Defining hazards of supplemental oxygen therapy in neonatology using the FMEA tool

MCN Am J Matern Child Nurs. 2013 Jul-Aug;38(4):221-8. doi: 10.1097/NMC.0b013e31828da238.


Purpose: To prospectively evaluate hazards in the process of supplemental oxygen therapy in very preterm infants hospitalized in a Dutch NICU.

Methods: A Failure Mode and Effects Analysis (FMEA) was conducted by a multidisciplinary team. This team identified, evaluated, and prioritized hazards of supplemental oxygen therapy in preterm infants. After accrediting "hazard scores" for each step in this process, recommendations were formulated for the main hazards.

Results: Performing the FMEA took seven meetings of 2 hours. The top 10 hazards could all be categorized into three main topics: incorrect adjustment of the fraction of inspired oxygen (FiO2), incorrect alarm limits for SpO2, and incorrect pulse-oximetry alarm limits on patient monitors for temporary use. The FMEA culminated in recommendations in both educational and technical directions. These included suggestions for (changes in) protocols on alarm limits and manual FiO2 adjustments, education of NICU staff on hazards of supplemental oxygen, and technical improvements in respiratory devices and patient monitors.

Conclusions: The FMEA prioritized flaws in the process of supplemental oxygen therapy in very preterm infants. Thanks to the structured approach of the analysis by a multidisciplinary team, several recommendations were made. These recommendations are currently implemented in the study's center.

Publication types

  • Evaluation Study

MeSH terms

  • Checklist
  • Continuous Positive Airway Pressure / adverse effects*
  • Continuous Positive Airway Pressure / methods
  • Continuous Positive Airway Pressure / nursing
  • Female
  • Humans
  • Hyperoxia / etiology
  • Hyperoxia / prevention & control*
  • Infant, Extremely Premature / physiology*
  • Infant, Newborn
  • Male
  • Monitoring, Physiologic / methods
  • Neonatal Nursing / methods*
  • Netherlands
  • Outcome and Process Assessment, Health Care
  • Oxygen / administration & dosage
  • Oxygen / adverse effects*
  • Prospective Studies
  • Risk Assessment / methods
  • Risk Management / methods


  • Oxygen