Avoid equipment graveyards: rigorous process to improve identification and procurement of effective, affordable, and usable newborn devices in low-resource hospital settings.

BACKGROUND: Millions 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. METHODS: We developed an evidence-based technology review process to identify medical devices suitable for small and sick newborn care in low-resource hospitals. The eight-step process consists of: identifying devices needed for effective newborn care; defining Target Product Profiles (TPPs); identifying commercially-available products that may meet TPPs; conducting desk research to evaluate technologies against TPPs; performing technical performance verification testing under laboratory conditions; verifying technical performance after exposure to heat, humidity, dust, and power loss; performing usability evaluations with nurses, and qualifying devices that pass all steps. Devices were purchased, installed, and monitored in newborn wards across Kenya, Malawi, Nigeria, and Tanzania. RESULTS: Of 271 devices considered, only 45 (16.6%) met corresponding TPPs based on desk research. Thirty-nine were purchased and evaluated in the laboratory; five (12.8%) failed to meet TPPs. Thirty-four products passing laboratory evaluation underwent short-term environmental testing; only one (2.9%) device failed. Thirty-seven products underwent usability testing with 127 clinicians; surprisingly, 14 (37.8%) failed to meet TPPs. Twenty-three products passed all evaluations, and 2457 devices were installed across 65 newborn wards in Kenya, Malawi, Nigeria, and Tanzania. Continuous device monitoring reported minimal device failures, with failed devices typically returned to service within two days, resulting in an average uptime (service days divided by days installed) of 99%. CONCLUSION: An evidence-based device selection process can improve procurement of effective, affordable, rugged, usable newborn care devices for low-resource hospitals, and feedback to manufacturers can improve device quality. Similar processes could be adapted beyond newborn care to identify medical devices suitable for implementation in any low-resource setting.

Target product profiles for neonatal care devices: systematic development and outcomes with NEST360 and UNICEF.

BACKGROUND: Medical 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. METHODS: We developed initial TPPs for 15 newborn product categories for LMIC settings. A Delphi-like process was used to develop the TPPs. Respondents completed an online survey where they scored their level of agreement with each of the proposed performance characteristics for each of the 15 devices. Characteristics with < 75% agreement between respondents were discussed and voted on using Mentimeter™ at an in-person consensus meeting. FINDINGS: The TPP online survey was sent to 180 people, of which 103 responded (57%). The majority of respondents were implementers/clinicians (51%, 53/103), with 50% (52/103) from LMIC. Across the 15 TPPs, 403 (60%) of the 668 performance characteristics did not achieve > 75% agreement. Areas of disagreement were voted on by 69 participants at an in-person consensus meeting, with consensus achieved for 648 (97%) performance characteristics. Only 20 (3%) performance characteristics did not achieve consensus, most (15/20) relating to quality management systems. UNICEF published the 15 TPPs in April 2020, accompanied by a report detailing the online survey results and consensus meeting discussion, which has been viewed 7,039 times (as of January 2023). CONCLUSIONS: These 15 TPPs can inform developers and enable implementers to select neonatal care products for LMIC. Over 2,400 medical devices and diagnostics meeting these TPPs have been installed in 65 hospitals in Nigeria, Tanzania, Kenya, and Malawi through the NEST360 Alliance. Twenty-three medical devices identified and qualified by NEST360 meet nearly all performance characteristics across 11 of the 15 TPPs. Eight of the 23 qualified medical devices are available in the UNICEF Supply Catalogue. Some developers have adjusted their technologies to meet these TPPs. There is potential to adapt the TPP process beyond newborn care.

Devices and furniture for small and sick newborn care: systematic development of a planning and costing tool.

