The application of failure mode and effect analysis in the retrospective management of high-value consumables in implant operation

Abstract

Objective The failure mode and effect analysis (FMEA) were used to monitor the managerial process of high-value consumables in the implantation surgery, and establish the traceable management process for high-value consumables of the implantation surgery. Methods FMEA was used to carry out risk assessment process, formulate specific measures for improvement. The risk priority number (RPN), the qualified rate of the management index of implant surgical consumables, the patients satisfaction, and the number of adverse events reported were compared before and after the implementation of this process management. Results After FMEA was used to conduct management over implant surgery consumables, the RPN value decreased dramatically due to difficulty of traceability, information recording, and imperfect management system, thereby showing that the difference was statistically significant (t=16.655, 10.664, 9.321, P<0.01). Quality management measures: the access to consumables meets the requirements, complete information record, quality of stock consumables, paste bar code standard, charge accurate, return visits and records on time, consumables traceability, patient satisfaction rate were 99.2% (373/376), 96.7% (363/376), 99.5% (374/376), 95.6% (361/376), 98.6% (371/376), 95.7% (360/376), 100.0% (376/376), 97.1% (365/376), respectively after the implementation of this process management, which were higher than 90.9% (355/390), 81.8% (319/390), 94.2% (367/390), 91.3% (356/390), 84.7% (330/390), 87.3% (341/390), 87.5% (342/390), 91.8% (358/390) before the implementation of this process management, thereby showing that the difference was statistically significant (χ2=7.149-49.371, P < 0.01). The number of adverse consumables event reports increased from 0 up to 5. Conclusions It was feasible and effective to improve the level of hospital management and ensure the safety of patients by using the FMEA model in the implantation surgical high-value consumables. Key words: Failure mode and effect analysis; Surgical consumables; Operating room