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Risks in the implementation and use of smart pumps in a pediatric intensive care unit: application of the failure

Silvia Manrique-Rodríguez1, Amelia C Sánchez-Galindo2, Jesús López-Herce2

  • 1Pharmacy Service,Gregorio Marañón University Hospital.

International Journal of Technology Assessment in Health Care
|April 30, 2014
PubMed

Insights

Failure Modes and Effects Analysis (FMEA) identified smart infusion pump implementation risks. Improvement measures, including training and monitoring, reduced risk likelihood and improved alarm management in the pediatric intensive care unit.

Area of Science:

  • Medical device safety
  • Health informatics
  • Pediatric intensive care

Background:

  • Smart infusion pumps are critical for medication safety in pediatric intensive care units (PICUs).
  • Implementation of new technology like smart pumps requires careful risk assessment to ensure optimal use and patient safety.

Purpose of the Study:

  • To identify potential risk points during the implementation of smart infusion pumps.
  • To prioritize and implement improvement measures for smart pump technology.

Main Methods:

  • Failure Modes and Effects Analysis (FMEA) was conducted in a PICU before and 18 months after smart pump implementation.
  • A multidisciplinary team assessed risks during drug library creation, clinical use, and data analysis stages.
  • Guardrails® CQI v4.1 Event Reporter software was used for data analysis.

Main Results:

  • Improvement actions included regular drug library reviews, support document creation, and enhanced alarm distinction.
  • These measures reduced the likelihood of risk occurrence and increased detection rates.
  • Eighteen months post-implementation, significant risk reduction was observed.

Conclusions:

  • FMEA effectively identified and addressed risks associated with smart pump use in the PICU.
  • User training, support tools, and continuous monitoring enhanced drug library utility and compliance.
  • The study led to improved drug library usefulness, increased user compliance, and a decrease in unnecessary alarms.
Abstract

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