Purpose: The aim of this paper is to use easily accessible smartphones as a straightforward means for physicians to objectively check Medical Device Inhaler (MDI) technique, without the need for additional devices. Additionally, we seek to assess the frequency of inhaler technique errors and their impact on asthma control. Patients and Methods: Thirty-two children between the ages of 5 and 18 receiving asthma therapy through MDIs were included. Three surveys were administered to all participants to gauge device history, asthma control, and patient characteristics. Patient technique was scored using inhaler audio signals recorded with a smartphone. For subjects that were able, forced oscillation technique (FOT) was performed during tidal breathing conditions before and after corticosteroid administration. Results: 81% (25/31) of participants used their MDIs incorrectly with the most common errors being rapid shallow breathing, inadequate breath-holding, and excessive actuations. Poor inhaler technique correlated with poorly controlled asthma symptoms. Conclusion: The use of smartphone recordings can a convenient way to evaluate technique errors and could allow patients to demonstrate and refine their technique and usage without a doctor's visit, ensuring proper technique and enhancing treatment effectiveness.

Introduction: Over 5.6 million stroke survivors in the United States experience hemiparesis of the upper limb. Assistive devices are used to help regain upper limb functionality for affected individuals; however, existing devices are bulky, costly, and lack adaptability. The objective of this pilot study was to test the performance of a newly developed hand exoskeleton on a sample of individuals with hand impairment. Methods: A hand exoskeleton was developed comprising of a novel linkage system with three four-bar linkages structures set up in a series and a novel algorithm that finds optimal Electroencephalogram (EEG) channels, through Common Spatial Pattern (CSP) Recognition, and classifies them with a stacked Linear Discriminant Analysis-Support Vector Machine (LDA-SVM) classifier. The functionality of the novel hand exoskeleton was tested by examining performance across a battery of hand mobility assessments among individuals in the experimental group with hand impairment (n=10) compared to controls (n=10). Results: A paired-t test was used to show better performance for the experimental group with the exoskeleton compared to those without the exoskeleton across function, grip force, and range of motion measures. An unpaired-t test was used to show that there was no statistical difference in the mean performance of the experimental group with the exoskeleton compared to the control group for most measures, indicating that functionality with the exoskeleton is comparable to a healthy hand. The LDA-SVM classifier resulted in an 88% accuracy in classifying which finger the user intends to move with minimal latency as a result of its computational efficiency. Conclusions: Findings suggest HANDLINK was effective in improving function, grip force, and range of motion among hand-impaired individuals. The HANDLINK, and its complementary stacked SVM-LDA classification algorithm, work as a viable solution for a fully adaptable and cost-effective assistive hand aide for individuals with paraplegia.

INTRODUCTION:The innovative Pratt pouch could optimize dispensing nevirapine prophylaxis to HIV-exposed infants in pre-measured single dose pouches to increase completion of the full 6 week infant nevirapine regimen.MATERIALS AND METHODS:Nineteen health facilities with highest HIV positivity rates among pregnant women across 9 districts in southwest and central Uganda were assigned to control and intervention groups. HIV-positive women enrolled at intervention facilities received pouches filled with premeasured single doses of nevirapine using Uganda national guidelines, which were integrated into the existing drug distribution system. During antenatal care (ANC) women received 14 pouches to cover time until the 6 day postpartum visit, with an additional 8 pouches if women were delayed in returning to the facility, and 28 pouches after delivery. Women enrolled at control facilities received standard nevirapine syrup following delivery for postnatal infant prophylaxis. In a select number of intervention facilities, during ANC, women received all 42 pouches needed to complete the 6 weeks regimen. Medical record data from enrolled women were extracted; interviews with HIV-positive women during postnatal care visits were conducted. Data were collected January to August 2018 (control sites) and October 2019 to February 2020 (intervention sites). Unadjusted and adjusted logistic regression models were used to identify factors associated with facility delivery, postnatal care follow-up visit, and completion of the full 6 weeks infant nevirapine regimen.RESULTS:Significantly more women in the intervention (n = 320) versus control (n = 340) group had facility delivery (292/316, 92.4% versus 169/340, 49.7%, p<0.0001), postnatal visits within 2 weeks postpartum (295/297, 99.3% versus 133/340, 39.1%, p<0.0001) and reported their infants completing the full 6 weeks infant prophylaxis regimen (299/313, 95.5% versus 210/242, 86.8%, p = 0.0002). Dispensing 42 versus 14 pouches during ANC did not have negative effects on these outcomes. Among out-of-facility deliveries, a higher proportion of infants received nevirapine within 72 hours of birth in the intervention versus control group, 95.8% versus 77.9%. In multivariate models, the intervention group was the only significant factor associated with facility delivery or completion of the full 6 weeks infant prophylaxis.CONCLUSIONS:Use of the Pratt pouch resulted in an increase in HIV-exposed infants completing the full 6weeks prophylaxis regimen and associated benefits including increasing facility delivery and women's adherence to postnatal care services.

