Development and usability evaluation of a software prototype for quality management in Human Milk Banks: a methodological study

Abstract

Human Milk Banks (HMB) are specialized services that promote, protect, and support breastfeeding, as well as process, control, and distribute donated human milk, especially for premature or hospitalized infants. Brazil has the largest and most consolidated HMB network worldwide, structured under standardized protocols and regulations to ensure human milk quality and safety. Despite this framework, systematic management of quality and safety remains challenging. This study aimed to develop and evaluate the usability and appearance of SisBLH, a prototype software designed to support the quality management in Brazilian HMB. A methodological study focused on technological development was conducted between 2022 and 2024 at the Ana Abrão Breastfeeding Center and HMB, in São Paulo, Brazil. The prototype software was developed in five stages: communication, planning, modeling, construction, and implementation, based on Pressman’s software development model and grounded in Donabedian’s quality and Brazilian Health Regulatory Agency (Resolution 918). Thirty evaluators participated in the study: 11 human milk donors, 11 health professionals, and eight information and communication technology (ICT) specialists. Usability was evaluated by donors using an instrument based on International Organization for Standardization standards, by professionals using the System Usability Scale, and by ICT specialists using Nielsen’s Heuristics. Visual appearance was assessed by professionals using the Instrument for Validation of Educational Health Technology Appearance. Data were analyzed using the Content Validity Index and the modified Kappa coefficient. The SisBLH prototype was developed in web and mobile versions, including modules for donor registration and monitoring of quality indicators. Usability scores indicated high adequacy, with a score 79.8% among donors and 77.5 points among health professionals. ICT specialists classified usability as good to excellent for most items analysed (Kappa ≥080). The evaluation identified opportunities for improvement in system response time, technical support needs, navigation, and error prevention. Visual appearance showed agreement level ranging from 0.90 to 1.00, indicating adequacy of the interface. The SisBLH demonstrated high usability and satisfactory visual appearance, with strong agreement among evaluators. These findings suggest that SisBLH may support safer management practices in human milk banks and inform the development of similar digital solutions in other contexts.