Applying High-reliability Principles to Infusion Pump Safety: A Case Study at a Multisite Health System

Area of Science:

• Healthcare safety engineering
• Medical device risk management
• Patient safety systems

Background:

• Infusion pumps are critical medical devices with potential safety concerns like over/underinfusions and occlusion alarms.
• A large, multisite healthcare system faced significant challenges with infusion pump malfunctions, including a 29% failure rate for upstream occlusion alarms.

Purpose of the Study:

• To identify, investigate, and mitigate infusion pump safety concerns using a high-reliability principles framework.
• To develop a systematic approach to address infusion pump challenges and enhance patient safety.

Main Methods:

• Applied five high-reliability principles: preoccupation with failure, deference to expertise, sensitivity to operations, reluctance to simplify, and practice of resilience.
• Established a multidisciplinary team, conducted human factors assessments, analyzed medication-specific factors, and evaluated tubing characteristics.

Main Results:

• A national recall of malfunctioning pumps was initiated, and system-wide training and mitigation protocols were developed.
• Internal patient safety systems and processes were optimized, successfully preventing serious patient harm despite ongoing pump challenges.

Conclusions:

• Continuous vigilance, interdisciplinary collaboration, and embracing complexity are crucial for enhancing patient safety in large healthcare organizations.
• Integrating high-reliability principles across healthcare delivery is essential for ongoing improvements in safety and quality outcomes.