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Back to Journal »Medical Devices: Evidence and Research» Volume 14
User-centered design: development of RELI delivery system-a low-cost, non-electric, pneumatic infusion pump
Authors Abu-Haydar E, Katuntu D, Bauer J, Wollen A, Eisenstein M, Sherman-Konkle J, Roche A, Ruffo M
Published on June 24, 2021, Volume 2021: 14 pages, pages 185-192
DOI https://doi.org/10.2147/MDER.S295893
Single anonymous peer review
Editor approved for publication: Dr. Scott Fraser
Elizabeth Abu-Haydar,1 David Katuntu2,†James Bauer,1 Alec Wollen,1 Mike Eisenstein,1 Jill Sherman-Konkle,1 Anthony Roche,3 Michael Ruffo1 1PATH, Department of Medical Devices and Health Technology Projects and Innovation, Seattle, Washington, United States; 2PATH, Uganda National Plan, Kampala, Uganda; 3 University of Washington Department of Global Health, Seattle, Washington, USA †David Katuntu passed away on September 1, 2020. WA, 98121, USA Phone +1 206 285-3500 Email [Email protected] Purpose: Infusion pump is the preferred method for intravenous injection of drugs and liquids, and it is also an indispensable tool in medical institutions. Their high cost, complexity, and dependence on electricity pose serious challenges to their widespread use, availability, and access in low- and middle-income countries. PATH developed the RELI Delivery System (RELI), a low-cost non-electric infusion pump to meet these challenges. The opinions collected from 59 newborn and maternal care providers and 7 national decision makers in Uganda were used to guide product development, further inform product design requirements and optimize design features to best meet their needs. Methods: A hybrid approach to formative assessment, including focus group discussions (FGD), stakeholder interviews and observations, is used to collect data from end users. Results: Stakeholders provided important opinions on the features of the RELI prototype design, safety standards, use environment of the infusion pump, and suggestions for design improvements. Infusion systems are highly needed, but not easy to obtain, and their use is limited to higher-level facilities with sufficient resources, even in non-tertiary care hospitals with large numbers of patients, scarce resources, unstable electricity, and well-equipped facilities Understaffed and overcrowded. Users expressed the need for an economical and simple device with an intuitive user interface, clear instructions and basic safety features. Conclusion: The study provided important guidance for further improving the design based on the opinions of the interviewees and confirmed the need for a sturdy and reasonably priced infusion pump that meets the requirements for use in resource-poor environments. Keywords: infusion pump, low- and middle-income countries, user-centered design, product development, Uganda
The infusion pump is an indispensable medical device and the preferred intravenous system for the safe delivery of nutrients, fluids and medicines to patients. In resource-rich countries, infusion pumps are common and used in a wide range of therapeutic applications, including emergency obstetrics, antibiotic therapy, anesthesia, and palliative care. These devices are complex devices with extensive flow rate adjustability, complex software and intelligent systems, including alarms. 1 Infusion pumps require operator training and a well-resourced and supported health system. In low- and middle-income countries, the supply and use of infusion pumps are limited. These countries often lack the infrastructure and technical resources to support and maintain the operation of electronic infusion pumps, as well as the financial resources to purchase sufficient quantities of these equipment to meet medical needs. 2 The result is a huge gap in access to fair and high-quality equipment. Take care of people in resource-constrained environments.
This article introduces our user-centric RELI delivery system (RELI) design method, which is a low-cost, non-electric, pneumatic infusion pump designed to improve the performance and access to infusion therapy in resource-constrained environments. Specifically, we report the results of user evaluations conducted in Uganda to solicit maternal and neonatal healthcare providers and other stakeholders on the perceived potential of RELI in maternal wards and neonatal intensive care units (ICUs). Feedback on acceptability and usability.
