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Volume 32 Supplement 1 January 2021
Human Factors and ergonomics
in healthcare
Guest Editors: Pascale Carayon, Sue Hignett, Sara Albolino
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This supplement was funded by ISQua
International Journal for Quality
in Health Care
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International Journal for
Quality in Health Care
Volume 33 Supplement 1 January 2021
Frontiers of Improvement
1 Human factors and ergonomics systems approach to the COVID-19 healthcare crisis
Pascale Carayon and Shawna Perry
Research Article
4 Human factors/ergonomics to support the design and testing of rapidly manufactured ventilators in the
UK during the COVID-19 pandemic
Sue Hignett, Janette Edmonds, Tracey Herlihey, Laura Pickup, Richard Bye, Emma Crumpton, Mark Sujan,
Fran Ives, Daniel P. Jenkins, Miranda Newbery, David Embrey, Paul Bowie, Chris Ramsden, Noorzaman Rashid,
Downloaded from https://academic.oup.com/intqhc/issue/33/Supplement_1 by guest on 09 October 2021
Alastair Williamson, Anne-Marie Bougeard and Peter Macnaughton
Editorials
11 HFE at the frontiers of COVID-19. Human factors/ergonomics to support the communication for safer
care in Italy during the COVID-19 pandemic
Sara Albolino, Giulia Dagliana, Michela Tanzini, Elena Beleffi, Francesco Ranzani and Elisabetta Flore
13 Frontiers in human factors: embedding specialists in multi-disciplinary efforts to improve healthcare
Ken Catchpole, Paul Bowie, Sarah Fouquet, Joy Rivera and Sue Hignett
Research Article
19 Reengineer healthcare: a human factors and ergonomics framework to improve the socio-technical
system
Raquel Santos
Frontiers of Improvement
25 Is the ‘never event’ concept a useful safety management strategy in complex primary healthcare systems?
Paul Bowie, Diane Baylis, Julie Price, Pallavi Bradshaw, Duncan Mcnab, Jean Ker, Andrew Carson-stevens and
Alastair Ross
Perspectives on Quality
31 Human factors engineering for medical devices: European regulation and current issues
Sylvia Pelayo, Romaric Marcilly and Tommaso Bellandi
Research article
37 Innovating health care: key characteristics of human-centered design
Marijke Melles, Armagan Albayrak and Richard Goossens
Frontiers of Improvement
45 Frontiers in human factors: integrating human factors and ergonomics to improve safety and quality in
Latin American healthcare systems
Carlos Aceves-González, Yordán Rodríguez, Carlos Manuel Escobar-Galindo, Elizabeth Pérez,
Beatriz Gutiérrez-Moreno, Sue Hignett and Alexandra Rosewall Lang
Original Research Article
51 Will the COVID-19 pandemic transform infection prevention and control in surgery? Seeking leverage
points for organizational learning
Giulio Toccafondi, Francesco Di Marzo, Massimo Sartelli, Mark Sujan, Molly Smyth, Paul Bowie, Martina Cardi
and Maurizio Cardi
Perspectives on Quality
56 Human factors: the pharmaceutical supply chain as a complex sociotechnical system
Brian Edwards, Charles A Gloor, Franck Toussaint, Chaofeng Guan and Dominic Furniss
Review Article
60 Human factors/ergonomics work system analysis of patient work: state of the science and future
directions
Nicole E. Werner, Siddarth Ponnala, Nadia Doutcheva and Richard J. Holden
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Abstracts in Spanish, Portuguese, Simplified Chinese, Traditional Chinese, and Japanese (online only)
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International Journal for Quality in Health Care, 2021, 33(S1), 1–3
doi:10.1093/intqhc/mzaa109
Advance Access Publication Date: 30 September 2020
Frontiers of Improvement
Frontiers of Improvement
Human factors and ergonomics systems
approach to the COVID-19 healthcare crisis
PASCALE CARAYON1 and SHAWNA PERRY2
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1
Leon and Elizabeth Janssen Professor in the College of Engineering, Department of Industrial & Systems
Engineering, Director of the Wisconsin Institute for Healthcare Systems Engineering; University of
Wisconsin-Madison, 1550 Engineering Drive, Madison, WI 53705, USA, and 2 Associate Professor, Emergency
Medicine, University of Florida Honorary Researcher, Center for Quality and Productivity Improvement (CPQI),
College of Engineering, University of Wisconsin-Madison College of Medicine-Jacksonville, 655 8th St W,
Jacksonville, FL 32209, USA
Address reprint requests to: Pascale Carayon, PhD, Leon and Elizabeth Janssen Professor in the College of Engineering,
Department of Industrial & Systems Engineering, Director of the Wisconsin Institute for Healthcare Systems Engineering,
University of Wisconsin-Madison, 3126 Engineering Centers Building, 1550 Engineering Drive, Madison, WI, 53706, USA.
