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Background Door-to-balloon (D2B) time is an important factor in the outcome of ST segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention. We aimed to use failure mode and effect analysis to reduce the D2B time for patients with STEMI and to improve clinical outcomes. Methods There were three stages in this study. In Stage 0, data collected from 2005-2006 was used to identify failures in the process, and during Stage 2 (2007) and Stage 3 (2008) the efficacy of intrahospital and interhospital strategies to reduce the D2B time were evaluated. This study enrolled 385 patients; 86 from 2005-2006; 80 in 2007; and 219 in 2008. Results By making improvements in these steps, the median D2B time was reduced from 146 min to 32 min for all patients. The proportion of patients with a D2B time of <90 min significantly increased from Stage 0 to Stage 1 and from Stage 1 to Stage 2, for all patients as well as for the non-transferred and transferred subgroups of patients (all p values <0.0001). For non-transferred patients, only reinfarction-free survival showed significant difference among the three stages (p=0.0225), and for transferred patients, only overall survival showed significant difference among the three stages (p=0.0322). Cox's proportional hazards regression analysis showed Stage 2 was associated with a lower risk of reinfarction and mortality compared with Stage 0. Conclusions This study found that failure mode and effect analysis is a powerful method for identifying weaknesses in D2B processes and evaluating strategies to reduce the D2B time. [ABSTRACT FROM AUTHOR]