Engineering World Health (EWH) developed and executed a unique model to train biomedical technicians (BMET) in Rwanda, Honduras, and Cambodia. This model significantly decreased out-of-service equipment, one to two years after the training’s initiation, when comparing hospitals with EWH trained BMETs to similar hospitals with BMETs without EWH training [1–4]. Despite this model’s past evidence of impact, no study has shown evidence for sustained impact and continued delivery of services after the termination of funding. Here, one year after external funding ended for the EWH Honduras program, the model’s sustainability was assessed using qualitative interviews guided by an established sustainability framework and quantitative measures of continued impact on out-of-service rates of medical equipment. Interviews found the program, institutionalized within a technical training college, was strongly sustainable in each domain of an established sustainability framework. Additionally, there was evidence of continuing production of benefits to the health system. Technicians whose training through EWH had ended two years earlier had 35.37% less out-of-service equipment compared to similarly sized control hospitals, demonstrating continued impact of training (p < .0001). Overall, the program in Honduras was found to be strongly sustainable, albeit with some threats to continued sustainability.

A substantial amount of equipment is out-of-service in the developing world. Out-of-service equipment limits access to important medical procedures. We measured the amount of out-of-service donated, purchased and loaned medical equipment and documented the barriers to returning them to service in hospitals in Honduras, Rwanda and Cambodia. From 2010 to 2012, we completed a cross-sectional survey of 3421 pieces of medical equipment in five departments from 64 hospitals. The time since arrival, source (donated, purchased or loaned), service contract status and functionality were determined. For any partially or non-functional equipment, the barriers to placing the equipment back into service were documented. In the first year, donated equipment was significantly more likely to be out-of-service than purchased and loaned equipment combined (p < 0.01), where the latter presumably gets more hospital scrutiny before acquisition. But, purchased equipment was more likely to be out-of-service than donated equipment 5 to 6 years after arrival (p < 0.05). Loaned equipment had the highest in-service rates. Service contracts did not significantly decrease out-of-service rates, except for high-complexity equipment (p < 0.001). The largest barrier to placing equipment back into service, according to technicians, was access to spare parts, accessories and consumables. Given the considerable out-of-service rates, the most sustainable and efficacious points of intervention could be the training of local technicians and leasing (rather than donating or purchasing) equipment in order to improve the availability of medical equipment and thus increase access to medical procedures.

Introduction: Modern day antiretroviral therapy allows HIV+ pregnant women to lower the likelihood of viral transmission to their infants before, during, and after birth from 20-45% to less than 5%. In developing countries, where non-facility births may outnumber facility births, infant access to safe antiretroviral medication during the critical first three days after birth is often limited. A single-dose, polyethylene pouch (“Pratt Pouch”) addresses this challenge by allowing the medication to be distributed to mothers during antenatal care. Methods: The Pratt Pouch was introduced as part of a one year clinical feasibility study in two districts in Southern Province, Zambia. Participating nurses, community health workers, and pharmacists were trained before implementation. Success in achieving improved antiretroviral medication access was assessed via pre intervention and post intervention survey responses by HIV+ mothers. Results: Access to medication for HIV-exposed infants born outside of a health facility increased from 35% (17/51) before the introduction of the pouch to 94% (15/16) after (p<0.05). A non-significant increase in homebirth rates from 33% (pre intervention cohort) to 50% (post intervention cohort) was observed (p>0.05). Results remained below the national average homebirth rate of 52%. Users reported minimal spillage and a high level of satisfaction with the Pratt Pouch. Conclusion: The Pratt Pouch enhances access to infant antiretroviral medication in a rural, non-facility birth setting. Wide scale implementation could have a substantial global impact on HIV transmission rates from mother to child.

