Browsing by Author "Oden, Z. Maria"
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Item A Shipping Container-Based Sterile Processing Unit for Low Resources Settings(Public Library of Science, 2016) Boubour, Jean; Jenson, Katherine; Richter, Hannah; Yarbrough, Josiah; Oden, Z. Maria; Schuler, Douglas A.; Rice 360 Institute of Global HealthDeficiencies in the sterile processing of medical instruments contribute to poor outcomes for patients, such as surgical site infections, longer hospital stays, and deaths. In low resources settings, such as some rural and semi-rural areas and secondary and tertiary cities of developing countries, deficiencies in sterile processing are accentuated due to the lack of access to sterilization equipment, improperly maintained and malfunctioning equipment, lack of power to operate equipment, poor protocols, and inadequate quality control over inventory. Inspired by our sterile processing fieldwork at a district hospital in Sierra Leone in 2013, we built an autonomous, shipping-container-based sterile processing unit to address these deficiencies. The sterile processing unit, dubbed “the sterile box,” is a full suite capable of handling instruments from the moment they leave the operating room to the point they are sterile and ready to be reused for the next surgery. The sterile processing unit is self-sufficient in power and water and features an intake for contaminated instruments, decontamination, sterilization via non-electric steam sterilizers, and secure inventory storage. To validate efficacy, we ran tests of decontamination and sterilization performance. Results of 61 trials validate convincingly that our sterile processing unit achieves satisfactory outcomes for decontamination and sterilization and as such holds promise to support healthcare facilities in low resources settings.Item Abdominal Fat Suspension Device for Maintaining Normal Cardiorespiratory Function in Patients Undergoing Conscious Sedation during Surgery: A Feasibility Study(Texas Heart Institute, 2014) Truong, Norman F.; Nathan, Joanna C.; Yoon, Daeun; Ochoa, Gabriel; Prevost, Marisa; Yun, Sehyun; Oden, Z. Maria; Razavi, MehdiObese patients undergoing conscious-sedation surgery have increased perioperative morbidity because their excess abdominal tissue limits diaphragmatic excursion. We describe a simple device that might help attenuate this risk. We created a noninvasive suction device for abdominal suspension. By lifting the burden of excess weight, this device should decrease respiratory effort. To test the feasibility of excess weight removal in relieving cardiac stress, we tested 22 supine, healthy, normal-weight subjects by measuring their heart rates with and without a 13-kg tissue model on their abdomen to simulate excess weight. There was no significant difference in blood oxygen saturation before and after weight removal (P=0.318). However, the decrease in heart rate was significant (P <0.0001; paired 2-sample, one-tailed t test), which implies decreased respiratory effort. This result suggests the possibility that abdominal mass suspension in obese patients is associated with decreased respiratory effort.Item AutoSyP: A Low-Cost, Low-Power Syringe Pump for Use in Low-Resource Settings(The American Society of Tropical Medicine and Hygiene, 2016) Juarez, Alexa; Maynard, Kelley; Skerrett, Erica; Molyneux, Elizabeth; Richards-Kortum, Rebecca; Dube, Queen; Oden, Z. Maria; Rice 360: Institute for Global Health TechnologiesThis article describes the design and evaluation of AutoSyP, a low-cost, low-power syringe pump intended to deliver intravenous (IV) infusions in low-resource hospitals. A constant-force spring within the device provides mechanical energy to depress the syringe plunger. As a result, the device can run on rechargeable battery power for 66 hours, a critical feature for low-resource settings where the power grid may be unreliable. The device is designed to be used with 5- to 60-mL syringes and can deliver fluids at flow rates ranging from 3 to 60 mL/hour. The cost of goods to build one AutoSyP device is approximately $500. AutoSyP was tested in a laboratory setting and in a pilot clinical study. Laboratory accuracy was within 4% of the programmed flow rate. The device was used to deliver fluid to 10 healthy adult volunteers and 30 infants requiring IV fluid therapy at Queen Elizabeth Central Hospital in Blantyre, Malawi. The device delivered fluid with an average mean flow rate error of −2.3% ± 1.9% for flow rates ranging from 3 to 60 mL/hour. AutoSyP has the potential to improve the accuracy and safety of IV fluid delivery in low-resource settings.Item Avoid equipment graveyards: rigorous process to improve identification and procurement of effective, affordable, and usable newborn devices in low-resource hospital settings(Springer Nature, 2023) Asma, Elizabeth; Heenan, Megan; Banda, George; Kirby, Rebecca P.; Mangwiro, Lucky; Acemyan, Claudia Ziegler; Palamountain, Kara M.; Kortum, Philip; Kawaza, Kondwani; Oden, Z. Maria; Richards-Kortum, Rebecca; Brandt, Alexsandra; Kumara, Danica; Jin, Li; Khalid, Ali; Osoo, Cliff; Bisceglia, Nicki; Gate, Vince; Valle, Maureen; Mjumira, Rowland; Chapin, Abby; Shapiro, Alyssa; Samuel, Christina; Kimmey, David; Belton, M. Grant; Wang, Yifan