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Medical Device Design and Maintenance in low-income settings: a case study on oxygen concentrators

Project Objectives

the industrial and public health sectors of low- and middle- income countries (LMICs) tend to have insufficient resources, compared to those of high-income countries. This leads to the lack of access to medical devices (MDs) and the exclusion of the larger part of the population from primary health care. [1]

The majority of the world's population does not benefit from the use of medical devices (MDs), with less than 15% of the world's population accounting for the use of more than 75% of the MDs, implying unequal access to healthcare in favour of higher resource settings. Indeed, those who require healthcare the most (i.e., those living in low-resource settings) have less access to it. [2] As a result, MD are designed for high-income countries, failing to be sufficiently resilient to the working condition of LMICs ones. [1]

In Sub-Saharan Africa (SSA), 80% of the available medical devices are donated, and more than 70% of them are broken or non-functional, mainly because those are not fit for the local working conditions (e.g., heat, temperature, humidity, unstable power supply, poor maintenance, luck of spare parts, poor supply chain). [2] [3] As result, donations have become a financial burden for end-users, who have had to reallocate scarce resources in order to repair or dispose of the equipment. [4]

Oxygen therapy is listed on the World Health Organization (WHO) list of essential medicines, yet it is still not widely available in developing-country settings that bear the greatest mortality burden of seriously ill new-borns, children and adults. Reasons for low oxygen availability are often associated with cost and lack of infrastructure to install and maintain reliable oxygen supply. Even where oxygen supplies are available, patient access may be limited due to missing accessories, inadequate electricity and/or shortage of trained technicians, and limited supply of Spare parts. [5][6]

Oxygen concentrators are devices that generate oxygen by removing nitrogen from ambient air. As a low-cost solution, have been used. In most cases, these portable devices are the best option for remote and/or low-resource areas lacking oxygen facilities and cylinder supply networks. Unfortunately, the environments in which these devices operate can be unstable, with faulty power systems and dusty, humid, and hot climates where the devices last less time due to a lack of a working supply of spare parts chain. These factors contribute to low oxygen concentration output, which has a direct impact on clinical outcome. While addressing these factors, it is important to note that the oxygen concentrator itself should be redesigned to include feature(s) such as redesign oxygen inlet filter, integrate some diagnostic components and regenerate the molecular sieve (zeolite) to overcome these unintended consequences.

Most studies focused on donation and utilization, of oxygen concentrator. Yet, little number of studies have investigated how to design the very basic important components to make them suitable for SSA working conditions. For this reason, this project aims to investigate the most appropriate and acceptable way to design and regenerate oxygen concentrators, making them suitable for SSA. This will include local production of zeolites, re-design inlet filters and add novel design to existing oxygen concentrators in low resource setting depending on the medical device guidelines and regulations. This is expected to increase the utilization of oxygen concentrator and make available of oxygen supply for patients save Cost of maintenance particularly in in the mentioned area.

METHOD and OBJECTIVES

The study will evaluate the performance and design features of currently available oxygen concentrators and review systematically current knowledge (literature review and survey of experts) on MD design and maintenance, investigating in detail specific issue (e.g., zeolite lifecycle, inlet filters local manufacturing, regulatory aspects) in SSA countries.

Specific goals will be:

• Identify the design gap among some of existing oxygen concentrator in SSA

• Identify the MD safety measure and regulatory policy relevant to SSA

• Develop methods to measure quality and local manufacture high-quality consumables and spare parts (filters, Zeolites, and other spare part components).

REFERENCES

[1] E. Williams, P. Davide, M. Andellini and L. Pecchia, "3D-printed activated charcoal inlet filters for oxygen concentrators: A circular economy approach.," Jan 19 2022.
[2] D. M. D. H. R. P. L. Piaggio, "Donation of Medical Devices in Low-Income Countries: Preliminary Results from Field Studies,"
Springer, vol. 73, pp. 7-64, 2020.
[3] E. Iadanza, Clinical engineering handbook, 2nd ed., Elsevier, 2019.
[4] D. a. J. K. Williams, "Maximizing the Value of Donated Medical Equipment in Resource-limited Settings: The Roles of Donors and End-users," p. 39(1), 2016.
[5] WHO, "Technical specifications for," World Health Organization, 2015.
[6] WHO, "Resilient-oxygen-concentrators," World Health Organization, 2015


Start/End Date

1 November 2022 / 31 October 2025

Principal Investigators

Leandro Pecchia - PI

Host Institution

UCBM

Source of funding

Fondazione MedOr

Budget

€ 75.500

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