to progressively alter the design of the BD Odon Device and (iii) validate that these changes have improved the ability of practitioners to use the BD Odon Device
Design
Human Factors evaluation study
Setting
Simulation suite designed to mimic delivery room.
Population or Sample
390 simulated operative births, performed by 100 practicing clinicians.
Methods
Simulated operative vaginal births performed using the BD Odon Device and Instructions For Use were subjected to four human factors evaluations. Following each evaluation, findings were reviewed and the design of the BD Odon Device and Instructions For Use were modified.
Main Outcome Measures
Successful performance of steps required to perform an operative vaginal birth using the BD Odon Device in accordance with provided training and Instructions For Use.
Results
Using version one of the BD Odon Device, and following exposure to face-to-face training and written instructions, 25% of accouchers were able to successfully perform a simulated operative vaginal birth. In the final evaluation, following device design and training material alterations, all accouchers were able to successfully perform a simulated operative vaginal birth using version four of the BD Odon Device.
Conclusions
Human factors evaluations have enabled a multi-professional device and training materials design team to alter the design of the BD Odon Device and the Instructions for Use in an evidence-based fashion. This process has resulted in a device which has a predictable and likely safe pattern of use.
Original languageEnglish
Pages (from-to)35-43
Number of pages8
JournalBJOG: An International Journal of Obstetrics and Gynaecology
Volume124
Issue numberS4
Early online date21 Sep 2017
DOIs
Publication statusPublished - Sep 2017

Bibliographical note

Special issue: The BD Odon device – the next step forward to operative vaginal birth?

Keywords

  • Odon
  • Human Factors
  • Improvement
  • Use

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  • Projects

    Odon: Development of the BD Odon Device

    O'Brien, S., Burden, C., Winter, C., Crofts, J. F. & Draycott, T. J.

    3/08/1520/07/17

    Project: Research

    Student Theses

    Simulation in developing new instruments for operative vaginal birth

    Author: O'Brien, S., 19 Jun 2018

    Supervisor: Burden, C. (Supervisor) & Siassakos, D. (Supervisor)

    Student thesis: Doctoral ThesisDoctor of Philosophy (PhD)

    File

    Cite this

    O'brien, S., Mouser, A., Odon, J., Winter, C., Draycott, T., Sumitro, T., Alisantoso, D., Lim, W. L., Merialdi, M., Stankovic, A., & Crofts, J. (2017). Design and development of the BD Odon DeviceTM: a human factors evaluation process. BJOG: An International Journal of Obstetrics and Gynaecology, 124(S4), 35-43. https://doi.org/10.1111/1471-0528.14758