Background: In developing countries, antiretroviral therapy provides life-saving treatment to HIV-positive women and their children before, during and after birth. However, supply chain challenges such as long distances, medication shortages and nonfacility deliveries often compromise consistent access to prophylactic treatment for at-risk infants. A proposed intervention to address these challenges, often referred to as the "Pratt Pouch," allows for liquid-formulation medications, such as nevirapine (NVP), to be repackaged into single-dose pouches. These pouches are distributed antenatally.Methods: HIV-positive women at Kilimanjaro Christian Medical Centre in Moshi, Tanzania received 14 pouches each containing a single dose of NVP for prevention of mother-to-child transmission. Women were trained on how to open the pouch and dispense the medication to their infants after delivery. All participating women were asked to return to Kilimanjaro Christian Medical Centre 7-14 days after delivery, where infant blood spots were collected to assess NVP levels.Results: All enrolled women (21/21) administered NVP to their infants within 24 hours of birth. All enrolled infants (22/22) had NVP blood concentrations over 100 ng/mL and exhibited no health concerns attributable to over or under dosing.Conclusions: The Pratt Pouch intervention provides a clinically appropriate solution for addressing liquid-formulation antiretroviral access challenges in developing countries.

Mother-to-child HIV transmission rates remain elevated in countries with high home birth rates. This risk can be dramatically reduced if infants receive antiretroviral (ARV) medication within 24 hours after birth. However, many barriers prevent access to these medications immediately after delivery, for example, there is currently no suitable mechanism to preserve predosed ARVs in the home during the months before birth. In response to this, students of the Duke University developed the Pratt pouch, a foilized polyethylene packet designed to preserve predosed ARVs.This cross-sectional study presents the data from the first clinical trials of the Pratt pouch in Guayaquil, Ecuador.Fourteen HIV-positive mothers and nurses were observed using the pouch to deliver a dose of ARVs to an infant. Weight measurements, time, and notes on spillage were taken at each observation period. Successful usage was quantitatively assessed through the calculation of dosing accuracy based on the volume of liquid medication emptied from the pouch. Additionally, mothers were surveyed after a month of using the device at home to assess their perception of the accuracy, acceptability, and ease of use of the pouch. Used pouches were collected for physical analysis of tearing.Observed users delivered accurate doses (M = 101.1%, standard deviation = 8.2%) in an average time of 2.6 minutes. A total of 2869 used pouches were recovered. No seal failures or failed attempts at opening/delivering the pouches were observed or detected. Forty-three mothers were surveyed. All mothers (100%) reported that they were able to follow their physician's treatment plan, all pouches were received in good condition and the pictorial sheets provided clear instructions.We conclude that the Pratt pouch is a highly accurate and easy-to-use device for delivering liquid oral ARVs to infants and is appropriate for prepackaging ARVs for home use.

Children can become HIV positive (HIV+) from their mother during home birth.If the infant ingests antiretroviral (ARV), medications immediately after birth, the risk of transmission can be dramatically reduced.We have previously proposed the use of foilized, polyethylene-lined pouches to store ARV's.Using the pouch, the mother receives the medication at an antenatal care visit, months before delivery, and if she delivers at home, tears open the pouch and drips the medication into her child's mouth.In this work, we extend the use of the pouch to store a modern ARV, Lamivudine (3TC), often used in multi-drug regimens.Under laboratory conditions, pouches were filled with 3TC and stored at 25˚C/60% relative humidity (RH) for twelve months.We found that the 3TC was stable throughout the year (maximum 5.6% of labeled concentration change).The preservatives were somewhat degraded by the act of repackaging the medicine, but sufficient preservatives remained to maintain the medication.The same impurities were identified in the 3TC stored in the pouches and the samples removed from the bottles indicating that the pouches do not introduce new impurities (impurities that are not already introduced by the bottle).We conclude that the pouch can preserve this modern ARV for up to twelve months.

