Failure mode effect analysis applied to the use of infusion pumps.

Failure Mode Effect Analysis (FMEA) offers a prospective approach to reducing the risk associated with health care delivery. Beginning in February, 2002, an interdisciplinary team of fifteen individuals, including end-users, conducted an FMEA for the use of infusion pumps at UCSF Medical Center. The use of infusion pumps was identified as the area of highest risk, based on incident report data. The team identified sixteen potential failure modes, including their potential effects and causes, and assigned a risk priority number to each based on the potential severity, probability, and detectability of the failure. Notable failure modes included: incorrect programming; improper or inconsistent labeling of solution, tubing, and pump; potential use of malfunctioning or damaged pumps; and incorrect programming by nurses related to device design. The team then broke into smaller work groups and invited more end-users to perform root cause analyses and suggest recommended actions/outcome measures for each failure mode with a risk priority number of 32 or higher (on our scale of 1 to 64). Finally, the FMEA team assembled all of the data, prepared a final report, and assigned responsibility for key recommended actions.