Ventilator-Related Adverse Events: A Taxonomy and Findings From 3 Incident Reporting Systems

Area of Science:

• Medical Safety
• Health Informatics
• Public Health

Background:

• Established in 2009, the Promotion of Patient Safety (P5S) initiative aimed to foster public-private collaboration for advancing patient safety.
• Key partners included Johns Hopkins University, the FDA, and the University HealthSystem Consortium (UHC).

Purpose of the Study:

• To test the P5S model for understanding ventilator-related safety issues.
• To develop a standardized classification system for mechanical ventilator adverse events.
• To compare adverse event reporting across multiple systems.

Main Methods:

• A cross-sectional analysis of ventilator adverse events reported in 2012 was conducted.
• Data were sourced from the Pennsylvania Patient Safety Authority, UHC's Safety Intelligence database, and the FDA's MAUDE database.
• Narrative descriptions of events were reviewed and classified using a common taxonomy.

Main Results:

• Searches yielded 252 (Pennsylvania), 274 (FDA), and 700 (UHC) relevant reports.
• Commonly reported events across UHC and Pennsylvania systems included airway/breathing circuit issues, human factors, and ventilator malfunctions.
• The FDA primarily reported ventilator malfunctions, power source issues, and alarm failures.

Conclusions:

• A common taxonomy enables the evaluation of adverse events from diverse reporting systems.
• Reported event types varied significantly based on database purpose and data source.
• The P5S model proved feasible for public-private collaboration in investigating ventilator safety.