Tel:+1-608-265-0503; E-mail:pcarayon@wisc.edu
Received 2 July 2020; Editorial Decision 24 August 2020; Revised 20 August 2020; Accepted 1 September 2020
Abstract
A human factors and ergonomics (HFE) systems approach offers a model for adjusting work sys-
tems and care processes in response to a healthcare crisis such as COVID-19. Using the Systems
Engineering Initiative for Patient Safety (SEIPS) model of work system and patient safety, we
describe various work system barriers and facilitators experienced by healthcare workers during
the COVID-19 crisis. We propose a set of five principles based on this HFE systems approach related
to novel pandemic: (i) deferring to local expertise, (ii) facilitating adaptive behaviors, (iii) enhanc-
ing interactions between system elements and levels along the patient journey, (iv) re-purposing
existing processes and (v) encouraging dynamic continuous learning.
Key words: human factors, ergonomics, workforce and workload, systems approach, resilience, patient safety, COVID-19
Introduction manner. In this paper, we use an HFE systems approach, i.e. the Sys-
The COVID-19 pandemic is challenging healthcare organizations and tems Engineering Initiative for Patient Safety (SEIPS) model [2, 3],
their workers around the world. Healthcare workers, in particular to describe some of the work system barriers and facilitators expe-
those on the frontline, have experienced dramatic changes in their rienced by healthcare workers and to suggest a range of HFE-based
daily routine work as a result of the novel SARS-CoV-2 virus and principles for moving forward with healthcare system improvement.
its evolving presentations and associated risk. This has been com-
pounded by a lack of (or limited) physical, technical, organizational
Work system barriers and facilitators in COVID-19
and psychological resources to respond to unexpected disruptions
precipitated with COVID-19, the disease, and the associated global
healthcare context
pandemic. The remarkable degree of variance in work ‘pre-COVID- The SEIPS model of work system and patient safety [2, 3] has been
19’ and ‘post-COVID-19’ has had a negative impact upon healthcare demonstrated to be useful within healthcare as a frame for identify-
workers, especially regarding their ability to provide high-quality safe ing the variety of work system barriers and facilitators experienced
care and their mental and physical health while attempting to cope by healthcare workers, such as tele-intensive care unit nurses [4]
with a continually changing clinical landscape [1]. The human fac- and healthcare professionals involved in pediatric trauma care [5].
tors and ergonomics (HFE) discipline can provide approaches and Barriers and facilitators can be found in any of the elements of the
methods for analyzing and addressing these challenges in a systematic work system and either hinder or support the ability of workers to
© The Author(s) 2020. Published by Oxford University Press on behalf of International Society for Quality in Health Care. All rights reserved.
For permissions, please e-mail: journals.permissions@oup.com 12 Carayon and Perry
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Figure 1 Work system barriers and facilitators in COVID-19.
do their job. Based on data from the emerging literature, workplace hospitalized COVID-19 patients by moving infusion pumps outside
stories, social media and personal experiences, we identified a range of the room for easier access. Adaptive behaviors such as this are
of work system barriers and facilitators within the COVID-19 health- positive local work-arounds aimed at supporting high-quality safe
care context (see Figure 1). In Figure 1, the work system barriers care during previously unheard-of system pressures. Understanding
and facilitators are associated with each of the ‘five work system ele- and learning from these types of work-arounds is critical as they are
ments’: the ‘people’ (at the center of the work system), ‘tasks,’ ‘tools often potential solutions to complex problems [7].
and technology,’ ‘physical environment’ and ‘organizational context.’
Some of these factors are clearly identified as barriers, such as infor- HFE systems approach to COVID-19
mation overload and underload, and breakdowns of existing technol-
ogy. Other factors could be either a barrier or a facilitator depending We suggest that an HFE systems approach to COVID-19 (and future
on their characteristics, stance with regard to context (Decision X has pandemics and health crises) should be based on five principles:
administrative benefit but increases clinical workload), and methods (i) deferring to local expertise, (ii) facilitating adaptive behaviors,
of implementation, such as leadership/management communication (iii) enhancing interactions between system elements and levels
and support. It is also important to emphasize that these work sys- along the patient journey, (iv) re-purposing existing processes and
tem barriers and facilitators are interconnected. For instance, ease (v) encouraging dynamic continuous learning.
of visualization of COVID-19 patients and their monitors through
Local expertise
windows or clear doors could reduce the number of times nurses
As with all work systems, healthcare work has barriers and facilita-
enter a patient room, with added benefit of reducing viral spread and
tors. Unique work system barriers and facilitators will emerge as all
utilization of scarce PPE (personal protective equipment) materials.
