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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...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2020
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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. |
format | Online Article Text |
id | pubmed-8749256 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
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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