Electronically Controlled Gravity Feed Infusion Set (ECGF)

The safe regulation of intravenous (IV) fluids and medication is a neglected component of healthcare in humanitarian contexts. The existing standard of care in Sub-Saharan Africa is manual regulation of the infusion therapy process, hence it is prone to human error. This challenge is further compounded by the clinician work burden. The ECGF device has been iteratively designed with close engagement of clinicians to safely administer IV fluids and medication within clinically acceptable accuracy. The implementation of the device has been coupled with clinician and biomedical technician training, on proper installation, operation and maintenance to ensure sustainability of use in rural hospitals. The ECGF  has been clinically validated in 12 adults and 168 children and has been proven to reduce on clinician time, improve on patient safety with the potential of positively impacting several patients in resource constrained settings requiring fluid resuscitation.

Errors associated with intravenous medication therapy have been relatively neglected, over and under dosage may lead to considerable patient harm including circulatory overload, electrolyte imbalance and its consequences and vascular damage which may lead to disability and even death. Results from the paediatric study of the ECGF in two remote districts in Uganda showed that almost 80% of children admitted in hospitals required intravenous infusion therapy. In addition clinicians are not properly trained on how to operate infusion equipment. The current standard of care is manual regulation of fluids and medication due to scarcity of infusion pumps and unstable power supply to fully utilize this equipment. Manual regulation requires continuous monitoring therefore it is prone to human error due to the clinician work overload. For instance Uganda has a nurse to patient ratio of 1:11,000 and a doctor to patient ratio of 1: 25,725, yet the WHO recommends a physician for every 1000 patients.

The population that is being directly served by this technology are patients requiring intravenous therapy, living below the poverty line accessing healthcare services from public hospitals that significantly subsidize healthcare costs. These patients live in rural settings, refugee camps, war torn areas and most low resource settings. The users of the device are clinicians working within these contexts. Clinicians have been involved in the entire design process starting from needs identification, provision of critical feedback right from idea conception to clinical validation and testing early prototypes on appropriateness for clinical use. In addition clinicians have provided suggestions on appropriate functionality and usability features of the device. The ECGF device provides an appropriate and affordable solution to efficiently and safely administer an infusion therapy. The ECGF is automated in nature and therefore alleviates the clinician work burden associated with continuous monitoring of IV fluids.

The Electronically Controlled Gravity Feed Infusion Set (ECGF) was designed to address inaccuracies in the flow rate during manual regulation of intravenous fluids and drugs and the lack of feedback during the infusion therapy in the form of safety features. The ECGF is an automated non-invasive fluid infusion system that utilizes the standard fluid giving set (intravenous tubing and drip chamber) to convey fluids with additional means for sensing and controlling the rate of fluid flow. The system for monitoring drop rate is clamped onto the drip chamber of the fluid giving set. It incorporates a sensor housing containing a reference light source located a fixed distance from a photocell to define a fixed optical sensing gap there between, with the reference light beam normally impinging upon the photocell. The sensor housing can be selectively clamped onto the drip chamber with the latter positioned within the sensing gap, in order to intercept the reference light beam. A falling drop of fluid within the drip chamber interrupts the reference beam, and the corresponding variation in the electrical response of the photocell is electronically communicated, indicating the presence of a drop. A non-invasive drop controller (actuator) attached to the IV tubing controls the rate of fluid flow based on feedback from the drop detector module. A simple user interface has been designed based on feedback from clinicians and has been pre-clinically tested before implementation in the hospital. The power supply unit features a rechargable battery that utilizes a charging bed powered by both solar and electricity. This technology is coupled with continuous training of clinicians and biomedical technicians on how to install, operate, troubleshoot and maintain the device. Materials have been created and translated to local languages to facilitate this process which include user and technical manuals and descriptive charts on set up of the device, alarms and subsequent troubleshooting steps.

