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Critical Incident Reports Related to Ventilator Use: Analysis of the Japan Quality Council National Database

This study aimed to assess the factors associated with medical device incidents. METHODS: In this mixed-methods study, we used incident reporting data from the Japan Council for Quality Health Care. Of the 232 medical device–related reports that were downloaded, 34 (14.7%) were ventilator-associated...

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Autores principales: Akiyama, Naomi, Kajiwara, Shihoko, Tamaki, Takahiro, Shiroiwa, Takeru
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9788929/
https://www.ncbi.nlm.nih.gov/pubmed/36260777
http://dx.doi.org/10.1097/PTS.0000000000001077
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author Akiyama, Naomi
Kajiwara, Shihoko
Tamaki, Takahiro
Shiroiwa, Takeru
author_facet Akiyama, Naomi
Kajiwara, Shihoko
Tamaki, Takahiro
Shiroiwa, Takeru
author_sort Akiyama, Naomi
collection PubMed
description This study aimed to assess the factors associated with medical device incidents. METHODS: In this mixed-methods study, we used incident reporting data from the Japan Council for Quality Health Care. Of the 232 medical device–related reports that were downloaded, 34 (14.7%) were ventilator-associated incidents. Data related to patients, situations, and incidents were collected and coded. RESULTS: The frequencies of ventilator-associated accidents were 20 (58.8%) during the daytime and 14 (41.2%) during the night/early morning. Ventilator-associated accidents occurred more frequently in the hospital room (n = 22 [64.7%]) than in the intensive care unit (n = 4 [11.8%]). Problems with ventilators occurred in only 4 cases (11.8%); in most cases, medical professionals experienced difficulty with the use or management of ventilators (n = 30 [88.2%]), and 50% of them were due to misuse/misapplication of ventilators (n = 17 [50.0%]). Ventilator-associated accidents were caused by an entanglement of complex factors—hardware, software, environment, liveware, and liveware-liveware interaction. Communication and alarm-related errors were reported to be related, as were intuitiveness or complicated specifications of the device. CONCLUSIONS: Our study revealed that ventilator-associated accidents were caused by an entanglement of complex factors and were related to inadequate communication among caregivers and families. Moreover, alarms were overlooked owing to inattentiveness. Mistakes were generally caused by a lack of experience, insufficient training, or outright negligence. To reduce the occurrence of ventilator-associated accidents, hospital administrators should develop protocols for employment of new devices. Medical devices should be developed from the perspective of human engineering, which could be one of the systems approaches.
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spelling pubmed-97889292022-12-28 Critical Incident Reports Related to Ventilator Use: Analysis of the Japan Quality Council National Database Akiyama, Naomi Kajiwara, Shihoko Tamaki, Takahiro Shiroiwa, Takeru J Patient Saf Original Studies This study aimed to assess the factors associated with medical device incidents. METHODS: In this mixed-methods study, we used incident reporting data from the Japan Council for Quality Health Care. Of the 232 medical device–related reports that were downloaded, 34 (14.7%) were ventilator-associated incidents. Data related to patients, situations, and incidents were collected and coded. RESULTS: The frequencies of ventilator-associated accidents were 20 (58.8%) during the daytime and 14 (41.2%) during the night/early morning. Ventilator-associated accidents occurred more frequently in the hospital room (n = 22 [64.7%]) than in the intensive care unit (n = 4 [11.8%]). Problems with ventilators occurred in only 4 cases (11.8%); in most cases, medical professionals experienced difficulty with the use or management of ventilators (n = 30 [88.2%]), and 50% of them were due to misuse/misapplication of ventilators (n = 17 [50.0%]). Ventilator-associated accidents were caused by an entanglement of complex factors—hardware, software, environment, liveware, and liveware-liveware interaction. Communication and alarm-related errors were reported to be related, as were intuitiveness or complicated specifications of the device. CONCLUSIONS: Our study revealed that ventilator-associated accidents were caused by an entanglement of complex factors and were related to inadequate communication among caregivers and families. Moreover, alarms were overlooked owing to inattentiveness. Mistakes were generally caused by a lack of experience, insufficient training, or outright negligence. To reduce the occurrence of ventilator-associated accidents, hospital administrators should develop protocols for employment of new devices. Medical devices should be developed from the perspective of human engineering, which could be one of the systems approaches. Lippincott Williams & Wilkins 2023-01 2022-10-13 /pmc/articles/PMC9788929/ /pubmed/36260777 http://dx.doi.org/10.1097/PTS.0000000000001077 Text en Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND) (https://creativecommons.org/licenses/by-nc-nd/4.0/) , where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
spellingShingle Original Studies
Akiyama, Naomi
Kajiwara, Shihoko
Tamaki, Takahiro
Shiroiwa, Takeru
Critical Incident Reports Related to Ventilator Use: Analysis of the Japan Quality Council National Database
title Critical Incident Reports Related to Ventilator Use: Analysis of the Japan Quality Council National Database
title_full Critical Incident Reports Related to Ventilator Use: Analysis of the Japan Quality Council National Database
title_fullStr Critical Incident Reports Related to Ventilator Use: Analysis of the Japan Quality Council National Database
title_full_unstemmed Critical Incident Reports Related to Ventilator Use: Analysis of the Japan Quality Council National Database
title_short Critical Incident Reports Related to Ventilator Use: Analysis of the Japan Quality Council National Database
title_sort critical incident reports related to ventilator use: analysis of the japan quality council national database
topic Original Studies
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9788929/
https://www.ncbi.nlm.nih.gov/pubmed/36260777
http://dx.doi.org/10.1097/PTS.0000000000001077
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