systems are dynamic. In the context of the COVID-19 pandemic, the
This simple example demonstrates the interdependencies of ‘people’
crisis has further exacerbated this feature (see Figure 1 for examples
(clinical workers/patients), ‘environment’ (glass doors/windows) and
of work system barriers and facilitators). These barriers and facilita-
‘technology/tools’ (monitors, PPE materials) within a work system.
tors often manifest as the outcome of organizational decisions from
The SEIPS model provides a frame from which to begin to elucidate
within healthcare organizations and various components of their
‘hard to see’ features of health care, a very complex system, under
external environments, e.g. leaders and supervisors of healthcare
inordinate and unexpected pressure during the COVID-19 pandemic.
organizations, designers of equipment and technology and regula-
It is important to recognize that the healthcare work system has
tory agencies. It is critical to understand the linkages between these
become more dynamic than it was ‘pre-COVID-19,’ as knowledge
decisions and the work system barriers and facilitators experienced
about the nature of the virus, methods for its diagnosis and treat-
within local contexts of healthcare workers. This can help to ensure
ment constantly evolve. This has resulted in barriers and facilitators
that frontline workers have adequate control and resources to react to
for work constantly changing and evolving at a rapid pace that has
changing circumstances. This calls for ‘deference to local expertise,’
surprisingly been day-to-day (e.g. surges in infection rates, limited
and requires dialogue with those on the frontline of clinical work [8].
hospital capacity for admissions, supply and demand for testing
and PPE materials). Healthcare workers have exhibited an amazing
ability to adapt and learn from the ever changing conditions and Adaptive behaviors
constraints within their work system, in line with the concept of Figuring out how to design, implement, evaluate and redesign care
‘resilience engineering’ and the ‘Safety II model’ [6]. For example, processes under novel disruptions to a work system is critical for
when faced with growing shortages of PPE, healthcare workers have rapidly evolving contexts. The COVID-19 crisis is characterized
devised methods for reducing the number of entries into rooms of by multiple, rapid changes in processes, procedures, criteria forHFE systems approach to COVID-19 • Frontiers of Improvement 3
diagnosis and recommendations for treatment. The rapid design– systems to the COVID-19 pandemic must occur in real-time and not
implementation–redesign process required needs to consider the once it has passed. As the global system of healthcare struggles to
actual ‘real-time’ work of healthcare workers facing the crisis day adjust to its ‘new normal’ related to the SARS-CoV-2 virus, healthcare
to day. Successful, sustainable changes in care processes cannot be organizations must establish multidisciplinary committees charged to
based on what we ‘think’ they are doing, but what they ‘are’ actually design greater adaptive capacity for their work systems [10]. The
doing [9]. Adaptive behaviors of healthcare workers are very useful overarching goal for this redesign should be resilient health care that
sources of information about the creative ways they go about meeting can quickly respond to perturbations and disruptions to clinical work
the goals for their work. We need to support sharing such behaviors [6]. Specific emphasis should be given to understanding the extempo-
and learning from them. raneous adaptive responses currently occurring within their systems
during the COVID-19 pandemic. This is valuable for informing the
Enhancing system interactions development of new adaptive processes and recommendations for the
In addition to ensuring that individual system elements are well- future. An HFE systems approach such as the SEIPS model and the
designed, we must pay attention to how the various elements fit inclusion of experts in HFE and safety sciences will also be required.
together; ‘this is the essence of the HFE systems approach.’ As
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described above, working through COVID-19 has spotlighted the
Funding
interdependency of multiple elements of the work system: PPE, ven-
tilators, monitoring equipment, staffing, work environment, etc. The papers were funded by ISQua. This publication was partially supported
by the Clinical and Translational Science Award (CTSA) program, through the
(see Figure 1). Acknowledging system interactions should be a
NIH National Center for Advancing Translational Sciences (NCATS), grant
priority, with an emphasis on enhancing work between connected
UL1TR002373. The content is solely the responsibility of the authors and does
work systems. This is even more important as we cope with COVID-
not necessarily represent the official views of the NIH.
19 and its impact on the clinical work for other types of patients.