The ECGF device has been designed to regulate the flow rate of intravenous fluids in real time. Most of the gravity fed infusion devices monitor the drop rate but do not regulate the rate of fluid flow. The ECGF features novel control algorithms that enable a flow rate to be delivered with +/-10% margin of error, which is the percentage difference between the prescribed and actual flow rate. In addition to flow rate regulation the device also offers a clinically acceptable accuracy in terms of volume of fluid delivered. The ECGF has been retrofitted with safety features unique to resource constrained settings such as faulty or unplugged sensor alarms due to the congested wards and challenges with maintenance in resource constrained settings. A solar powered battery runs the device for a period of approximately 8 hours before a recharge cycle is required.

The ECGF device combines both existing technology as well as new approaches to regulation of intravenous fluids. The drop sensor unit comprises of an optical sensor couple of an emitter and receiver which detects a drop rate when there is interference between the optical beam. This optical principle is not new. However, the control algorithms within the firmware that were designed to steer the regulation are new, which have been implemented by programming microcontrollers which perform the specific functions of the device. The entire device comprises of four modules a drop sensor which detects the drop rate, an actuator that constricts the tubing, a user interface for user input and a power supply unit to run the unit. This modular design greatly eases the troubleshooting and maintenance processes for the biomedical technicians that maintain the device. The device is able to generate detailed data sets for the each therapy on the actual flow rate and volume of fluid administered during  a therapy which can provide meaningful information on device functionality and ensured safety of the patient.

The ECGF device has been clinically validated in adults with infectious diseases and was able to deliver fluids within a flow rate accuracy of +/-7% and provide the minimum safety features such as alarms for over and under infusion. The ECGF device has also been validated in children under the age of 5 years at 2 regional referral hospitals that cater for rural populations in Uganda. A total of 168 children were enrolled on the study which included refugees from surrounding refugee camps. The device proved to be robust and sturdy with rough handling, there were numerous occasions where saline solution spilled onto the device during the therapy but it continued to function normally in these hazardous conditions. The ECGF device was sensitive to slow or fast flow rates in addition to detecting air bubbles. The study was completed in February 2019 with no serious unanticipated adverse device events and an overall improvement in the patients clinical conditions. The usability of the device was appreciated by clinicians who were trained before using the device and the device manuals and set up posters were appropriate for use in the clinical setting. With this background the ECGF has the potential to improve on the efficacy and safety of proper infusion therapy in rural communities.

A total of 180 adults and children have been beneficiaries of the ECGF device, we anticipate that every patient requiring intravenous fluids across the continuum of care would benefit from the ECGF device, this includes emergency, ICU, heart, kidney, paediatric and internal medicine areas. At scale a total of over 20,000 patients could benefit from the device in the next 5 to 7 years, in the medium term an additional 200 patients will be served within the next year in the context of clinical trials. The medical device regulation process is critical to achieve if thousands of patients are to benefit from the device.

Following completion of the clinical trials, the team is currently working with the Fraunhofer Institute in Germany to develop the next version of the ECGF device based on data obtained on its performance during the clinical trials in adults and children. The goal of this engagement is to CE mark the device due to the challenges with limited capacity of local drug and medical device authorities to regulate investigative medical devices. The National Drug Authority in Uganda has the capacity to regulate devices that have already been approved elsewhere therefore this is the most feasible approach to effectively scale the ECGF device within Uganda and the East African Community member states.

Regulation of medical devices within Uganda and the East African Community is a challenge because of device standards are not harmonized and the local regulatory authorities lack the laboratory infrastructure to effectively test investigative devices to verify their efficacy and safety for market use. Regulatory aspects are a priority activity for the next year of development. The local regulatory authorities, however, are able to approve for use devices that have been cleared in another jurisdiction such as CE mark or FDA approval. The financial investment required for manufacturing the ECGF device (injection moulding technique and large scale printed circuit board manufacturing capacity)and establishment of a reliable and cost effective supply chain for initial production within Uganda is steep. 

To tackle the challenges with regulation, the team will be undertaking the CE marking route, albeit costly, to ensure quick implementation of the medical device for hospital use as medical device guidelines are being developed by the local regulatory authority. For manufacturing the team will consider a third party company for the initial production of the units to reduce on initial infrastructure investment as capital is being raised to set up a production facility within Uganda. This is key to ensure job creation and capacity building of the medical device industry in Uganda. Cipla Quality Chemicals Limited a pharmaceutical manufacturing plant within Uganda is an example of the potential for medical device manufacturing within Uganda.

