An Integrated FMEA-RCA Risk-Management Approach for Deep Vein Thrombosis Prevention in Patients Undergoing Total Knee Arthroplasty.

BACKGROUND: To explore the effectiveness of Failure Mode and Effects Analysis (FMEA) combined with Root Cause Analysis (RCA) in deep vein thrombosis (DVT) risk management for patients undergoing total knee arthroplasty (TKA). METHODS: In this prospective, non-randomized, quasi-experimental before-after design study, consecutive patients undergoing primary unilateral TKA were allocated according to admission period to receive either routine DVT risk management or an integrated FMEA-RCA program. Sample size calculation indicated that at least 64 patients per group were required, and 68 were enrolled in each group. Outcomes included RPN values, DVT incidence, length of stay, and HSS knee scores assessed preoperatively and at 6 weeks postoperatively. RESULTS: The RPN values for all eight high-risk failure modes in the DVT prevention process were lower in the intervention group than in the control group (all Bonferroni-adjusted P values < 0.00625). The incidence of DVT was significantly lower in the intervention group than in the control group (5.88% vs 23.53%; χ2 = 8.442, P = 0.004), and this association remained significant after adjustment for age, BMI, and baseline Caprini score (aOR = 0.24, 95% CI: 0.08-0.72; P = 0.011). The length of stay was shorter in the intervention group than in the control group (7.99 ± 2.06 vs 11.20 ± 4.21 days; mean difference = -3.21 days, 95% CI: -4.33 to -2.09; t = 5.647, P < 0.001). At 6 weeks postoperatively, HSS knee scores were higher in the intervention group than in the control group (82.30 ± 5.60 vs 76.80 ± 6.90; t = 4.327, P < 0.001). CONCLUSION: Combining FMEA with RCA could help identify key nursing control points in DVT prevention for patients undergoing TKA.