For instance, how do we support the safe journey of patients from
an emergency department to an intensive care unit; or from the hos- References
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doi:10.1093/intqhc/mzaa089
Advance Access Publication Date: 11 August 2020
Research Article
Research Article
Human factors/ergonomics to support the
design and testing of rapidly manufactured
ventilators in the UK during the COVID-19
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pandemic
SUE HIGNETT1,* , JANETTE EDMONDS2 , TRACEY HERLIHEY3 ,
LAURA PICKUP3 , RICHARD BYE4 , EMMA CRUMPTON5 , MARK SUJAN6 ,
FRAN IVES7 , DANIEL P. JENKINS8 , MIRANDA NEWBERY9 ,
DAVID EMBREY10 , PAUL BOWIE11 , CHRIS RAMSDEN12 ,
NOORZAMAN RASHID13 , ALASTAIR WILLIAMSON14 ,
ANNE-MARIE BOUGEARD15 and PETER MACNAUGHTON16
1
School of Design & Creative Arts, Loughborough University, Loughborough, LE11 3TU, UK, 2 The Keil Centre Ltd.,
Edinburgh, EH3 8HQ, UK, 3 Healthcare Safety Investigation Branch, Farnborough, GU14 0LX, UK, 4 Network Rail,
London, NW1 2DN, UK, 5 Systems-Concepts Ltd., London, WC1X 8DP, UK, 6 Human Factors Everywhere Ltd, Woking,
GU21 2TJ, UK, 7 West Midlands Academic Health Science Network, Birmingham, B15 2TH, UK, 8 DCA Design
International, Warwick, CV34 4AB, UK, 9 Inspired Usability Ltd., Knaresborough, HG5 8HT, UK, 10 Human Reliability
Associates, Wigan, WN8 7RP, UK, 11 NHS Education for Scotland, Glasgow, G3 8BW, UK, 12 The Chartered Society of
Designers, London, SE1 3GA, UK, 13 Chartered Institute of Ergonomics & Human Factors, Stratford-upon-Avon, B95
6HJ, UK, 14 University Hospitals Birmingham NHS Foundation Trust, Birmingham, B15 2TH, UK, 15 University Hospitals
Plymouth NHS Trust, Plymouth, PL6 8DH, UK, and 16 Faculty of Intensive Care Medicine, London, WC1R 4SG, UK,
*Address reprint requests to: Professor Sue Hignett, Professor of Healthcare Ergonomics & Patient Safety, School of Design
& Creative Arts, Loughborough University, Loughborough, Leicestershire LE11 3TU, UK, E-mail: S.M.Hignett@lboro.ac.uk
Received 19 May 2020; Editorial Decision 19 July 2020; Revised 16 July 2020; Accepted 19 July 2020
Abstract
Background: This paper describes a rapid response project from the Chartered Institute of
Ergonomics & Human Factors (CIEHF) to support the design, development, usability testing and
operation of new ventilators as part of the UK response during the COVID-19 pandemic.
Method: A five-step approach was taken to (1) assess the COVID-19 situation and decide to for-
mulate a response; (2) mobilise and coordinate Human Factors/Ergonomics (HFE) specialists; (3)
ideate, with HFE specialists collaborating to identify, analyse the issues and opportunities, and
develop strategies, plans and processes; (4) generate outputs and solutions; and (5) respond to the
COVID-19 situation via targeted support and guidance.
Results: The response for the rapidly manufactured ventilator systems (RMVS) has been used to
influence both strategy and practice to address concerns about changing safety standards and the
detailed design procedure with RMVS manufacturers.
Conclusion: The documents are part of a wider collection of HFE advice which is available on the
CIEHF COVID-19 website (https://covid19.ergonomics.org.uk/).
Key words: ergonomics, mechanical ventilators, standards, safety, design, usability
© The Author(s) 2020. Published by Oxford University Press on behalf of International Society for Quality in Health Care. 4
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted
reuse, distribution, and reproduction in any medium, provided the original work is properly cited.Design and testing of rapidly manufactured ventilators • Research Article 5
Introduction 3. IDEATE: HFE specialists collaborate to identify, analyse
issues and opportunities and develop strategies, plans and
The COVID-19 pandemic has led to a massive demand for Inten-
processes.
sive Care Unit (ICU) facilities, with healthcare providers working
4. GENERATE OUTPUTS AND SOLUTIONS: outputs and
to increase the surge capacity of hospitals. To respond to the antic-
solutions were produced.
ipated demand, the UK Government called for UK manufacturers
5. RESPOND: response includes targeted support and guid-
to increase the number of available ventilators through a process of
ance.
rapid manufacturing [1]. There were specific challenges, including
manufacturers with little experience of healthcare or ventilators, a
trade-off between regulatory control, international standards, rapid
manufacturing and design for users with less experience of using Principles of HFE in ventilator design and
ventilators. operation
In the UK, National Health Service design has been accepted as an The first rapid project provided guidance on basic HFE principles
important component in patient safety since the 2000s [2]. Interna- (Figure 2). The aim was to support RMVS manufacturers with a
tionally, a Usability and Human Factors/Ergonomics (HFE) standard structured, yet simple, process for the design of the user interface
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for medical device development was established in 2007 [3] and was and instructions for use, and with the development of training based
adopted in the UK in 2017 to address the ‘errors in use leading to on consideration of users and use environment, the tasks and the
patient harm … Such errors may be due to poor device design, par- associated risks [6]. Each principle was explained clearly using plain
ticularly where a complex user interface is involved. Medical devices, language and key learning points. This was followed with a more
such as infusion pumps, ventilators, … are recognised as poten- detailed protocol for usability testing, including patient profiles and
tially having use-related design issues that can result in problems’ clinical test scenarios [7].
