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Purpose: Infusion pumps are the preferred method for intravenous delivery of drugs and fluids, and an essential tool in health facilities. Their high cost, complexity and reliance on electricity pose serious challenges to wide-spread 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 address these challenges. Input collected from fifty-nine newborn and maternal care providers and from seven national level decision makers in Uganda was used to guide product development, further informing product design require-ments, and optimal design features to best serve their needs. Methods: A formative evaluation following a mixed methods approach including focus group discussions (FGDs), stakeholder interviews, and observations was used to collect data from end users. Results: Stakeholders provided critical input on the RELI prototype design features, safety criteria, and contexts of use of infusion pumps, as well as recommendations for design refine-ments. Infusion systems are greatly needed but not readily available and their use is limited to well-resourced higher level facilities, even though the need is high in non-tertiary care hospital where patient volume is high, resources are scarce, power is inconsistent, and facilities are understaffed and overcrowded. Users expressed a need for an affordable and simple device with an intuitive user interface, clear instructions for use, and basic safety features. Conclusion: The study provided important guidance for further design refinements based on input from respondents and confirmed the need for robust, affordable, infusion pumps that meet the requirements for use in low-resource settings.
Implementing a user-centered design approach that relied on expert advice and context analysis PATH (Seattle, Washington, USA) developed the RELI to be a robust, portable, non-electric, pneumatic infusion pump designed specifically for use in LRS. The RELI is powered by an air tank pressurized by a built-in hand pump. The output pressure from the tank is controlled by a precision regulator. The regulated air drives a piston that pushes the syringe, delivering the medicine or fluid. The combined effects of the input air pressure to the piston and the resistance provided by the movement of hydraulic fluid through the flow-restricting tubing controls the rate at which the piston moves and hence the flow rate of the fluid delivered by the syringe.12 The user controls the flow rate by adjusting the precision regulator with the flow rate adjustment knob. The air pressure in the tank and the air pressure applied to the piston are read from two dial gauges on the front of the device. Initiation and cessation of the infusion are controlled by a pneumatic start/stop switch. A reset valve allows the user to adjust the position of the syringe pusher before the start of infusion. (See Figure 1.) Illustration of a prototype of the RELI Delivery System. Similar to conventional infusion systems, the RELI features precise flow control and adjustment. Unlike the conventional systems, it does not require a software-based user interface (Figure 2), sidestepping the most common safety issues related to user interactions with infusion pumps.13 Furthermore, by not using electronic components, software, or sources of electricity (such as batteries or mains power), or requiring specialized tubing, this non-electric RELI device could cost significantly less than an electric device while overcoming the challenges posed by non-electric infusion systems. Key features of infusion pump categories. The primary objective of the study was to gather input from health care providers and experts in Uganda on the key features of the RELI prototype and its appropriateness for use cases identified by the stakeholders. An iterative, user-centered approach from concept development through this user evaluation phase informed our understanding of those primarily responsible for administering infusions in health facilities, challenges they currently face, and how the RELI can best be designed to support these needs. Using this approach throughout the product development lifecycle is intended to result in a final design that assures the administration of safe infusions while addressing human factors requirements. The ultimate goal is to design a product that meets user needs and addresses the four “A’s”—appropriateness, affordability, availability, and awareness—which will support successful introduction of this innovation. A formative evaluation following a mixed methods approach was used to collect information and feedback from end users, including focus group discussions (FGDs), stakeholder interviews, device demonstrations, and secondary document reviews. Data were collected from April 2018 through May 2018. Data were collected in two districts in Uganda: Jinja and Kampala. The Jinja District is located in the eastern region of the country. Administrative units in the district include 200 counties, 11 sub-counties, and 69 parishes. The population was approximately 470,000 in 2014, of which nearly 300,000 reside rural areas, with farming as the main source of income.14 FGDs and interviews were conducted with staff at Jinja Referral Hospital, Iganga District Hospital, and the Bundondo level IV health center. The Kampala District, located north of Lake Victoria, has five sub-counties and 76 parishes and encompasses Kampala City, the capital of Uganda. The population was approximately 7 million in 2020.15 Feedback was collected from staff of Naguru District Hospital and Mulago National Referral Hospital. The targeted facilities were identified as government facilities representative of rural and urban areas and of different levels of public-sector health care in Uganda. All participating facilities had infusion therapy capacity and expertise at the time of the study. Medical officers, nurses, nurse midwives, and attending physicians providing care to women, newborns, and children and who were familiar with infusion systems, were selected for participation. A convenience sampling approach was used to recruit providers present at the facility at the time of the planned visits. The FGDs were held at Jinja Regional Referral Hospital in Jinja District and Naguru District Hospital in Kampala District. Individual semi-structured interviews were conducted with medical specialists, product development experts, and officials with expertise in regulatory requirements and supply chain processes in Kampala District. Medical specialists included obstetricians and gynecologists, anesthesiologists, and neonatologists. All respondents provided written consent prior to participation in the FGDs and the interviews. Verbal consent to record the FGD sessions and take pictures was obtained from all participants. In all, 48 health care providers participated in the FGDs, and interviews were conducted with 11 physicians at Mulago National Referral Hospital in Kampala, three biomedical engineers at Makerere University, three government officials at the Ministry of Health, and one member of the National Advisory Committee on Medical Equipment (NACME), based in Kampala. The purpose of the data collection was to learn about current infusion pump use in the health facilities in Uganda, and to gather end user input on the RELI features and form factor to inform design optimization and ensure the syringe driver is acceptable, easy to use, feasible, and meets the needs of both providers and the health system. Guides for conducting FGDs and semi-structured interviews were developed for use in gathering information. Prior to the start of the FGDs and the individual interviews, the research team described the device and demonstrated how it functions. Participants were invited to handle the device and comment, following the group discussions and the interviews. The FGDs were conducted by a trained facilitator and lasted between 60 and 70 minutes. The interviews took between 60 and 90 minutes each. Prior to the start of the study, an extensive review of key documents pertaining to medical devices in Uganda was undertaken. These included a review of the national Essential Medicines and Health Supplies List for Uganda (2016), the national functional inventory for medical equipment, the Health Sector Development Plan 2015/16–2019/20, the National Medical Equipment Policy, the lists of approved medical devices by level of health facility (2015), the Roadmap for Accelerating the Reduction of Maternal and Neonatal Mortality and Morbidity in Uganda (2007–2015), the Annual Health Sector Performance Report: Financial Year 2015/2016, and the lists of approved medical equipment for public procurement and reimbursement (2015–2016). The document review provided insight into current procurement and regulatory requirements for infusion pump use, as well as policy around certification, training, and which cadres of workers are allowed to administer drugs using infusion systems. For the assessment in Uganda, PATH brought a working RELI prototype to demonstrate functionality and collect user feedback on the device design.
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