The ECGF device is being developed by a team of engineers at the Instrumentation Division within the Uganda Industrial Research Institute, a government agency, however, the intention is to set up a company when the device transitions to scale. The innovators of the device own the intellectual property of the ECGF device.

A total of 5 full-time staff (engineers) and 4 part time staff (engineers) work on the product development and 3 clinicians work as part time staff with an advisory role, mostly in relation to clinical validation of the device.

The team of engineers and clinicians are based within Uganda and are very well versed with the challenges with medical technology and its use within the context of a resource limited setting. Being on the ground enables quick iteration of the ECGF device design with clinical input, and also enables the engineers to have a deeper understanding of the regulatory framework and usability of the device within the setting. The team has already gathered evidence through training of over 70 clinicians ( nurses and doctors) on the appropriateness of the device in addition to the actual use of the device on 180 patients in total. The team has also been able to secure necessary funding, key partnerships with experienced local and international partners and government support in preparation to effectively scale the ECGF device.

Currently the team is working with Design without Borders, a Ugandan company of industrial designers with support from Norway that designs for humanitarian and rural contexts. The team has also partnered with the Fraunhofer Institute specifically the department for Automation in Medicine and Biology (IPA), who will work with the team to refine the existing design and prepare the device for CE marking. Through an existing partnership with Ugandan Ministry of Science Technology and Innovation and the Ministry of Health, the team will access some midterm funding through and Innovation Fund and work on implementation of the device in Ugandan public hospitals. The team seeks to explore partnerships with non-government organizations for future implementation options.

The key customers for the ECGF device are the government and private hospitals. Through and existing partnership with the Ministry of Health, the ECGF device will seek to be listed on the essential list of medicines and devices to be procured by the National Medical Stores. A framework contract will also be pursued with public hospitals. Sale of consumables for the ECGF device such as fluid giving sets will ensure cash flow as capital purchases are made. In addition, a preventive and corrective maintenance contract will be implemented together with the device purchase. The primary beneficiaries are patients from rural communities who are living close to and below the poverty line who will be accessing subsidized health services in government hospitals, in addition to patients in semi-rural areas accessing care from private health facilities. Secondary beneficiaries would be clinicians who would use the ECGF device to optimize their workflow in addition to improving patient safety. 

Initial financial support will be through grants, awards and donations. Once the device has been successfully CE marked a company will be set up to specifically market the device and establish clients and distribution channels. Revenue will be generated through venture capital investment, and through initial sales at scale.  A public private partnership will be implemented that would seek clients from both the government and the private sector. There are a growing number of private healthcare facilities within Uganda and East Africa that could procure the ECGF device for use.

Support on effectively setting up a company that would scale and market the ECGF device, the team would appreciate support through a technology and business incubator to further refine its business model. Access to implementing partners with existing presence in low resource countries to advise on how to effectively scale the ECGF device. Contacts with larger medical device companies to explore the option of licencing the technology. Access to potential venture capital investors.

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The Red Cross, Doctors without Borders, Save the Children as implementing partners. For large manufacturing companies that the ECGF device could be licenced to, Baxter and Hospira.

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This prize would be used to further train clinicians with a specific focus on biomedical technicians who are a neglected component of sustaining medical devices. Preventive and corrective maintenance structures will be designed and implemented to ensure the sustenance of the ECGF device in the hospitals.

Nurses are at the forefront in medical device use in hospitals in low resource countries. Almost 80% of nurses in these communities are women. Funding from this prize will go to directly empower women nurses through focused training and engagement to improve clinical outcomes within communities. The impact of this intervention will be measured  in terms of numbers of women nurses trained, number of women nurses mentoring other nurses on proper medical device use, and improved clinical outcomes of patients that have received care from these nurses.

The team would aim to establish a partnership with the Uganda Red Cross that already has presence in several refugee camps in Uganda close to Fort Portal Regional Referral hospital where the clinical trial on the ECGF was conducted i.e. Kyaka II. Refugees have already been beneficiaries of the device during the paediatric study. A clinical study would be designed specifically to validate the appropriateness of the device for use within the refugee camps and data would be collected on usability and efficacy.

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