Who Left the Defibrillator On?

Abstract

Background

Two related scenarios involving defibrillator devices reveal how inadvertent hazardous design can go unnoticed until engineers or patient safety personnel use human factors engineering (HFE) analysis. The first adverse event, in which the device was inadvertently turned off while being used to externally pace the patient’s heart, resulted in an increased length of stay. The second scenario describes a similar close call and the useless acts of sanctioning the nurse and firing the engineer technician.

Comments and Recommendations

Feedback to the end user about a device’s status is an important design issue. It does not take much expertise to detect when there are problems with “dialogue” from the device to the person (that is, feedback). Many HFE issues have been cited in emergency care areas, and many medical devices—not just defibrillators—do not have readable and understandable feedback to the end user or the kind of automation that would make the wrong action harder to accomplish. All the interactions of multifunction devices with end users in a hectic, noisy, and dynamic environment need to be usability tested and validated. Nurses and engineering personnel can be trained to more easily see HFE design issues—and not dismiss them as individual failings or “someone else’s job.” Medical device companies are starting to follow the guidelines and regulations that should help prevent adverse events.

Conclusion

The defibrillator’s design problems had successfully masqueraded as “expected” glitches with hospital electrical utilities, personnel shortcomings, and personality problems. Adverse events related to seemingly simple devices can be prevented with HFE analysis.