BACKGROUND: High-quality neonatal care requires sufficient functional medical devices, furniture, fixtures, and use by trained healthcare workers, however there is lack of publicly available tools for quantification and costing. This paper describes development and use of a planning and costing tool regarding furniture, fixtures and devices to support scale-up of WHO level-2 neonatal care, for national and global newborn survival targets. METHODS: We followed a systematic process. First, we reviewed planning and costing tools of relevance. Second, we co-designed a new tool to estimate furniture and device set-up costs for a default 40-bed level-2 neonatal unit, incorporating input from multi-disciplinary experts and newborn care guidelines. Furniture and device lists were based off WHO guidelines/norms, UNICEF and national manuals/guides. Due to lack of evidence-based quantification, ratios were based on operational manuals, multi-country facility assessment data, and expert opinion. Default unit costs were from government procurement agency costs in Kenya, Nigeria, and Tanzania. Third, we refined the tool by national use in Tanzania. RESULTS: The tool adapts activity-based costing (ABC) to estimate quantities and costs to equip a level-2 neonatal unit based on three components: (1) furniture/fixtures (18 default but editable items); (2) neonatal medical devices (16 product categories with minimum specifications for use in low-resource settings); (3) user training at device installation. The tool was used in Tanzania to generate procurement lists and cost estimates for level-2 scale-up in 171 hospitals (146 District and 25 Regional Referral). Total incremental cost of all new furniture and equipment acquisition, installation, and user training were US$93,000 per District hospital (level-2 care) and US$346,000 per Regional Referral hospital. Estimated cost per capita for whole-country district coverage was US$0.23, representing 0.57% increase in government health expenditure per capita and additional 0.35% for all Regional Referral hospitals. CONCLUSION: Given 2.3 million neonatal deaths and potential impact of level-2 newborn care, rational and efficient planning of devices linked to systems change is foundational. In future iterations, we aim to include consumables, spare parts, and maintenance cost options. More rigorous implementation research data are crucial to formulating evidence-based ratios for devices numbers per baby. Use of this tool could help overcome gaps in devices numbers, advance efficiency and quality of neonatal care.

In vitro comparison of performance including imposed work of breathing of CPAP systems used in low-resource settings.

Respiratory 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 [Formula: see text]; three CPAP devices had resistances < 0.4 [Formula: see text]: 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 [Formula: see text]. 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.

Evaluation of a continuous neonatal temperature monitor for low-resource settings: a device feasibility pilot study.

OBJECTIVE: Evaluate a novel continuous temperature monitor in a low-resource neonatal ward. DESIGN: We developed a low-cost continuous neonatal temperature monitor (NTM) for use in low-resource settings. Accuracy of NTM was initially assessed in the laboratory. Clinical evaluation then was performed in a neonatal ward in a central hospital in Malawi; eligible neonates (<1 week of age) were recruited for continuous temperature monitoring with NTM and a Philips Intellivue MP30 Patient Monitor. INTERVENTIONS AND OUTCOME MEASURES: The temperature probes of NTM and the reference patient monitor were attached to the infant's abdomen, and core temperature was continuously recorded for up to 3 hours. Axillary temperatures were taken every hour. We compared temperatures measured using NTM, the patient monitor and the axillary thermometer. RESULTS: Laboratory temperature measurements obtained with NTM were within 0.059°C (range: -0.035°C to 0.195°C) of a reference thermometer. A total of 39 patients were recruited to participate in the clinical evaluation of NTM; data from four patients were excluded due to faulty hardware connections. The mean difference in measured temperatures between the NTM and the Intellivue MP30 was -0.04°C (95% CI -0.52°C to 0.44°C). CONCLUSION: NTM meets ISO 80601-2-56 standards for accuracy and is an appropriate, low-cost continuous temperature monitor for neonatal wards in low-resource settings. TRIAL REGISTRATION NUMBERS: NCT03965312 and NCT03866122.

Evaluation of a low-cost, low-power syringe pump to deliver magnesium sulfate intravenously to pre-eclamptic women in a Malawian referral hospital.

BACKGROUND: 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 ).

AutoSyP: A Low-Cost, Low-Power Syringe Pump for Use in Low-Resource Settings.

This 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.

A Shipping Container-Based Sterile Processing Unit for Low Resources Settings.

Deficiencies 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.

Outcomes of Patients with Respiratory Distress Treated with Bubble CPAP on a Pediatric Ward in Malawi.

OBJECTIVE: To describe the outcomes of infants and young children with respiratory distress when treated with a novel, low-cost, stand-alone bubble Continuous Positive Airway Pressure (bCPAP) system in a resource-limited setting. METHODS: A non-randomized, convenience sample study in a pediatric unit in Blantyre, Malawi, 2013. Patients weighing ≤10 kg with respiratory distress were eligible. We compared outcomes for patients with bronchiolitis, pneumonia and Pneumocystis jiroveci pneumonia (PJP) after treatment with bCPAP. RESULTS: Seventy percent of patients treated with bCPAP survived. Outcomes were best for patients with bronchiolitis and worst for those with PJP. Most survivors (80%) showed improvement within 24 h. All treating physicians found bCPAP useful, leading to a change in practice. CONCLUSIONS: Bubble CPAP was most beneficial to patients with bronchiolitis. Children, who were going to get well, tended to get well quickly. Physicians believed the bCPAP system provided a higher level of care than nasal oxygen.

