The project's purpose was to investigate the development of a medical sharps waste device appropriate for use and manufacture in Nepal. Medical sharps waste management in Nepal is still somewhat dangerous, despite the physical and environmental dangers. After considering several design directions, it was determined to create a mechanism capable of mechanically pulling the needle tube out of the hub. A device like this will render needles unusable while simultaneously opening up possibilities for the recycling of the materials of needle waste. Additionally a device that mechanically separates the materials of needles does not currently exist. Tensile tests were performed with various needle sizes and temperatures to better investigate this. There were no statistically significant differences between temperatures, although the results from 16 G needles differed significantly from the results from 20 G and 23 G needles. It was discovered that the device's minimum pulling force should be 500 N; this, along with information taken from several set standards and previous projects on needle devices, was then included into a set of requirements for the device. After exploring several clamping, pulling, and combined mechanisms, a roller mechanism was chosen for the device. A functional prototype capable of extracting a needle tube from its hub was created. This prototype was then tested, and various experiments were carried out to try to enhance the design because needle tubes were still slipping in between the rollers on occasion, and some needle tubes broke off. Adding other structures or a different material like rubber on the rollers did not result in better performance, and a knurling pattern worked best for creating grip on the needle tube. Adding a ridge did not improve the performance, however removing some material from both sides of the gap in Roller A did enhance performance temporarily. Making the rollers out of stainless steel 431 rather than 316 did not increase their performance; however, stainless steel 431 with a heat treatment did improve the performance and showed consistent test results. This final prototype, including the rollers made out of stainless steel 431 with a heat treatment was then used to do final verification and validation. 20 G needles could be pulled with the device consistently at a needle length of 33.8 mm, both wet and dry. 27 G needles however kept breaking off, both wet and dry. A design choice should be made here about if the device should be aimed at a smaller range of needles or a redesign should be made where different spring forces could be applied. The device showed not springback and no parts became trapped in the mechanism. It was impossible to insert needles of various diameters at greater angles from the vertical of the aperture and 16 G needles did not fit into the device at all. A redesign is needed for this. The average activation force of the device was 14.72 N and the distance from the hand holding the needle to the hand operating the device did not exceed 50 mm. The cycle time per needle was still too long for the device. Further research is required to improve these parameters. The prototype did meet the weight and size requirements. The device did not have a sharps box attached to it, this should be added in a redesign. If the rollers of the device are to be constructed of stainless steel 431, they should be made in India, since stainless steel 431 was not available in Nepal. The case, cubes, pushing plate, socket, spring axis, and lever may all be made in Nepal. Standard components, such as springs and bearings, may be obtained in India. However still choices and more research is needed in the area of where exactly the product should be produced and assembled. More research is needed to determine how the metal components of needles may be recycled and how a device like this would work with different types of needles. Also researching if applying force to both rollers and a redesign either with a different spring of multiple spring forces should still be done. More testing is needed to determine the pulling force and how many cycles the device can sustain. As well as a drop test, a tipping test on an angular surface and users tests. Lastly research into how to incorporate a redesign where the syringe is also rendered unusable is needed, since this study only focused on making the needle part unusable by separating the materials.