Jack; Johnston, Jake; Anderson, Jessica; Bailey, Joseph; Coyle, Josh; Gordon, Kaede; Weld, Madeleine Tadros; Bond, Meaghan; Mitchell, Natalie; Mobarhan, Sara Liaghati; Salter, Sarah Elina; Matin, Shababa B.; Saenz, Sonia E. Sosa; Kalikoff, Sylvie; Boles, Taylor; Technical Collaborative Authorship Group; Rice360 Institute for Global Health TechnologiesMillions of newborns die annually from preventable causes, with the highest rates occurring in Africa. Reducing neonatal mortality requires investment to scale hospital care, which includes providing hospitals with appropriate technology to care for small and sick newborns. Expensive medical devices designed for high-resource settings often fail to withstand conditions in low-resource hospitals, including humidity, dust, frequent user turnover, complex maintenance, lack of stable power, or difficulty sourcing expensive consumables. Rigorous evaluation protocols are needed to identify effective, affordable, rugged, and easy-to-use medical devices appropriate for quality hospital-based newborn care in low-resource hospitals.Item Evaluation of a low-cost, low-power syringe pump to deliver magnesium sulfate intravenously to pre-eclamptic women in a Malawian referral hospital(BioMed Central, 6/19/2017) Skerrett, Erica; Kommwa, Edward; Maynard, Kelley; Juarez, Alexa; Mataya, Ronald; Richards-Kortum, Rebecca; Oden, Z. MariaBackground: Magnesium sulfate is an affordable and effective treatment for pre-eclampsia and eclampsia. In settings where infusion pumps are not available to regulate the flow rate of intravenous delivery, healthcare providers must administer magnesium sulfate (MgSO4) via time-consuming and painful, large-volume intramuscular injections. As an alternative to costly commercially available syringe pumps, we developed AutoSyp, an accurate, low-cost, and low-powered syringe pump designed to meet the needs and constraints these low-resource settings. This paper describes results of a pilot study to evaluate the feasibility of using AutoSyp to administer MgSO4 intravenously to women suffering from pre-eclampsia at a referral hospital in Blantyre, Malawi. Methods: AutoSyp was programmed to deliver MgSO4 following the Zuspan regimen to pregnant and post-partum women suffering from pre-eclampsia at Queen Elizabeth Central Hospital in Blatnyre, Malawi. Given the selection of either loading or maintenance dose on AutoSyp’s user interface, the flow rate was automatically programmed to dispense 60 mL/h or 5 mL/h of 20% MgSO4 solution, respectively. During each treatment, the dispensed volume was automatically calculated by the device based on the plunger position and stored on a computer for accuracy analysis of the mean flow rate and total volume delivered. The clinical results for both the loading and maintenance dose administrations were compared to the device’s accuracy during tests performed in the laboratory setting. Results: Twenty-two women were enrolled in this study. In both the clinical and laboratory settings, the mean flow rate errors for the loading and maintenance dose infusions were under 2%. During 466 h of testing, the device sounded 129 occlusion alarms across 14 subjects. Of these, 71 alarms were false positives. Conclusion: Results of this study support the use of AutoSyp as a less painful and accurate means of MgSO4 administration in clinical environments that lack infusion systems. There were a large number of false alarms in the current system which will be addressed in future designs. AutoSyp maintains the comfort of intravenous MgSO4 administration, but unlike commercially available syringe pumps, it is capable of operating with a variety of syringe brands and sizes and requires no additional consumables. AutoSyp’s appropriate design will benefit its implementation and sustained use in low-resource settings. Trial Registration: Trial registered prospectively on November 18, 2014 with ClinicalTrials.gov (NCT02296931)Item In vitro comparison of performance including imposed work of breathing of CPAP systems used in low-resource settings(Public Library of Science, 2020) Heenan, Megan; Rojas, Jose D.; Oden, Z. Maria; Richards-Kortum, Rebecca; Rice 360°: Institute for Global HealthRespiratory distress due to preterm birth is a significant cause of death in low-resource settings. The introduction of continuous positive airway pressure (CPAP) systems to treat respiratory distress significantly reduced mortality in high-resource settings, but CPAP was only recently introduced in low-resource settings due to cost and infrastructure limitations. We evaluated pressure stability and imposed work of breathing (iWOB) of five CPAP systems used in low resource settings: the Fisher and Paykel bubble CPAP, the Diamedica baby CPAP, the Medijet nCPAP generator, and the first (2015) and second (2017) generation commercially available Pumani CPAPs. Pressure changes due to fresh gas flow were evaluated for each system by examining the relationship between flow and pressure at the patient interface for four pressures generated at the bottle (0, 3, 5, and 7 cm H2O); for the Medijet nCPAP generator, no bottle was used. The slope of the resulting relationship was used to calculate system resistance. Poiseuille’s