Avoid equipment graveyards: rigorous process to improve identification and procurement of effective, affordable, and usable newborn devices in low-resource hospital settings
Authors: 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 ,   Technical Collaborative Authorship Group, 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 
Published: November 2023

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.