A barrier to keeping medical equipment in service in low resource settings is access to knowledge on how to maintain and repair medical equipment. In order to address this barrier, Engineering World Heath and Robert Malkin's Developing World Healthcare Technologies Lab (DHT) at Duke University have created a digital library of open source materials. The library contains information on anatomy and physiology, basic technician skills, electronics, Healthcare Technology Management, and mathematics. The library uses Google translate to provide the material in multiple languages. To understand if the library is useful to technicians in a variety of contexts the DHTLab undertook a pilot study with technicians and engineers from Uganda, Cambodia, Kenya, France, and Honduras. The pilot aims to gather data on two main areas: the usability and utility of the library.

Two engineering professors founded Engineering World Health (EWH) in 2001 with the initial goal of sending refurbished medical equipment to hospitals in the developing world. That mission quickly changed to a more sustainable, student-driven model where students spend nine weeks in a Tanzania, Nicaragua or Rwanda. Despite the linguistic, technical and cultural challenges, students are very successful. For example, in 2013 alone, they worked on 602 pieces of non-functioning hospital medical equipment and were able to place 73% of it back into service. The creation of university-based chapters as an integral part of the summer program has allowed EWH to expand the impact of the program on both the hospitals and the students themselves. An essential element in the continued success and growth of the summer institute has been a rigorous admissions process.

Many children become HIV+ due to mother-to-child transmission during home birth. This risk can be largely eliminated if infants ingest antiretroviral (ARV) medications immediately after birth. Unfortunately, there is currently no mechanism to provide dosed medication at a mothers first and perhaps only, antenatal care visit, months before delivery. We propose a foilized, polyethylene pouch to preserve pre-dosed ARV's. In this work we show that pharmacists can fill and seal the pouch, the pouch can preserve the medication and HIV+ mothers can empty the pouch into a simulated infant's mouth. A pharmacists in Moshi Tanzania was trained and then filled and sealed 60 pouches which were tested for their effect on the medication, their mechanical strength (burst and leakage) and their volume accuracy. Under laboratory conditions, pouches from two manufacturers were filled with AZT and NVP (two common ARV's) and stored in conditions ranging from 25o C/60% relative humidity (RH) to 40o C/75% RH for twelve (AZT) or four (NVP) months. Sixty-one HIV+ mothers were asked to tear open pouches and empty the contents into plastic cups of approximately the size and shape of an infant's mouth. No pharmacist sealed pouches burst or leaked (average percent weight loss maximum 0.080%). The AZT (102.2% of labeled concentration) and NVP (96.4%) in the pharmacist sealed pouches were stable. Pharmacist handling of the mediation did consume some of the sacrificial preservatives (72.4% remaining in AZT and 40.2% remaining for NVP) but not enough to affect the active ingredient. The same impurities were identified in the NVP and AZT samples sealed in Africa and the NVP and AZT samples removed from the bottles indicating that the pouches do not introduce impurities that are not already introduced from the bottle. The pharmacist filled pouches with an overall volume error of 0.13% +/- 6.6%. When the pouches were filled under laboratory conditions, there was no significant change in AZT (97.4% to 97.9%) or NVP (102.3% to 101.9%) concentrations after months of storage. All tested mothers were easily able to empty the contents of the pouch (89.8%: NVP, 89.7%, AZT) into the simulated mouth. We conclude that the pouch can be sealed by pharmacists in in realistic settings, the pouch can preserve the medication for months and HIV+ mothers can open the pouch and empty its contents.

In Brief This article assesses the impact of a unique evidence-based biomedical equipment technician training program on the healthcare infrastructure and the productivity of technicians in Rwanda. Matched cohorts of hospitals included 9 technicians who received no training and 11 with 1 year of training. Equipment from selected departments were surveyed and classified based on functionality and use. Technician and hospital director interviews included management processes and requests for technical assistance and details of equipment repairs from the past 12 months. Obstacles to returning partially functional and out-of-service equipment to use were recorded. Nearly twice as much equipment is out of service at hospitals where the technicians are not trained (10.2% vs 17.8%, P < .01). Trained technicians show 114% higher productivity and are using more of the unique elements of the curriculum than nontrained technicians P < .05). Biomedical equipment technicians seek assistance 3 times more often within Rwanda (245% increase, P < .05) and 5 times more outside Rwanda (461%, P < .001). Technicians who completed 1 year of this unique biomedical equipment technician training program are dramatically improving healthcare by effectively using and sharing taught skills. This article assesses the impact of a unique evidence-based biomedical equipment technician training program on the healthcare infrastructure and the productivity of technicians in Rwanda. Matched cohorts of hospitals included 9 technicians who received no training and 11 with 1 year of training.

