Low-cost Maternal Hypothermia Prevention

A low-cost device that safely and accurately warms intravenous fluids to prevent maternal hypothermia during cesarean sections.

This summer our team conducted ethnographic research at various hospitals in Kampala, Uganda's capital city. We saw first-hand a range of serious problems resulting from a lack of resources. Hence, we endeavored to contribute to finding a solution to one in particular. This was the issue of perioperative Maternal Hypothermia.

Cesarean sections are medical interventions used in around 6% of deliveries in Uganda. During the procedure spinal anesthesia is used to numb the lower body; this can also interrupt normal thermoregulation. The result: an abnormal decrease in core body temperature (to less than 35°C), referred to as maternal hypothermia. This condition occurs in approximately 23% of cases. Initial symptoms are discomfort and shivering, which often develop into serious medical complications such as hypotension, cardiac arrhythmias, respiratory depression, and postoperative infections. Maternal hypothermia was a dangerous and often overlooked problem in every surgical ward we visited. The long-term health impacts include an increased risk of premature birth, neonatal death, and lengthy recovery time. 

During cesarean sections, intravenous saline (IV fluids) administration is needed to control blood loss. In warmer climates like Uganda, these fluids are often refrigerated for preservation. Before surgery, however, there is often no safe way to warm them. Hence when they are administered, core body cooling is compounded. Staff are forced to use their limited resources to warm the fluids the best they can. A common example of a rudimentary technique used in a desperate effort to warm mothers was submerging the bags in boiling water. This is impossible to control leading to inaccurate temperatures (which can not be measured). It also compromises the sterile field of the operating room, increasing infection risk. Often already limited supplies are wasted when issues like these arise during bag heating and they must be discarded.

In Uganda, maternal mortality rates are as high as 343 deaths per 100,000 live births; as engineers, it is imperative that we prioritize maternal healthcare. This is difficult, as lack of medical devices, staff shortages, and other socio-economic factors make the issue of maternal healthcare a complicated one with no simple solution. However, treating maternal hypothermia is a tangible goal that we believe will greatly impact antenatal protocols. 

Maternal hypothermia, and all of its medical implications, is highly preventable. In many higher-income countries, expensive heating devices are used to prevent patient cooling by warming the mother's body and the intravenous fluids that are provided to her. Requiring regular maintenance, expensive materials, and high electricity outputs, these products are not a viable solution in lower-income medical settings. It was upsetting to see that healthcare providers in Uganda's hospitals were left feeling helpless, with no interventions designed and available for their low-resourced hospital settings. Ugandan healthcare workers deserve better so we created a product that uses local materials to create a low-cost alternative to these devices, reducing the risk to the mother and newborn. Our hope is that this will help to reduce the rates of medical complications and reduce the burden on healthcare workers.

Our solution is a low-cost intravenous(IV) fluid warmer designed to heat two 500mL bags to 36-40 within 15 minutes. We developed the product using local materials sourced from markets in Kampala. 

We spent eight weeks this summer iterating on our prototype. We now have a functional design. Our prototype consists of a box made of high-density polyethylene (from water storage cans), and recycled acrylic. It is insulated with foam and rubber seals and encapsulated in a sterilizable mackintosh cover. The box-like structure can be hung on an IV pole, and with the flick of a switch automatic heating begins! 

A 100W incandescent light bulb on the base heats the IV bags (using a mechanism inspired by chicken egg incubators). The product is powered by low amounts of wall electricity and has integrated electronics and code that control the heating and maintain the temperature at the desired threshold. An Arduino monitors the temperature, using a moving threshold to regulate the light bulb. The bulb automatically switches on and off to achieve and maintain the required temperature for bag heating while optimizing energy use. The progress is communicated through an intuitive interface with a red light indicating "wait" and a green light indicating "fully heated". The bags can be viewed through a side panel, and new bags can be inserted safely at any time. The relative simplicity of our device means that it can be maintained and used by hospital staff, giving a new level of autonomy to lower-resource hospitals. 

Our aim was to create a low-cost device to fill the need we found during ethnographic research. With a functional mechanism and materials cost of only 200,000 UGX (52.4 USD), our device has this potential.