AIM: In order to contribute to the research concerning the large quantities of out-of-service medical equipment in LMIC, this master thesis will focus on evaluating which combination of factors related to a MOOC’s design, structure, logistics, content and delivery method; result in a better course performance, engagement and experience for the user; and consequently, how to translate these findings to the design of the future BMET MOOC to maximise its impact. Additionally, it will also evaluate whether the delivery of materials through interactive content could exhibit potential benefits for the students, directly reflected on the performance, by encouraging their involvement in the course and promoting active engagement. METHODS: A single blinded pilot study was created on edX Edge, in collaboration with local experts (NSI). It covered topics related to the Patient Monitor in four modules. To validate the hypothesis, the participants were allocated in two groups, related to the delivery method they were exposed to, after a stratified randomisation. Following a Pre-test/Post test design, the performance was measured as the mean of difference between the grades on each test. The corresponding statistical analyses on the independent variables and covariates were performed. The content was validated by experts on the field; and the methodology behind the pilot was approved by the HREC of the Delft University of Technology. RESULTS: The differences in the delivery method, lead to a significant improvement in the performance of 11.9%, compared to regular content. The female students were more prone to this enhancement, as well as the African participants. Besides, these findings suggest that this new delivery method not only boosted the involvement in the course, and was able to take up part of the responsibility placed on the students in online education courses; but it also prevented the reduction in engagement. The structure, and materials provided were sufficient and successful to teach the key concepts of this module. Moreover, there was no evidence found that suggested the need to segregate the future MOOC in difficulty levels based on the participants previous experience or location. However, since the main challenge faced by the students to finalise a MOOC, is to allocate sufficient time to work on it; it was recommended if the amount of work load per week could be reduced to 6 hours maximum. CONCLUSIONS: The overall analysis presented in this project concluded with a series of key factors, issues, and barriers related to the course’s design, structure, logistics, content and delivery method. The study was not only fairly successful in reaching its targeted audience, but it also built a network of BMETs from diverse backgrounds, locations, and experience, interested in the pilot, and willing to collaborate in the versions to come. On that account, the BMET MOOC presents itself as a great alternative to prevent the great amount of out-of-service medical equipment in LMICs, and these outcomes can be of great value in eventually transferring and implementing the complete curriculum to an online platform to train these professionals on how to properly use, maintain, and repair medical devices; and therefore, have a direct impact on the maintenance of medical equipment in these countries, to ensure a proper quality of the health care delivery.

Leprosy is a neglected tropical disease affecting people worldwide. Left untreated or starting therapy too late, the infection can cause permanent damage to the nerves, skin, eyes, and limbs of patients. While current standard diagnostic techniques generally detect the disease once symptoms have manifested, infrared thermography presents a potential tool for the early detection of leprosy-related neuropathy. A research initiative has been established to explore whether autonomic nerve impairment in the hands can be identified using infrared thermography, necessitating a new method for temperature evaluation. This work discusses the development of a semi-automatic temperature analysis method for twelve regions of interest on the hands. The approach utilises real-time landmark tracking based on an existing machine-learning model, adapted to the context of the application. After applying a cold impulse and recording the response with an infrared camera, the rewarming temperature and recovery values are determined within the regions. Results presented in this report indicate no significant improvement compared to the existing manual method. The success of the model outcomes highly depends on the accuracy of the machine-learning-based hand landmark detection, resulting in insufficiently reliable outcomes. The underlying explanations and the potential for future improvements are further discussed in this thesis, considering the evident potential and benefits of the automated approach.

Leprosy is a neglected tropical disease affecting people worldwide. Left untreated or starting therapy too late, the infection can cause permanent damage to the nerves, skin, eyes, and limbs of patients. While current standard diagnostic techniques generally detect the disease once symptoms have manifested, infrared thermography presents a potential tool for the early detection of leprosy-related neuropathy. A research initiative has been established to explore whether autonomic nerve impairment in the hands can be identified using infrared thermography, necessitating a new method for temperature evaluation. This work discusses the development of a semi-automatic temperature analysis method for twelve regions of interest on the hands. The approach utilises real-time landmark tracking based on an existing machine-learning model, adapted to the context of the application. After applying a cold impulse and recording the response with an infrared camera, the rewarming temperature and recovery values are determined within the regions. Results presented in this report indicate no significant improvement compared to the existing manual method. The success of the model outcomes highly depends on the accuracy of the machine-learning-based hand landmark detection, resulting in insufficiently reliable outcomes. The underlying explanations and the potential for future improvements are further discussed in this thesis, considering the evident potential and benefits of the automated approach.