law of resistance was used to investigate significant contributors to resistance. Resistance ranged from 0.05 to 1.40 ; three CPAP devices had resistances < 0.4 : the Fisher and Paykel system, the Diamedica system, and the second generation Pumani bubble CPAP. The other two systems, the Medijet nCPAP generator and the first generation Pumani bCPAP, had resistances >1.0 . Imposed WOB was measured using an ASL5000 test lung to simulate the breath cycle for an infant (5.5 kg), a term neonate (4.0 kg), and a preterm neonate (2.5 kg). Imposed WOB ranged from 1.4 to 39.5 mJ/breath across all systems and simulated infant sizes. Changes in pressure generated by fresh gas flow, resistance, and iWOB differ between the five systems evaluated under ideal laboratory conditions. The available literature does not indicate that these differences affect clinical outcomes.Item Novel open-source electronic medical records system for palliative care in low-resource settings(BioMed Central, 2013) Shah, Kamal G.; Slough, Tara Lyn; Yeh, Ping Teresa; Gombwa, Suave; Kiromera, Athanase; Oden, Z. Maria; Richards-Kortum, Rebecca R.; Rice 360: Institute for Global Health TechnologiesBackground: The need for palliative care in sub-Saharan Africa is staggering: this region shoulders over 67% of the global burden of HIV/AIDS and cancer. However, provisions for these essential services remain limited and poorly integrated with national health systems in most nations. Moreover, the evidence base for palliative care in the region remains scarce. This study chronicles the development and evaluation of DataPall, an open-source electronic medical records system that can be used to track patients, manage data, and generate reports for palliative care providers in these settings. DataPall was developed using design criteria encompassing both functional and technical objectives articulated by hospital leaders and palliative care staff at a leading palliative care center in Malawi. The database can be used with computers that run Windows XP SP 2 or newer, and does not require an internet connection for use. Subsequent to its development and implementation in two hospitals, DataPall was tested among both trained and untrained hospital staff populations on the basis of its usability with comparison to existing paper records systems as well as on the speed at which users could perform basic database functions. Additionally, all participants evaluated this program on a standard system usability scale. Results: In a study of health professionals in a Malawian hospital, DataPall enabled palliative care providers to find patients' appointments, on average, in less than half the time required to locate the same record in current paper records. Moreover, participants generated customizable reports documenting patient records and comprehensive reports on providers' activities with little training necessary. Participants affirmed this ease of use on the system usability scale. Conclusions: DataPall is a simple, effective electronic medical records system that can assist in developing an evidence base of clinical data for palliative care in low resource settings. The system is available at no cost, is specifically designed to chronicle care in the region, and is catered to meet the technical needs and user specifications of such facilities.Item Target product profiles for neonatal care devices: systematic development and outcomes with NEST360 and UNICEF(Springer Nature, 2023) Kirby, Rebecca P.; Molyneux, Elizabeth M.; Dube, Queen; McWhorter, Cindy; Bradley, Beverly D.; Gartley, Martha; Oden, Z. Maria; Richards-Kortum, Rebecca; Werdenberg-Hall, Jennifer; Kumara, Danica; Liaghati-Mobarhan, Sara; Heenan, Megan; Bond, Meaghan; Ezeaka, Chinyere; Salim, Nahya; Irimu, Grace; Palamountain, Kara M.; Manasyan, Albert; Worm, Anna; Zuechner, Antke; Chepkemoi, Audrey; Tembo, Bentry; Trubo, Casey; Mudenyanga, Chishamiso; Wald, Daniel; Goldfarb, David; Gicheha, Edith; Asma, Elizabeth; Ciccone, Emily; Mbale, Emmie; Gheorghe, Florin; Dumont, Guy; Naburi, Helga; Pernica, Jeffrey; Appiah, John; Strysko, Jonathan; Langton, Josephine; Lawn, Joy; Klein, Kate; Kawaza, Kondwani; Gandrup-Marino, Kristoffer; Lloyd, Lizel; Woo Kinshella, Maggie; Chise, Mamiki; Myszkowski, Marc; Mkony, Martha Franklin; Waiyego, Mary; Khoory, Matthew; Medvedev, Melissa; Chiume, Msandeni; Spotswood, Naomi; Mataruse, Noah; Lufesi, Norman; Lincetto, Ornella; Lavoie, Pascal; Mbuthia, Rachel; Chifisi, Rhoda; Owino, Rita; Moshiro, Robert; Mbwasi, Ronald; Akech, Sam; Shah, Sona; Reschwamm, Steffen; Adudans, Steve; Mogotsi, Thabiso; Karlen, Walter; Demeke, Zelalem; the TPP Survey, Consensus Meeting Participants Collaborative Authorship Group; Rice360 Institute for Global Health TechnologiesMedical devices are critical to providing high-quality, hospital-based newborn care, yet many of these devices are unavailable in low- and middle-income countries (LMIC) and are not designed to be suitable for these settings. Target Product Profiles (TPPs) are often utilised at an early stage in the medical device development process to enable user-defined performance characteristics for a given setting. TPPs can also be applied to assess the profile and match of existing devices for a given context.