Every year, obstetric and neonatal emergencies cause approximately 290,000 maternal and 2.5 million newborn deaths worldwide, most of which occur in low-resource areas (LRS). 3,4 If the patient can receive timely and appropriate medical treatment. Equipping health workers with the tools they need is one of the key factors in improving the fairness and quality of medical care. One such tool-ubiquitous in resource-rich environments-is the infusion pump. The World Health Organization recommends controlled intravenous administration of critically ill newborns, such as antibiotics, fluid therapy and nutrition, as well as magnesium sulfate, oxytocin, and anesthetics for emergency obstetrics. 5-8 However, in LRS, the complexity and high cost of electric infusion pumps and the lack of reliable electricity affect the availability and accessibility of these pumps and the number required to meet the medical needs of patients. Non-electric manual infusion systems fill a key gap in LRS, but they are not the best choice because they require more labor, are less reliable, may require expensive proprietary disposables, and some systems lack flow rates and Adjustable dose. 9,10
In situations where time and dose accuracy are of the utmost importance, these factors are key barriers to the provision of high-quality, effective medical services. The lack of appropriate equipment to control intravenous administration may cause patient safety issues or limit the treatment that clinicians can provide. In many resource-poor environments, safe, reliable, cost-effective and appropriate infusion systems are required, which can be used not only in high-level facilities, but also in lower-level healthcare systems (mainly in rural areas). Regions), where they are most needed. 11
Ideally, these devices should be designed to be safe, sturdy, and easy to use, with intuitive user controls, without requiring special disposable components or relying only on electricity.
In our early product development stage, we carried out the landscape design of competitive products. A review of the US Food and Drug Administration (USFDA) database to identify more than 400 infusion pumps currently sold in our target markets in low-income countries. Most of these devices are electric infusion pumps. We have identified three predicate devices: Springfusor syringe infusion pump, Freedom60 syringe infusion system and Beeline system. Like the proposed RELI delivery system, these three devices are syringe infusion systems, which are non-electric and mechanically driven. However, unlike these predicates, RELI does not require proprietary disposables, can be used with a variety of syringe sizes, can be delivered in a continuous flow rate range, and can adjust the infusion speed during the infusion process.
Implementation of a user-centered design method that relies on expert advice and contextual analysis, PATH (Seattle, Washington, USA) developed RELI as a rugged, portable, non-electric, pneumatic infusion pump designed for use with LRS.
RELI is powered by an air tank pressurized by a built-in hand pump. The output pressure of the tank is controlled by a precision regulator. The conditioned air drives the piston to push the syringe to deliver drugs or liquids. The combined influence of the input air pressure of the piston and the resistance provided by the movement of the hydraulic fluid through the restrictor tube controls the movement speed of the piston, thereby controlling the flow rate of the fluid delivered by the syringe. 12 The user adjusts the precision regulator through the flow adjustment knob to control the flow. The air pressure in the tank and the air pressure applied to the piston are read from the two dial gauges on the front of the device. The start and stop of the infusion are controlled by a pneumatic start/stop switch. The reset valve allows the user to adjust the position of the syringe plunger before starting the infusion. (See Figure 1.) Figure 1 Schematic representation of the RELI delivery system prototype.
Figure 1 Diagram of the prototype of the RELI delivery system.
Similar to traditional infusion systems, RELI has precise flow control and regulation functions. Unlike traditional systems, it does not require a software-based user interface (Figure 2), avoiding the most common safety issues related to user interaction with the infusion pump. 13 In addition, by not using electronic components, software, or power sources (such as batteries or main power sources), or requiring special pipelines, the cost of such non-electric RELI devices may be much lower than that of electric devices, and at the same time, it overcomes the need for non-electric infusion systems. Challenges coming. Figure 2 The main characteristics of the infusion pump category.
Figure 2 The main characteristics of the infusion pump category.
