Objective To screen out high-risk events of healthcare-associated infection(HAI)and catheter-related infection in intensive care unit (ICU) by failure mode and effect analysis (FMEA), and provide basis for the formulation of prevention and control measures of HAI in ICU. Methods Twenty risk factors were determined by risk identification, FMEA risk assessment was used to screen out high and medium-high risk factors, corresponding infection prevention and control measures were formulated and supervised, ventilator-associated pneumonia (VAP), central line-associated bloodstream infection (CLABSI) and catheter-associated urinary tract infection (CAUTI) before and after the implementation of intervention measures were compared. Results Four high-risk factors were screened out, including patients infected with multidrug-resistant organisms didn't follow effective isolation mea-sures, high-dose use of antimicrobial agents, unqualified cleaning and disinfection of bed units, and cross use of diagnosis and treatment articles; four medium-high risk factors were screened out, which were neglect of secretion clearance on the airbag before extubation or air bag deflation, poor hand hygiene compliance, excessive non-staff of department, as well as poor implementation of accompanying and visiting system. In view of the high and medium-high risk factors, corresponding prevention and control measures were implemented, incidences of VAP, CLABSI and CAUTI per 1 000 catheter day decreased from 7.62 ‰, 2.99 ‰ and 1.90 ‰ in 2018 to 3.93 ‰, 1.01 ‰ and 0.62 ‰ in 2019 respectively; incidences and case incidences of HAI decreased from 4.98% and 6.89% to 2.37% and 3.14% respectively. Conclusion The risk assessment based on FMEA method can find out the weak links in the prevention and control of HAI in ICU, provide scientific and powerful evidence for the prevention and control of HAI in ICU.