Our solution serves the target population of pregnant women undergoing cesarean sections in LMICs, all of whom are at risk of maternal hypothermia without appropriate interventions. These women are currently underserved due to the lack of access to proper warming equipment during surgery. They experience unnecessary discomfort, medical complications, and long-term health impacts. Our solution addresses this need by providing a low-cost alternative to expensive warming equipment, using local materials. When combined with blankets for physical warming, our device can heat two 500mL bags to be delivered to the patient in only 15 minutes. It is reusable and sterilizable so is safe and easy to use in an operating theatre. 

Our clientele of nurses and biomedical engineers in Kampala agree that this IV bag warmer has the potential to directly and meaningfully improve the lives of the target population by reducing the risk of maternal hypothermia and improving the overall quality of care during cesarean sections in LMICs. In automating reliable warming, we hope to relieve the burden of hard-working healthcare staff who help patients with maternal hypothermia daily. 

Our team is a group of five internationally-minded and civically engaged young professionals who strive to promote global health development through engineering. We were brought together during a partnership project between Duke University and Makerere University. Makerere staff graciously hosted a number of Duke students for eight weeks in the summer of 2022. Immersing themselves in Ugandan culture helped the US students gain a deeper insight into Uganda’s healthcare system. Hence, a unique team with diverse perspectives and experiences was born. We believe we are well-positioned to deliver this solution thanks to our strong background in engineering and industry experience. 

Edgar Atamba is our team lead. He is a Biomedical Engineer, who recently graduated from Makerere University. He has used his experience in medical device development and entrepreneurship to build a viable prototype considering many socio-economic factors. He has a strong understanding of the challenges and needs in the medical device field and is able to bring a practical perspective to the project. As a Kampala resident, he has expertise in finding local materials and in innovating original solutions to minimize cost. 

Kate Flanagan, a Mechanical Engineering student at Duke, has valuable experience in product design and iterative prototyping used to solve real-life issues through her coursework. As an international student from the UK at Duke she brings a unique global perspective to the challenges of international development. She also has excellent writing and communication skills, aided by her Psychology minor, which will be crucial for documenting our work and communicating our progress.  

Lilly Chiavetta is an Electrical and Biomedical Engineering student, also at Duke University, with knowledge of electronic circuit design and programming. She has worked on some projects that have required her to design and build electronic control systems and her skills will be invaluable in developing our solution. Her established skills in virtual prototyping from an electronics perspective complement her mechanically minded counterparts well. 

Oloya James is a Biomedical Engineering graduate, from Makerere University. He has experience in rapid prototyping and presentation. James finds joy in taking bold ideas and implementing them in innovative research settings - this forward-thinking attitude has led to many original solutions to issues we have faced; his enthusiasm and dedication help quickly and effectively bring ideas into low-fidelity prototypes! His skills have been important in the prototyping and testing stages of the project. 

Lutaaya Edward is a Biomedical Engineer with a strong background in problem-solving and system integration. During his undergraduate career at Makerere University, he worked on complex systems such as his project dealing with vital signs monitoring. Now, as a graduate, he continues to pursue projects where he can implement his interests in system safety and complex system design. His skills are key to ensuring that our solution is reliable and effective through stringent testing protocols.

We feel strongly that our diversity in nationality, gender, age, and skillsets provide a well-rounded team. We have experience working together in person and online, and hence flexibility is our strong suit. We love working together on our IV bag project. We hope to work together to make a high-quality healthcare device, in lower-income settings, serving the expectant mothers of the future. 

At the heart of our product is a clear and observable need. We were welcomed into many of Kampala’s hospitals and found much need within the maternal healthcare departments. A Biomedical Engineer at Kawempe National Referral Hospital showed us many of the devices he works with and highlighted some of the major challenges in healthcare technology in Uganda. This was very helpful in setting the scene for our research. He was also able to direct us to other individuals who could provide more feedback on our design.

