MAUDE-Dash: An Open-Source, Interactive Dashboard for Real-Time Post-Market Surveillance of Medical Devices
Discuss this preprint
Start a discussion What are Sciety discussions?Listed in
This article is not in any list yet, why not save it to one of your lists.Abstract
Introduction Manufacturer and User Facility Device Experience (MAUDE) database is a cornerstone of post-market medical device surveillance in the United States, yet its large size, heterogeneous formats, and complex relational structure make it difficult for clinicians and researchers without advanced programming skills to use. This study describes the design and implementation of MAUDE-Dash, an open-source, interactive dashboard that streamlines the ingestion, management, and analysis of MAUDE data. Methods MAUDE-Dash utilizes a two-layer Python-based architecture. A dedicated ingestion pipeline normalizes and loads the public MAUDE text files into a single, efficient analytical database built on DuckDB. A Streamlit web application provides accessible modules for filtering reports, computing key performance indicators, visualizing temporal trends, characterizing patient demographics, interpreting device and patient problem codes, and performing narrative text analysis. Results In a demonstration use case involving pedicle screw systems, MAUDE-Dash rapidly identified thousands of relevant reports from 2018–2023. The dashboard enabled interactive exploration of yearly report volumes, distributions of event types, predominant manufacturers, common problem codes, and recurrent narrative terms (e.g., screw fracture, loosening). The complete analytic workflow—from query definition to denormalized dataset export—was achieved within minutes, significantly reducing technical barriers and analytic time compared to traditional methods. Conclusions MAUDE-Dash operationalizes an efficient, reproducible framework for post-market surveillance. By integrating an optimized local database with an accessible, modular interface, it democratizes large-scale signal exploration and hypothesis generation, providing an extensible platform for advanced safety analyses.