This thesis proposes a method of detecting autonomic neuropathy in low-income countries using an infrared camera. Access to healthcare is often limited in low-income countries delaying the detection of neuropathy. If neuropathy can be detected in the earliest stage, often the autonomic state, damage to motor and sensory nerves can be prevented. To develop the method for detecting autonomic neuropathy, first the autonomic system was researched, followed by looking into the effects of neuropathy on the autonomic system to discover what physical properties might be measured with the detection device. Four affected physical properties were determined through literature research: blood flow, blood pressure, skin resistance, and skin temperature. Of these properties, skin temperature was found to be the most promising based on a literature study, as it seemed to be both easily measurable and relatively independent of other bodily functions. Then the constraints of healthcare in low-income countries were examined and devices that work within these constraints were identified. Of these, the infrared camera showed the most promise, because of its ease of use and cost to accuracy ratio. A single-subject study was performed to test the restorative capacity of the autonomous system by deliberately changing the temperature of the hand with a heating and cooling agent. Four locations were used on both hands, and both palmar and dorsal side of the hand, using different doses of the agents. The temperature change of the skin was measured using an InfraRed (IR) camera. A large variation in results was found, but the results did show some evidence for structural differences in the temperature normalization between the affected and unaffected hand. The palmar side shows a stronger reaction than the dorsal side. The cooling agent seems to be more effective, but there are some caveats attached to its use. An interesting observation is that the most noticeable difference between left and right was measured in an area of low circulation. This gives some indication that this area has the most difficulty with returning to the neutral state. Conclusion: This research shows that skin temperature variation as a result of applying heating or cooling agents to the skin can be measured using an infrared camera, suggesting that minor variations in skin temperature as a result of neuropathy can also be measured, further research with more test subjects should be done.

Ensuring reliable and safe performance of medical devices in healthcare institutions is crucial for the wellbeing of patients. For this, physiological simulators may be used, which provide reference signals to compare against. The usage of physiological simulators, such as ECG simulators, as medical device testers is widely extended in high-income countries. However, their high cost and need for frequent calibration by the manufacturer make their availability and usage in low-resource settings (LRs) unfeasible. Remote healthcare facilities, low- and middle-income countries (LMICs), and hospitals in general would highly benefit from new designs of simulators that can be produced, repaired and maintained locally. Therefore, we present the design of an affordable, portable Arduino UNO-based prototype ECG simulator with the novel feature of visual indicators for self-calibration checks. The ECG simulator was built with affordable and broadly available components and tools, retrieved from an educational electronics workshop. The current prototype can be used to test 3-lead ECG meters. It reproduces a lead II waveform extracted from MIT-BIH database, with 1.3 mV peak-to-peak and 0.1 mV negative offset. Heart rage simulation ranges from 35 to 130 bpm, in steps of 5 bpm. Signal data points defining a desired waveform and heart rate can be uploaded into the simulator via the user-friendly and open-source Arduino software. The simulator could also be modified to generate 10- or 12-leads by upscaling the electronics and adding more storage space. Analog signal generation is based on a pulse-width modulation signal, which is smoothened by a low-pass filter and decreased in amplitude with operational amplifiers, which also add a negative voltage offset. Visual indicators enable simulated frequency and amplitude checks without the need of external tools, while amplitude can be calibrated manually. Additionally, rechargeable batteries facilitate on-site testing of medical equipment. Evaluation of the prototype included performance and functionality tests. HR and amplitude accuracy of the simulated signal were quantified and compared to those from a commercial simulator. Lastly, the performance of the simulator in a real scenario was tested at the Green Pastures Hospital of Pokhara, Nepal. Functionality tests proved the correct detection of the simulated signal by 6 patient monitors of different models, manufacturers and purchase year.

