Breathing confidence into the value of fit for purpose oxygen concentrators that save lives in low-and middle-income countries
A human-centered design evaluation to identify opportunities to improve oxygen concentrator usability in low and middle-income countries (LMICs)
Elizabeth Johansen, Spark Health Design & Lynne Ruddick, Oxygen CoLab
Why the oxygen concentrator?
Oxygen is an essential life saving medicine with no substitute. Imagine a world where any child who needed oxygen could access it. Prior to the global COVID-19 pandemic, oxygen shortages led to the avoidable deaths of many thousands of children under 5 years old in low and middle-income countries (LMICs). Two years of COVID-19 has put this stark inequity of oxygen access into sharp relief with significant oxygen shortages and stockouts throughout LMICs.
The oxygen concentrator has saved lives throughout the pandemic. This medical device converts the permanently available supply of air into medical grade oxygen by removing nitrogen. Its original use case is the home care market in the global north, for individuals with chronic respiratory conditions. The design assumes access to a stable power supply and operation in a low dust and low humidity environment, where it is operated by a single patient who sits next to the device all day. Concentrators are typically provided by home care companies who provide all repairs needed.
This use case is considerably different in LMICs, where Concentrators are expected to provide continuous life saving oxygen to multiple acutely unwell adult or paediatric patients in settings with poor quality power supply and in dusty and/or high humidity environments. In these settings, there is a constantly rotating set of clinical users who must learn to operate many different models of concentrator and perform regular cleaning and maintenance. In these contexts, Concentrators must continually function despite a dearth of repair services. As a result, the supply of medical grade oxygen in LMICs is intermittent, and the lifespan of an oxygen concentrator is severely limited. Concentrators often degrade, leading to low purity oxygen. This negatively impacts clinician confidence in them as a beneficial medical device.
Why a usability evaluation?
The Oxygen CoLab has been exploring the opportunity to improve oxygen concentrator technology and support local ecosystems for use and repair. This is part of the oxygen colab’s effort to clear the path to market for fit-for-purpose oxygen concentrators from initial product inception to the final transition to scaled distribution.
As part of this work we commissioned Spark Health Design to undertake a usability evaluation of oxygen concentrators in LMICs. The aim is to provide guidance for innovators and manufacturers on human factors and usability considerations when designing fit-for-purpose concentrators for under-resourced settings (URS). Improving safety and ease of use through usability testing will give clinical users and service technicians confidence in the oxygen concentrator in acute settings in URS. As described above, oxygen concentrators were not initially designed for this purpose and most have been grandfathered into usability requirements. Furthermore, there is little evidence that any human factors and usability work has been conducted that considers LMIC users, use cases, and use environments.
What will success look like?
- Develop a usability guide with recommendations that ensure safe use, ease of use, and confidence in the product among users.
- Identify and understand critical tasks, and provide recommendations for how to minimize or mitigate the associated risks.
- Ensure safety and effectiveness throughout the use of the product in LMICs.
- Understand the unique needs of LMIC users regarding the user interface and alarms.
- Providing manufacturers with insights which enable improved design for fit-for-purpose oxygen concentrators a for LMIC users.
The process
Spark Health Design is using a human-centered design approach married with a human factors / usability engineering approach described in IEC 62366–1: Application of usability engineering to medical devices to illustrate the requirements for a successful oxygen concentrator for use in under-resources settings in low and middle-income countries. They are working with Oxygen for Life Initiative, Nigeria, and the Center for Public Health and Development, Kenya to gather feedback from stakeholders regarding the use of oxygen concentrators.
The final deliverable will be a publicly available document with usability insights that manufacturers can use to design context-appropriate oxygen concentrators for LMICs. We will also publish the use-related risk analysis (in collaboration with Loring Human Factors) and usability evaluation protocol we used to determine the insights as a reference for manufacturers who will perform their own usability evaluations in LMICs.
What next?
Oxygen for Life Initiative is currently conducting the work in Nigeria. The Center for Public Health and Development will begin the work in Kenya this month. Check in here to see updates as we progress. We look forward to convening a forum to present the work when it is finalised in Spring 2022, if you would like to join us please email elizabeth@sparkhealthdesign.com.
Working together, we hope we can bring about a new world where any child who needs oxygen is able to access it, no matter where they live. If you have any ideas or questions for the Oxygen CoLab then get in touch with lynne@hellobrink.co.
