Objective To systematically evaluate the effectiveness of failure mode and effect analysis (FMEA) in the prevention of intensive care unit (ICU)-acquired infection. Methods Two researchers independently searched relevant literatures from foreign and Chinese databases, with a search deadline of July 15, 2022. Independent screening of literatures, extraction of data and evaluation on overall quality were performed according to inclusion and exclusion criteria. RevMan 5.4 software was used to conduct Meta-analysis on the preventive effect of the included literatures. Results A total of 19 literatures were included in analysis. Meta-analysis results showed that application of FMEA method reduced the incidences of ventilator-associated pneumonia (OR=0.40, 95%CI [0.31-0.51], P < 0.01), catheter-associated urinary tract infection (OR=0.29, 95%CI [0.17-0.51], P < 0.01), central line-associated bloodstream infection (OR=0.28, 95%CI [0.18-0.46], P < 0.01), and multidrug-resistant organism infection (OR=0.46, 95%CI [0.37-0.58], P < 0.01) in ICU patients, as well as incidence of healthcare-associated infection(HAI) in ICU (OR=0.46, 95%CI [0.37-0.59], P < 0.01), and significantly improved the satisfaction of ICU patients and their families (OR=2.34, 95%CI [1.72-3.17], P < 0.01). Conclusion FMEA can effectively prevent ICU-acquired infection and improve the quality of HAI management.