Currently between 30% till 50%, some even state up to 70%, of medical and laboratory equipment is reported as out of service, due to small or large technical failures or due to missing knowledge of how to use well-functioning equipment in Low-/ Middle- Income Countries (LMIC). This is not due to the complexity of the required repair, but due to, among others, the shortage of sufficiently educated and motivated Biomedical Equipment Technicians (BMETs). This research will focus on the knowledge gap of how to use, maintain and repair medical and laboratory equipment and the missing motivation of BMETs in LMIC by setting up a Pilot Course. The objective of this research is to verify the possibility to train BMETs in LMIC with the required set of skills and knowledge with an online training and the possibility to intrinsically motivate participants to perform better within an online training, whilst taking local limitations and cultural norms and values into account. Based on the findings, a recommendation will be given for the creation of a Massive Open Online Course (MOOC) to train BMETs in LMIC. In addition, if proven intrinsic motivation can be stimulated during training, the next step would be to prove intrinsic motivation to perform better on the job as BMET can be stimulated during training. In that manner, this research aims to set the first step in decreasing the large number of reported out of service medical and laboratory equipment by closing the knowledge gap and by increasing motivation among future BMETs. A Pilot Course was created educating participants with knowledge and skills required to use, maintain and repair the Patient Monitor. In addition, several surveys were spread to request expectations, feedback and general input with regards to the development of a MOOC to train BMETs. Within the Pilot Course four cohort groups were created. This research will focus on the distinction between two of the four groups; a group exposed to motivational incentives and a group not exposed to motivational incentives. This distinction must verify the possibility to intrinsically motivate participants to perform better in a Pilot Course. The Pilot Course itself, together with the surveys must give insights on how to design and setup a MOOC to train BMETs in LMIC. It was found that BMETs can indeed be educated with the set of skills and knowledge exposed to in an online training. There was no significant difference found in performance in the Pilot Course between the different cohort groups and thus no significant impact of the motivational incentives on performance detected. The completion rate was higher for the group not exposed to the motivational incentives. It was also found that the completion rate was higher among participants from South-East Asia compared to Africa, which was not caused by the different cohort groups, but by the propensity to stick to discipline coherent to the Asian culture. No other significant relations or results were found. Based on these conclusions my recommendation is to create a MOOC to train BMETs in LMIC to close the currently existing knowledge gap. When designing the MOOC, I would recommend using guidelines and recommendations presented in this research. Additionally, I recommend to further investigate the possibility to intrinsically motivate participants during training and thereby influence their behaviour to perform better as a BMET.

The objective of this thesis project is to develop an economically viable design for a titanium total ossicular replacement prosthesis (TORP) that caters to the needs of low- and middle-income countries (LMICs). The author focused on addressing the problem from the manufacturing aspect and two primary approaches, additive manufacturing (AM or 3DP) and metal forming, were selected in the literature review attached in Appendix A. One concept was generated for 3DP, utilizing selective laser melting (SLM) to fabricate a straightforward structure using Ti6Al4V. Additionally, two similar concepts, 2A and 2B, were proposed for metal forming, involving precise metal laser cutting of a two-dimensional piece and subsequent bending to achieve a three-dimensional TORP shape. Concept 2A features a fixed-length shaft, whereas Concept 2B incorporates an adjustable zigzagged shaft, aiming to obviate the need for storing multiple sizes of TORPs. These concepts were manufactured into prototypes and systematically evaluated based on predetermined assessment criteria including affordability, manufacturing process, precision, sound transmission property, and simplicity. After assessment, Concept 1 was omitted from the final solutions due to its high cost and demanding post processing steps. And Concept 2A and 2B were deemed as potential TORP designs for the costs of 3.5 and 0.9 euros, dimensional errors of 2.22 % and 2.33 %, preparation duration of 0 and 5 minutes, and the comparable performances in manufacturing process and sound transmission with the commercial products. In conclusion, the TORP designs produced by precision laser cutting were considered the more cost-effective and accessible solutions for LMICs in need of ossiculoplasty.

The goal of this project is to design and create a low cost total ossicular reconstruction prosthesis (TORP) for use in low-middle income countries (LMIC). These middle ear prostheses are available on the market but are unaffordable for the general populace in LIMCs. A mould is designed with which a titanium wire TORP could be created . A multitude of wire TORPs are made and measured to test the performance of the mould. Transmission properties of the TORP are measured by using a Mechanical Middle ear Model(MMM), a synthetic recreation of the middle ear. This model is used to make a comparison of transfer functions between the wire TORP and a commercial model. The comparison showed slightly worse transmission properties for the wire TORP compared to its commercial counterpart. The result is a production method suitable for LIMCs that can create affordable TORPs that can fit in every middle ear.