[4]. To support the call for Rapidly Manufactured Ventilator Sys-
tems (RMVS; [5]), the Chartered Institute of Ergonomics & Human
Factors (CIEHF) produced guidance to help and support manufac- User interface
turers through the requirement for formative usability testing. It was
It was recommended that, where possible, the new ventilator designs
‘accepted that full demonstration of compliance to ISO 80601-2-
should be aligned to existing designs to support existing operational
12:2020 is unrealistic in the time frame required for development’
mental models, allow rapid learning and reduce use errors.
and that when ‘the current emergency has passed these devices will
The user interface should be intuitive with buttons/controls
NOT be usable for routine care unless they have been CE marked
spaced to minimise accidental operation. There should be informa-
through the Medical Device Regulations’ [5].
tive feedback to users, which is informed by a risk analysis to identify
This paper describes the response process by the CIEHF
any required warnings or alarms for critical steps and/or unsafe sit-
to develop rapid advisory guidance documents, which was cir-
uations. Alarm design should consider the environment(s) of use
culated by the UK Government to all RMVS manufacturers.
and be audible in a noisy critical care environment, the potential
Figure 1 provides a representation of how the CIEHF responded
for alarm fatigue due to multiple alarm systems, as well as light-
to COVID-10 for the design of ventilators and other projects
ing at different times of day/night [8]. Generally, if a situation does
(https://covid19.ergonomics.org.uk/).
not require a user action, an alarm should not be used but should
1. ASSESS: assess the COVID-19 situation and decide to for- instead just display information indicator (feedback). Generic heuris-
mulate a response. tics for interface design quality included consistency of the layout
2. MOBILISE AND COORDINATE: mobilise and coordinate (e.g. colour-coding), transparency about device status and reducing
HFE specialists. the number of items a user needs to remember.
Figure 1 CIEHF response: assess, mobilise and co-ordinate, ideate, generate outputs and solutions, respond.6 Hignett et al.
The physical design recommendations included ensuring that
physical connectors were easily recognisable and worked across set-
tings. To design for relocating the ventilator, the weight should
be considered, with easy repositioning/adjustments to avoid muscu-
loskeletal health risks to staff (including the adjustment of screens
and displays). Retractable cables could reduce trip hazards in the bed
space and for storage.
To reflect the different use during the COVID-19 pandemic, it was
recommended that manufacturers design interfaces for users wear-
ing personal protective equipment (PPE). This includes eye cover
(safety glasses, safety goggles), face cover (surgical mask, face visor),
body cover including surgical gowns (with and without sleeves),
plastic aprons, one-piece disposable protection suit (and possibly
a full gas-tight protection suit) and hand cover with two layers
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of gloves sticky taped onto the sleeves of gowns in between the
layers.
Tasks
A range of operational tasks were considered, including fre-
quently occurring and safety critical tasks, exceptional or emergency
responses, tasks where novice users may make mistakes or where
errors are known to be common, and maintenance/inspection and
moving tasks. The task [9] requires a thorough understanding of the
work, so when developing the Usability Testing Protocol, existing
procedures and documentation from three different models of ven-
tilators were used to generate hierarchical task analyses which were
used by the clinicians to develop the task scenario (Table 1).
Errors were identified from previous research [10] to use both
as prompts during the task scenario walk/talk through and to
develop the evaluation proforma (Table 2). Key error types identified
included:
• Failure to set up correctly: including ability to use, despite
failure to pass self-test; ability of novice to set up ven-
tilator circuit according to on-screen instructions; inter-
changeability of circuit with other types of ventilator cir-
cuitry that look similar.
• Failure to find a setting site or display site: difficulty with indi-
rect adjustment of a requested setting; difficulty manipulating
multiple controls of different types; difficulty making basic
adjustments; confusion and error for the new or occasional
user when adjusting for advanced parameters.
• Setting site identified correctly but inappropriate setting:
illogical default settings, not necessarily immediately obvious
to user; errors in adjusting the inspiratory trigger; unclear
indication on the controls of the trigger sensitivity where
changing one parameter leads to change in other parameters
which is not immediately recognised.
• Failure to confirm settings: poor tactile and visual interface
design/feedback.
• Errors of interpretation: difficulty in reading/interpreting dis-
play linked to information design and mode presentation
(thresholds, configuration, default values, etc.).