Maji: a new tool to prevent overhydration of children receiving intravenous fluid therapy in low-resource settings.

We designed and evaluated the accuracy and usability of a device to regulate the volume of fluid dispensed during intravenous drip therapy. The mechanical system was developed in response to a pressing need articulated by clinicians in pediatric wards throughout sub-Saharan Africa, who require a tool to prevent overhydration in children receiving intravenous fluid in settings that lack burettes or electronic infusion pumps. The device is compatible with most intravenous bags and limits the volume dispensed to a preset amount that can be adjusted in 50 mL increments. Laboratory accuracy over a range of clinically-relevant flow rates, initial bag volumes, and target volumes was within 12.0 mL of the target volume. The ease of use is "excellent," with a mean system usability score of 84.4 out of 100. Use of the device limits the volume of fluid dispensed during intravenous therapy and could potentially reduce the morbidity and mortality associated with overhydration in children receiving intravenous therapy.

Abdominal fat suspension device for maintaining normal cardiorespiratory function in patients undergoing conscious sedation during surgery: a feasibility study.

Obese 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.

Novel open-source electronic medical records system for palliative care in low-resource settings.

BACKGROUND: 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.

A hand-powered, portable, low-cost centrifuge for diagnosing anemia in low-resource settings.

This report describes the development of a hand-powered centrifuge to determine hematocrit values in low-resource settings. A hand-powered centrifuge was constructed by using a salad spinner. Hematocrit values were measured by using the hand-powered device, and results were compared with those of a benchtop centrifuge. The packed cell volume (PCV) measured with the hand-powered device correlated linearly with results obtained with a benchtop centrifuge (r = 0.986, P < 0.001). The PCVs measured with the hand-powered centrifuge were consistently 1.14 times higher than those measured with the benchtop system. The 14% increase in PCV measured with the hand-powered centrifuge is caused by increased plasma trapped in the cell column. The reader card was adjusted to compensate for trapped plasma. A hand-powered centrifuge and calibrated reader card can be constructed for U.S. $35 and can accurately determine hematocrit values. It is suitable for use in low-resource settings because it is mechanically-powered, inexpensive, and accurate.

Portable, battery-operated, low-cost, bright field and fluorescence microscope.

This study describes the design and evaluation of a portable bright-field and fluorescence microscope that can be manufactured for $240 USD. The microscope uses a battery-operated LED-based flashlight as the light source and achieves a resolution of 0.8 microm at 1000x magnification in fluorescence mode. We tested the diagnostic capability of this new instrument to identify infections caused by the human pathogen, Mycobacterium tuberculosis. Sixty-four direct, decontaminated, and serially diluted smears were prepared from sputa obtained from 19 patients suspected to have M. tuberculosis infection. Slides were stained with auramine orange and evaluated as being positive or negative for M. tuberculosis with both the new portable fluorescence microscope and a laboratory grade fluorescence microscope. Concordant results were obtained in 98.4% of cases. This highly portable, low cost, fluorescence microscope may be a useful diagnostic tool to expand the availability of M. tuberculosis testing at the point-of-care in low resource settings.

Mechanical testing of small fracture implants for comparison of insertion and failure torques.

INTRODUCTION: Small fracture screws are among the most commonly used implants in the field of orthopedic surgery. The goal of this study was to compare the insertion and failure torques of three screw types: cortical, partially threaded cancellous, and fully threaded cancellous from three manufacturers: Zimmer, Richards, and Synthes. MATERIALS AND METHODS: Each type of screw was subjected to biomechanical tests to determine the insertion ( n=6/group) and failure ( n=10/group) torques. RESULTS: Two-factor ANOVA tests were run to determine whether the insertion or failure torques were different for the different screw types and manufacturers. In the case of insertion torques, neither the screw nor the manufacturer had any significant effect. In the case of failure torque, significant differences were found based on both the screw type and the manufacturer, with the cortical screws manufactured by Zimmer being the strongest. Although there were strength differences, the most important comparison clinically is between the failure torque and the insertion torque of each screw. In all cases, the failure torques were approximately 20 times larger than the insertion torques, and therefore no failures should occur if only torsional loads are applied during insertion. This comparison shows that factors other than screw strength and manufacturing processes may be involved in cases of screw failure during insertion. CONCLUSION: All three screw types from all three manufacturers appear to be mechanically reliable, with the proper insertion to failure torque ratio. The surgeon's choice of implant should be based on other considerations.