Effects of FMEA-based bleeding risk-stratified nursing on recovery process and safety after coronary angiography.

Background: Access-site bleeding and postprocedural pain after coronary angiography are linked by a "bleeding-inflammation-pain" positive feedback coupling mechanism. Traditional event-driven nursing models lack prospective risk stratification and preemptive control, making it difficult to break this vicious cycle at its source. Purpose: To systematically evaluate the effects of a Failure Mode and Effects Analysis (FMEA)-based bleeding risk-stratified nursing intervention on recovery process and safety outcomes in patients after coronary angiography. Methods: A prospective randomized controlled study was conducted in a tertiary teaching hospital from January 2023 to December 2024. A total of 240 patients scheduled for elective coronary angiography or angiography with interventional therapy were enrolled and allocated to a control group or an FMEA group. In the FMEA group, failure modes in the nursing workflow were systematically identified, the Risk Priority Number (RPN) was calculated, and patients were stratified into low-, moderate-, and high-risk tiers, with correspondingly differentiated nursing protocols, low-risk patients received routine monitoring and standard haemostasis; moderate-risk patients received intensified monitoring, prolonged compression, and structured activity guidance; and high-risk patients received continuous monitoring, individualised analgesic titration, and nurse-led progressive ambulation training. Primary outcomes included postoperative pain intensity, access-site bleeding volume, and hemoglobin decline; secondary outcomes were time to first ambulation and functional independence score at discharge; system-level indicators included unplanned nursing interventions, nursing documentation time, and safety incident reporting rate. Results: Compared with the control group, the FMEA group showed significantly lower NRS pain scores at 24 h postoperatively and a 23.4% reduction in cumulative opioid consumption at 72 h. The incidence of clinically significant access-site bleeding decreased from 17.5 to 8.3%, estimated 48-h bleeding volume was reduced by 22.9%, and postoperative hemoglobin decline was significantly less in the FMEA group. First ambulation time was advanced by approximately 8.2 h, functional independence score at discharge improved by 11.2%, and length of hospital stay was shortened by about 1.8 days, with no significant difference in 30-day readmission rates between groups. At the system level, the FMEA group had significantly fewer unplanned nursing interventions, shorter documentation time, and a lower safety incident reporting rate. Conclusion: This single-centre prospective controlled study suggests that FMEA-based bleeding risk-stratified nursing was associated with improvements in short-term bleeding-related, pain-related, mobility-related, and selected workflow outcomes. These findings support the potential of the FMEA framework to facilitate the transition from an event-driven, reactive nursing model to a risk-driven, preemptive approach. However, given the exploratory nature of this study, the results should be interpreted as preliminary and require further validation.