Exploring Health Information Technology Events from FDA MAUDE Database

Area of Science:

• Medical device safety
• Health Information Technology (HIT)
• Regulatory science

Background:

• The Federal Drug Administration (FDA) Manufacturer and User Device Experience (MAUDE) database is a key resource for medical device safety information.
• Current search strategies for Health Information Technology (HIT) devices in MAUDE primarily rely on keyword searches in fields like Generic Name, Brand Name, and Manufacturer.
• The structured field 'Classification Product Code' is underutilized in MAUDE data retrieval for HIT devices.

Purpose of the Study:

• To improve the retrieval and analysis of Health Information Technology (HIT) device events within the FDA MAUDE database.
• To explore the utility of the 'Classification Product Code' field in enhancing search strategies for HIT-related adverse events.
• To provide a novel perspective for understanding HIT events and improving patient safety through optimized MAUDE database utilization.

Main Methods:

• Extracted Health Information Technology (HIT) reports from a nine-year MAUDE dataset.
• Employed a combined approach of keyword filtering and expert review for data extraction.
• Analyzed and visualized the distributions and relationships between Classification Product Codes and keywords (Generic Name/Manufacturer) within the extracted HIT reports.

Main Results:

• Demonstrated the potential of Classification Product Codes to refine search strategies for HIT device events.
• Visualized the landscape of Product Codes and their association with device names and manufacturers in HIT reports.
• Identified patterns and relationships previously overlooked by traditional keyword-based searches.

Conclusions:

• The Classification Product Code field offers a valuable, underutilized resource for improving HIT event retrieval in the MAUDE database.
• Integrating Classification Product Codes into search strategies can lead to a more comprehensive understanding of HIT-related patient safety events.
• This enhanced approach facilitates better identification and analysis of medical device issues, ultimately contributing to improved patient safety.