At the many hospitals we visited, we felt that maternal hypothermia is often overlooked, hence we committed to tackling it. At Nagura Hospital, we were invited into the operating theatre, where we discussed our objectives with an anesthesiologist (one of only approximately 72 trained anesthesiologists in Uganda). He described how he struggles to balance the high demand for Cesarian Sections with the lack of resources while prioritizing patient health. The detriments of maternal hypothermia worried him and his colleagues deeply, and hence we knew we should research the issue more. We looked at many academic journals, as well as interviewed hospital staff and patients in other facilities, and found a gap in the market for cheaper solutions to this widespread need. We were able to meet many mothers, Doctors, Nurses, and anesthesiologists. Each had a unique take on their needs for warming mothers equipment-wise; each helped us brainstorm new aspects of our product so that it was appropriate for hospital settings. 

Once we established a need and a subsequent problem statement we sought out a long-term client who we could visit and receive feedback over the eight weeks we completed our initial prototype. At Nguru Hospital, we found the perfect individual. Surgical Nurse Agnes Nkwenge has worked with expectant mothers throughout her career. She agreed to meet us incrementally to review our product and provide areas for improvement. With the help of Nurse Agnes, we decided to create an IV fluid warmer which would be used alongside sterile blankets to warm mothers in the operating theatre.

Nurse Agnes helped us find machinery and fluid bags which were commonly used in the hospital. She also provided accounts of how the impact of maternal hypothermia on mothers and how she currently attempts to warm them. This helped us make crucial decisions on balancing the speed of heating with the energy consumption of our incandescent bulb (an important decision for more rural hospitals with limited electricity). She also helped us to test the user interface and design, providing insights that aided in sanitation, anthropometrics, visualization of the IV bags, and quantity of bags warmed at once. 

The opinions of Nurse Agnes and other healthcare providers were pivotal in establishing the need and creating an appropriate solution. We are proud to say that Nurse Agnes was very impressed with our finished prototype, and we hope to continue working with her as one of our clients to perfect our product!

Our solution is designed to be made from local materials and has a very limited budget, which makes it accessible to many hospitals, especially in resource-limited settings. This is a significant improvement over existing solutions which are often expensive and not accessible to many hospitals in these areas. Our solution uses a light bulb controlled by electronics to warm the fluids, and an Arduino controls a relay, which monitors the temperature and uses a moving threshold for bulb regulation. This mechanism allows for accurate temperature control of the IV fluids, which is crucial for preventing maternal hypothermia.

Our solution is easy to use and plug into wall power, with the press of a button, integrated electronics and code take over, heating and maintaining the bag very accurately to a set threshold. This makes it safer than other methods, such as boiling water, that are often used as a workaround. By providing an easy-to-use and accurate solution for warming IV fluids, you are able to prevent maternal hypothermia, which in turn improves maternal health and reduces the risk of complications and maternal mortality.

We will conduct feasibility studies to test the technical and economic feasibility of our solution. This will involve testing the prototype in a simulated environment and gathering feedback from healthcare providers to identify any areas for improvement. Based on the results of the feasibility studies, we will develop a high-fidelity prototype that incorporates any necessary changes and improvements identified. We will also conduct further testing to ensure that the prototype meets the necessary safety and performance standards.

We will secure funding and partnerships with hospitals, local manufacturers and suppliers to support the scaling up and commercialization of the solution. Once the high-fidelity prototype is developed and tested, we will conduct a pilot study in at least ten hospitals in Uganda to test the effectiveness of the solution in preventing maternal hypothermia. The results of the pilot study will be used to optimize the design of the solution and to gather feedback from healthcare providers.

Based on the results of the pilot study, we will scale up the production of the solution and disseminate it to more hospitals in Uganda and other countries.

• Reduce maternal hypothermia rates in cesarean sections by 50% in the pilot hospitals within the next year
• Scale up production and distribution of the solution to reach at least 10 hospitals in Uganda within the next two years.
• Train at least 50 healthcare providers on the use and importance of the solution in preventing maternal hypothermia within the next year
• Improve maternal health outcomes and reduce maternal mortality rates by 10% within the next two years.

We will also continue to monitor and evaluate the impact of the solution and gather feedback to identify any areas for improvement.

Our solution uses an electronic control system to regulate the temperature of the IV fluids. The system consists of an Arduino microcontroller, which is programmed to monitor the temperature of the fluids and control the heating mechanism. The system also includes a relay, which is used to switch the heating mechanism on and off as needed to maintain the desired temperature. We use insulation materials such as foam, recycled acrylic and sterilizable macintosh to maintain the warmth of the IV fluids. These materials help to keep the heat generated by the heating mechanism inside the cabin, and thus ensure that the fluids are heated to the desired temperature.

