Design and development of the BD Odon Device^TM: a human factors evaluation process

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.