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Usability assessment of Versius, a new robot-assisted surgical device for use in minimal access surgery

OBJECTIVES: Versius is a teleoperated surgical robotic system intended for use in minimal access surgery. This study aimed to validate the safety and effectiveness of the Versius user interface in the hands of trained users and identify and address the causes of any user errors. DESIGN: Surgical tea...

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Autores principales: Haig, Fiona, Medeiros, Ana Cristina Barbosa, Chitty, Karen, Slack, Mark
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8749256/
https://www.ncbi.nlm.nih.gov/pubmed/35047788
http://dx.doi.org/10.1136/bmjsit-2019-000028
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author Haig, Fiona
Medeiros, Ana Cristina Barbosa
Chitty, Karen
Slack, Mark
author_facet Haig, Fiona
Medeiros, Ana Cristina Barbosa
Chitty, Karen
Slack, Mark
author_sort Haig, Fiona
collection PubMed
description OBJECTIVES: Versius is a teleoperated surgical robotic system intended for use in minimal access surgery. This study aimed to validate the safety and effectiveness of the Versius user interface in the hands of trained users and identify and address the causes of any user errors. DESIGN: Surgical teams completed a commercially representative training program over 3.5 days. After training was completed, the usability-related aspects of the system were assessed. SETTING: A simulated operating room using a cadaveric model. PARTICIPANTS: Surgical teams consisting of a lead surgeon, assistant surgeon, scrub nurse and circulating nurse. MAIN OUTCOME MEASURES: Usability-related aspects of the system were assessed through the completion of critical and non-critical tasks. A critical task was defined according to the Food and Drug Administration’s definition, as a user task which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm is defined to include compromised medical care. RESULTS: In total, 17 surgical teams participated in the study and all were experienced in laparoscopic surgery. The number of robotic surgeries performed by the participants per month ranged from 0 to 100. Surgical specialties were similarly represented from obstetrics and gynecology, colorectal, urology and upper gastrointestinal. No critical task failures were observed. Of all the tasks completed, 98% were recorded as a pass or a pass with difficulty. CONCLUSIONS: These results demonstrate that in a simulated clinical setting, Versius can be safely used by both laparoscopically and robotically trained healthcare professionals. These results support the progression to assessment of Versius in preclinical studies.
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spelling pubmed-87492562022-01-18 Usability assessment of Versius, a new robot-assisted surgical device for use in minimal access surgery Haig, Fiona Medeiros, Ana Cristina Barbosa Chitty, Karen Slack, Mark BMJ Surg Interv Health Technol Original Research OBJECTIVES: Versius is a teleoperated surgical robotic system intended for use in minimal access surgery. This study aimed to validate the safety and effectiveness of the Versius user interface in the hands of trained users and identify and address the causes of any user errors. DESIGN: Surgical teams completed a commercially representative training program over 3.5 days. After training was completed, the usability-related aspects of the system were assessed. SETTING: A simulated operating room using a cadaveric model. PARTICIPANTS: Surgical teams consisting of a lead surgeon, assistant surgeon, scrub nurse and circulating nurse. MAIN OUTCOME MEASURES: Usability-related aspects of the system were assessed through the completion of critical and non-critical tasks. A critical task was defined according to the Food and Drug Administration’s definition, as a user task which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm is defined to include compromised medical care. RESULTS: In total, 17 surgical teams participated in the study and all were experienced in laparoscopic surgery. The number of robotic surgeries performed by the participants per month ranged from 0 to 100. Surgical specialties were similarly represented from obstetrics and gynecology, colorectal, urology and upper gastrointestinal. No critical task failures were observed. Of all the tasks completed, 98% were recorded as a pass or a pass with difficulty. CONCLUSIONS: These results demonstrate that in a simulated clinical setting, Versius can be safely used by both laparoscopically and robotically trained healthcare professionals. These results support the progression to assessment of Versius in preclinical studies. BMJ Publishing Group 2020-05-22 /pmc/articles/PMC8749256/ /pubmed/35047788 http://dx.doi.org/10.1136/bmjsit-2019-000028 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Haig, Fiona
Medeiros, Ana Cristina Barbosa
Chitty, Karen
Slack, Mark
Usability assessment of Versius, a new robot-assisted surgical device for use in minimal access surgery
title Usability assessment of Versius, a new robot-assisted surgical device for use in minimal access surgery
title_full Usability assessment of Versius, a new robot-assisted surgical device for use in minimal access surgery
title_fullStr Usability assessment of Versius, a new robot-assisted surgical device for use in minimal access surgery
title_full_unstemmed Usability assessment of Versius, a new robot-assisted surgical device for use in minimal access surgery
title_short Usability assessment of Versius, a new robot-assisted surgical device for use in minimal access surgery
title_sort usability assessment of versius, a new robot-assisted surgical device for use in minimal access surgery
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8749256/
https://www.ncbi.nlm.nih.gov/pubmed/35047788
http://dx.doi.org/10.1136/bmjsit-2019-000028
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