• Errors of cleaning: risks associated with poor cleaning or
failure to replace contaminated parts, missing parts during
Figure 2 CIEHF guidance infographic. reassembly.Design and testing of rapidly manufactured ventilators • Research Article 7
Table 1 Task scenario for usability testing
Tasks Participants (N = Nurse, Detailed sub-tasks Equipment/keys/knobs/dials/
D = Doctor) screen, etc.
Ventilator set up and check prior to receiving patient
Assemble circuit N1 + D1 Check for integrity of Ventilator; test equipment
valves/diaphragms, etc. (e.g. test lung, flow sen-
sor calibration equipment);
power supply
Install circuit onto ventilator Connect to test simulator (test
lung) and perform self-test
Set up ventilator to patient- Choose mandatory mode, set
specific parameters inspiratory pressure or tidal
volume (IBW based) accord-
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ing to mode. Respiratory
rate, I:E ratio (if adjustable)
FiO2 and PEEP
Check alarms (disconnect, Disconnect, high pressure,
high pressure, apnoea, vol- apnoea, volume alarms, O2
ume alarms, O2 supply and supply and battery level.
battery level). Change alarm Change alarm parameters.
parameters
Perform leak test and test
patency of circuit with all
parts attached (incl. filters)
Check integrity and func-
tion of flow sensors Oxygen
calibration
Initiation of mechanical ventilation and adjust to initial parameters
Intubation of patient, attach N1 + D1 + D2 + runner Complex process, separate Airway trolley; ventilator;
to ventilator, initiating and evaluation, outside of scope monitor; Sim Man/lung
confirming safe ventilation. of this evaluation
Initiate ventilation and con- N1 or D1 Assess tidal volume,
firm safe delivery of set peak/plateau airway
ventilator parameters pressure, PEEP, FiO2 , res-
piratory rate as displayed by
ventilator
Adjust respiratory rate and I:E N1 or D1
ratio (if adjustable)
Rapidly increase or decrease N1
FiO2
Optimise PEEP N1 or D1 Sequential adjustments to
improve oxygenation and
titrate to compliance
React to sudden change in status and alarms
Respond to low supply Evaluate integrity of sup-
pressure alarm ply pressure, look for
disconnection
Respond to high airway Systematic evaluation from Monitor; ventilator; Sim
pressure alarm patient to ventilator Man/lung
Respond to low airway pres- Systematic evaluation from
sure alarm (circuit or patient patient to ventilator looking
disconnection) for leaks or disconnections
Rapidly adjust FiO2 in Single button (O2 flush) or
response to desaturation complex step involving
or enable suction adjustment of FiO2
Respond to volume alarms High Vt or low Vt or MV
Respond to apnoea alarm Ensure backup mode initiates
Respond to low battery or Identify source of power
power disconnection8 Hignett et al.
Table 2 Evaluation template (strongly agree (5), agree (4), neutral (3), disagree (2), strongly disagree (1))
Eneral appearance and transportation 5 4 3 2 1 NA
1. The ventilator system is too large and heavy to transport easily □ □ □ □ □ □
2. The ventilator is very fragile and can be damaged during transportation □ □ □ □ □ □
3. It is very easy to transport (handles, wheels, manoeuvrability etc.) □ □ □ □ □ □
4. It is very easy to use the ventilator system during stretcher use □ □ □ □ □ □
5. It is very easy to determine battery charge □ □ □ □ □ □
6. It is very easy to set up the circuit □ □ □ □ □ □
Starting up and adjusting the settings 5 4 3 2 1 NA
7. It is very easy to set the PSV with PEEP mode and apnoea ventilation □ □ □ □ □ □
8. It is very easy to specify inspiratory flow (e.g. assist volume control) □ □ □ □ □ □
9. It is very easy to identify inspiratory trigger sensitivity □ □ □ □ □ □
□ □ □ □ □ □
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10. It is very easy to set the volume modes
11. It is very easy to switch from PSV with PEEP in volume mode (CV or ACV) □ □ □ □ □ □
12. The time taken to setup and programme the ventilator system was reasonable □ □ □ □ □ □
Alarms 5 4 3 2 1 NA
13. It is very easy to identify pre-set alarm ranges □ □ □ □ □ □
14. It is very easy to modify an alarm range □ □ □ □ □ □
15. It is very easy to identify the alarm(s) e.g. audio, visual alarms □ □ □ □ □ □
16. The automatic alarms are very useful □ □ □ □ □ □
17. It is very easy to cancel/reduce alarm sound □ □ □ □ □ □
18. The error messages are meaningful □ □ □ □ □ □
Interface 5 4 3 2 1 NA
19. The overall interface (screen, knobs, dials) is very easy to use □ □ □ □ □ □
20. It is very easy to read/interpret the display from a distance □ □ □ □ □ □
21. The plots are very useful □ □ □ □ □ □
22. It is very easy to identify patient parameters □ □ □ □ □ □
23. I think that I would need the support of a technical person to be able to use this system □ □ □ □ □ □
24. I found the various functions in this system were well integrated □ □ □ □ □ □
25. There are an acceptable number of menus to navigate to find what you need easily □ □ □ □ □ □
Instructions for use and job aids 5 4 3 2 1 NA