The main goal of the study was to gather opinions from Ugandan healthcare providers and experts on the key features of the RELI prototype and its applicability to the use cases identified by stakeholders. From concept development to this user evaluation phase, the user-centric iterative approach allowed us to understand the people who are primarily responsible for managing infusions in medical institutions, the challenges they face, and how to best design RELI to support these needs. The use of this method throughout the product development life cycle aims to produce a final design to ensure the management of safe infusion while meeting the requirements of human factors. The ultimate goal is to design a product that meets user needs and meets the four "A"s—appropriateness, affordability, usability, and awareness—that will support the successful introduction of this innovation.
Formative assessment using a hybrid approach to gather information and feedback from end users, including focus group discussions (FGD), stakeholder interviews, equipment demonstrations, and secondary document reviews. The data collection period is from April 2018 to May 2018.
The data was collected in two regions of Uganda: Jinja and Kampala. Jinja District is located in the eastern part of the country. The administrative unit of the district includes 200 counties, 11 sub-counties, and 69 parishes. The population in 2014 was approximately 470,000, of which nearly 300,000 people lived in rural areas, with agriculture as their main source of income. 14 FGDs and interviews were conducted among staff of Jinja Referral Hospital, Iganga District Hospital, and Bundondo Class IV Health Center.
Kampala District is located north of Lake Victoria and has five sub-counties and 76 parishes, including Kampala, the capital of Uganda. The population in 2020 is approximately 7 million. 15 Feedback was collected from staff at Naguru Regional Hospital and Murago National Referral Hospital.
The target facility was identified as a government facility representing rural and urban areas of Uganda and various levels of public sector healthcare. At the time of the research, all participating facilities had infusion treatment capabilities and expertise.
Medical staff, nurses, midwife nurses, and attending physicians who provide care for women, newborns and children and are familiar with the infusion system are selected to participate. Use convenience sampling methods to recruit providers in the facility at the time of the planned visit. FGD is held at Jinja District Referral Hospital in Jinja District and Naguru District Hospital in Kampala District. Separate semi-structured interviews were conducted with medical experts, product development experts and officials with expertise in regulatory requirements and supply chain processes in Kampala. Medical experts include obstetricians and gynecologists, anesthesiologists and neonatologists. All interviewees provided written consent before participating in FGD and interviews. Verbal consent was obtained from all participants to record the FGD session and take pictures. A total of 48 healthcare providers participated in FGD and interviewed 11 doctors from the Murago National Referral Hospital in Kampala, three biomedical engineers from Makerere University, three government officials from the Ministry of Health, and one A member of the National Advisory Council is located in the Medical Equipment Council (NACME) in Kampala. The purpose of data collection is to understand the current use of infusion pumps in medical institutions in Uganda, and to collect end-user input on the function and shape of RELI to inform design optimization and ensure that the syringe driver is acceptable, easy to use, feasible, and meets the needs of providers and hygiene. System requirements.
Guidelines for conducting FGD and semi-structured interviews were developed for information gathering. Before the start of the FGD and personal interviews, the research team described the device and demonstrated its functions. After group discussions and interviews, participants were invited to deal with equipment and make comments. FGD is conducted by a well-trained coordinator and lasts 60 to 70 minutes. The duration of each interview is between 60 and 90 minutes. Before the study began, an extensive review of key documents related to Ugandan medical devices was conducted. These include the review of the Uganda National List of Essential Medicines and Hygiene Supplies (2016), the National Medical Equipment Function List, the 2015/16-2019/20 Health Sector Development Plan, the National Medical Equipment Policy, and the approved list of medical equipment at the level of medical institutions (2015) Year), the road map to accelerate the reduction of maternal and newborn mortality and morbidity in Uganda (2007-2015), the annual health sector performance report: 2015/2016 fiscal year, and the approved list for public procurement and reimbursement of medical care Equipment (2015-2016). The document review provides an in-depth understanding of the current procurement and regulatory requirements for the use of infusion pumps, as well as the policies regarding certification, training, and which workers and cadres are allowed to use the infusion system for drug delivery.
