Protocol for Usability Testing and Validation of the ISO Draft International Standard 19223 for Lung Ventilators
Loading...
Date
2017-09
Authors
Minotra, Dev
Dain, Steven
Burns, Catherine M
Journal Title
Journal ISSN
Volume Title
Publisher
JMIR
Abstract
Background: Clinicians, such as respiratory therapists and physicians, are often required to set up pieces of medical equipment that use inconsistent terminology. Current lung ventilator terminology that is used by different manufacturers contributes to the risk of usage errors, and in turn the risk of ventilator-associated lung injuries and other conditions. Human factors and communication issues are often associated with ventilator-related sentinel events, and inconsistent ventilator terminology compounds these issues. This paper describes our proposed protocol, which will be implemented at the University of Waterloo, Canada when this project is externally funded.
Objective: We propose to determine whether a standardized vocabulary improves the ease of use, safety, and utility as it relates to the usability of medical devices, compared to legacy medical devices from multiple manufacturers, which use different terms.
Methods: We hypothesize that usage errors by clinicians will be lower when standardization is consistently applied by all manufacturers. The proposed study will experimentally examine the impact of standardized nomenclature on performance declines in the use of an unfamiliar ventilator product in clinically relevant scenarios. Participants will be respiratory therapy practitioners and trainees, and we propose studying approximately 60 participants.
Results: The work reported here is in the proposal phase. Once the protocol is implemented, we will report the results in a follow-up paper.
Conclusions: The proposed study will help us better understand the effects of standardization on medical device usability. The study will also help identify any terms in the International Organization for Standardization (ISO) Draft International Standard (DIS) 19223 that may be associated with recurrent errors. Amendments to the standard will be proposed if recurrent errors are identified. This report contributes a protocol that can be used to assess the effect of standardization in any given domain that involves equipment, multiple manufacturers, inconsistent vocabulary, symbology, audio tones, or patterns in interface navigation. Second, the protocol can be used to experimentally evaluate the ISO DIS 19223 for its effectiveness, as researchers around the world may wish to conduct such tests and compare results.
Description
©Dev Minotra, Steven L Dain, Catherine M Burns. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 08.09.2017. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
Keywords
usability, terminology, standardization, lung ventilators