To explore the effectiveness of healthcare failure mode and effect analysis (HFMEA) in the safety management of clinical trial drug infusion.

Under the guidance of HFMEA theory, a risk assessment was conducted on the clinical trial drug infusion management process. Potential failure modes were analyzed, and the causes and effects of failure were explored. Based on risk factors, improvement measures were developed and implemented, and then the improvement effectiveness was evaluated, including the risk priority number (RPN), standardization rates of drug infusion, infusion bottle stickers, medical consumables, data collection and document recording, and satisfaction of nurses and doctors.

Through decision tree analysis, 28 potential failure causes were identified as key improvement targets. After implementing the HFMEA model, the total RPN score decreased from 247 to 93, with a decrease of 62.3%. Meanwhile, there were no adverse nursing events related to clinical trials. The standardization rates of drug infusion [95.0% (95 / 100) vs. 86.0% (86 / 100), χ² = 4.711, P = 0.030], infusion bottle stickers [100.0% (100 / 100) vs. 75.0% (75 / 100), χ² = 28.571, P < 0.001], medical consumables [96.0% (288 / 300) vs. 77.7% (233 / 300), χ² = 44.097, P < 0.001], data collection [93.0% (93 / 100) vs. 82.0% (82 / 100), χ² = 5.531, P = 0.019], and document recording [90.0% (90 / 100) vs. 76.0% (76 / 100), χ² = 6.945, P = 0.008] after implementation all significantly improved compared with those before implementation. Besides, the satisfaction scores of nurses and doctors increased from (4.2 ± 2.0) and (6.5 ± 2.4) before implementation to (8.2 ± 1.5) and (8.9 ± 1.2) after implementation respectively (t = 4.309, P = 0.040; t = 55.910, P < 0.001).

The prospective application of HFMEA can effectively improve the safety management level of clinical trial drug infusion by shifting passive post treatment to proactive prevention.