26. The Instructions for use are very legible and clear □ □ □ □ □ □
27. It is very easy to identify critical steps and required actions □ □ □ □ □ □
28. It is very clear what I should do if the ventilator fails □ □ □ □ □ □
29. I would imagine that most people would learn to use this system very quickly □ □ □ □ □ □
30. It is very easy to learn how to use the ventilator system without a manual (instructions for use) □ □ □ □ □ □
Overall feedback 5 4 3 2 1 NA
31. I thought the system was very easy to use □ □ □ □ □ □
32. I think that I would like to use this system frequently □ □ □ □ □ □
33. I found the system unnecessarily complex □ □ □ □ □ □
34. I thought there was too much inconsistency in this system □ □ □ □ □ □
35. I felt very confident using the system □ □ □ □ □ □
36. I will need to learn a lot of things before I could get going with this system □ □ □ □ □ □
37. The number of steps required to programme the ventilator system was acceptable □ □ □ □ □ □
38. This ventilator system will be very safe to use on a patient □ □ □ □ □ □
• Errors of maintenance: lack of knowledge (i.e. train- testing [5]. To support the manufacturers, the CIEHF produced a
ing/qualifications) of technical support staff; lack of aware- task scenario (Table 1) and patient profiles to provide end users
ness of common failures and failure modes. with the opportunity either to undertake simulated tasks with the
physical prototype (walk-through) or to talk-through for an online
evaluation. The development of the usability protocol included
telephone assistance by CIEHF expert group members with the
Formative usability testing RMVS manufacturing teams.
As this was a rapid manufacturing project, the Government The task scenario and patient profiles used previously published
specification only allowed for one day of formative usability templates [11] and were developed by the clinicians on the CIEHFDesign and testing of rapidly manufactured ventilators • Research Article 9
writing team (AW, A-MB and PM). The task scenario was designed structured approach [15]. Clinical staff working in ICUs and at the
as a pathway to reflect an individual patient requirement for venti- new National Health Service field hospitals could have been asked
lator use. It depicts a combined set of patient pathways to test the to use different types of ventilators with known risks of accidently
ventilator across a range of circumstances that would be unlikely to pressing the wrong buttons or misreading information on screens.
occur in an individual patient experience. The scenario starts from The CIEHF community responded by providing structured guid-
admission and initial testing of the ventilator, initiation of mechan- ance to help manufacturers with the novel requirements and chal-
ical ventilation, mandatory modes (likely to be used in the initial lenges. The CIEHF guidance was issued to RMVS manufacturers to
phase), switching to spontaneous/triggered modes, monitoring and support the design and testing of new machines and to encourage
then finishes with the weaning process. standard designs and protocols to prevent avoidable harm to patients.
Patient profiles were developed to reflect common issues and The usability testing protocol supported realistic testing (work-as-
patient presentations. Each profile included details about the patient, done), including operability whilst wearing a range of PPE. The
the task and the equipment to be used, for example: guidance and usability evaluation protocol are simple tools with the
potential to make a significant contribution and could be adapted to
• Patient: 62-year-old male, COVID positive, assessed by
other medical devices or equipment. This opens debate for national
ICU consultant as deteriorating and tiring. Decision has
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policymakers and others about the role and contribution of HFE
been made to transfer to ICU for intubation and ventilation
in healthcare, which should be sustained beyond the immediate
and ICU care. Standard operating procedure (SOP) requires
COVID-19 pandemic.
transfer in full PPE and intubation and stabilisation in a
dedicated area on ICU before transfer to bed space.
• Task: Set up ventilator, intubate patient and re-programme Acknowledgements
ventilator based on feedback once patient ventilated (e.g.
No funding was received for this project.
changing respiratory rate, tidal volumes, positive end expi- Thanks to Professor Chris Frerk, Northampton General Hospital for providing
ratory pressure (PEEP) according to values on ventilator, expert knowledge about ventilator use at the start of the project.
ETCO2 trace, oxygen saturations and arterial blood gases). Caveat: This HFE advice was offered by C.ErgHF on a rapid response basis
• Equipment to be used: patient bed, transfer monitor, ventila- and does not reflect a full HFE analysis. The advice was offered within CIEHF
tor under test and tubing, arterial and central venous pressure scope of practice for a Chartered Registered Member/Fellow.
