Pumani Bubble Continuous Positive Airway Pressure (bCPAP) Device
Hadleigh Health Technologies, Rice 360° and Queen Elizabeth Central Hospital
The Pumani bCPAP is a bubble continuous positive airway pressure (bCPAP) system to treat infants with respiratory distress syndrome in the developing world. The system delivers a blended flow of oxygen and room air.
GAVI Alliance countries and other developing country sites where there is an appropriate need for low-cost respiratory support for neonates and infants. Rice 360°, its partners, 3rd Stone Design and the Malawi Ministry of Health have scaled implementation of the device in all central and district hospitals in Malawi, as well as 12 district hospital in Zambia, Tanzania, and South Africa.Interview with representative
The Pumani bCPAP is now commercially available and has been distributed in 12 countries in Sub-Saharan Africa, Asia and Latin America.Interview with representativeRice 360° works with its partners to implement the bCPAP Pumani device in hospitals. Partners include the Malawian Ministry of Health, Médecins Sans Frontières (MSF), Save the Children. The Pumani bCPAP is distributed via Hadleigh Health Technologies (a subsidiary of 3rd Stone Design, Inc) located in San Rafael, CA.
Pumani is now being sold worldwide for $800 per unit.Interview with representative
Goal 3: to improve and promote good health.
Decrease in neonatal mortality related to respiratory distress syndrome. Conditions associated with premature birth, often related to breathing problems, are a leading cause of child mortality.
Healthcare professionals working in low-resource secondary and tertiary health facilities that provide neonatal care.^Interview ^with ^representative
3rd Stone Design and its subsidiary company, Hadleigh Health Technologies, have licensed the Pumani bCPAP from Rice and manufacture it in the US.Interview withrepresentative
Rice University has applied for a patent for the Pumani bCPAP. Interview with representative
The Pumani bCPAP is sold to individual clinicians, hospitals, and supporting organizations such as Ministries of Health or Non-Governmental Organizations engaged in providing neonatal and pediatric care. Hadleigh Health Technologies is the primary distributor for the system. Purchase inquiries can be submitted here
The Pumani bCPAP is now commercially available. 170 Pumani units have been distributed to date. The units were disseminated to 27 central and district government hospitals throughout Malawi and has been distributed in 12 countries in Sub-Saharan Africa, Asia and Latin America. Interview with representative
List or none.
Continuous, Recharging only, None, Other
The Pumani bCPAP is made of consumer-grade regulators and air pumps and opted for analog flow meters and gravimetric flow tubes, sheet metal casing, a flow generator, and a patient interface. The flow generator provides ambient airflow to the infant, and an optional oxygen port allows caregivers to treat patients with supplemental oxygen. Submersion of one end of the tubing in a bottle of water creates pressure. By increasing the depth of the tube, the caregiver increases the pressure and the production of bubbles. Pressurized flow helps prevent air sac collapse, thereby allowing the infant to breathe easier. Interview with representative
The Pumani is capable of delivering flow from 0 to 10 L/min and pressure from 5-8 cm H2O. Adjusting these settings is achieved by turning a knob or filling a water bottle. The device also has the ability to blend room air with oxygen from a concentrator or oxygen tank.
Dimensions: 48 x 38 x 31cm Weight: 12kg Power consumption: 15 Watts
BTB and RICE 360 students train the healthcare professionals in the use of the CPAP Pumani. A teaching module, user manual, and repair manual are included with the system HHD provides online training videos, documents and training aids to customers.
The system includes a spare parts kit. The pump filter is to be replaced every one to two years and is included with the device.
Pumani bCPAP is designed to run for years at a time and comes with a 2 year warranty.
The Pumani is suggested to provide the same therapeutic pressure as bCPAP systems in the United States. Additional details available in the published paper: A High-Value, Low-Cost Bubble Continuous Positive Airway Pressure System for Low-Resource Settings: Technical Assessment and Initial Case Reports, Published: January 23, 2013DOI: 10.1371/journal.pone.0053622
In 2012, results of the Pumani clinical trial conducted at Queen Elizabeth Central Hospital (QECH) in Blantyre, Malawi, showed that use of the Pumani to treat neonatal respiratory distress resulted in 27% absolute improvement in survival, as compared to patients treated with oxygen therapy. Additional details available in the published paper: Efficacy of a Low-Cost Bubble CPAP System in Treatment of Respiratory Distress in a Neonatal Ward in Malawi PLoS ONE 9(1): e86327. (2014) doi:10.1371/journal.pone.0086327
Rice University in Houston, Texas and Queen Elizabeth Central Hospital in Blantyre, Malawi
Common minor bCPAP complications can result such as facial and nasal irritation.
Pulse oximeter, respiratory rate timer, oxygen concentrator and suction machine.
Machen HE Kawaza K, et al., Efficacy of a low-cost bubble CPAP system in treatment of respiratory distress in a neonatal ward in Malawi. PLoS ONE. 2014; 9(1):e86327.Brown Jocelyn, et al., A High-Value, Low-Cost Bubble Continuous Positive Airway Pressure System for Low-Resource Settings: Technical Assessment and Initial Case Reports, Published: January 23, 2013DOI: 10.1371/journal.pone.0053622
Chen A, Deshmukh AA, Richards-Kortum R, Molyneux E, Kawaza K, Cantor SB. Cost-effectiveness analysis of a low-cost bubble CPAP device in providing ventilatory support for neonates in Malawi – a preliminary report. BMC Pediatr. 2014 Nov 25;14:288. doi: 10.1186/s12887-014-0288-1. PubMed PMID: 25421903; PubMed Central PMCID: PMC4247223.
Kawaza K, Machen HE, Brown J, Mwanza Z, Iniguez S, Gest A, et al. Efficacy of a Low-Cost Bubble CPAP System in Treatment of Respiratory Distress in a Neonatal Ward in Malawi PLoS ONE 9(1): e86327. (2014) doi:10.1371/journal.pone.0086327
Hadleigh Health Technologies is an ISO 13485 registered company Pumani bCPAP has received the CE Mark 0120. Interview with representative
Clinical trials Additional details on evaluation methods are available in the published paper: Efficacy of a Low-Cost Bubble CPAP System in Treatment of Respiratory Distress in a Neonatal Ward in Malawi PLoS ONE 9(1): e86327. (2014) doi:10.1371/journal.pone.0086327
For further product and information visit pumani.com or email HHD at firstname.lastname@example.org
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