For the evaluation in Uganda, PATH brought a working RELI prototype to demonstrate the functionality and collect user feedback on the device design.
Our research questions focus on two themes: (1) the user experience of the current infusion system; (2) the user's input to the specific functions of the RELI interface. The results of FGD and key informant interviews are organized under these two themes. The information extracted from the document review was verified during FGD and interviews.
Focus group participants (n=48) were mainly nurses and midwives who had received several years of training and were selected for their work experience in intensive care and infusion therapy. Also attending FGD were medical staff and some doctors. These providers follow well-established protocols that guide the infusion regimen, and they are responsible for the infusion of drugs and fluids in accordance with the treatment orders prescribed by the responsible medical officer. Infusion pumps are a scarce commodity in their facilities, mainly due to cost. Therefore, the use of infusion pumps is limited to services that meet the most urgent needs, including intensive care units, neonatal care units, operating rooms, and in a few cases, maternity wards. For example, the 100-bed Naguru Regional Hospital (which has been designated as a regional hospital since our research) has a total of 6 pumps: two in the operating room, two in the intensive care unit, one in the internal medicine ward, and one in the intensive care unit. ICU. Respondents worry that the shortage of infusion pumps means that all patients who need intravenous treatment will not benefit from it. The research team observed that nurses use a basic infusion set with a droplet system to infuse fluids and medications. They also observed the use of a dropper as a drip chamber to measure the amount of liquid or medicine needed, and a roller clamp to control the infusion rate. Since there are few infusion pumps available, these temporary systems are necessary, but all participants agreed that these systems are imprecise, labor intensive, and require continuous monitoring to ensure the safety and effectiveness of the treatment. This is especially true in busy neonatal wards and ICUs, where accuracy is critical and health workers are overwhelmed. Most FGD participants pointed out that due to the large number of patients, scarce resources, unstable electricity supply, and understaffed and overcrowded, small hospitals (most of which are located in rural areas) have the least chance of receiving infusion treatment but the most demand for facilities. They admit that most of the electric infusion pumps they use are unaffordable for small hospitals, are not built for harsh environments, and are unsustainable in these facilities with generally weak maintenance infrastructure.
The main informants interviewed at the Murago National Referral Hospital in Kampala (n=11) included anesthesiologists, obstetricians and neonatologists. The doctor confirmed that the infusion pump is mainly used for sedation and administration of vasopressors and inotropic drugs, fluids, palliative care and antibiotics. All interviewees stated that non-electric pumps may not be needed in national referral hospitals, especially intensive care units and operating rooms, because these hospitals are fully equipped and have backup generators. However, affordable mechanical pumps like RELI can meet the critical needs of medical wards where the large number of patients and cost constraints limit the availability of basic equipment.
Generally speaking, the interviewees said that the supplier is overworked; the service staff is insufficient; the health workers are equipped with appropriate tools that are easy to use, powerful, reasonably priced and sufficient in quantity to support their work. They emphasized that training on the use of infusion pumps, the availability of clear and graphical instructions for use, and maintenance and repair regulations are key elements to ensure continuous, safe and effective use.
Discussions with biomedical engineers and government officials from Makerere University provided information on the procurement and distribution process of medical equipment in Uganda. The opinions from this group of experts are essential to inform the design, specifications, requirements and cost constraints. These stakeholders confirmed that the budget for medical equipment is limited. Although the procurement of medical equipment is based on the government's assessment of demand and equipment specifications, it mainly depends on the cost of the equipment. Discussions with these experts further confirmed the need for low-cost infusion systems. The unique value proposition and low target price point of the RELI delivery system will be the key differentiating factors. Our goal is to provide an easy-to-use, electricity-free syringe driver at an affordable price, thereby increasing the accessibility of infusion therapy. In the early stages of development, the target end-user price has been set between US$500 and US$1,000. This goal is based on the price of existing competing products between $600 and $2,000.
Before collecting the opinions of FGD participants and key insiders, the research team demonstrated the RELI prototype. After discussion and interview, participants were invited to operate and use the device.
