Research: User Interface Software Errors in Medical Devices: Study of U.S. Recall Data

Area of Science:

• Medical Device Safety
• Software Engineering
• Human-Computer Interaction

Background:

• Medical device recalls pose significant risks to patient safety and healthcare operations.
• Software errors are a growing concern in the functionality and reliability of medical devices.
• User interface (UI) software is critical for safe and effective medical device operation.

Purpose of the Study:

• To assess the frequency and nature of user interface (UI) software errors in U.S. medical device recalls from 2012-2015.
• To develop a comprehensive classification system for UI software errors in medical devices.
• To inform stakeholders about UI software error types and their impact to improve device quality.

Main Methods:

• Analysis of U.S. Food and Drug Administration (FDA) recall databases (public and internal) from 2012-2015.
• Identification and quantification of medical device recalls attributed to UI software errors.
• Development of a 20-category classification system for identified UI software errors.

Main Results:

• 423 medical device recalls (approximately 140 per year) were linked to UI software errors between 2012-2015.
• UI software errors constituted nearly 50% of all software-related medical device recalls during the study period.
• A total of 499 distinct UI software errors were identified as root causes, categorized into 20 types.

Conclusions:

• UI software errors represent a substantial portion of medical device recalls, highlighting a critical area for improvement.
• The established error classification provides a standardized framework for understanding and addressing UI software issues.
• This classification can guide device manufacturers, healthcare providers, and regulatory bodies in enhancing medical device UI software quality and safety.