We use a 100W incandescent light bulb as the heating mechanism. This mechanism is inspired by chicken egg incubators, which use low-cost bulbs to maintain eggs at approximately core human body temperature. The bulb is placed on the base of the cabin, and when switched on, it heats the fluids. The solution uses a temperature sensor to measure the ambient air temperature at the tube exit site. This allows for external temperature monitoring and calibration to a standard IV bag temperature

Currently, our solution is still in the prototype stage and has not been launched yet, therefore it does not currently serve any people. However, in the next year, we plan to serve the following number of people:

We plan to conduct a pilot study in at least two hospitals, which will directly and meaningfully impact approximately 100 women who will be undergoing cesarean sections during the study period. Based on the results of the pilot study and assuming a successful outcome, we plan to scale up production and distribution of the solution to at least 10 hospitals in Uganda, which will directly and meaningfully impact approximately 1000 women who will be undergoing cesarean sections in these hospitals in the next year. Additionally, we plan to train at least 50 healthcare providers on the use and importance of the solution in preventing maternal hypothermia, which will indirectly impact the number of women who will be receiving care from these healthcare providers.

Developing and conducting a pilot study, scaling up production, and distributing the solution in hospitals require significant financial resources. This is a major barrier for us as we may not have enough funding to support these activities. To overcome this barrier, we have been actively seeking grants and partnerships with relevant organizations and companies to secure additional funding. Our solution may require regulatory approvals and certifications before it can be used in hospitals. This can be a significant barrier as the process may require additional resources. To overcome this barrier, we have been consulting with relevant regulatory bodies to understand the requirements and have been working on ensuring that our solution meets these requirements.

Our solution is designed for use in Ugandan hospitals, and it may be necessary to consider cultural barriers such as the acceptance of the solution by healthcare providers and patients. This may require additional resources for communication and training. To overcome this barrier, we have been engaging with some healthcare providers and patients to understand their needs and concerns, and have been working on addressing these issues in our design and communication strategies.

Currently, we do not have any established partnerships with organizations. However, we have been actively seeking out potential partners and collaborators to support the development and implementation of our solution We have been in communication with Kawempe National Referral hospital and Naguru Hospital in Uganda to understand their needs and gather feedback on our solution. We hope to establish partnerships with these hospitals to conduct a pilot study. 

Our business model revolves around providing a low-cost and effective solution for preventing maternal hypothermia through intravenous fluid warming. Our key customers are hospitals and clinics in Uganda, particularly those that provide maternal healthcare services.

Our primary product is the low-cost IV bag warmer, which is designed to heat two 500 ml bags to 36-40°C within 15 minutes. Our solution is made from locally available materials, and is low-cost, making it affordable and accessible to hospitals and clinics in Uganda.

We plan to provide our solution through a B2C model, where we will sell our IV bag warmer to hospitals and clinics. We will also provide training and support to healthcare providers to ensure proper use and maintenance of the device. Additionally, we plan to offer after-sales services such as maintenance, repair and replacement of parts.

Our solution addresses a real need in the healthcare system, as maternal hypothermia is a serious condition that affects a significant number of women undergoing cesarean sections in Uganda. Hospitals and clinics are in need of effective and affordable solutions to prevent maternal hypothermia and our IV bag warmer offers a reliable and safe solution that is within their budget.

We plan to generate revenue by selling our IV bag warmer to hospitals and clinics and also providing after-sales services, which will help us sustain the business. We also plan to explore other revenue streams such as licensing or franchising our solution to other countries or regions facing similar challenges in maternal healthcare.

Our primary revenue stream will be through the sales of our IV bag warmer to hospitals and clinics in Uganda. We plan to price our solution competitively at $60 to make it accessible to as many healthcare providers as possible.  We plan to provide after-sales services such as maintenance, repair, and replacement of parts to our customers. This will generate additional revenue and also ensure that our solution is being used and maintained properly.

We plan to explore the possibility of franchising our solution to other countries or regions facing similar challenges in maternal healthcare. This will generate additional revenue and also help us scale our impact. We are actively seeking grants and funding from various organizations and foundations to support the development and implementation of our solution.