Throughout the discussion, interviewees provided important opinions on equipment design features, safety standards, and usage environment. Participants suggested that the device is intuitive, easy to use, sturdy, and most importantly, it is safe and effective to provide treatment at the correct dosage and infusion rate.
"The pump must be very sturdy; things always break here." ~ICU nurse
Keep it simple, safe and effective. Don't try to make a device that can do everything. The needs of newborns and women are so great, you can start from there and have a huge impact. ~Physician
Table 1 summarizes the user's input to RELI's specific functions and potential design modifications to solve user problems. The feedback we received from nurses, doctors, decision makers, and engineers did not differ significantly. Table 1 User input to the main functions of RELI delivery system
Table 1 The user's input to the main functions of the RELI conveying system
Although ubiquitous in resource-rich medical institutions, in Uganda, electric infusion pumps are mainly found in tertiary centers, large regional hospitals and some regional hospitals-but the number is not enough to meet the medical needs of the people they serve, mainly due to Cost and not suitable for resource-poor environments. Electric infusion pumps are rare in rural hospitals. Generally, few commercial devices are designed to be rugged and suitable for the high temperature and high humidity environments of many low- and middle-income countries. Equipment that cannot withstand these conditions will stop working and will usually not be repaired or replaced, resulting in limited capacity for medical institutions to provide patients with infusions. 16,17 In addition, the backup battery life of the electronic infusion pump may not be optimized for such settings, especially where the power supply is inconsistent. The innovation and design of appropriate medical technologies to meet these challenges remains a high priority for decision makers, donors, healthcare providers, and key stakeholders.
User input collected in Uganda is part of the continuous iterative design approach leading to the current prototype. Respondents brought important clinical expertise, which provided information to our engineering and technical experts, and informed of important changes in the user interface and functions of RELI before the next stage of clinical validation of the device. Some simple things, such as including clear, illustrated user instructions (printed or firmly attached to the device), can provide a quick reference for nurses providing infusion therapy, which can be very important. The description of the physical environment in which the device is used emphasizes the need for compact portable devices that can be safely secured to ensure safe management in crowded ICUs, medical wards, and medical transportation vehicles. Infection control is listed as a high priority. Interviewees emphasized the need for smooth surfaces on knobs and handles to facilitate infection control measures. Experts call for special attention to the need for a device that ensures consistent flow rate and pressure maintenance, which will lead to major engineering modifications to the next-generation RELI design. In addition, gathering information about the supply chain and regulatory requirements from non-medical personnel is also critical to the project, and will support the selection of manufacturing partners and price points to purchase affordable products that are more likely to be purchased and used by national programs .
In general, Ugandan healthcare providers and other stakeholders have put forward important opinions on RELI's design features, safety standards, and use environment. They expressed a strong need for a robust and affordable infusion pump that meets the requirements for use in resource-poor environments, which will provide important directions for further design improvements.
The ethics approval for this study was obtained from the Research Ethics Committee of Mbarara University of Technology in May 2018 (approval registration #05/05-18). Study participants must provide written consent prior to the interview and FGD. Recorded meetings and photographs were collected from each participant for the oral consent of the report.
We thank Robbie Adams and Jessica Bolich for their research and editing help. We would also like to thank Zach Clemens, Dan Myers, and Elizabeth Griffin for their technical expertise and input. Mike Eisenstein recently moved to Equalize Health, 695 Minnesota Street, San Francisco, CA 94107.
All authors who have contributed to data analysis, drafting or revising the article agree to the journal to which the article will be submitted, finally approve the version to be published, and agree to be responsible for all aspects of the work.
