Protocol for Usability Testing and Validation of the ISO Draft International Standard 19223 for Lung Ventilators.

Dev Minotra,Steven L Dain,Catherine M Burns

doi:10.2196/resprot.7298

Dev Minotra, Steven L Dain + Show 1 more

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https://doi.org/10.2196/resprot.7298

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Journal: JMIR research protocols	Publication Date: Sep 8, 2017
Citations: 3	License type: cc-by

Affiliation: University of Waterloo

Abstract

BackgroundClinicians, 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.ObjectiveWe 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.MethodsWe 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.ResultsThe work reported here is in the proposal phase. Once the protocol is implemented, we will report the results in a follow-up paper.ConclusionsThe 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.

Highlights

In 2011, CDC convened a Working Group composed of members of several stakeholder organizations to address the limitations of the NHSN PNEU definitions and propose a new approach to surveillance for Ventilator-Associated Events (VAE) for NHSN [15]
The organizations represented in the Working Group include: the Critical Care Societies Collaborative; the American Association for Respiratory Care; the Association of Professionals in Infection Control and Epidemiology; the Council of State and Territorial Epidemiologists; the Healthcare Infection Control Practices Advisory Committee’s Surveillance Working Group; the Infectious Diseases Society of America; and the Society for Healthcare Epidemiology of America
The VAE surveillance definition algorithm developed by the Working Group and implemented in the NHSN in January 2013 is based on objective, streamlined, and potentially automatable criteria that identify a broad range of conditions and complications occurring in mechanically-ventilated adult patients [16]

Summary

Introduction

This is defined as the first calendar day in which the daily minimum PEEP or FiO2 increases above the thresholds outlined in the VAE definition algorithm ( day 1 of the required ≥ 2-day period of worsening oxygenation following a ≥ 2-day period of stability or improvement on the ventilator). A sustained increase (defined later in this protocol) in the daily minimum PEEP of ≥ 3 cmH2O following a period of stability or improvement on the ventilator is one of two criteria that can be used in meeting the VAC definition.

Results

Conclusion