On the need for revising healthcare failure mode and effect analysis for assessing potential for patient harm in healthcare processes

•This article discusses the appropriateness of using HFMEA in healthcare processes.•We conclude that HFMEA has an important role to play in such contexts.•We argue for two adjustments in the traditional HFMEA.•One is regarding the way risk is evaluated.•The other is to adopt a broader evaluation of barrier performance.

Healthcare Failure Mode and Effect Analysis is a proactive, systematic method adapted from safety-critical industries increasingly used to assess the potential for patient harm in high-risk healthcare processes. In this paper we review and discuss this method. We point to some weaknesses and finally argue for two adjustments. One adjustment is regarding the way in which risk is evaluated, and the other is to adopt a broader evaluation of barrier performance. Examples are given from prehospital critical care and from the operating room environment within hospitals to illustrate these ideas.