The project is supported by the United Kingdom (UK) Foreign Affairs, Federal and Development Office (FCDO) through the provision of equipment, diagnostics and medicines (D3AWN) awards to PATH to meet the needs of women (D3AWN) and the generous support of life-saving organizations to provide fertility partners (by American International UNDP is funded by the Save Life Challenge). The content is under the responsibility of PATH and does not necessarily reflect the views of FCDO, the British government or the partners in the birth of Save Life. PATH formulated the research design, collected data, and led the analysis and decision to publish. PATH staff prepared the original content of the manuscript.
The author declares that there are no competing economic interests. The author reports that there is no potential conflict of interest for this work.
1. Lönnqvist PA. How continuous is the continuous drug infusion? Intensive care medicine. 2000;26(6):660–661. doi:10.1007/s001340051229
2. Mundle S, Regi A, Easterling T, etc. The treatment of pre-eclampsia in resource-poor settings: a randomized trial of Springfusor pump for delivery of magnesium sulfate. Hypertension in pregnancy. 2012;2(1):32-38. doi:10.1016/j.preghy.2011.09.002
3. World Health Organization. Maternal mortality [key facts]. Geneva, Switzerland: World Health Organization; September 19, 2019. It can be obtained from the following website: https://www.who.int/en/news-room/fact-sheets/detail/maternal-mortality. Visited on September 24, 2020.
4. World Health Organization. Newborns: Improve survival and well-being [key facts]. Geneva, Switzerland: World Health Organization; September 19, 2019. It can be obtained from the following website: https://www.who.int/news-room/fact-sheets/detail/newborns-reducing-mortality. Visited on September 24, 2020.
5. Maine D, Patsy B, Lobis S, Fortney J. Monitoring emergency obstetric care: a manual. Geneva, Switzerland: World Health Organization; 2009.
6. World Health Organization. Children's Hospital Nursing Pocket Book. Geneva, Switzerland: World Health Organization; 2013.
7. World Health Organization. Infusion Pump. Geneva, Switzerland: World Health Organization; 2012.
8. World Health Organization. Managing newborn problems: A guide for doctors, nurses, and midwives. Geneva, Switzerland: World Health Organization; 2003.
9. Skryabina EA, Dunn TS. Disposable infusion pump. Am J Health Syst Pharm. 2006;63(13):1260–1268. doi:10.2146/ajhp050408
10. Pierce ET, Kumar V, Zheng H, Peterfreund RA. Drug and volume delivery via gravity-driven intravenous infusion of droplets: potential changes during "full-open" flow. Anesthesia analysis. 2013;116(3):614–618. doi:10.1213/ANE.0b013e31827bc235
11. Shah K, Skerrett E, Nojoomi M, etc. Maji: A new tool to prevent excessive hydration in children receiving intravenous fluid therapy in resource-poor settings. Am J Trop Med Hyg. 2015;92(5):1053–1058. doi:10.4269/ajtmh.14-0495
12. Guelig D, Bauer J, Wollen A, etc. Design a novel, adjustable flow rate, reusable, no electricity, low-cost syringe infusion pump. J Medical equipment. 2017;11(4):041006 (6 pages). doi:10.1115/1.4037935
13. United States Food and Drug Administration. Infusion pump [Internet page]. Available from: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/default.htm. Visited on February 9, 2016.
14. Uganda Bureau of Statistics. 2014 National Population and Housing Census: Main Report. Kampala, Uganda: Uganda Bureau of Statistics; 2016: Vol. 50.
15. Populationstat.com. Kampala, Uganda Population (2020)-Demographics. [Online]; 2020. Available from: https://populationstat.com/uganda/kampala. Visited on September 24, 2020.
16. Perry L, Malkin R. Medical equipment donations improve the effectiveness of health systems: how many medical equipment is damaged in developing countries? Medical bioengineering calculations. 2011;49(7):719-722. doi:10.1007/s11517-011-0786-3
17. World Health Organization: Medical Devices: Management Mismatch-2010. Available from the following URL: https://apps.who.int/iris/bitstream/handle/10665/44407/9789241564045_eng.pdf?sequence=1. Accessed on May 12, 2021.
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