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Background: Failure mode, effects, and criticality analysis (FMECA) is a systematic and proactive risk analysis method to determine major failures in complex processes.

Objective: To identify all articles involving the use of failure mode and effects analysis (FMEA), FMECA, or FMECA in health care within the medication use system.

Data Sources Study Selection And Data Extraction: The MEDLINE database was searched, for the period January 1990 to January 2017. The search included studies using the FMECA method, in part or in full, and dealing with one or several components of the medication use system. The reference lists of articles identified in the initial search were checked manually for additional pertinent references.

Data Synthesis: The researchers identified 171 articles, and retained 39 for analysis: 32 describing use of the FMEA or FMECA approach and 7 describing use of the FMECA in health care approach. They identified between 4 to 378 failure modes, according to the published studies. Among the 39 articles, 10 reported a pre- and post-implementation analysis of corrective measures. In 4 of those 10 articles, the analysis was conducted on a theoretical basis, that is, before the corrective measures were actually implemented. Using the articles retained for analysis, a summary table was developed with the following elements: publication year, main author, country, primary objective, secondary objectives, descriptions of both method and results, and comments. The summary table gave the opportunity to comment on the use of the FMECA-type analysis within the medication use system.

Conclusions: This literature review included 39 published articles using an FMEA, FMECA, or FMECA in health care approach within the medication use system. Most studies used either the FMEA or the FMECA approach, whereas the FMECA in health care approach was used only rarely. Only a minority of studies assessed the effects of corrective measures that were implemented. This overall approach allows for mapping of a care process, determination of failure modes, and prioritization of corrective measures. Its use for the assessment of the medication use system should be promoted.