A new product has completed clinical trials in a distant, resource poor hospital using a few dozen prototypes. The data looks great. The novel medical device solves a widely felt problem. The next goal is to integrate the device into the country’s healthcare system and spread the device to other countries. But how? In order to be widely used, the device must be manufactured and distributed. One option is to license the intellectual property (IP) to an interested third party, if one can be found. However, it is possible to manage the manufacturing and distribution without licensing. There are at least two common means for manufacturing a novel medical device targeted to resource poor settings: (a) formal (contract) manufacturing and (b) informal (local) manufacturing. There are three primary routes to diffusion of novel medical devices in the developing world: (1) local distributors (2) direct international sales and (3) international donations. Perhaps surprisingly, the least effective mechanism is direct importation through donation. The most successful mechanism, the method used by nearly all working medical devices in resource-poor settings, is the use of contract manufacturing and a local distributor. This article is written for the biomedical innovator and entrepreneur who wishes to make a novel healthcare technology or product available and accessible to healthcare providers and patients in the developing world. There are very few documented cases and little formal research in this area. To this end, this article describes and explores the manufacturing and distribution options in order to provide insights into when and how each can be applied to scale up a novel technology to make a difference in a resource poor setting.

Many children become HIV+ due to mother-to-child transmission, a risk that can be largely eliminated if infants ingest antiretroviral (ARV) medications immediately after birth. As most mothers in Africa deliver at home, the ARV must be provided at their last antenatal visit, sometimes months before birth. No current drug delivery system allows the mother to store the medication at home long enough to be effective. We propose a preserving, foilized, polyethylene pouch to be pre-dosed and sealed by a pharmacist for later delivery to the newborn.Pouches were filled with 0.6 ml of Nevirapine (NVP). Thirty-three pouches were immediately studied to measure the impact of medication handling (oxygen, light, filling and sealing the pouches). The remaining samples were stored for up to one year at three storage conditions (25°C/60%RH, 30°C/65%RH, and 40°C/75%RH). Every two months, moisture loss, preservative concentration, impurity concentrations and NVP concentration were measured. Flora and fauna challenges were conducted.THE POUCH NEARLY ELIMINATED MOISTURE LOSS: pouches lost less than 0.7% of their weight over twelve months. As expected, exposing the medication to light, oxygen, and handling significantly affected the sacrificial preservative concentrations (Propyl paraben dropped 38%, Methyl paraben dropped 12% at time point zero). However, after the initial time point, preservative levels were stable in the package over twelve months under all storage conditions (4.1% average concentration drop), leaving sufficient preservatives to protect the medication. The concentration of NVP changed an average of only 1.3% over all storage conditions and times points (maximum 1.4%).We conclude that the foilized polyethylene pouch can preserve NVP, and perhaps other ARV's, for up to one year.

The Developing World Healthcare Technology Laboratory (DHTLab) at Duke University has developed a comprehensive, open-source biomedical equipment technician's (BMET) library. In this work we experimented with making the DHTLab BMET library and medical equipment manuals available via electronic reader (e-reader). In this paper we describe an early deployment of e-readers to Haiti. The results were mixed. One Kindle machine was damaged in shipping. A Sony reader's charger was forgotten in the US. Preliminary information suggests that the technicians are capable of using the e-readers to view documents without training. Interviewed technicians were enthusiastic about the readers. In conclusion, these devices have the ability to solve several long standing issues for BMET's in resource-poor settings: 1) They have the potential to translate a library into multiple languages; 2) They are easily stored and maintained, potentially remotely; 3) They can receive and store manuals for equipment that the hospital owns, circumventing the need for generic copyright permissions. But, the technology is in an early stage and more work is needed.

The Developing World Healthcare Technology Laboratory (DHTLab) at Duke University recently developed the first evidence-based approach to training technicians to repair and maintain medical equipment in resource-poor settings, the BTA program. In this paper we describe a matched-pair study of hospitals with and without a BTA trained technician in Rwanda. Hospitals without a BTA trained technician had 54% more out-of-service equipment (14.8%) in critical clinical areas than hospitals with BTA trained technicians (9.6%). We conclude that the new curriculum has a significant impact on the healthcare of the hospitals.