(CVP) transducer sets, intubation equipment including face https://www.ergonomics.org.uk/Public/membership/registered_member.aspx
mask, airway adjuncts, video laryngoscope, bougie, range of
endotracheal tube (ETT) sizes, ETCO2 monitoring, tube ties,
Funding
heat and moisture exchanger (HME) filter, waters’ circuit,
airway rescue trolley, Naosgastric (NG) tube, drip stand, full The papers were funded by ISQua.
PPE for aerosol generating procedures, intubation drugs.
References
1. Department for Business, Energy & Industrial Strategy, UK. Call for
User evaluation questionnaire Businesses to Help Make NHS Ventilators. https://www.gov.uk/
A user evaluation questionnaire was developed based on previous government/news/production-and-supply-of-ventilators-and-ventilator-
research [10, 12–14] to provide a standardised template for gath- components (18 May 2020, date last accessed).
2. NHS, UK. Design for Patient Safety. https://webarchive.nationalarchives.
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gov.uk/20171030124501/http://www.nrls.npsa.nhs.uk/resources/
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collections/design-for-patient-safety/ (18 May 2020, date last accessed).
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doi:10.1093/intqhc/mzaa110
Editorial
Editorial
HFE at the frontiers of COVID-19. Human factors/ergonomics
to support the communication for safer care in Italy during the
COVID-19 pandemic
Downloaded from https://academic.oup.com/intqhc/issue/33/Supplement_1 by guest on 09 October 2021
Abstract
Italy was the first country after China to be affected by COVID-19. The wave of the emergency found
our country unprepared to cope with the surge of patients going to first aid departments to seek
assistance in the almost complete paralysis of community health. Human factors and ergonomics
(HFE) can effectively contribute to, and improve the effectiveness of, a pandemic response working
on several key areas: training, adapting workflows and processes, restructuring teams and tasks,
effective mechanisms and tools for communication, engaging patients and families and learn-
ing from failures and successes. In Italy, HFE expertise has been able to provide our healthcare
systems with some easy-to-realize solutions (particularly dedicated to improving communication,
team work and situational awareness) in order to cope with the need for rapid adaptations to
new and unknown scenarios: ensuring information and communication continuity in the differ-
ent levels of the healthcare system; identifying hazard opportunity through risk management tool;
providing training through simulation; organizing regular briefing and debriefing; enhancing the
reporting and learning system as an informal way of communicating adverse events and supporting
information campaign and education initiatives for the public.
Key words: human factors and ergonomics, COVID-19, patient safety, communication
Introduction decision-makers, system influencers that play strategic roles in facing
complex and uncertain situations [3]. This suggests that HFE should
Italy was the first country after China to be affected by COVID-19.
always be embedded in the practice of healthcare for effective patient
The wave of the emergency found our country unprepared to cope
safety [4, 5]. An HFE approach helps in making explicit ‘how’ to
with the surge of patients going to first aid departments to seek
make a change happens in a specific context, how to fit any theory
assistance in the almost complete paralysis of community health.
into the real world, taking into account peculiarities of the system
We were not ready from different perspectives: from managerial to
and answering questions: who are the stakeholders, their relations
logistics and equipment. Several of these key organizational issues
and needs, the interactions they have with the different elements of
were related to human factors and ergonomics (HFE) and safety
the system and the level at which those stakeholders are acting. Dur-
culture [1]. As Gurses et al. pointed out, HFE can effectively con-
ing the emergency period, all these questions became fundamental
tribute to, and improve the effectiveness of, a pandemic response
issues. Moreover the poor, discontinuous, opaque communication
working on several key areas: just-in-time training development,
among the stakeholders represented one of the most critical areas
adapting workflows and processes, restructuring teams and tasks,
during the management of the pandemic by creating what has been
developing effective mechanisms and tools for communication,
named ‘infodemic’, the overload of information creating cognitive
engaging patients and families to follow the recommended practices,
overload and a sense of disorientation both in the population and
identifying and mitigating barriers to the implementation of improve-
also inside healthcare system.
ment plans and learning from failures and successes to improve both
the current and future pandemic responses [2].
HFE experts can play a fundamental role in facilitating the harmo- Applied HFE solutions for improvement
nization of issues rising from stakeholders at different levels (hospital, With the need for rapid adaptations to new and unknown scenar-
trusts, region, national and international) as well as adapting infor- ios, HFE and patient safety tools provided our healthcare systems
mation to the local context before it is sent to the front line. HFE with some easy-to-realize solutions to cope with the emergency, in
experts support the deep understanding of stakeholders acting in particular for improving communication, team work and situational
any sociotechnical context: system actors, system experts, system awareness.
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